IPN 2022 November

MORE PATIENTS CAN DO IT WITH THEIR PHONES1

Digital health tools that work together for seamless diabetes management

Healthcare providers have secure, online access to glucose insights2

Caregivers can remotely monitor their loved ones4 People with diabetes can conveniently check their glucose using their phone1,3

For more information visit www.FreeStyleDiabetes.ie Images are for illustrative purposes only. Not actual patient or data.

1. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink requires registration with LibreView. 2. The LibreView website is only compatible with certain operating systems and browsers. Please check www.LibreView.com for additional information. 3. The FreeStyle LibreLink app and the FreeStyle Libre reader have similar but not identical features. Finger pricks are required if readings do not match symptoms or expectations. The FreeStyle Libre sensor communicates with the FreeStyle Libre reader that started it or the FreeStyle LibreLink app that started it. A sensor started by the FreeStyle Libre reader will also communicate with the FreeStyle LibreLink app. 4. The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of LibreLinkUp and FreeStyle LibreLink requires registration with LibreView. The LibreLinkUp mobile app is not intended to be a primary glucose monitor: home users must consult their primary device(s) and consult a healthcare professional before making any medical interpretation and therapy adjustments from the information provided by the app. © 2021 Abbott. FreeStyle, Libre, and related brand marks are marks of Abbott. ADC-37632 v1.0 04/21.

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Contents

Foreword

Page 4: New Pharmacy opens in Glenageary

Community pharmacy has voiced disappointment at the Budget 2023, Whilst the Irish Pharmacy Union (IPU), which represents Ireland’s 1,900 community pharmacies, has welcomed patient friendly measures announced in Budget 2023, it says with the extension of free GP care to over 400,000 children it is more important than ever to properly resource and utilise the pharmacy sector.

Page 6: Budget 2023 falls short for Medicines Page 8: Research highlights potential of community pharmacy

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Page 10: Irish Pharmacist shines light on Respiratory Health

Turn to page 5 to read more about this.

Page 12: Key Trends in the Pharmacy Market Page 20: The People’s Pharmacist 2022: Meet the Finalists

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Page 56: Treatmentresistant Blood Pressure Page 58: National Trends in Cancer – New Report PUBLISHER: IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562

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MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

DESIGN DIRECTOR Ian Stoddart Design PHARMACYNEWSIRELAND.COM @Irish_PharmNews IrishPharmacyNews

Michael O’Connell, IPHA President says, “We recognise that the Government faced extraordinary pressures in framing Budget 2023, especially in dealing with a cost-of-living crisis and the consequences of the appalling invasion of Ukraine. But the ¤18 million allocation is about half of what will be needed next year to give patients access to the broadest range of treatment options.”

In other news, we detail how researchers at Trinity, along with colleagues in RCSI University of Medicine and Health Sciences and the Economic and Social Research Institute (ESRI) have found that patients with more than one chronic health condition are under a significantly higher financial burden with healthcare expenses than those without a chronic health condition. You can read more about this on page 72.

We had over 300 nominations, making the shortlisting process no easy feat. We have eight incredibly worthy Finalists this year, who all now go to a public vote. Make sure you catch the December issue of Irish Pharmacy News to read all about the winner.

ADVERTISING EXECUTIVE Amy Evans: amy@ipn.ie

CONTRIBUTORS Dr Claire McCarthy Diana Hogan-Murphy Dr Muireann de Paor Mary Felley Donna Cosgrove Dr Rosie Kelly Professor Eddie Moloney Audrey Purcell Caitriona Cunningham Dr Edward O’Sullivan

Meanwhile, on page 6 of this issue, the Irish Pharmaceutical Healthcare Association determines that the Government’s Budget allocation of ¤18 million for new medicines falls short of the amount needed to optimise patients’ access to new medicines next year and to help Ireland catch up with peer European countries.

This issue also carries the Finalists for the 2022 People’s Pharmacist Award. The offices at IPN were inundated with nominations and stories of extraordinary dedication and commitment to the profession and the communities they serve.

EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie

EDITORIAL/ EVENTS & MARKETING EXECUTIVE Aoife Jackson: aoife@ipn.ie

Speaking following the announcement of Budget 2023, IPU President, Dermot Twomey said, “We welcome the extension of the recently introduced free contraception scheme to include women of up to 30 years of age. However, cost is not the only barrier to contraception and there must be an equal focus on enhancing ease of access. Women should have the choice to access oral contraception (the pill) direct from their pharmacy without prescription.”

56 Irish Pharmacy IRISH News is PHARMACY circulated to all NEWS independent, multiple Pharmacists and academics in Ireland.

All rights reserved by Irish Pharmacy News. All material published in Irish Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written permission.

IPN Communications Ltd. has taken every care in compiling the magazine to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions or errors.

I hope you enjoy the issue.

Regulars FEATURE: DIABETES

P14

FEATURE: WINTER HEALTH

P30

CPD: MANAGING OVERACTIVE BLADDER

P41

FEATURE: PULMONARY HYPERTENSION IN COPD

P64

FEATURE: MEDICATION IN PREGNANCY

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CLINICAL PR:

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PHARMACYNEWSIRELAND.COM

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News

New Pharmacy for Glenageary The McGreals Group opened the doors of their new pharmacy in Glenageary shopping centre in County Dublin this week. The pharmacy was officially opened by Jennifer Carroll McNeill TD who cut the ribbon alongside McGreals Glenageary Pharmacy Supervising Pharmacist Ronan Ward and Managing Director of McGreals Group, Kilian McGreal.

Seapoint Club President Barry Chadwick, McGreals Managing Director Kilian McGreal and McGreals Supervising Pharmacist Ronan Ward

Pictured at the opening of McGreals Glenageary Pharmacy (left to right): McGreals Managing Director Kilian McGreal, Seapoint Club President Barry Chadwick, Jennifer Carroll McNeill TD, McGreals Supervising Pharmacist Ronan Ward, St Josephs AFC Greg Delaney, McGreals staff member Mary Thornton along with Senior players from St Josephs AFC

To mark the opening the pharmacy donated and installed a brandnew AED defibrillator outside the premises to support the local community and held a demonstration on how to use the device with a local first aid responder on the day. In addition the company has donated sports first aid bags to the value of ¤2,500 to two local sports clubs Seapoint and St Joesphs AFC. Managing Director of McGreals Group, Kilian McGreal said: “We are delighted to be opening our new look pharmacy in Glenageary and to be expanding our network of pharmacies to 10 across the Leinster region. Ronan has over 15 years of experience and he and the team in Glenageary play an integral role within the local community healthcare systems. They work

alongside GPs and other healthcare professionals to support and advance customers wellbeing and we look forward to working with him to support his clients in the months and years ahead.”

Ronan Ward, Supervising Pharmacist at McGreals Gleanageary Pharmacy said: “We are very much embedded in the community and strive to provide the best-in-class healthcare services. I’m really happy to be officially opened and to welcome new and familiar faces into our new pharmacy. It’s been a busy start already! and we are seeing a high demand for flu vaccines this week along with our other core services.”

McGreals Glenageary is based in Glenageary Shopping Centre and is open 9am to 6:30pm Monday to Friday and 9am to 6pm on Saturday. Services include blood pressure monitoring, flu and covid-19 vaccines, antibody-testing services as well as access to nutritionist consultations, audiologist, and optician appointments.

Visit www.mcgreals.ie for more information.

New Resources for Pharmacists Two new resources to help pharmacists provide services to people with chronic respiratory diseases (namely asthma and chronic obstructive pulmonary disorder) have been published by the International Pharmaceutical Federation (FIP).

These are: o “Chronic respiratory diseases — A handbook for pharmacists”; and o “Knowledge and skills reference guide for professional development in chronic respiratory diseases”.

The handbook, authored by an international group of experts brought together by

FIP (including representatives from the International Primary Care Respiratory Group and the European Society of Clinical Pharmacy), contains chapters on prevention and control of chronic respiratory diseases, screening, interprofessional working, nonpharmacological management, pharmacological management (including medicines optimisation) and palliative care.

PHARMACYNEWSIRELAND.COM

The new publication also presents metrics for services for chronic respiratory diseases and barriers to the implementation of these services, and explores ethical considerations and practicebased research related to this disease area. The reference guide accompanying the handbook and defines the knowledge and skills that pharmacists need to acquire to provide services for chronic respiratory diseases.

Pharmacy: Barriers Remain The announcement of a new service to provide free contraception for women aged 17-25 has been welcomed by the Irish Pharmacy Union (IPU).

This service will significantly reduce costs barriers which prevent people using contraception effectively.

However, the IPU has said that barriers to accessibility remain, and recommend that the service should be expanded to provide the option of accessing oral contraception, directly from their local pharmacy, through consultation with a pharmacist and be aligned to the model of care and access provided for in the emergency hormonal contraception service.

Community pharmacist and Chair of the IPU’s Pharmacy Contractors’ Committee, Kathy Maher said, “This is a very welcome and positive development for the healthcare of young women in Ireland. The ambition of this plan is to ensure that women can access the contraception they need, and it successfully removes cost as a barrier of doing so for younger women. We must now focus on ensuring that access is not a barrier either.

“This new service quite rightly gives women the choice over what form of contraception they wish to use. However, they are not being provided with a choice on where to access this contraception. Young women who wish to use oral contraception (the pill) should be able to access it directly from pharmacies without first having to get a prescription from a GP.” “The Pill is available prescription free in the UK, US, Canada and New Zealand. It is a safe and well-studied medicine and has been used by women for almost half a century. Where there is no clinical need for a patient to go to a GP to access the pill, they should not be made to do so.”

Kathy outlined that pharmacies already have experience providing women with contraception in Ireland.

News Medicine Shortages The Health Products Regulatory Authority has been notified of a shortage of the following products: • Actilyse 20mg Powder and Solvent for Solution for Injection and Infusion PA0775/011/002 • Clonazepam Rosemont 0.5mg/5ml Oral Solution PA23081/009/001 • Lustral 100mg Film Coated Tablets - PA23055/001/002 • Meropenem Aurobindo 1g Powder for Solution for Injection or Infusion PA1445/014/002 • Methylthioninium Chloride Proveblue 5mg/ml Solution for Injection - EU/1/11/682/001 • Minims Cyclopentolate Hydrochloride 1% w/v Eye Drops- PA23259/011/001 • Paracetamol 500mg Film Coated Tablets (100 pack) PA2315/065/003 • Tritace 10mg Tablets PA0540/084/008

Pharmacy ‘Disappointed’ at Budget 2023 The Irish Pharmacy Union (IPU), which represents Ireland’s 1,900 community pharmacies, has welcomed patient friendly measures announced in Budget 2023. However, the IPU has said with the extension of free GP care to over 400,000 children it is more important than ever to properly resource and utilise the pharmacy sector.

Speaking following the announcement of Budget 2023, IPU President, Dermot Twomey said, “We welcome the extension of the recently introduced free contraception scheme to include women of up to 30 years of age.

However, cost is not the only barrier to contraception and there must be an equal focus on enhancing ease of access. Women should have the choice to access oral contraception (the pill) direct from their pharmacy without prescription. This is safely practised in many other countries and failure to do so in Ireland makes it more difficult for women and creates needless work for GPs. “Today’s announcement that free GP care will be extended to all children under the age of eight will be welcome news for families.

However, this will only increase the demand on over-stretched GPs further and add to the long

waiting lists that are developing in many towns nationwide. The pharmacy sector should be better utilised to alleviate pressures on GPs. The IPU has consistently called for the introduction of a Minor Ailment Scheme which has proven to work extremely well in a number of other countries.

card patients. The sector urgently needs reform of the fees it receives and had been seeking a modest increase in the dispensing fee to ¤6.50 per item. Failure to adequately fund the sector will heap challenges upon many pharmacies which could result in closures or reduced hours.”

“The removal of VAT on products used in Nicotine Replacement Therapy (NRT) will help encourage more smokers to avail of help to quit. This could be further enhanced by allowing pharmacies to provide NRT to medical card patients without prior consultation with a GP.

Mr Twomey concluded by urging the government to engage with the pharmacy sector to maximise its potential: “The pharmacy sector is accessed more than any other part of Ireland’s healthcare system. It functions exceptionally well, and we are calling loudly for more responsibility so we can do more for patients. However, this will require commitment from government to the pharmacy sector and a willingness to address the growing underfunding which is greatly impacting the sector.”

“Pharmacists will, however, be extremely disappointed that the government continues to underfund pharmacists for the work and expertise involved in dispensing medication to medical

• Zithromax 250mg Capsules PA0822/191/001

Best Managed Pharmacies

• Zithromax 200mg/5ml Powder for Oral Suspension PA0822/191/002

Two Irish pharmacy groups were celebrating last month, after being recognised as a Deloitte Best Managed Company.

The following shortages have been resolved and supply has resumed to the Irish market:

McCabes Pharmacy Group and Meaghers Pharmacy Group were both awarded the accolade at the 14th annual awards programme.

• Abstral 300mcg Sublingual Tablets - PA2288/004/004 • Concerta XL 18mg Prolonged Release Tablets PA22612/002/001 • Distaclor LA 375 mg Prolonged Release Tablets PA1226/001/004 • Fucibet Lipid 20mg/g + 1mg/g Cream - PA0046/040/002 • Kentera Transdermal Patches EU/1/03/270/001-2 • Rapifen 500mcg/ml Solution for Injection or Infusion PA22583/001/001 • Tecentriq 1200mg Concentrate for Solution for Infusion EU/1/17/1220/001 • Trileptal 150mg Film Coated Tablets - PA0896/033/001 • Xarelto 1mg/ml Granules for Oral Suspension (100ml bottle) - EU/1/08/472/050

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“We are delighted to once again be recognised as a Deloitte Best Managed Company.

Feeling very proud of our leadership team Sharen McCabe Karen Doherty Lisa Byrne & Conor McDonald pictured at the 2022 Deloitte Best Managed Companies Awards,” said a McCabes Pharmacy spokesperson.

Meanwhile the team at Meaghers added, “We are thrilled to have been recognised as the Best Managed Company by Deloitte.

Not only are we delighted with our win, but we’ve also managed to achieve Platinum Status, the highest possible award level. This is the 8th time in a row we have won and is a testament to the incredible work of our team here at Meaghers.

“At Meaghers we aim to deliver the best service possible to our customers, whether they shop online or in any of our 9 stores

Sharen McCabe and team from McCabes Pharmacy Group

in Dublin. We have an extremely hard-working and educated team capable of keeping everything running smoothly and delivering the highest quality service and education to our customers.

Oonagh O’Hagan, MD, Meaghers Pharmacy and team “We couldn’t be more proud of our team and what we continue to achieve!”

PHARMACYNEWSIRELAND.COM

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News

Budget’s ¤18m for new Medicines falls Short The Government’s Budget allocation of €18 million for new medicines falls short of the amount needed to optimise patients’ access to new medicines next year and to help Ireland catch up with peer European countries.

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chemotherapy were How long after your ® your Pelgraz ? you told to take 24 hrs 48 hrs 72 hrs Other (hrs) fitter and faster reimbursement system. As we prepare to do that, we want to collaborate with health policymakers on solutions that work for everyone,” said Mr O’Connell.

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“Last December, we concluded a new medicines supply Agreement. That Agreement, allied with adequate and sustained funding, can improve Ireland’s capacity to deliver the latest treatments to patients. IPHA members have implemented a lot of price cuts and new rebates under the Agreement already this year.”

The industry acknowledged the extraordinary pressures faced by the Government when framing the Budget, especially in dealing with a cost-of-living crisis. It acknowledged, too, that though ¤18 million falls well short of the funding needed, it is still an investment in innovation, building on the ¤80 million allocated in the past two Budgets.

IPHA member companies expect to launch 30 new medicines next year, potentially treating more than 7,000 patients. These medicines are for a range of serious medical conditions, including ulcerative colitis, heart disease, lung disease and many forms of cancer. The industry has estimated the cost of these new medicines at ¤35 million – twice as much as what has been allocated by the Government in Budget 2023. IPHA members have implemented a range of price cuts and rebates this year under the new Framework Agreement for the Supply and Pricing of Medicines to contribute to creating headroom to fund new medicines.

The concern now is that the process for reimbursement of new medicines remains too slow because funding is inadequate.

The industry wants Ireland to be as fast as peer European countries in adopting new medicines in the health services.

Michael O’Connell, IPHA’s President, said the Budget allocation falls short of the amount needed to optimise patients’ access to new medicines.

“We recognise that the Government faced extraordinary pressures in framing Budget 2023, especially in dealing with a cost-ofliving crisis and the consequences of the appalling invasion of Ukraine. But the ¤18 million allocation is about half of what will be needed next year to give patients access to the broadest range of treatment options.

“Last December, we concluded a new medicines supply Agreement.

That Agreement, allied with adequate and sustained funding, can improve Ireland’s capacity to deliver the latest treatments to patients. IPHA members have implemented a lot of price cuts and new rebates under the Agreement already this year.

“In parallel, it is vital that the medicines reimbursement system be improved. It is not designed to bring innovation to patients as fast as possible. We must narrow the gap between the completion of health technology assessments and the availability of new medicines. As an industry, we are not bystanders in solving the problem. We have an obligation to bring forward proposals for a

PHARMACYNEWSIRELAND.COM

IPHA’s analysis shows that some medicines are still taking 650 days, on average, from authorisation by the European Medicines Agency to reimbursement for patients.

Medicines subject to a full health technology assessment – for example, cell and gene therapies – are taking 900 days.

That is much longer than in peer European countries.

Ireland is almost four months slower to reimburse and make new cancer medicines available to patients compared to the average across the European Union’s 27 members, according to the most recent EFPIA Patients WAIT Indicator Survey. The survey, which analysed data for the four years between 2017 and 2020 using centrally authorised medicines, found that, among western European countries, only Portugal was slower than Ireland to make new medicines available to patients. Denmark and Germany were three and four times faster, respectively, than Ireland to make new medicines available to patients.

Oliver O’Connor, IPHA’s CEO, said the latest Budget funding was still investment but the amount is not near enough.

“Ireland has a poor record on speed of access to new medicines. Adequate funding and reimbursement system reforms can improve the environment.

While we have been making progress on funding, today’s announcement falls well short of expectations. The new medicines supply Agreement was a step on the road to an access environment that can be competitive with peer countries in Europe.”

Record Funding for Mental Health Minister for Mental Health and Older People, Mary Butler, has announced another record year tropenia info with further increases inNeuthe Mental Health budget for 2023. ropenia a and febrile neut Minister Mary Butler commented, Neutropaeni “Reflecting the government’s e? r treatment involv What does cance strong commitment to Mental Health, Budget 2023 seesia?an What is neutropen additional ¤72.8 million of funding for Mental Health services into op in the ia devel Why does neutropen 2023. This brings our total apy? course of chemother investment for Mental Health to over ¤1.2 billion andIs neutr including us? openia always serio ¤14 million of new developments and ¤43.8 million forWhatexisting level tics of are the characteris ia? febrile neutropen of services.

“This historic funding will provide its and n of neutropaenia Preventio for continued Mental Health complications supports in both community gical any pharmacolo Are therea and acute settings, with continued focus on Clinical Programmes for eating disorders, early intervention in psychosis, Attention Deficit Hyperactivity Disorder (ADHD) and self-harm.”

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Minister Butler concluded, “Importantly, this funding will also ensure a dedicated approach to waiting lists, especially for Child and Adolescent Mental Health Services (CAMHS) and primary care psychology for young people.

“Funding will also be made available to community-based voluntary organisations that support health and social care, including Mental Health. This support is being made available in recognition of the challenges being faced by the sector in delivering and maintaining key health and social care services against a backdrop of increased inflationary pressures affecting energy, heating and related costs.”

Announced additional supports include: • ¤10 million in Mental Health Capital funding and ¤4 million for improving regulatory compliance in mental health in-patient services in alignment with Mental Health Commission regulations • ¤750,000 for Counselling and Psychology Training Places in a new HSE initiative • ¤9 million for New Mental Health Developments • ¤2 million has been provided for new accommodation, ¤5 million has been provided for emergency placements over 2023 by the HSE, and ¤3 million funding under New Development funding for emergency placement additional capacity.

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Pelgraz® PFI Patient Support App The Pelgraz® PFI App is designed to support patients self-administering Pelgraz® PFI at home How severe is your Wellness Close

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Pre-Filled Injector One Dose for ANC Recovery

Confidence, Convenience, Compliance ABBREVIATED PRESCRIBING INFORMATION Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pelgraz▼(pegfilgrastim) 6 mg solution for injection in pre-filled syringe or prefilled injector. Presentation: Each pre-filled syringe or pre-filled injector contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/mL if the PEG moiety is included. Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and Administration: Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.

Posology: One 6 mg dose (a single pre-filled syringe or pre-filled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Safety and efficacy of Pelgraz in children and adolescents has not yet been established and no recommendation on a posology can be made. No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. See SmPC for instructions on handling of the medicinal product before administration.

Contraindications: Hypersensitivity to pegfilgrastim or any of the excipients in Pelgraz.

Warnings and precautions: To improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded. The long-term effects of pegfilgrastim have not been established in acute myeloid leukaemia (AML); therefore, it should be used with caution in this patient population. Granulocytecolony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro. The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established. The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of adult respiratory distress syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given. Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, glomerulonephritis resolved after dose reduction

or withdrawal of filgrastim and pegfilgrastim. Urinalysis monitoring is recommended.

Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim. Spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia. Pegfilgrastim in conjunction with chemotherapy and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) in breast and lung cancer patients. Patients treated in these settings should be monitored for signs and symptoms of MDS/AML. Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or sickle cell disease. Therefore, use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vasoocclusive crisis. White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported.

Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product. Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity, including anaphylactic reactions, have been reported with pegfilgrastim. Permanently discontinue pegfilgrastim in patients with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment. If the patient has developed SJS with the use of pegfilgrastim, treatment must not be restarted at any time. As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against pegfilgrastim is generally low.

Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. Aortitis has been reported after filgrastim or pegfilgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was Associated member of:

Oncology & Haematology

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injection is due

diagnosed by CT scan and generally resolved after withdrawal of filgrastim or pegfilgrastim. The safety and efficacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings. This should be considered when interpreting bone-imaging results. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. Pelgraz contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’. The needle cover contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Pregnancy and Lactation: Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Adverse Events include: Adverse events which could be considered serious include: Common: Thrombocytopenia. Uncommon: Myelodysplastic syndrome, acute myeloid leukaemia, sickle cell anaemia with crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile neutrophilic dermatosis), pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema and pulmonary fibrosis have been reported.

Uncommonly cases have resulted in respiratory failure or ARDS which may be fatal. Rare: Aortitis, pulmonary haemorrhage, Stevens-Johnson syndrome. Other Very Common adverse events: Headache, nausea, bone pain. Other Common adverse events: Leukocytosis, musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, non-cardiac chest pain. See SmPC for details of other adverse events. Shelf Life: 3 years. Store in a refrigerator (2∞C – 8∞C).

Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Pelgraz. Keep the container in the outer carton in order to protect from light. Pack Size: One prefilled syringe or prefilled syringe injector with one alcohol swab, in a blistered packaging.

Marketing Authorisation Numbers: Pre-filled syringe: EU/1/18/1313/001, Prefilled injector: EU/1/18/1313/002. Marketing Authorisation Holder (MAH): Accord Healthcare S.L.U, World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6a planta, Barcelona, 08039 Spain. Legal Category: POM. Full prescribing information including the SmPC is available on request from Accord Healthcare Ireland Ltd, Euro House, Little Island, Co. Cork, Tel: 021-4619040 or www.accord-healthcare.ie/products. Adverse reactions can be reported to Medical Information at Accord Healthcare Ltd. via E-mail: medinfo@accord-healthcare.com or Tel: +44(0)1271385257.

Date of Generation of API: May 2021. IE-01426

Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie), or by e-mailing medsafety@hpra.ie. Adverse events should also be reported to Medical Information via email; medinfo@accord-healthcare.com or tel:0044 (0) 1271 385257

July 2021. IE-01663

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Research highlights potential of Pharmacy The School of Pharmacy and Biomolecular Sciences at RCSI University of Medicine and Health Sciences has launched a research project to enhance understanding of how some higher risk medicines are used in Ireland.

The CDRx project, led by Dr Frank Moriarty and funded by the Health Research Board, uses HSE data on medications prescribed to medical card patients (with identifying information removed) to understand how trends in medications like opioids have changed in recent years, how policies can affect prescribing, and how use of medications varies between prescribers and geographical areas.

The project aims to generate evidence on policies and practices to support optimal use of these medications and reduce medication harm. This is particularly relevant as the World Health Organisation have set ‘Medication Without Harm’ as their Third Global Patient Safety Challenge.

This research highlights the importance of the community pharmacist in supporting the safe and effective use of medicines.

There are almost 7,000 registered pharmacists in Ireland, nearly two thirds of whom work in community pharmacies. While pharmacists offer an increasing range of services, like vaccinations and emergency hormonal contraception, the safe supply of prescriptions, as well as advice and guidance, remain central to the role.

Pharmacists are responsible for clinically reviewing each prescription to ensure the medicines and doses are appropriate for the patient, locating and preparing the medicines, liaising with doctors as needed, and ensuring that the prescription

is dispensed accurately and safely.

This often comes with advice, providing information on what the medicines are for, how to take them and store them, what to watch out for, and how to avoid or manage side effects.

For community pharmacists, the goal is to ensure patients get as much benefit as possible from the prescribed medicine, and to reduce any risks. Pharmacists across all settings have this at the heart of their work, ranging from those providing clinical input in hospital on management of patients, to those working to discover and produce new medicines, or those working in research that focuses on developing new medicines or understanding how to use medicines more safely.

McCabes Partners with ALONE McCabes Pharmacy Group have announced their new charity partnership with ALONE.

This incredible organisation offers support to older people around the country, helping those who are lonely, isolated, frail, or living in poverty to live at home safely and securely.

Housing, medical assistance and mental wellbeing are just some of the practical supports they offer to vulnerable older people in our communities.

PHARMACYNEWSIRELAND.COM

Pictured Sean Moynihan, Sharen McCabe officially launching their charity partnership in McCabes Pharmacy Dundrum Town Centre

Early Intervention in Psychosis Minister for Mental Health and Older People, Mary Butler, T.D. has launched the HSE’s National Clinical Programme for Early Intervention in Psychosis Independent Evaluation Report.

Carried out by TCD, the independent evaluation report, titled ‘A Process Evaluation of the Implementation of a new model of care in three demonstration sites’, is the first of its kind in Irish Mental Health Services. It sought to establish the experience of service users, families and staff as these new evidence-based Early Intervention in Psychosis teams were implemented in Ireland.

Professor Catherine Darker, Associate Professor of Health Services Research, Discipline of Public Health and Primary Care, Trinity College Dublin said: “The speed in which a person can be identified as having their first episode of psychosis, be assessed and commenced in treatment matters. The three demonstration sites attempting to implement this new model of care for Early Intervention in Psychosis did very well overall.

They demonstrated that they could, in the majority of cases, see service users within three working days, standardise assessment practices, and treatment interventions for those presenting to the services.

“In the instances where demonstration teams were slow starting up and had to implement a waiting list for a period of time, our findings suggest this was due to challenges in drawing down budget allocations due to derogation of funds and securing backfill for posts, which subsequently had a knock on effect on the ability of Clinical Leads to identify skilled staff to develop the teams in line with the Model of Care. We have identified solution-focused ways for the HSE to remedy these problems, so as that these much needed services, can be rolled out nationally without some of the teething issues identified in this evaluation.”

YOUR PATIENTS AGED 50 YEARS OF AGE OR OLDER ARE AT INCREASED RISK OF DEVELOPING SHINGLES.1 YOU CAN PREVENT IT.2,3 SHINGRIX demonstrated >90% efficacy against shingles in all age groups aged 50 years of age or older, based on pooled data from two large, phase 3 randomised control trials.2,3

SHINGRIX IS NOW AVAILABLE For more information on SHINGRIX, please scan the QR code.

Shingrix powder and suspension for injection in vials (Please refer to SmPC before prescribing) Composition: After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus glycoprotein E antigen1,2 50 micrograms. (1 adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms, 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms, 2 glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology). Therapeutic indications: Prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older and in adults 18 years of age or older at increased risk of HZ. The use of this vaccine should be in accordance with official recommendations. Posology and method of administration: For intramuscular injection only, preferably in the deltoid muscle. Primary Vaccination: Initial dose of 0.5 ml followed by a second 0.5 ml dose 2 months later. For flexibility the 2nd dose can be administered between 2 and 6 months after the first dose. For subjects who are or might become immunodeficient or immunosuppressed and whom would benefit from a shorter vaccination schedule, the 2nd dose can be given 1 to 2 months after the initial dose. Booster doses: need not established. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions for use: The name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should be readily available in case of an anaphylactic event. Administration of Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in deferral. A protective immune response may not be elicited in all vaccinees. Never administer intravascularly or intradermally; subcutaneous administration not recommended as it may lead to an increase in transient local reactions. Caution in individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration. Syncope can occur following, or before any vaccination as a psychogenic response. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. There are no data to support replacing a dose of Shingrix with another HZ vaccine. There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities. The benefits and risks of HZ vaccination should be weighed on an individual basis. Interactions: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheriatetanusacellular pertussis vaccine (dTpa). The vaccines should be administered at different injection sites. Fertility, pregnancy and lactation: There were no effects on male or female fertility in animal studies. It is preferable to avoid the use of Shingrix during pregnancy. The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied.

It is unknown whether Shingrix is excreted in human milk. Effects on ability to drive and use machines: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Undesirable effects: Very common (≥1/10): Headache, GIT symptoms, myalgia, injection site reactions, fatigue, chills, fever. Common (≥1/100 to <1/10): injection site pruritus, malaise. Uncommon (≥1/1000 to <1/100): lymphadenopathy, arthralgia. Rare (≥1/1000 to <1/100): Hypersensitivity reactions. Legal Category: POM A. Marketing Authorisation Number: EU/1/18/1272/001. Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A., Rue de l’institut 89, B-1330 Rixensart, Belgium. Further information is available from GlaxoSmithKline (Ireland) Ltd. 12 Riverwalk, Citywest Business Campus, Dublin 24. Telephone: 01-4955000. Code: PI-7757. Date of preparation: March 2021.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

References : 1. Gauthier et al. Epidemiology and costs of herpes zoster and postherpetic neuralgia in the United Kingdom. Epidemiol infecti. 2009 137 38-47. 2. Lal H et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015; 372(22):2087-96. 3. Cunningham AL et al.

Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016; 375(11):1019-32.

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

Trade marks are owned by or licensed to the GSK group of companies ©2022 GSK group of companies or its licensor.

PM-IE-SGX-JRNA-220001 | Date of Preparation: September 2022

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Irish Pharmacist Mum shines a light on Respiratory Health Taking care of your family’s health is every parent’s priority. But with more information at our fingertips than ever before, Doctor Google can sometimes cause more confusion for mums and dads. Finding an accessible resource that you can trust for your family’s healthcare is so important, especially for when you need it most.

Sheena Mitchell, Pharmacist start a family healthcare platform for her community to access out of hours – WonderBaba.ie As a third-generation pharmacist and over 15-years’ experience on the frontline, Sheena has advised on everything from common childhood illnesses and conditions to more unusual symptoms. Now almost 10-years old, WonderBaba. ie has provided a combination of healthcare and practical advice to thousands of families in Ireland.

The most recent podcast addition to her spectrum of advisory platforms has recently taken to the airwaves with its second season focusing on Respiratory Health.

Sheena Mitchell is an Irish Pharmacist and mum of three children. She knows only too well how accessing the correct advice at the right time, can make a big

difference to the wellbeing of both a parent and their children. Her daily interactions with both new and experienced parents in her pharmacy in Dublin, inspired her to

Speaking about the new season of the WonderBaba Podcast, Sheena Mitchell, owner of Milltown totalhealth pharmacy and the WonderBaba.ie advice platform

said, “Through my experience in the pharmacy, I know that there are many parents who would benefit from balanced professional healthcare advice grounded in the real-life experience of being a mother. That’s why I created the WonderBaba.ie digital advice platform. I wanted to be available to connect with parents at a time and place that suited them.”

Now in its second season, the WonderBaba.ie podcast takes a deep dive into the world of Respiratory Health. With weekly episodes dropping every Tuesday morning, Sheena educates, informs, and even entertains listeners through her concise WonderBaba Explains podcast episodes. With a format of Real Lives parent interviews, Expert Advice from fellow professionals, and finally Little Voices where the small people in our lives get to have their say, you’ll benefit from a whole new perspective on family healthcare.

Mother & Baby Event at totalhealth and Haven Pharmacies Haven and totalhealth pharmacies held their first joint Mother & Baby Event, in August.

As well as offering fantastic promotions, In-store events were held where suppliers were on hand to give expert advice to customers on Baby & Toddler supplements (Scope Healthcare), Kiddies Dental Care (Spotlight Oral Care), the Importance of Probiotics for Kids & Infants (Naturalife) and Supplements for Mother & Baby (Valeo Foods).

The Mother & Baby Event also offered online events on the important topics of 1st Aid for Parents (Fleming Medical).

The event was a resounding success due to the collaborative efforts of both Haven & totalhealth pharmacy staff and its suppliers.

The Group looks forward to hosting more events in the future.

Haven & totalhealth Pharmacies in-store displays from the Mother & Baby Event

PHARMACYNEWSIRELAND.COM

Pain relief for little ones And a sigh of relief for grown-ups ACTSFAST FASTON ONPAIN PAIN&&FEVER FEVER ACTS

For Children Children ABBREVIATED PRESCRIBING PRESCRIBINGINFORMATION INFORMATION ABBREVIATED Product Name: Name: Brupro Brupro for for Children Children100mg/5ml 100mg/5mlOral OralSuspension Suspension&&Brupro Bruprofor forChildren ChildrenSix SixPlus Plus200mg/5ml 200mg/5mloral oralsuspension. suspension.

Product Composition: Each Each 55 ml ml of of oral oral suspension suspensioncontains contains100 100mg mgoror200 200mg mgibuprofen ibuprofenrespectively. respectively.

Composition: Description: White or almost white suspension, homogeneous after agitation Description: White or almost white suspension, homogeneous after agitation Indication(s): 100 100 mg/5 mg/5 ml: ml: Reduction Reductionofoffever feverand andrelief reliefofofmild mildtotomoderate moderatepain, pain,such suchasascold coldand andfluflusymptoms, symptoms,teething teethingpain, pain, headache, sprains and strains and ease pain of sore throats Indication(s): headache, sprains and strains and to to ease thethe pain of sore throats andand earache. For For short short term term use use only. only. 200 200mg/5 mg/5ml: ml:For Forthe theshort-term short-termsymptomatic symptomatictreatment treatmentofofmild mildtotomoderate moderatepain. pain.For Forthetheshort-term short-term symptomatic treatment fever. symptomatic treatment of of fever.

Infants aged aged 3-6 3-6 months monthswho whoweigh weighmore morethan than5kg.

5kg.Do Donot notdose dosemore morefrequently frequentlythan thanatat66hourly hourlyintervals intervalsand anddodonotnotexceed exceed recommended dose. infants aged months medical advice Dosage: Infants thethe recommended dose.

ForFor infants aged 3-53-5 months medical advice should be sought sought ifif symptoms symptoms worsen worsenor ornot notlater laterthan than24 24hours hoursififsymptoms symptomspersist persistand andnonolater laterthan than33days daysininchildren childrenaged agedfrom from6 6 months and adolescents.

Recommended time interval 3 times in 24 months and in in adolescents.

Recommended time interval is 3istimes in 24 mg/5 ml: ml: 3-12 3-12 months months(5-9 (5-9kg kgbodyweight): bodyweight):2.5 2.5ml; ml;11toto33years years(10-16 (10-16kg): kg):55ml; ml;44toto66years years(17-20 (17-20kg): kg):7.5 7.5ml;ml;7 7toto years (21-30 kg): (two 5ml spoonfuls); to 12 years (31-40 hours: 100 mg/5 99 years (21-30 kg): 1010 mlml (two 5ml spoonfuls); 1010 to 12 years (31-40 kg): 15 ml (three (three 5ml 5ml spoonfuls). spoonfuls). 200 200mg/5 mg/5ml: ml:Not Notfor foruse useininchildren childrenunder under66years yearsofofage ageororunder under20 20kgkgbody bodyweight. weight.6-9 6-9years years (20-29 kg): 5ml (200 mg); 10-12 years (30-40 kg): 7.5ml (300 mg).

(20-29 kg): 5ml (200 mg); 10-12 years (30-40 kg): 7.5ml (300 mg). insufficiency: No No dose dose reduction reductionininmild mildtotomoderate moderateimpairment. impairment.Hepatic Hepaticinsufficiency: insufficiency:No Nodose dosereduction reductionininmild mildtotomoderate moderate impairment.

Renal insufficiency: impairment.

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

In patients: who have previously shown hypersensitivity (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) Contraindications: Hypersensitivity to the active substance or to any of the excipients. In patients: - who have previously shown hypersensitivity (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) with acetylsalicylic acetylsalicylic acid, acid,ibuprofen ibuprofenor orother othernon-steroidal non-steroidalanti-inflammatory anti-inflammatory(NSAID) (NSAID)medicinal medicinalproducts; products;- with - witha ahistory historyofof gastrointestinal bleeding perforation, related to previous NSAID associated with gastrointestinal bleeding or or perforation, related to previous NSAID therapy; - with with active, active, or or aa history historyof ofrecurrent recurrentpeptic pepticulcer/haemorrhage ulcer/haemorrhage(two (twoorormore moredistinct distinctepisodes episodesofofproven provenulceration ulcerationororbleeding); bleeding); - with cerebrovascular other active bleeding; - with severe hepatic - with cerebrovascular or or other active bleeding; - with severe hepatic severe renal renal failure; failure; -- with withsevere severeheart heartfailure; failure;-with -withunclarified unclarifiedblood-formation blood-formationdisturbances; disturbances;-with -withsevere severedehydration dehydration(caused (caused vomiting, diarrhoea insufficient fluid intake).

During failure or severe byby vomiting, diarrhoea or or insufficient fluid intake).

During thethe lastlast pregnancy. Warnings Warningsand andPrecautions Precautionsfor forUse: Use:Refer Refertotothe theSPC SPCfor fordetailed detailedwarnings. warnings.Undesirable Undesirableeffects effectsmay maybebeminimized minimized using lowest effective dose shortest duration trimester of pregnancy. byby using thethe lowest effective dose forfor thethe shortest duration to control control symptoms symptoms and andpatients patientsshould shouldreport reportany anyunusual unusualsymptoms symptomsespecially especiallyany anyGIGIbleeding. bleeding.Elderly: Elderly:Have Haveananincreased increased frequency adverse reactions NSAIDs especially gastrointestinal necessary to frequency of of adverse reactions to to NSAIDs especially gastrointestinal and perforation perforation which which may maybe befatal. fatal.Are Areatatincreased increasedrisk riskofofthe theconsequences consequencesofofadverse adversereactions. reactions.Caution Cautionin:in:Systemic Systemic lupus erythematosus well those with mixed connective tissue disease, bleeding and lupus erythematosus asas well as as those with mixed connective tissue disease, increased risk risk of of aseptic aseptic meningitis; meningitis;Congenital Congenitaldisorder disorderofofporphyrin porphyrinmetabolism metabolism(e.g. (e.g.acute acuteintermittent intermittentporphyria); porphyria);Gastrointestinal Gastrointestinal disorders and chronic inflammatory intestinal disease (ulcerative due to increased disorders and chronic inflammatory intestinal disease (ulcerative Crohn’s disease). disease). Consider Considercombination combinationtherapy therapywith withprotective protectiveagents agents(e.g. (e.g.misoprostol misoprostolororproton protonpump pumpinhibitors) inhibitors)and andalso also patients requiring concomitant dose acetylsalicylic acid, or other colitis, Crohn’s forfor patients requiring concomitant lowlow dose acetylsalicylic acid, or other to increase increase gastrointestinal gastrointestinalrisk; risk;AAhistory historyofofhypertension hypertensionand/or and/orheart heartfailure failureasasfluid fluidretention retentionand andoedema oedemahave havebeen been reported association with NSAID therapy; Renal impairment renal drugs likely to reported in in association with NSAID therapy; Renal impairment as as renal function may respiratory disorders as as anan increased riskrisk forfor them of allergic may further further deteriorate; deteriorate; Hepatic Hepaticdysfunction; dysfunction;Dehydration; Dehydration;Directly Directlyafter aftermajor majorsurgery; surgery;Hayfever, Hayfever,nasal nasalpolyps polypsororchronic chronicobstructive obstructive respiratory disorders increased them of allergic reactions occurring. who have already reacted allergically to other substances, as as an an occurring. These These may may be bepresent presentas asasthma asthmaattacks attacks(so-called (so-calledanalgesic analgesicasthma), asthma),Quincke’s Quincke’soedema oedemaororurticaria; urticaria;InInpatients patients who have already reacted allergically to other substances, increased risk patients suffering from, or or with a history of,of, bronchial asthma or allergic risk of of hypersensitivity hypersensitivity reactions reactionsoccurring occurringalso alsoexists existsfor forthem themon onuse useofofthis thisproduct; product;Bronchospasm Bronchospasmmay maybebeprecipitated precipitatedin in patients suffering from, with a history bronchial asthma or allergic disease. Dermatological and toxic epidermal necrolysis, have been reported very rarely in in Dermatological effects: effects: Serious Seriousskin skinreactions, reactions,some someofofthem themfatal, fatal,including includingexfoliative exfoliativedermatitis, dermatitis,Stevens-Johnson Stevens-Johnsonsyndrome syndrome and toxic epidermal necrolysis, have been reported very rarely association with thethe reaction occurring in in thethe majority of of cases within thethe firstfirst month of of with the the use use of of NSAIDs. NSAIDs.Patients Patientsappear appeartotobe beatathighest highestrisk riskofofthese thesereactions reactionsearly earlyininthe thecourse courseofoftherapy, therapy,thetheonset onsetofof reaction occurring majority cases within month treatment. Acute of of signs and symptoms of of severe skinskin reactions, such as as skinskin rash, Acute generalized generalized exanthematous exanthematouspustulosis pustulosis(AGEP) (AGEP)has hasbeen beenreported. reported.Discontinue DiscontinueBrupro BruproforforChildren Childrenatatthethefirst firstappearance appearance signs and symptoms severe reactions, such rash, mucosal lesions, delayed initiation of of appropriate treatment and thereby worsening thethe lesions, or or any any other other sign signof ofhypersensitivity. hypersensitivity.Symptoms Symptomsofofunderlying underlyinginfections infectionsand andfever fevercan canbebemasked maskedwhich whichmay maylead leadtoto delayed initiation appropriate treatment and thereby worsening outcome of the Monitoring of of infection is advised.

In nonhospital settings, thethe patient the infection. infection. This This has has been beenobserved observedininbacterial bacterialcommunity communityacquired acquiredpneumonia pneumoniaand andbacterial bacterialcomplications complicationstotovaricella. varicella.

Monitoring infection is advised.

In nonhospital settings, patient should consult infectious complications.

It isIt advisable to avoid useuse of ibuprofen in case consult aa doctor doctor ifif symptoms symptomspersist persistor orworsen. worsen.Exceptionally, Exceptionally,varicella varicellacan canbe beatatthe theorigin originofofserious seriouscutaneous cutaneousand andsoft softtissues tissues infectious complications. is advisable to avoid of ibuprofen in case of varicella. with a small increased riskrisk of of arterial thrombotic events (for(for example varicella. Cardiovascular Cardiovascular and and cerebrovascular cerebrovasculareffects: effects:Ibuprofen, Ibuprofen,particularly particularlyatataahigh highdose dose(2400 (2400mg/day) mg/day)may maybebeassociated associated with a small increased arterial thrombotic events example myocardial infarction risk of of arterial thrombotic events.

Patients with uncontrolled hypertension, infarction or or stroke). stroke). Low Lowdose doseibuprofen ibuprofen(e.g. (e.g.≤≤1200 1200mg/day) mg/day)isissuggested suggestednot nottotobebeassociated associatedwith witha asmall smallincreased increased risk arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart should only bebe treated with ibuprofen after careful consideration andand heart failure failure (NYHA (NYHA II-III), II-III),established establishedischaemic ischaemicheart heartdisease, disease,peripheral peripheralarterial arterialdisease, disease,and/or and/orcerebrovascular cerebrovasculardisease disease should only treated with ibuprofen after careful consideration high doses (2400 reactions (for(for example anaphylactic shock) areare observed (2400 mg/day) mg/day) should shouldbe beavoided avoidedand andconsider considercarefully carefullyififlong longterm termtreatment treatmentisisneeded. needed.Other Othernotes: notes:Severe Severeacute acutehypersensitivity hypersensitivity reactions example anaphylactic shock) observed very rarely. Discontinue (thrombocyte aggregation).

Monitor patients with coagulation Discontinue treatment treatmentimmediately immediatelyand andseek seekmedical medicalattention. attention.Ibuprofen Ibuprofenmay maytemporarily temporarilyinhibit inhibitthe theblood-platelet blood-plateletfunction function (thrombocyte aggregation).

Monitor patients with coagulation disturbances overuse headache (MOH), suspected in patients who have frequent or or disturbances carefully. carefully. Check Check liver livervalues, values,kidney kidneyfunction functionand andblood bloodcount countininprolonged prolongedtreatment. treatment.BeBeaware awareofofdiagnosis diagnosisofofmedication medication overuse headache (MOH), suspected in patients who have frequent daily headaches thethe gastrointestinal tract or or thethe central nervous system.

Renal: Habitual headaches despite despite (or (or because becauseof) of)the theregular regularuse useofofheadache headachemedications. medications.Alcohol Alcoholmay mayincrease increaseadverse adverseeffects effectsthat thatconcern concern gastrointestinal tract central nervous system.

Renal: Habitual use renal failure (analgesic nephropathy).

There is aisrisk of renal impairment in in use of of analgesics, analgesics, especially especially the the combination combinationofofdifferent differentanalgesic analgesicdrug drugsubstances, substances,can canlead leadtotolasting lastingrenal renallesions lesionswith withthetherisk riskofof renal failure (analgesic nephropathy).

There a risk of renal impairment dehydrated Avoid in in combination with: Other NSAIDs including cyclooxygenase-2 dehydrated children. children. Contains Contains sorbitol sorbitoland andpropylene propyleneglycol. glycol.Interactions: Interactions:Refer Refertotothe theSPC SPCfor fordetailed detailedinformation informationononthetheinteractions. interactions.

Avoid combination with: Other NSAIDs including cyclooxygenase-2 selective and diuretics; Cardiac glycosides: e.g.e.g. digoxin; Lithium; Potassium selective inhibitors; inhibitors; Acetylsalicylic Acetylsalicylicacid; acid;Antihypertensives, Antihypertensives,(ACE (ACEinhibitors, inhibitors,beta-receptor beta-receptorblocking blockingmedicines medicinesand andangiotensin-II angiotensin-IIantagonists) antagonists) and diuretics; Cardiac glycosides: digoxin; Lithium; Potassium sparing diuretics; Phenytoin; Methotrexate; Tacrolimus; Ciclosporin; Corticosteroids; Anti-coagulants; Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs); Mifepristone; Sulphonylureas; sparing diuretics; Phenytoin; Methotrexate; Tacrolimus; Ciclosporin; Corticosteroids; Anti-coagulants; Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs); Mifepristone; Sulphonylureas; Zidovudine; CYP2C9 inhibitors: e.g. voriconazole and fluconazole.

Zidovudine; Probenecid Probenecid and and sulfinpyrazone; sulfinpyrazone;Baclofen; Baclofen;Ritonavir; Ritonavir;Aminoglycosides; Aminoglycosides;Quinolone Quinoloneantibiotics; antibiotics;Cholestyramine; Cholestyramine;Captopril; Captopril; CYP2C9 inhibitors: e.g. voriconazole and fluconazole.

Pregnancy necessary.

If ibuprofen is used byby a woman attempting to conceive, or or Pregnancy and and Lactation: Lactation: Pregnancy: Pregnancy:During Duringthe thefirst firstand andsecond secondtrimester trimesterofofpregnancy, pregnancy,ibuprofen ibuprofenshould shouldnot notbebegiven givenunless unlessclearly clearly necessary.

If ibuprofen is used a woman attempting to conceive, during during thethe third trimester of of pregnancy.

Breast-feeding: during the the first first and and second second trimester trimesterof ofpregnancy, pregnancy,the thedose doseshould shouldbe bekept keptasaslow lowand andduration durationofoftreatment treatmentasasshort shortasaspossible. possible.Contraindicated Contraindicated during third trimester pregnancy.

Breast-feeding: Ibuprofen and its metabolites can pass in low concentrations into the breast milk.

No harmful effects to infants are known to date, so for short-term treatment with the recommended dose for pain and fever Ibuprofen and its metabolites can pass in low concentrations into the breast milk. No harmful effects to infants are known to date, so for short-term treatment with the recommended dose for pain and fever interruption prostaglandin synthesis may cause impairment of female interruption of of breast breast feeding feeding would wouldnot notgenerally generallybe benecessary. necessary.Fertility: Fertility:There Thereisissome someevidence evidencethat thatsubstances substanceswhich whichinhibit inhibitcyclo-oxygenase/ cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility fertility by by an an effect effect on on ovulation. ovulation. This Thisisisreversible reversibleupon uponwithdrawal withdrawalofoftreatment. treatment.

Ability and useuse machines.

Ability to to Drive Drive and and Use Use Machinery: Machinery:For Forshort-term short-termuse usethis thismedicinal medicinalproduct, product,has hasnonoorornegligible negligibleinfluence influenceononthetheability abilitytotodrive drive and machines.

Undesirable and slight gastrointestinal blood losses thatthat may cause anaemia in in Undesirable Effects: Effects: Gastro-intestinal: Gastro-intestinal:abdominal abdominalpain, pain,nausea nauseaand anddyspepsia, dyspepsia,diarrhoea, diarrhoea,flatulence, flatulence,constipation, constipation,heartburn, heartburn,vomiting vomiting and slight gastrointestinal blood losses may cause anaemia exceptional cases. other Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd., Co. Cork. exceptional Authorisation cases. Refer Refer to to the the SPC SPCfor forPA0074/067/004-005 otherundesirable undesirableeffects. effects.

Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd.,Bantry, Bantry, Co. Cork.

Marketing Number: Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork.

Freephone: 1800 304 400 Fax: 027 50417 Marketing Authorisation Number: PA0074/067/004-005 Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417 E-mail: Legal prescription.

Date March E-mail: rowex@rowa-pharma.ie. rowex@rowa-pharma.ie.

LegalCategory: Category:Not Notsubject subjecttotomedical medicalbe prescription.

DateofofPreparation: Preparation: March2021 2021 Adverse Rowex pv@rowa-pharma.ie Adverse events events should should be be reported. reported.Reporting Reportingforms formsand andinformation informationcan can befound foundononthe theHPRA HPRAwebsite website(www.hpra.ie) (www.hpra.ie)ororbybyemailing emailing Rowex pv@rowa-pharma.ie Supply status: Supply through pharmacies only Supply status: Supply through pharmacies only Date of of Preparation: 07-22 CCF 25112 Date Preparation: 07-22 CCF 25112

12

Report

Key Trends in Irish Community Pharmacy Fitzgerald Power regularly update community pharmacy across Ireland as to the latest trends affecting the sector.

Their quarterly reports offer valuable insight and expert analysis into how the Pharmacy and SME markets are performing.

Summary

Every three months the team look at the key trends of certain sectors, and provide thorough breakdowns to help you get members get their heads around the numbers.

The Irish Pharmacy awards took place in May; winners included Laura Dowling of Lloyds Pharmacy for PrecisionBiotics Community Pharmacist of the Year, and Perrystown Allcare Pharmacy for the Originalis Community Pharmacy Team of the Year Award.

Congratulations to all the winners!

The below is a summary of the latest analysis of the key trends in the Irish Community Pharmacy sector, prepared on a quarterly basis.

Pharmacy Awards

Rising prices Inflation in the Eurozone rose 8.6% year on year in June, with energy prices remaining the biggest contributor to accelerating prices, rising 41.9%. Core inflation, which excludes volatile factors such as energy but also food, alcohol and tobacco, and is watched closely by European Central Bank policymakers, remained stable at 3.7%.

Walgreens halts Boots sale Upheaval in the credit markets has led Walgreens Boots Alliance to stop the sale process for the Boots chain in the UK. Walgreens announced that despite interest no offers had been received that reflected the value of the business.

Global economic trends Global economic growth is expected to decrease over the year as the US Federal Reserve continued to increase interest rates, targeting a range of 2.25% to 2.5%. The United States officially entered a recession, although there are debates whether an economy still creating 528,000 jobs a month can be in recession.

Irish economy Irish economic growth is projected to remain strong, but faces substantial uncertainty due to the indirect effects from the war in Ukraine. In the latest health check on the country’s economy the IMF said that energy and commodity prices would likely push average inflation above 6% this year, projected to average 6.5%, before falling to 2.8% next year.

PHARMACYNEWSIRELAND.COM

6.6%

Volume of Sales: CSO

13

SOURCE: CSO

Unit Trends

Revenue PulseAccording to HMR Ireland research, the Irish prescription ar on year in June, market grew by 3.92% in units compared to the same period last Volume st contributor to of sales year. nflation, which The volume of sales, as measured by the CSO, increased by 6.6% June 2022 against the same period last year. y but also in food, alcohol

OTC Tracker IQVIA data shows the largest growth in OTC classes was in the cough, cold & other respiratory category this quarter.

OTC Tracker

3.92%

Minor OTC categories have seen significant IQVIA data shows the largest growth in OTC classes was in the growth, with urinary & reproductive care cough, cold & other respiratory category this quarter. seeing 45% growth over the period.

SOURCE: HMR IRELAND

s sale Unit Trends

Turnover

Top 5 Major OTC Classes by Growth

According to HMR Ireland research, the Irish prescription market grew by 3.92% in units Walgreens Boots Retail Excellence & AIB report an increase of 9% in pharmacy compared e Boots chain in the to the same period last year. sales by card in June 2022 versus the same period last year. This interest no offers had HMR Ireland Unit Growth: 3.92% includes an increase of 11% instore and 25% online. of the business.

SOURCE: HMR IRELAND Turnover

60 45

9%

Value of Sales: Retail Excellence/AIB

Excellence & AIB report anEXCELLENCE/AIB increase of 9% in pharmacy sales by card in June 2022 versus o decreaseRetail over the SOURCE: RETAIL the same period last year. This includes an increase of 11% instore and 25% online. ued to increase interest Value of Sales: Retail Excellence/AIB 9% %. The United States there areSOURCE: debates RETAIL EXCELLENCE/AIB It was another strong quarter for sales, with Fitzgerald Power Compared to the previous period in 2021, mobility increased 2% in the 2nd Quarter of 2022. Out estimating 8 transactions completed 000 jobs a month can Footfall Pulse in supermarkets and pharmacies. of those 8 sales, 5 were bought by independents, 2 by indigenous groups, and 1 by2% a corporate group.

OTC Tracker Compared to the previous period in 2021, mobility increased in supermarkets and The largest increase was in Leitrim at 58%. Mobility decreased pharmacies. The largest increase was in Leitrim atIQVIA 58%.

Mobility decreased 8% inclasses Dublin and PSI data there havegrowth been 2 net closures since the datasuggests shows the largest in OTC was inDecember the 8% in Dublin and 1% in Limerick, but increased 6% in Cork over 1% in Limerick, but increased 6% in Cork over the period.

2021(the werespiratory ended the Q4 2021 report on due to data cough, coldperiod & other category this quarter. the period. remain strong, but availability), bringing the number of community pharmacies in Ireland to 1,905. e indirect effects There has been a steep increase in closures over the quarter. This ealth check on the Changes in Footfall Mobility Top 5 Major OTC Classes by Growth may be partly explained by as a consequence from the experience of nergy and commodity 60 the pandemic changing pharmacists desire to work in the sector. on above 6% this year, 75 These figures are different than in the first quarter due to changes in ng to 2.8% next year.

45

30

Market Pulse

Footfall Pulse

data 60 reporting in the PSI dataset.

30

45 New Openings and Closures

15

30 New Openings between

0

Overall 2%

Closures between 1st December ‘21 –respiratory 30th June73% ‘22 Cough, cold & other

Leitrim 58%

Biggest positive movement

Cork 6%

Market Pulse

SOURCE: GOOGLE MOBILITY

Pain relief 29% Digestive (other Net Closures between Dublinintestinal) -8% 12% Limerick -1% VMS & tonics 6% 1st December ‘21 – 3oth June ‘22 Skin treatment 5%

It was another strong quarter for sales, with Fitzgerald Power estimating 8 transactions completed in the 2nd Quarter of 2022. Out of those 8 sales, 5 were bought by independents, 2 by indigenous groups, and 1 by a corporate group.

Market Pulse

PSI data suggests there have been 2 net closures since the December

0 Cough, cold & other respiratory 73%

Completed Deals in Q2 by Geographical Pain relief 29% Location Digestive (other intestinal) 12% VMS & tonics 6% Skin treatment 5%

SOURCE: IQVIA

Minor OTC categories haveClasses seen significant growth, with Top 5 Major OTC

by Value urinary & reproductive care seeing 45% growth over the period.

12% 18% Top 5 Minor14% OTC Classes by Growth 7%

16%

80

15 1st December ‘21 – 30th June ‘22

0

15

5

20%

29%

60

40Pain relief 29% Cough, cold & respiratory 18% Leinster 3 Munster 2 VMS & tonics 14% 20 Dublin 2 Ulster/Connacht 1 Digestive (other intestinal) 12%

7

2

Skin treatment 7% 0

SOURCE: IQVIA SOURCE: PSI

Minor OTC Classes 20%

SOURCE: IQVIA

Urinary & reproductive care 45%

13%

Deals Q2significant

by Geographical MinorCompleted OTC categories have in seen growth, with Completed Deals in Q2 by HSE Fees List Position urinary & reproductive care seeing 45% growth over the Location period.

15

Antinauseants 36% Q1 Ear care 14%

16%

Habit treatment 10%

Q2

YTD

13%

It was another strong quarter for sales, with Fitzgerald Power estimating 8 transactions completed in the 2nd Quarter 2022.

Calm, sleep andofmood 7% Out of those 8 sales, 2021(the period we ended the Q4 2021 report on due to data 5 were bought by independents, 2 by indigenous groups, and 1 by a corporate group. availability), bringing the number of community pharmacies in Ireland

10 5 Minor OTC Classes by Growth Top

7

Top 5 IQVIA Minor OTC Classes by Value SOURCE:

to 1,905.

PSI data suggests there have been 2 net closures since the December 2021(the period we ended the Q4 2021 report on due to data availability), bringing thea steep number in Ireland There has been increaseofin community closures over thepharmacies quarter. This 80 5 to 1,905.

2

may be partly explained by as a consequence from the experience of

4

6

2

2

4 3 There has been a steep increase in closures over the quarter. This may be partly explained by as a consequence from the experience of the 0 0 0 0 the pandemic changing pharmacists desire to work in the sector.

7% 0 pandemic changing pharmacists desire to work in the sector.

These figures are different than in the first quarter due to changes in data reporting in 60 ThesePSI figures are different than in the first quarter due to changes in €250k and over €175k-249k €100k-174k Under €100k the dataset.

40

New Openings and Closures

Completed Deals in Q2 by Pharmacy Type Sold

20

New Openings between 1st December ‘21 – 30th June ‘22

5

Closures between 1st December ‘21 – 30th June ‘22

7

Net Closures between 1st December ‘21 – 3oth June ‘22

SOURCE: FITZGERALD POWER

data reporting in the PSI dataset.

0

15

10 Urinary & reproductive care 45% Leinster 3 Munster 2 5 Antinauseants 36% Dublin 2 0 Ulster/Connacht 0 1 0 0 0 0 Ear care 14% 0 Habit treatment 10% Indigenous Group Corporate Group Calm, sleep and mood 7%

2

SOURCE: PSI

SOURCE: IQVIA

15 10

7

6% Q2 4%

Q1

1%

YTD

1%

13 Habit treatment 7% 5

8 6% Eye care

Urinary and reproductive 2care 4%0 Calm, sleep and mood 1% Independent Circulatory products 1%

2

Symbol

SOURCE: IQVIA

Q1

Q2

YTD

ALD POWER

Completed Deals in Q2 by HSE Fees List Position

28%

SOURCE: FITZGERALD POWER

ds

75

SOURCE: FITZGERALD POWER

Unit Growth: HMR Ireland EuropeanVolume Central of Sales: CSO

6.6% 3.7%.

SOURCE: CSO

SOURCE: FITZGERALD POWER

st of the Year, and Originalis Community ngratulations to all the

PHARMACYNEWSIRELAND.COM

28

14

Diabetes

Insulin prescribing, administration, and glucose monitoring trends in a hospital setting AUTHORS: D. Hogan-Murphy1, L. Reddington2, M.C. Dennedy2,3, L. Egan3,4, J. Okiro2, J. Given1, S. Donnellan1, M.R. Salehmohamed2 1. Department of Pharmacy, Galway University Hospitals, Galway, Ireland 2. Department of Endocrinology, Diabetes and Metabolism, Galway University Hospitals, Galway, Ireland 3. Department of Pharmacology and Therapeutics, School of Medicine, National University of Ireland, Galway, Ireland 4. Department of Gastroenterology, Galway University Hospitals, Galway, Ireland

ABSTRACT Aims: Insulin is a high-alert critical medication which can cause significant patient harm when used inappropriately. The aim of this study was to conduct a prospective audit on insulin prescribing, administration, and glucose monitoring trends in Galway University Hospitals.

Methods: This audit was conducted over one day in March 2022. The audit was approved by the local Clinical Audit Committee, piloted on two inpatients, and communicated to all data collectors prior to commencement. Generated data were anonymous and securely stored. Independent analysis was conducted by three researchers to confirm reliability of results.

Results: Four hundred and fifty-four inpatients were reviewed of which 17% [75] had diabetes and 9% [41] were prescribed insulin. The overall insulin error rate with one or more errors comprising prescribing and/or administration per inpatient drug record was 90% [37]. In total, 95% [235] insulin brand names and 89% [220] dose units were clearly prescribed, 84% [208] administration times were clearly specified by a prescriber, 87% [214] orders were signed, 58% [25] prescribers clearly documented their registration number/bleep/name at least once for contact purposes, 35% [30] meal time supplements were documented clearly by a nurse, 70% [202] administrations were double checked by a second person, 53% [142] administration times were documented by a nurse, and 26% [10] of inpatients were administered insulin by a nurse when not prescribed.

Conclusion: Results will assist in developing quality improvement initiatives to optimise patient care.

DM/Insulin Prevalence GUH

Diabetes mellitus (DM) is a heterogeneous complex metabolic condition characterised by hyperglycaemia with a degenerative potential resulting from changes in the production, secretion and/or inability of insulin to adequately exercise its effects1.

The most common classifications include Type 1 DM and Type 2 DM, the latter accounting for more than 90% of all cases2. Type 2 DM is characterised by insulin resistance and a relative deficiency of insulin secretion which progressively worsens over time3,4.

Type 1 DM results in an absolute deficiency in beta-cell function with autoimmune destruction of beta-cells a common origin5.

Current estimates suggest more

inpatient drug record was 90% [n=41] as presented in Table 1.

Table 1: Overall insulin error rate per inpatient drug record

Table 1: Overall insulin error rate per inpatient drug record Error description Insulin brand incorrect

0%

Insulin name not clearly prescribed

5%

Insulin dose units not clearly prescribed

11%

Insulin administration times not clearly specified by the prescriber 16% Insulin orders not signed by the prescriber

13%

Prescriber MCRN/bleep/name unclear for contact purposes

42%

Meal time supplement documented incorrectly

65%

Insulin administration not double checked by a 2 person

30%

Insulin administration times not documented

47%

Insulin administered when not prescribed

26%

nd

Error type

Prescribing error 80%

90%

Introduction

Administration error 89%

Insulin error

Dr Diana Hogan-Murphy

dosing leading to hyperglycaemia DM related health expenditure than half a billion adults live with and hypoglycaemia16. per person7, and as high as ¤1.4 DM worldwide, a rise of 16% since Number of inpatients documented with DM 75 billion annually with costs mostly previous estimates in 20196. This Insulin has been identified as is predicted to escalate to almost associated with hospitalisations a significant medication safety and treatment of complications6.

800 million by 20456. In Ireland, concern in Galway University Number of inpatients 41 in the absence of a national DM on Insulin Hospitals (GUH). The aim of Insulin is a high-alert medicine registry, the current approximate this study was to conduct a used in the treatment of DM 7 projection is 5.6% .

Number of inpatients using an Insulin and prospective audit on insulin which bears a heightened risk 117 Glucose Monitoring Record prescribing, administration, and of causing significant patient DM is a leading cause of death glucose monitoring trends in GUH harm. With limited Irish data globally8 and described as the in order to identify and develop mostNumber challenging health excluded problem at intimeavailability and few local incidents of inpatients of 54 agreed quality improvement the 21st century9,10 driven primarily reported, anecdotal evidence data collection initiatives to enhance patient care. by rising levels of obesity and an suggests insulin accounts for a ageing population9,11. A systematic substantial number of medication Methods Number of inpatients on ward 508 review and meta-analysis on errors13,14. A review by the States the epidemiology of DM and its Claims Agency of over 20,000 A prospective audit on insulin complications amongst adults medication incidents reported prescribing, administration, and in Ireland variables from

by Irish acute hospitals in 2017 glucose monitoring was conducted Figure 1:found DM/Insulin prevalence GUH 7–25% for retinopathy; 3–32% and 2018 found insulin was the over one day in March 2022 on 24 for neuropathy; and 3-5% for fourth most commonly implicated wards in GUH. GUH comprises 12 Overall insulin error rate per inpatient drug record nephropathy therapeutic subgroup15, many . The economic University Hospital Galway (UHG), burden also plays heavily with comprising omissions leading to a Model 4 public hospital, and The overall insulin error rate with one or more errors comprising prescribing and/or administration per th Ireland ranked 7 in the world for hyperglycaemia and inaccurate Merlin Park University Hospital

Insulin prescribing patterns Nineteen inpatients [n=37; 51%] were prescribed the same insulin as pre-admission, four inpatients [n=37; PHARMACYNEWSIRELAND.COM 11%] were not prescribed the same insulin as pre-admission, and 14 inpatients [n=37; 38%] were not on insulin pre-admission and were either prescribed a meal time supplement [10 inpatients; n=37; 27%] or were

16

DM/Insulin Prevalence GUH Number of inpatients documented with DM Number of inpatients on Insulin

75 41

Number of inpatients using an Insulin and Glucose Monitoring Record

117

Figure 1: DM/Insulin prevalence GUH [61%; n=41] had changes to their insulin regimen made during their inpatient stay. This included changes to a brand name of insulin [4; n=37; 11%], the initiation of insulin and/or a meal time supplement [14; n=37; 38%], and/or a dose change [9; n=32; 28%; median 3; range 1-6]. Three inpatients had their insulin omitted after an episode of hypoglycaemia (blood glucose <4 mmol/L).

Discussion

Number of inpatients excluded at time of data collection

This study identified 17% of inpatients had DM on audit day of the audit in GUH of which 9% were insulin dependent and 55% of all inpatients with DM were treated Number of inpatients on ward 508 with insulin. This is similar to the most recently published National Health Service (NHS) National Diabetes Inpatient Audit (NaDIA) England 2019 report which found Figure 1: DM/Insulin prevalence GUH 18% of all inpatients in 188 NHS [n=37; 11%] were not prescribed commencement. All audit forms (MPUH), a Model 2 public hospital, hospitals had documented DM17. were anonymous and securely the same insulin as pre-admission, and provides a comprehensive The NaDIA England and Wales Overall insulin error rate perstored inpatient drug record in a locked cabinet and and 14 inpatients [n=37; 38%] range of services to emergency 2015 report identified a lower all generated data were securely and elective patients within the were not on insulin pre-admission prevalence of 6% of all inpatients The overall insulin error rate with one or more errors comprising prescribing and/or administration per Saolta University Healthcare Group stored on an encrypted password and were either prescribed a meal in 206 NHS hospitals were insulin protected work computer.

Any in the West of Ireland. time supplement [10 inpatients; inpatient drug record was 90% [n=41] as presented in Table 1. dependent and 36% of inpatients audit records will be destroyed n=37; 27%] or were newly with DM were treated with insulin18.

Inclusion criteria comprised after full dissemination of audit prescribed insulin on admission [4 inpatients prescribed/administered The majority of inpatients in this findings. Independent analysis inpatients; n=37; 11%].

Tablein1: Overall insulin rate per inpatient drug record insulin UHG and MPUH for theerrorwas audit were medical and prescribed conducted by the two primary previous 72 hours until 9am on A total of 247 insulin doses were the same insulin as pre-admission. researchers and a specialist Error description Error type the morning of audit. Exclusion All inpatients not prescribed the registrar in endocrinology to confirm prescribed of which 235 orders Insulin brand non-admitted incorrect 0%insulin name clearly same insulin as pre-admission criteria comprised [95%] had the reliability of results. This process patients, Day Wards, Emergency documented. Two hundred and were altered by the DM team involved independently inputting Department, Acutenot Medical Unit, prescribed twenty [89%]5% insulin dose units during admission and were Insulin name clearly content of paper audit forms Short Stay Unit, Emergency were clearly prescribed, 208 [84%] therefore appropriately changed. into excel, analysing data, and Surgical Unit, Critical Care administration times were clearly The remaining inpatients were comparing results.

No significant InsulinPost dose units not clearly prescribed 11% including Anaesthetic Care specified by a prescriber, and 214 not on insulin pre-admission and discrepancies were identified.

Prescribing error Unit, Maternity Department, and [87%] orders were signed by a were either prescribed a meal Insulin administration times not clearly specified by the prescriber Results Psychiatry Department. Content prescriber 16% (Figure 2).80% time supplement or were newly of the audit protocol and tool was prescribed insulin on admission.

General participation and Twenty-five13% prescribers [n=43; informed the research objective, Insulinbyorders not signed by the prescriber prevalence The overall insulin error rate 58%] clearly documented their local practices, and existing comprising both prescribing [80%] medical council registration evidence-based international and In total, 454 inpatients were Prescriber MCRN/bleep/name unclear for contact purposesnumber (MCRN)/bleep/name 42% and administration [89%] per on national literature. The audit tool reviewed of which 41 [9%] were inpatient drug record was 90%. the insulin drug record at least was piloted on a medical ward in prescribed insulin and included Meal supplement documented incorrectly 65% purposes and 25 This is significantly higher than the once for contact UHG withtime two random inpatients in the audit.

The number of NaDIA 2019 report which found inpatients [61%] had the meal time prescribed and administered inpatients using an Insulin and 18% of inpatient drug records supplement signed by a prescriber. insulin.

Minor amendments were Insulin administration not double checked

by Record a 2nd person 30% Glucose Monitoring was had one or more insulin errors17.

The meal time supplement was made to its content and the pilot 117 [26%] of which 75 inpatients Administration error This figure is also higher than documented clearly 30 times out was excluded from data analysis.

[17%] had a documented history Insulin administration times not documented 47% findings from an analysis of the of a total of 86 entries [35%].

89% of DM (Figure 1). This equates The audit was led by two lead National Reporting and Learning to 55% of all inpatients with DM Insulin administration patterns researchers and conducted by System database of patient safety Insulin administered when not prescribed 26% were treated with insulin. Patient 29 data collectors comprising incidents concerning insulin specialty comprised medical [27, Two hundred and eighty-seven endocrine consultant and nonreported from NHS providers 66%], surgical [12, 29%], and doses were administered of which consultant hospital doctors, in England and Wales over a paediatric [2, 5%].

202 [70%] were double checked diabetes nurse specialists, patterns and six year period which found Insulin prescribing by an independent second pharmacists. The audit tool was 61% of incidents occurred at Overall insulin error rate per person.insulin Administration times were Nineteen inpatients 51%] were prescribed the same as pre-admission, four inpatients [n=37; guided by the protocol which [n=37; inpatient the administration stage and drug record documented for 142 doses [n=270; was communicated to all data 17% at the prescribing stage19.

11%] were prescribed the sameinsulin insulin as pre-admission, and 14 inpatients [n=37; were not on 53%] as illustrated in Figure 3.

The overall error rate with collectors prior tonot the audit via The most38%] common medication Ten inpatients [n=39; 26%] were one or more errors comprising video conferencing and faceerror types were wrong dose, insulin pre-admission and were either prescribed a mealadministered time supplement [10 inpatients; n=37; 27%] or were insulin by a nurse prescribing and/or administration to-face meetings and emails. strength, or frequency followed when not prescribed. per inpatient drug record was 90% newly on admission [4 inpatients; n=37; 11%].

This auditprescribed was conductedinsulin in by omitted or delayed insulin19. [n=41] as presented in Table 1. accordance with the HSE Code Most prescriptions in this audit Glucose management of Governance (2021) and HSE had the insulin name, dose, Insulin prescribing patterns The GUH team reviewed/ Healthcare Qualityinsulin Assurance and administration times clearly A total Audit of 247 doses were prescribed of which 235 DM orders [95%] had the insulin name clearly was contacted to review 21 Nineteen inpatients [n=37; 51%] and Verification Standards (2019) documented and signed by the documented. hundred and twenty [89%] doseinsulin units prescribed, [84%] inpatients drugwere record clearlyprescriber were prescribed the same insulininsulin and was approved byTwo the GUH which are208 positive as pre-admission, four inpatients [55%, n=38]. Twenty-five inpatients findings. However, less than Clinical Audit Committee prior to

Insulin error

90%

54

administration times were clearly specified by a prescriber, and 214 [87%] orders were signed by a prescriber (Figure 2).

PHARMACYNEWSIRELAND.COM

17 Figure 2: Insulin prescribing patterns

Insulin Prescribing Patterns What number of insulin orders have been signed by the prescriber?

214

Future quality improvement interventions for consideration to optimise patient care include What number of insulin administration times are implementing a dedicated insulin 208 clearly specified by the prescriber? safety team that comprises a broad membership to facilitate What number of insulin orders have been signed by sustainability and spread What number of insulin dose units are clearly 214 of 220 the prescriber? interventions to improve insulin prescribed? prescribing and administration practice; electronic prescribing What number of insulin orders have the nameWhat clearlynumber of insulin administration times are as a part of the 208 ongoing 235 prescribed? implementation of a new pharmacy clearly specified by the prescriber? system; an insulin inpatient and discharge checklist; and What number of insulin doses have been prescribed?

247 What number of insulin dose units are clearly promotion of an annual national 220 audit on insulin prescribing, prescribed? administration, and glucose monitoring trends similar to the Figure 2: Insulin prescribing patterns What number of insulin orders have the name clearly UK. Once interventions are in situ 235 it is anticipated that results of a represcribed? audit in GUH will be favourable. three out of five prescribers with a special interest in diabetes; is lower than a study evaluating Twenty-five prescribers [n=43; 58%] clearly documented their medical council registration number clearly documented their MCRN/ insulin information on discharge implementation of mandatory Declaration (MCRN)/bleep/name the insulin drug record at least once fore-learning contact for purposes anddoctors 25 inpatients [61%] of Conflicts of bleep/name on the insulinon drug summaries in a United Kingdom nurses and Interest What number of insulin doses have been prescribed? record at least forsupplement contact (UK) hospital found 33 outmealon had the mealonce time signed by a which prescriber.

The time supplement insulin prescribing was and documented clearly purposes leading to possible time of 42[35%]. patients [79%] had changes The authors report no conflict administration; updated/newly 30 times out of a total of 86 entries delays and patient care issues if made including the initiation and/or approved policies, procedures, of interest. communication is required. discontinuation of insulin therapy, protocols, and guidelines; Corresponding Author: dose insulin Figure 2: changes, Insulin and prescribing patterns Insulintheadministration patterns insulin piloting of a self-administration Whilst majority of inpatients 20 preparation/brand .

Dr Diana policy; continuous education and checked were mealeighty-seven time Twoprescribed hundredaand doses were administered of which 202 [70%] were double

by Hogan-Murphy an training to patients as well as supplement, it was only Based on audit results as well as Department of Pharmacy independent second person.

Administration times were documented for 142 doses [n=270; 53%] Twenty-five [n=43; clearly documented as their medical council medical, 58%] nursing, and pharmacy documented clearly by nurses evidence from localprescribers insulin error illustrated in Figure 3.

Ten inpatients [n=39; 26%] were administered insulin by a nurse when not prescribed. undergraduate students and University Hospital Galway for approximately one in every reporting, local practices, and (MCRN)/bleep/name on theemployees insulin indrug record at least once for contact purposes and GUH; expansion three inpatients potentiating best practice, some of the current Galway of a medication safety portal administration errors and significant had the meal time supplement signed by a prescriber.

The meal time supplement was interventions implemented specific patient harm. Almost one in three inclusive of educational videos; E-Mail: to insulin in GUH with support 30 times out of a total of 86use entries [35%]. insulin doses were also not double of hospital screens and social diana.hogan-murphy@hse.ie from hospital management and checked by an independent media to disseminate prudent medication safety committees References available on request second person and almost half information; and further promotion which are transferrable to other Insulin include administration administration times were not of error reporting. No challenges hospitals an updated patterns What number ofisdoses with administration documented.

Insulin a highwere encountered as all key inpatient Insulin and and Glucose Two hundred eighty-seven doses were administered of which 202 [70%] were d 142 alert medication which a times arerequires documented? stakeholders were involved from Monitoring Drug Record; two-person check of both dose independent second person.

Administration times were documented for 142 dos the onset. recruitment of a clinical pharmacist preparation and administration illustrated in Figure 3. Ten inpatients [n=39; 26%] wereFigure administered insulin by a nurse at the bedside as well as precise 3: Insulin administration patterns administration timing to minimise What number of doses are double checked by hypoglycaemia, hyperglycaemia, 202 an independent second wide glycaemic excursions, and person? diabetic ketoacidosis.

Insulin Prescribing Patterns

Insulin Administration Patterns

Insulin Administration Patterns

More than one in four inpatients were administered insulin by number of doses have been a nurse when What not prescribed.

287 A nurse may only administer administered?

What number of doses with administration a non-prescribed medication in a situation that requires times are documented? immediate intervention in lifethreatening situations and there Figure 3: Insulin administration patterns is no immediate access to an appropriate prescriber. All insulin doses should be prescribed prior Glucose management What number of doses are double checked by to nurse administration.

142

The GUH DM team reviewed/was contacted to review 21 second inpatients insulin drug record [55%, n=38]. Twenty-202 an independent person?

The GUH DM team reviewed or five inpatients [61%; n=41] had changes to their insulin regimen made during their inpatient stay. This was contacted to review more than included changesprescribed to a brand name of insulin [4; n=37; 11%], the initiation of insulin and/or a meal time half of the inpatients insulin.

More than out38%], of five and/or a dose change [9; n=32; 28%; median 3; range 1-6]. Three inpatients had supplement [14;three n=37; inpatients had changes to their their insulin after an episode of hypoglycaemia (blood glucose <4been mmol/L).

What number of doses have insulin regimenomitted made during their inpatient stay including brand of administered? insulin, the initiation of insulin, and dose changes. Three inpatients had their insulin omitted after an episode of hypoglycaemia. This

287

Figure 3: Insulin administration patterns

PHARMACYNEWSIRELAND.COM Glucose management The GUH DM team reviewed/was contacted to review 21 inpatients insulin drug record

18

LifeScan

Improving Diabetes Care Through Technology Written by Mary Feeley Clinical Nurse Specialist Diabetes Integrated Care, North Tipperary/East Limerick Technology is evolving at a fast pace & has become an integral part of diabetes care in Ireland today. Healthcare providers & diabetes patients are harnessing the benefits of a wide variety of technologies such as:

in physical interaction - but patients are increasingly informed, empowered & connected to the internet, they demand a varied, personalised, self-management healthcare system that fits their varied & busy lifestyle.

• connected blood glucose meters,

Nursing requires a cultural shift.

Too often, support for nursing technology to enhance care can be poorly configured, resourced or not up graded in response to practice and societal trends. We need to revisit cultural interpretations of how technology can complement nursing practices & processes, rather than seeing technology as competition or adversaries.

Collaboration with technology developers, providers & all users is essential to ensure success.

Amidst technology, nurses can incorporate practical know-how with empathic understanding and technical knowledge to provide human and sensitive care. Practicing respect, actively listening, committing to taking the time to sit with patients, and establishing trust and transparency will balance the presence of technology while advocating safe, quality care.

• data sharing platforms, • telehealth, • remote monitoring, • continuous glucose monitors, • insulin pumps, • smart phone apps to help improve clinical outcomes.

In general practice & the community setting diabetes technology can be utilised to improve health outcomes. This will be enhanced when the person using is well-informed & actively engaged with the technology.

For our patients with Diabetes, we want to ensure the latest technology & best treatment options are available to them, so quality of life will be enhanced & clinical outcomes will improve.

As health care professionals we want to make informed better care decisions, feel less stress & be able to cope with providing required care to our clients with this chronic condition.

At its core, diabetes is a behavioural challenge, as diabetes management is dependent on the initiation and maintenance of a complex series of behaviours of both the person with diabetes and their healthcare professionals.

Although technological and pharmacological advancements are vital, a new medication or device can only influence outcomes if appropriately prescribed by a healthcare professional and used as prescribed by the person with diabetes.

As a nursing profession we need to reframe how we interact with & care for our clients in a digital world. The sheer volume of health & wellness applications, mobile & social media apps (e.g., wearables, online communities) & virtual healthcare (e.g., telemedicine, virtual consultations) available to patients today is impressive.

All this may seem antithetical towards the traditional nursing role - having a therapeutic relationship

The theory of technologic capability as caring in nursing illuminates the cohabitation of technology and caring with three key nursing processes: 1. Technological understanding: competent use of technology in treating and caring for the patient as a coparticipant.

2. Mutual design: the nurse and patient agree on diabetes a care plan.

3. Participative engagement: shared activities in implementing the care plan and evaluating the patient’s response and outcomes.

People living with diabetes can feel like they are participants in a lifelong science experiment.

Needing to track what they eat and then measure the food’s effect on their blood sugar levels. If you take insulin, you must

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administer the correct amount to compensate for the number of carbs you’ve eaten. If you exercise, this needs to be factor in as well. A variety of technologies and devices exist that can help manage all of this — and it can make a big difference to a person living with diabetes by targeting blood glucose control, medication adherence, weight loss, and enhancing quality of life. Technologies for diabetes are intended to support people with diabetes in their therapy and such technologies must also be accepted and used by them. It is therefore important to know the attitudes, wishes, and needs of patients so that new technologies and digital offerings can be developed to suit them.

Digital diabetes products such as connected devices & digital applications, can provide a more seamless & continuous care for people with diabetes, with the potential to achieve better care efficiency & outcomes.

Technology in practice: A RealWorld Example There are a wide range of devices and supporting Apps available. One such device with a supporting App is an example of digital Diabetes technology that can be utilized in general practice is the OneTouch Reveal® web application. It enables health care professionals to monitor patient progress, offer remote consultations, and allow more effective and informed treatment

decisions between patients and the health care professional The OneTouch Reveal app aggregates data from a OneTouch Verio Reflect® blood glucose meter and provides analytics to help patients and health care professionals visualise glycaemic trends and patterns, enabling more informed treatment and lifestyle decisions.

The app also allows patients and health care professionals to stay connected.

The everyday use of technology empowers people with Diabetes to manage their blood sugar and easily connects them with their Diabetes Care Support team.

An Easy-to-use interconnected diabetes management system changes the way patients see their blood sugar readings and enables nurses, doctors, family, and friends to help them manage their diabetes.

It’s up to us!

Irish Health care professionals need to accelerate the digital health transformation, allowing us to become digitally enabled professionals. How do we do this, we invest in informatic education, practice & research. We also need to upskill in data science & other digital health topics to allow emerging technologies develop that are appropriate & safe for nursing practices & patient care.

We need to invest in and lead digital health developments, collaborate with others to deliver & develop digital tools that we as health care professionals, patients, and the public need.

OneTouch Verio Reflect® meter Discover a simple way to use colours in managing diabetes!

Colours are important, they can signal what’s going on.

With the colour range indicator, it is easy to see if you are below, within or above your range.

The meter provides Insights, Guidance and cheers you on, straight from the meter screen.

OneTouch Verio Reflect® meter: inspired by nature.

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Apple and the Apple logo are trademarks of Apple Inc., registered in the US and other countries. App Store is a service mark of Apple Inc. Google Play and Google Play logo are trademarks of Google LLC. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG. Inc, and any use of such marks by LifeScan IP Holdings, LLC is under license.

Other trademarks and trade names are those of their respective owners. © 2021-2022 LifeScan IP Holdings, LLC. GL-VRF-2100078 (22-004)

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Fadi Almasri

me and my family, try to help the community here, and even to offer jobs for people.

Syrian refugee Fadi Almasri opened the first pharmacy in Ballon, Co Carlow after coming to Ireland with the help of the UN in 2014.

In that short period of just over a year, he has endeared himself and his staff to the whole community.

One nominee told us of how he is extremely obliging and would even deliver medicines to homes if people were under pressure.

“His pharmacy is always very well stocked but importantly the addition of the pharmacy to our village is a very welcome service.

Ballon pharmacy has gone above and beyond in helping out the Ukrainian refugees who have been in our local community centre since April. All the staff at the pharmacy are friendly chatty and extremely helpful.”

Fadiand his family fled their native Syria for neighboring Jordan when the uprising against Bashar al-Assad began in 2011. In Syria, Almasri’s home and pharmacy were destroyed.

He says, ““It’s the time to pay back Ireland,” Almasri said. “It’s time to start a new future here for

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“We have been welcomed with open arms in our community since we opened our doors. I have been overwhelmed with the support of our customers and to receive this nomination for such an important Award has really been the highlight of this entire journey, not just for me but for the whole team.

“What so many people have been saying to me is that it’s so handy to have a pharmacy in Ballon. Now they don’t have to drive to Carlow or Bunclody for their medication, which is so important, particularly for elderly people. I think having things local, particularly during the pandemic, was never more important,” he added.

“I do feel that when you open a business in a community, you have a responsibility to that community, to be part of it and to help support the community.”

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Philippa Beeley Philippa Beeley, known as Pippa to her team and customers at Daarwood Pharmacy in Limerick has been an inspiration and source of enormous help and comfort to so many within her community.

One customer in particular has been overwhelmed with the guidance and advice she has given during a difficult time. A local couple undergoing IVF treatment needed a lot of support from the pharmacy; when they couldn’t manage the necessary injections and treatment needed, Pippa administered them every evening at 6pm without fail, even on her day off – and some morning up until only recently.

The couple approached Pippa at the end of August following their initiation on IVF treatment. ““We were sent away from the fertility clinic with a variety of different medications including different combinations of injections that required reconstruction, some vials and pre-filled pens etc. I was unable to administer the injection myself as I have poor vision and was relying on my partner. He had no previous experience with injections and struggled to follow instructional videos. Pippa helped by providing us with a clean consultation room to administer the injections and taught us her knowledge of injections and reconstitution techniques.

“Through the treatment course, Pippa saw us on a daily basis to provide instruction and support and the result was that my partner learnt how reconstitute and administer

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medications and so far the treatment has been successful.”

They told us in nominating Pippa, “Even though we are now able to manage much of the treatment ourselves, we still visit the pharmacy and Pippa regularly as she has been such a source of inspiration and guidance. So far we are seeing good results which is even more amazing. She has really done such a massive thing for us.

“Pippa never complained, she only got on with it as she knew we couldn’t manage. She really wanted to help.”

Pippa says of her nomination, “I was very pleasantly surprised and honoured to be nominated for this Award.

“I love being a pharmacist as I get to help members of the community and bridge the gap between science, healthcare and lifestyle as well as mentoring pharmacy staff to pass on their knowledge onto our community.

“The team and I strive each day to learn and up skill so that we can offer more to our patients. Being a pharmacist is one of my greatest achievements in life and every day is rewarding.”

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John Tallon

and a medical advisor to so many throughout his pharmacy’s area.

John Tallon is Pharmacist at Bergin’s Pharmacy in Newbridge.

John has become recognisable during the past number of years throughout his community due to his professionalism, compassion and dedicated hard work.

John has also made great efforts in his work with the homeless community, making sure no-one misses out, he has dedicated a huge part of his time to assisting this sector.

“I am a customer of Bergin’s Pharmacy for 30 plus years and Johns care and knowledge has saved my life,” noted his nominee.

“John is a never-ending professional with a true kindness and understanding of complex medical issues. I have witnessed first-hand his dedication to the homeless and less fortunate.

He is shy, non-assuming and has a true vocation to serve his community. We would be lost without him in Newbridge and the surrounding areas.”

Always greeting every customer with a smile and a warm welcome, John has stepped up over and beyond during this pandemic and has been a friend, a counsellor

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John said on being nominated, “I feel incredibly honoured to be even nominated for the People’s Pharmacist Award and delighted to be shortlisted. I was pleasantly surprised to receive such a nomination and the recognition of the entire Pharmacy team at Bergin’s Pharmacy.

“We always try and give 100% to all our customers every day and that they feel that they are our priority at all times.

“I am very proud of all our team and the service they provide to each customer every day and receiving the nomination is fantastic acknowledgement of all the hard work.”

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Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol, caffeine or any ingredients. Precautions: Avoid concurrent use with other paracetamol-containing products. Diagnosed liver of kidney impairment. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels or chronic alcoholism or sepsis. Avoid excessive caffeine intake. Caution in those with hereditary sugar intolerance or on a low sodium diet. Should not be used in pregnancy or lactation without medical advice. Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur or if symptoms persist for longer than 3 days, consult your doctor. Side effects: See SPC for full details. All very rare: Thrombocytopenia, hypersensitivity reactions including anaphylaxis and skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Frequency unknown: Nervousness, dizziness.

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Rebecca Barry

Rebecca Barry, Pharmacist at LloydsPharmacy in Castletroy Shopping Centre, Limerick is one of the most passionate committed pharmacists always going the extra mile in her community for her patients.

One of her many nominees told us, “Rebecca has embraced many services including vaccinations over the past year and has provided both walk in clinics several times a week as well as appointment booking service.

Rebecca is a regular guest speaker on Limerick FM providing insights, tips and advice on a range of health topics from Menopause, Vitamin D, heart health management, smoking cessation, Emergency Contraception to name a few.

“She also provides talks in her local community sharing her knowledge and expertise from mum and baby events, to the Menopause summit. All of these extra services demonstrate how far she is prepared to go to ensure her patients and customers receive the optimum care and attention.”

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Rebbeca told us, “I’m really delighted to have received a nomination for The People’s Pharmacist Award, never mind being shortlisted.

“I try as much as possible to get out talking to my customers; about minor ailments, about their medication, about general pharmacy queries. I think that’s a huge part of what people appreciate about their community pharmacist, the personal touch and the few words of advice, the accessibility to a healthcare professional.

“I really believe that’s part of the reason why we’re at the heart of every community in Ireland, most particularly when it comes to healthcare. Long may this be the case!”

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Derek Haughey Derek Haughey is Pharmacist at Haugheys Pharmacy Dundalk, a small and independent pharmacy located in the Demsense Shopping Centre.

Derek has been nominated by a customer from his local community who has described him as a ‘lifeline’ when it comes to patient care. Not only that, but both he and his team have been described as a pharmacy that not only helps provide knowledge and expertise in abundance, but a warm welcome with an open door; with all team members always happy to take time out of an incredibly pressured and busy day to check in on others and those around them.

Derek’s nominee said, “I have been a customer of Haugheys Pharmacy for many years and, alongside additional members of my family, I have had many prescriptions to be filled. Derek has gone above and beyond, sourcing difficult to get medications, trying to get the longest life possible on epi pens for me and assisting during Covid when times were very challenging.

“When I was prescribed a medication in 2015, Derek wouldn’t dispense it until I carried out a pregnancy test. I was sure it would be negative it wasn’t. That pregnancy was challenging and our beautiful son passed away shortly after birth. We went on to have a little girl a year later. The gentle

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kindness shown by Derek and his staff during those very challenging two years, and since, made us feel cared for and looked after. When we go in, he checks on how we are doing and is just so utterly kind.

He goes above and beyond the call of duty.”

Derek said on being nominated, “It was a tremendous surprise and shock to have discovered I was nominated for the People’s Pharmacist Award. I am of course very humbled by it.

“I have been in business now in Dundalk for over twenty years, and as a result I know almost the entire community, the individuals and the families. As a team we know our customers very well and so we are always striving to do and achieve the best levels of care and service for them.

“We are an independent pharmacy and a small team, with a very loyal customer base, so during Covid we made sure to go that extra distance and strived to do our best to meet everyones needs. We are all in this together.

“The entire team are deeply touched, as am I, to know that we are appreciated for all that we do and will continue to do for our customers and patients into the future.”

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Victoria Jones

Bonnybroook Pharmacy and along with this is our passion in women’s health and all things menopause which drives us every day.

Victoria Jones, Pharmacist with Bonnybrook Pharmacy in Dublin has made huge and measurable difference to the lives of many women in her community.

Bonnybrook Pharmacy specialise in women’s health including Menopause and Victoria is passionate about these topics.

“Our local pharmacist Victoria Jones so knowledgeable and generous with her time,” said one nominee. “She doesn’t just provide the advice she backs it up with research. It is so refreshing to have someone to talk to about female issues who genuinely cares.

“Victoria is so supportive. She invites experts onto her Instagram live sessions to talk about things we have just kept quiet about for years. We need more pharmacists in the community such as Victoria.

She is also now training her staff and the rest of the pharmacy team to be able to offer the same guidance, advice and support.”

Victoria says, “As a small independent pharmacy, making a difference in the community is the essence of why I opened Bonnybrook Pharmacy in 2019.

My passion is to become an integral part of the community and ultimately help our community in any way we can. Kindness is at the forefront of our ethos at

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“Sharing my personal Perimenopause struggle has helped many women in my community. As a woman and a Pharmacist I am in a privileged position to help empower women by giving them the knowledge and tools to aid them on their own hormone journey.

“We use our social media platforms to reach as many women as possible, helping women gain strength from knowledge. Information is power, and reaching women through free, easily accessible social media platforms is a great way for me to help as many women as I can.

“I use my days off and also time in the pharmacy to spread the correct information to women and provide support to my local community.

We try to recommend a holistic approach to health, encouraging not just medicine but health, fitness and nutrition for our patients.

We are blessed to be surrounded by a wonderful supportive community.

Seeing the positive effect myself and my team have on our patients’ lives is the driving force for our continued enthusiasm for what we do.

“This nomination is validation for myself and my teams’ continued hard work and dedication and has made our year!”

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Jennifer Gallagher Jennifer Gallagher of Kildare Pharmacy received an enormous amount of nominations. One in particular that stood out was when she was critical in helping to recently save a patients’ life.

When a customer began having a seizure in the pharmacy, Jennifer dropped everything else that was going on, protected the customer, organised and administered a Buccolam pen and stayed with them until they came round and were feeling better. “She saved my life and I suffered no injuries because of the care Jennifer gave me,” they reflect.

Jenny was shocked by her nomination as she told us, “This was a huge surprise, not something I was expecting at all.

“As a Pharmacist I really enjoy patient engagement; I like making a difference. I think communication is key and there is a great sense of satisfaction when one makes a difference to help a customer/patient.

“Backed by a great team I was able to bring an essential service to the community — vaccination, (covid-19 and flu). There was a huge demand for this service and much needed training and skill incorporated a successful well executed service. Organisation, interpersonal skills and teamwork were essential to this service provision.

a tough few years for everybody, but thankfully we have all pulled through. With illness, staff shortages and supply and demand of essential items not readily available we have managed well.

“During the pandemic Pharmacy was the only patient facing medical service that was readily available to all in need unless hospitalisation was needed of course. GP’s were predominately using phone consultation and in my opinion extra pressure was put on all of us in the Pharmacy to deal with this footfall, I was thankful for a supportive team even though the pressure sometimes was overwhelming.

“The Pharmacy support team are often the first patient contact when entering the Pharmacy. They set the tone for what can be expected of a healthcare service we provide, This nomination recognises the immense effort we have accomplished over the last few years and it is reflects the integral role we play in our community.”

“My team is very important to me and without their help, without a good support network the service would cease. It has been

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Emmett McCann

Emmett McCann is a Pharmacist at Tony Walsh’s Allcare Pharmacy in Merrion Shopping Centre, Dublin. He has been described as a healthcare professional at the heart of the community who always goes ‘above and beyond in terms of service, friendliness and support offered to everyone customers.’

One particular customer was suffering from very low self-esteem following their first child, when their immune system was low. As a result they developed worsening of their psoriasis. Emmett stepped up, took the customer through a private consultation and explained their treatment and management thoroughly.

Furthermore, he advised on vitamins and supplements and offered reassurance, which his nominee describes as ‘invaluable’ and a huge factor in their being able to overcome their ailments.

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“Nearly eight months later and my psoriasis is almost totally cleared.

Not only that but I feel mentally and physically fitter and stronger, and that is all down to Emmett and the extraordinary care I have received from him.”

Emmett commented, “It is an honour to be nominated for The People’s Pharmacist Award. I love what I do and have a real passion for the profession of pharmacy; so to know that my customers are appreciative makes all the hard work very worthwhile. I think any pharmacist can only be as good as the team behind them and we have a great ethos at Tony Walsh’s Allcare Pharmacy of working together for the betterment of the patient. We always try to go that extra mile.

“Pharmacy can often be the underdog of the health services and this Award truly gives the public the opportunity to demonstrate how they feel about the services and care we provide.

My priority is for my customers, making sure they have access to the care and medicines they need; and to be on hand for important advice and direction. To receive this acknowledgment and recognition is fantastic for me, the team and for our community.”

McLernons are pleased to announce their latest module MPS Script Finder, our fully integrated storage solution, and it has already been described as ‘A Game Changer’ by one of its early adopters.

Continuously Working for Pharmacists

Script Finder

One of the many changes imposed upon community pharmacy during the Pandemic was finding a new way to handle, process and store large volumes of dispensed medication. The introduction of Healthmail allowing prescriptions to be sent ahead of the patient presenting in pharmacy has meant the number of dispensed and bagged medication has multiplied – yet the physical size of your premises has not changed.

The McLernons ‘Script Finder’ Solution allows the MPS user to print a storage location label for each area, and these can be assigned to specific storage spaces such as the fridge, the CD cabinet, shelves and other areas within your pharmacy. By efficiently storing your patient’s dispensed and bagged prescriptions, you increase the productivity of your pharmacy staff, reduce the length of time that patients spend queuing in your premises. The system can also automatically text the patient if they’ve forgotten to collect within a number of days, this can help with the challenges of compliance.

However, don’t take our word for it – this is what one of our community pharmacists had to say, “Now we don’t need to send individual texts anymore and staff are able to find bags in a fraction of the time – this is a real game changer.”

Piero Cambursano, Newtownpark Pharmacy, Dublin Another added, “Script Finder completes the circle for dispensing, and empowers the team in the front of shop whose role changed so dramatically during the pandemic. We are educating customers to wait for their text message to advise their script is ready for collection, and it has taken a lot of stress out of dispensing.”

Michael Joe Cooper, Coopers Pharmacy Group, Belfast We have designed this storage solution in such a way that it involves minimal staff training, requires no new storage yet will vastly improve the way that you and your team manage the storage of bagged items.

The only hardware required is a wireless scanner, and it can be run on your main dispensing system, at the till if MPS is enabled, or on a tablet, and is available at an annual licence charge of ¤495. For further information please contact us on scriptfinder@mclernons.com

Winter Planning in Pharmacy

The 2022 Winter Health Index from LloydsPharmacy has shown a lack of concern from the Irish public towards the flu ahead of the ‘twindemic’ COVID-19 and winter flu season. The concern follows the latest trends seen in Australia where the winter flu, combined with COVID-19 led to a difficult winter for the health service. It is often observed that winter flu difficulties experienced in Australia are replicated across Europe in the months that follow. This year, Australia saw the flu virus affecting all age groups, and not just the elderly or vulnerable.

Research commissioned by LloydsPharmacy shows 71% of Irish adults aged 35-44 intend to either not go for flu vaccination or are still unsure, despite the evidence of the flu vaccination playing a vital role in keeping people well and healthy during the tough winter months. This article takes a brief look at what pharmacy teams need to be aware of when presented with the cold & flu patient in store this year.

The number of people turning to over-thecounter cold remedies continues to increase year-on-year. Sales of decongestants, lozenges and cough mixtures are also rising.

generally associated with the common cold and the seasonal flu. For many patients, especially those taking prescription medications and those with other medical conditions, the selection of OTC products is overwhelming. Pharmacists can be an indispensable resource when it comes to aiding patients in the selection and proper use of these products and can also refer patients to seek further medical care from their GP when warranted.

When speaking to customers, pharmacists may also be able to help patients in distinguishing between cold and flu symptoms (Table 1), and they should always seize this opportunity to remind patients about the safety and efficacy of the annual flu vaccination.

Common Cold The term “common cold” is widely used to describe an upper respiratory tract infection of viral origin. Adults in general suffer from cold approximately two to four times annually while children can contract the virus three to eight times as their immune systems aren’t as developed.

With increasing encouragement from GPs not to attend practices for common seasonal symptoms, it is more important than ever for pharmacists to stock a wide range of products, including. Consumers can then treat cold and flu symptoms at home rather than visiting their GP.

Distinctive symptoms means that people often diagnose and treat themselves through a combination of self-care and OTC products, without needing to go to the doctor. If there is no improvement then an appointment with a doctor should be arranged. A GP can do an investigation to rule out whether the symptoms are being caused by a more serious infection, such as pneumonia or glandular fever.

During this time of year, many patients are likely to seek advice regarding the proper selection to treat and manage the symptoms

All members of staff should be trained up on when to refer a patient for further medical attention, especially if they present with cold or

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flu-like symptoms that are accompanied by any of the following: high fever, vomiting, a nonblanching rash, photophobia, severe headache and/or confusion. Children presenting with high-pitched screaming, floppiness, bulging fontanelle, convulsions or stiff neck should go straight to A&E. There is no cure for a cold, but certain measures can be taken to improve comfort levels while the virus dissipates: decongestants, antihistamines and pain relievers might offer some relief from symptoms however they won’t stop a cold from developing and will not shorten its duration. Vitamin C is useful for people in high risk groups who are at high risk of colds due to frequent exposure — for example, nurses or pharmacy staff. Echinacea and Zinc may also benefit patients during the cough and cold season Influenza is the winter ailment most likely to drive sufferers to the GP or to A&E, and nearly half of them will require antibiotics.

The European Commission estimates that the seasonal flu vaccine prevents somewhere in the region of 37,000 deaths per annum in Europe.

Pharmacists have been authorised to administer the flu vaccine, once appropriately trained, since October 2011. The uptake on the flu vaccine has increased every year since and research from the NHS has shown that people are more likely to avail of the flu vaccination service if it is convenient, quick and locally available.

As the vaccine can only be developed once the virus has been identified (which can take months), the European Commission and the European Medicines Agency work together to “speed up the marketing authorisation procedure once a pandemic has been declared”.

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Food supplements do not replace a varied, balanced diet and a healthy lifestyle. Always read the label carefully.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system HPRA Pharmacovigilance, Website: www.hpra.ie Adverse reactions/events should also be reported to the marketing authorisation holder at email address: pv.ireland@viatris.com or phone 0044 (0) 800 1218267.

Viatris, Newenham Court, Northern Cross, Malahide Road, Dublin 17, Dublin, Ireland. www.viatris.ie Job code: COL-2022-0005 | DOP: August 2022

In order for the flu vaccination programme to maintain its ongoing success, there must be a high level of uptake among those aged sixty five years and older. At risk groups should also be targeted by pharmacy teams and the EU urges member countries to commit to vaccinating 75% of at risk groups each year.

Those most at risk of developing serious complications from the flu virus include the youngest and the oldest, pregnant women, persons with a BMI over 40, patients with pre-existing long term conditions such as heart, kidney, liver, neurological disease or diabetes, smokers, and patients who are immunosuppressed or immunocompromised.

It can also disproportionately affect people with Down syndrome and the virus is known to spread quickly in congregated settings, such as nursing homes or supported living environments. The HSE estimates that over one million people should be vaccinated in Ireland for the programme to be fully effective.

From the flu vaccine to OTC remedies to prescription antibiotics, winter is a good time to drive home the message that the local pharmacy is a one-stop-shop for all those seasonal ailments.

Effective Planning The changing season brings opportunities to re-organise your store, to rearrange fixtures and fittings and to develop a clear merchandising plan featuring beacon brands in both the P and GSL sections. Planograms are helpful guides that can be used to assist with arranging retail

shelves to help maximise front-end sales. These visual plans, that are backed by research, show exactly where in the store certain products should be placed and they indicate the products that will increase profits and move quickly.

Store plans also show how products should be arranged based on the general categories and subcategories with the most profitable products typically going onto the shelf at eye level, known as the ‘cone of vision’. Products that shoppers seek out no matter where they are, called destination items, can go on shelves outside of the cone of vision.

Have a look at the shelves that are devoted to winter remedies, both on the shop floor and on the medicines counter, and ask yourself the following questions: • Is it clear to customers and staff which products are suitable for children and which are for adults only?

• Are your staff up-to-date and clear on the risk of analgesic overdose due to combination products?

• Are staff aware of the sales restrictions for certain decongestants?

• How could you make this fixture easier to understand and navigate?

• Are all staff clear on the symptoms that should ring an alarm bell if mentioned by a patient with a cough, cold or flu?

• Are details about your flu vaccination service clearly displayed?

Symptoms

Flu

Cold

Runny nose or nasal congestion

Rare

Common

Sneezing

Rare

Common

Sore throat

Common

Common

Fever

Common

Rare

Temperatures between 38°C and 40°C Sudden onset Cough

Common

Common

Sudden onset Mild or moderate Headache

Common

Rare

Sometimes intense Aches and pains

Fatigue

Common

Rare

Sometimes intense

Mild

Common

Common

Intense

Mild

Duration: a few days, sometimes longer Nausea and vomiting

Common in children

Rare

Rare in adults

Mild

Often accompanied by diarrhoea and abdominal pain in children

32 | PHARMACYNEWSIRELAND.COM

HSE’s Winter Vaccination Programme The HSE’s winter vaccination programme is now underway with the roll out of the free flu vaccine to recommended groups, while those aged over 65 and all aged 12 and over with a weak immune system are invited for their next COVID-19 vaccine.

Last month also marked the rollout of the adapted bivalent vaccines. Three adapted bivalent mRNA COVID-19 vaccines have been recommended for use for booster vaccination by the National Immunisation Advisory Committee (NIAC), following approval by the European Medicines Agency.

Minister for Health, Stephen Donnelly TD said, “As the weather becomes cooler and the nights become darker, all of our thoughts turn to how best we can protect ourselves and our loved ones from the worst impacts of COVID-19 and other respiratory viruses that circulate at this time of year. I welcome today’s roll-out of the HSEs winter vaccination programme that will facilitate booster doses of COVID-19 vaccine and seasonal flu vaccines being administered at the same time in GPs and Pharmacies.

“15 Vaccination Centres across the country are also continuing to provide COVID-19 primary vaccines and 2nd and 3rd booster doses this winter.

We know that vaccines offer good protection from both COVID-19 and seasonal flu and urge everyone eligible to avail of this opportunity as soon as possible.”

Dr Aparna Keegan, Specialist in Public Health Medicine, HSE National Immunisation Office, adds,“This winter, both the flu and COVID-19 viruses are expected to circulate. It is very important that all those who are invited get both their free flu vaccine and COVID-19 booster vaccines. Flu and COVID-19 are caused by different viruses but both can cause serious illness. The flu vaccine does not protect against COVID-19. That is why it is important that if you have had a COVID-19 vaccine you should still get your free flu vaccine. Both Flu and COVID-19 vaccines will be available from participating GPs and Pharmacies and can be given at the same time.”

COVID-19 primary and booster vaccines for people aged 12 or over are also available in the 15 vaccination centres across the country.

From October 17th the children’s flu nasal spray vaccine will also be available free for all children aged 2 to 17 years from GPs and Pharmacies.

IRELANDS

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Buttercup Bronchostop Cough Syrup contains thyme herb extract and marshmallow root extract. A traditional herbal medicinal product for the relief of coughs, such as chesty coughs and dry, tickly, irritating coughs and catarrh, exclusively based upon long-standing use as a traditional remedy. Adults and children over 12 years: 15ml every 4 hours, 4 times per day. Max 6 doses (90ml) per day. Max dose should not be exceeded. To be taken 30 to 60 minutes before or after intake of other medicines. Not recommended for children under 12 years. To be administered undiluted or diluted in water or warm tea. Seek medical advice if symptoms persist after 7 days or if dyspnoea, fever or purulent sputum occurs. Contraindications: Hypersensitivity to marshmallow root, thyme, to other members of the Lamiaceae family or to any of the excipients. Warnings and precautions: Asthmatics and atopic patients should consult a doctor before using the medicine. Contains E218 and E216 that may cause allergic reactions (possibly delayed). Patients with HFI, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take themedicine. The additive effect of concomitantly administered products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be considered. Pregnancy and lactation: Not recommended. Side effects: pruritus, rash, urticaria, angioedema, anaphylactic reaction, oral mucosal blistering, abdominal pain, diarrhoea, nausea, vomiting, dyspnoea, exacerbation of asthma.

Legal classification: GSL. TR 2006/001/001.TR Holder: Kwizda Pharma GmbH, Effingergasse 21, A-1160 Vienna, Austria. RRP (ex VAT): €4.99 Date of preparation: 05/2022. SPC: http://www.medicines.ie/medicine/16380/SPC/Buttercup+Bronchostop+Cough+Syrup/ Bronchostop Junior is a medical device according to Directive 93/42/EEC, used to relieve any cough (dry & chesty) associated with a cold for children from 1 year. Children under 3 years of age should consult with a doctor to exclude more serious diseases being present. Use in children under 1 year of age is not recommended. Children aged 1 year and above: 5ml up to 3 times daily. Children 2 to 3 years: 5ml up to 4 times daily. Children 4 to 5 years: 7.5ml up to 4 times daily. Children 6 to 11 years: 15 ml up to 4 times daily. Always read the Instructions for Use. Date of preparation: 05/2022.

Date of preparation: August 2022. IRE/BRO/2022/37

34

Sore Throat

Sore Throat Management in Pharmacy Sore throat is a common presenting symptom in primary care. A systematic review from 2019, including data from primary care patients across twelve countries, found that sore throat was the fourth most common reason for presentation.1 It is a symptom that disproportionately affects children and younger adults, with incidence declining from the age of forty onwards.2 Written by Dr Muireann de Paor Specialist Registrar in Public Health Medicine Muireann de Paor graduated from Medicine in UCC in 2005 and completed GP vocational training in 2011. She has worked in clinical and academic general practice up to recently, and has now started specialist training in Public Health.

Sore throat can be caused by a number of pathogens; viral (5080% of cases), bacterial (10-20%), or fungal (<1% of cases), and from non-infectious causes e.g., gastroesophageal reflux disease or allergic rhinitis.3-5 The patient’s history can help differentiate infectious from non-infectious causes, and the patient’s age is an important aspect of this.

However, the causative pathogens of cases of acute sore throat can be difficult to distinguish clinically.

Viral causes (e.g. rhinovirus, adenovirus, coronavirus, EBV) can often be associated with other features of an upper respiratory tract infection (URTI) e.g. cough, coryza and fatigue.6 Clinical condition: sore throat caused by Group A Beta Haemolytic Streptococcus (GABHS) GABHS is the most common bacterial cause of acute sore throat, estimated to cause approximately 5-15% of adult cases of sore throat in developed countries, and higher rates in less developed countries.7 A systematic review from 2000 found rates of between 10-36% of GABHS in adults and children presenting with sore throat.8 Clinical Features A systematic review of nine studies concluded that the most predictive signs and symptoms of GABHS were: presence of tonsillar or pharyngeal exudate, exposure to GABHS infection in

the previous two weeks, history of fever, and the absence of tender anterior cervical nodes, absence of tonsillar enlargement, or exudate, and absence of cough.8 No single symptom or sign was deemed predictive enough to rule in or rule out GABHS sore throat on its own.

GABHS sore throat is usually a self-limiting condition; and generally resolves spontaneously (even without antibiotic intervention) by about 7-10 days.8 However, complications can rarely include sinusitis, otitis media, peritonsillar abscess, rheumatic fever and glomerulonephritis.

GABHS carrier state Asymptomatic carriage of GABHS is frequent, especially in children.

A 2018 systematic review which examined rates of GABHS carriage found a rate of 2.8% of carriage in adults (based on 12 included studies), and 8.0% in children (based on 46 included studies).9 Because of the overlap of symptoms, patients with acute viral sore throat who have a positive throat swab for GABHS may just be carriers of GABHS and receive antibiotics inappropriately.

Diagnosis and management Clinical prediction rules ‘Clinical prediction rules’ (CPRs) or ‘clinical decision rules’ are clinical tools that calculate the independent influence of factors from a patient’s history, clinical examination and diagnostic tests, and stratify patients according

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to the probability of having the disorder of interest.10 CPRs are progressively more being used to aid in the diagnostic process and subsequent clinical management decisions.11 They are often used to help clinicians refine their diagnosis or to ‘rule in’ or ‘rule out’ certain conditions depending on the setting in which they are used and the condition they are used for.12 In primary care they are particularly helpful in ruling out conditions of interest or when adopting an expectant approach to management.

from acute infection.18,19 Another disadvantage of the throat swab is that it typically takes more than 24 hours, and often takes several days to obtain the result.

A variety of clinical prediction rules (CPRs) exist to aid in the diagnosis and management of GABHS sore throat, the originally CPR being the Centor score.13 The four elements of the Centor Criteria are tonsillar exudate, anterior cervical lymphadenopathy, fever, and absence of cough. A variation of the Centor score which was developed in the UK in a larger derivation cohort and was deemed to perform better at identifying people at low risk of diagnosis of streptococcus is the FeverPAIN score.14 The FeverPAIN score uses the five variables: fever in past 24 hours, absence of cough or coryza, symptom onset ≤3 days, purulent tonsils and severe tonsil inflammation. The FeverPAIN score can be used for diagnosis of group A, C or G GABHS infection.

Rapid antigen detection testing (RADT) for GABHS is used in some clinical settings and is currently used more frequently in the USA than in the UK and Ireland. These tests provide a quick indication to the clinician about the presence of GABHS, usually giving a result within 15 minutes. In symptomatic people, they have a sensitivity of approximately 85% and a specificity of 95%, which may make them more appropriate for use as a ‘rule in’ test.20,21 However, they cannot provide information about any other potential bacterial causes of sore throat, which may be identified on the result of a throat swab culture. A recent study piloting pharmacists’ use of RADT to test and treat GABHS in Wales resulted in a small reduction in prescriptions for phenoxymethylpenicillin.22 This was based on 1725 consultations in 56 pharmacies.

The pharmacists used a minimum Centor score of 2 or a FeverPAIN score of 1 to offer RADT. Using RADT for diagnosis, 28.2% of participants had positive tests for GABHS and 27.4% of participants were supplied with antibiotics.

Question 1: Does a throat swab improve diagnostic accuracy for GABHS? Most international guidelines do not currently recommend throat swab for diagnosis of GABHS sore throat. However, for research and occasional diagnostic purposes, the reference standard for diagnosis of GABHS is by throat swab culture, despite several issues.15 This test has a sensitivity of approximately 90%,according to studies that used duplicate throat culture testing.16 Other advantages are its low cost, acceptability to patients, and the fact that the culture can identify other causative pathogens and guide antibiotic sensitivities.17 However, throat swab culture results can be controversial, as it cannot distinguish carrier state

Point of care tests (POCT) / near patient tests / rapid antigen tests are tests (blood / urine / swab) that are performed during a patient’s consultation. They are generally used to detect the presence of a pathogen or an inflammatory marker and they are used as clinical decision aids in some settings.

The gold standard reference test for GABHS is considered to be serial serum sampling for antistreptococcal antibodies; namely antistreptolysin O titre (ASOT) and antideoxyribonuclease B (ADNaseB). The combination of these two antibodies gives results for GABHS at a sensitivity of 96% and specificity of 89%.23 However, this is rarely used in practice due to cost, delay and inconvenience for patients and clinicians.

practice due to cost, delay and inconvenience for patients and clinicians.

35

Table 1: comparison of available tests for GABHS Table 1: comparison of available tests for GABHS

RADT= rapid antigen detection testing POCT= point of care testing

Question 2: Do antibiotics improve symptoms and reduce the risk of complications?

A large UK primary care study from 2018 found that sore throat is the condition associated with the highest frequency of inappropriate antibiotic prescribing.24 A 2021 Cochrane review examining the effects of antibiotics for sore throat (from any aetiology) included 29 trials and 15,337 adults and children with sore throat. The systematic review found that antibiotics provided a modest reduction in the risk of being symptomatic with sore throat (along with headache) and also of developing suppurative and non-suppurative complications.25 In terms of symptom reduction, the number needed to prevent one sore throat was <6 at day three (but 3.7 for those with GABHS on throat swab) and increased to 18 overall at day seven. They reported that 82% of patients in the control groups are symptom-free by one week (without antibiotic treatment).

The authors commented that the number needed to treat for a beneficial outcome might be lower in low-income countries, or in socioeconomically deprived areas of high-income countries, where complications such as

Test Throat swab culture

Sensitivity (ref) 90-95% 15

Specificity (ref) 95-99% 15

Turnaround Time Lab: 2-5 days

RADT for GABHS

85% 20,21

95% 20,21

POCT: 15 mins

Antistreptococcal antibodies

96% 23

89% 23

Serial testing over weeks

A set of 2001 guidelines from acute rheumatic fever are more The Nationaland Institute for Health 1.1.1.2 Do antibiotics improve symptoms reduce the risk of complications? and Care Excellence (NICE) in the the USA (recommended by the widespread. There are obvious UK and Scottish Intercollegiate American Academy of Family drawbacks of prescribing Guidelines Network (SIGN) in (AAFP), the American antibiotics; antimicrobial A large UK primary care study from 2018 found that sore throat isPhysicians the condition associated Scotland have similar guidelines College of Physicians–American resistance, side effects of the in relation to the management of Society of Internal Medicine (ACPmedication (including allergy), of inappropriate antibiotic prescribing.24 A 2021 Cochrane with the highest frequency sore throat.29,30 Both recommend ASIM) and Center for Disease costs. Another unwanted outcome against the use of throat swab.

Control (CDC)), recommend is that the usually self-limiting Both recommend using the combining the Centor score CPR presentation of sore throat FeverPAIN or Centor score CPR. with rapid antigen testing to guide becomes ‘medicalised’, resulting in The NICE guidelines recommend diagnosis.18 increasing presentation to the GP not to offer an antibiotic at Centor for future episodes.26 Duration of antibiotic therapy score levels of 0,1 or 2, and to consider an antibiotic at levels International guidelines for A study from 2019 found that 3 or 4. The SIGN guidelines management of sore throat Penicillin V four times daily for five recommend not to use antibiotics days was non-inferior in clinical for sore throat but that ‘antibiotics Many countries have their own outcomes to penicillin V three should not be withheld’ in severe guidelines for the treatment of sore times daily for ten days, in patients cases. First line recommended throat, some of which with their with GABHS sore throat.32 There is antibiotic is the NICE guideline most up to date recommendations no Cochrane review on this topic is phenoxymethylpenicillin 500 are summarised below. in adults, although the equivalent mg 4 times a day or 1000 mg review focussing on children twice a day for 5 to 10 days The Health Service Executive under 18 with GABHS sore throat and in the SIGN, guideline is (HSE) in Ireland issues guidelines found that shorter courses of phenoxymethylpenicillin 500 mg 4 in relation to antibiotic prescribing oral antibiotics (3-6 days) had 27 times a day for 10 days. for sore throat. The advice does comparable efficacy compared not mention using throat swab to the standard 10-day course of European Society for Clinical for diagnosis. They advise that oral penicillin.33 Current sore throat Microbiology and Infectious most people with sore throat do guidelines from Ireland recommend Diseases (ESCMID) guidelines not benefit from antibiotics and a 5 day course of antibiotics, and from 2012 suggest using rapid recommend using the FeverPAIN the UK guidelines recommend a antigen testing if Centor score is scoring system to aid decisions 5-10 days course of antibiotics, 3-4 but advises that the clinical about antibiotic prescribing.28 when they are indicated. Many of utility of the Centor score is lower First line recommended antibiotic the international guidelines have in children because of the differing is phenoxymethylpenicillin 666mg not been updated to reflect this presentations of sore throat in the recent research. (or 500mg) 4 times daily for 5 days. early years of life.31

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36

Sore Throat

Table 2: comparison of guidelines for the diagnosis and treatment of GABHS sore throat Guideline

Diagnostic criteria

When to initiate antibiotic treatment

Recommended first line antibiotic

HSE (Ireland) 2021

Clinical and CPR (FeverPAIN score).

Score 2-3: Offer delayed antibiotic.

Score 4-5: Offer immediate antibiotic prescription.

Phenoxymethylpenicillin 666mg (or 500mg) four times daily for 5 days.

NICE (United Kingdom) 2019

Clinical and CPR (FeverPAIN or Centor score).

FeverPAIN score 4 or 5, or Centor score 3 or 4: Consider an immediate antibiotic or a back-up antibiotic prescription.

Phenoxymethylpenicillin 500 mg four times a day or 1000 mg twice a day for 5 to 10 days.

SIGN (Scotland) 2010

Clinical and CPR (FeverPAIN or Centor score.

Antibiotics not to be used routinely. In severe cases, where there is concern about Throat swabs not to be the clinical condition conducted routinely. of the patient, They may be used to antibiotics should not establish pathogenicity be withheld. of recurrent severe episodes in adults when considering referral for tonsillectomy.

Phenoxymethylpenicillin 500 mg four times a day for 10 days.

ESCMID (European) 2012

Clinical and Centor score CPR

Penicillin V, twice or three times daily for 10 days.

ACP-ASIM (USA) 2001

Clinical and Centor score CPR. Perform RADT only if Centor score is 2–3

Antibiotics not to be used in less severe cases e.g., 0–2 Centor criteria. In more severe cases, e.g., 3–4 Centor criteria, physicians should consider discussion of the likely benefits with patients.

Centor score of 4 or RADT or throat culture positive.

Penicillin V, 500 mg twice or three times daily for 10 days.

RADT = rapid antigen diagnostic test

RADT = rapid antigen diagnostic test

A summary of some of the most recent guidelines is presented in Table 2.

The surprising differences between guidelines (which should be based on the same underpinning best evidence) has been the case with clinical guidelines for other conditions also. Explanations given for the variations have

included insufficient evidence, different interpretation of the evidence, unsystematic guideline development, influence of professional societies, patient preferences, cultural factors and societal factors.34 The WHO has recommended a systematic process incorporating nineteen key components to ensure that clinical

PHARMACYNEWSIRELAND.COM

guidelines are based on best available evidence.35 Corticosteroids for sore throat A BMJ ‘rapid recommendation’ article from 2017 gave a weak recommendation to use a single dose of oral steroids in cases of acute viral or bacterial sore throat, regardless of severity, for patients aged five and

Table 2: comparison of guidelines for the diagnosis and treatment of GABHS sore throat

older (excluding those patients in whom IM is suspected or immunocompromised patients, as these were not included in the systematic review on which the recommendation was based).36 The systematic review of the available evidence included a RCT published in April 2017, which included over 500 primary care patients.37,38 The recommendation was stated as ‘weak’ because of the modest reduction in patients symptoms (intensity and duration of sore throat), and because of variability in patient preferences; shared decisionmaking is recommended.

Conclusion The literature demonstrates that there is a direct link between attendance rates for primary care physicians and antibiotic prescribing, and that the threshold to interact with a GP is lowered by telemedicine.39-41 With the advent of the Covid-19 pandemic, increasing use of telemedicine, and huge pressures on all aspects of the health service, clinicians should be mindful of the risks of overprescribing of antibiotics.

In terms of guidelines for the diagnosis and management of sore throat, and in light of increasing antimicrobial resistance, it seems prudent to adopt the guidelines of the HSE, NICE and SIGN, incorporating a CPR (rather than throat swab or RADT) to aid in diagnosis, and reduce antibiotic prescribing. It is likely that most patients would benefit more from sensible self-management advice, with safety netting systems in place in case of deterioration.

The literature demonstrates that antibiotics are of minimal benefit in sore throat, even when GABHS is present.25 References available on request

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38

Sore Throat

Sore Throat vs Strep Throat Sore throat (also called pharyngitis) is typically caused by a viral or bacterial infection. An estimated 200 to 300 different strains of virus cause colds and sore throat.

Some of the signs of strep throat will be visible. They may include • white patches on the tonsils or throat, • dark red splotches or spots on the roof of the mouth, and • a skin rash.

Those white spots are pus pockets. In addition, some patients may exhibit swollen, tender lymph nodes in the neck and some with fever above about 101-102 F. The signs and symptoms are the same for both children and adults.

In up to 90% of cases, sore throat is caused by viruses linked to the common cold or flu. The other 10% of cases result from bacterial infections or some other medical condition. The bacteria that most commonly cause sore throat are streptococci. Infection with streptococcal bacteria is commonly called strep throat.

Finding relief is a top priority for anyone experiencing the pain and discomfort often associated with a sore throat, or pharyngitis.

Patients complaining of a sore throat may present with symptoms such as difficulty swallowing accompanied by pain, tenderness, irritation, or swelling in the throat. In addition, depending on the cause, patients may present with fever, headache, white patches in the throat or tonsils, red or swollen tonsils, and a general feeling of malaise.

Although a host of conditions and factors can cause a sore throat, the majority of cases are caused by cold and flu viruses.

Sore throats are typically the first symptom noted at the onset of a cold, followed by nasal symptoms. Sore throats caused by viruses usually resolve on their own within a few days.

Strep throat is the most common cause of bacterial infections of the throat.

• Sore throat (viral pharyngitis): Viruses are the most common cause of sore throat, including rhinoviruses or a respiratory syncytial virus. These viruses can cause other symptoms, such as: o a cold o earache o bronchitis o sinus infection

Although these signs may indicate strep, a visit to their GP is necessary to make a full determination. A full diagnosed is impossible by visual signs alone.

Adults are less likely to have this disease than children. For schoolage children, their odds of a sore throat being strep are about 20% to 30%. For adults, the odds are more like 5% to 15%.

Although the majority of sore throats resolve without treatment, various OTC products—including sugarfree formulations—can

provide symptomatic relief. In general, the selected treatment depends on the cause of the sore throat.

These products may contain local anaesthetics, such as benzydamine, which provides temporary relief of sore throat pain. OTC products are formulated as lozenges and throat sprays and may be used every 2 to 4 hours as needed.

Some products also contain local antiseptics (eg, cetylpyridinium chloride or hexylresorcinol) and/ or camphor or menthol.

Difflam is an anti-inflammatory and painkilling medicine, which acts fast and is most effective.

It reduces pain and discomfort associated with sore throat or mouth conditions such as ulcers and sore throat.

Swollen lymph nodes under the chin and the front of the neck could indicate any kind of infection. They could accompany an ear infection or sinus infection, for example.

Condition

Symptoms

Throat Appearance

Healthy Throat

A healthy throat should not cause pain or difficulty swallowing

A healthy throat is usually consistently pink and shiny.

Some people may have noticeable pink tissue on either side of the back of their throat, which is usually the tonsils.

Sore Throat

Cough, runny nose, or hoarseness that changes the sound of a person’s voice. Some people may also have conjunctivitis or pink eye symptoms. Most people’s symptoms subside within a week or two, but are usually mild and not accompanied by a high fever.

Redness or mild swelling.

Strep Throat

Fast onset with pain when swallowing, fever greater than 101°F (38°C), swollen tonsils, and swollen lymph nodes.

Swollen, very red tonsils and/or white, patchy areas on the tonsils or in the back of the throat. Sometimes, the throat may be red with moderate swelling.

The following are some of the most common sore throat causes: • Strep throat: The bacteria group A Streptococcus is the most common cause of strep throat.

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CPD: Overactive Bladder Continuing Professional Development

CPD 60 Second Summary Overactive bladder (OAB) is a common chronic condition associated with voiding dysfunction. The underlying OAB pathophysiology is overactivity of the detrusor muscle, which is a smooth muscle found in the wall of the bladder that contracts during urination.

Because urinary urgency and incontinence symptoms can be difficult to objectively characterise for research and clinical purposes, many studies of OAB treatments have used other measures (number of daily micturitions or incontinence episodes) to enable quantification of treatment response.

Often, patients have been living with OAB symptoms for substantial lengths of time, only seeking treatment when symptoms become particularly problematic. Diagnosis of OAB is made based on symptoms of daytime urinary frequency and urgency, potentially occurring with urge incontinence.

Taking a clinical history is important, i.e. symptoms, aggravating/alleviating factors, 24 hour incontinence pad use.

Physical examination of the genitourinary system, prostate assessment in men and vaginal examination in women should be performed.

There are multiple guidelines for management of OAB such as those from the National Institute for Health and Care Excellence (NICE), European Association of Urology (EAU) and American Urological Association (AUA), which are generally in agreement with each other in terms of the type of stepwise approach to use. This stepwise approach should be tailored to the patient’s needs: they do not necessarily need to go through every step in the set order.

41

AUTHOR: Donna Cosgrove PhD MPSI Donna graduated with a BSc in Pharmacy from the Royal College of Surgeons in Ireland.

She then returned to university to complete a MSc in Neuropharmacology. This led to a PhD investigating the genetics of schizophrenia, followed by a postdoctoral research position in the same area. Currently Donna works as a pharmacist in Galway, and as a clinical writer.

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

knowledge gap - will this article satisfy those needs - or will more reading be required?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

3. PLAN - If I have identified a

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the

4 previous steps, log and record your findings.

Published by IPN. Copies can be downloaded from www.irishpharmacytraining.ie Disclaimer: All material published is copyright, no part of this can be used in any other publication without permission of the publishers and author.

Managing Symptoms of Overactive Bladder Introduction Overactive bladder (OAB) is a common chronic condition associated with voiding dysfunction.1 The underlying OAB pathophysiology is overactivity of the detrusor muscle (Figure 1), which is a smooth muscle found in the wall of the bladder that contracts during urination.

OAB is often (not always) linked to detrusor muscle overactivity on urodynamic evaluation.2 It is defined by the International Continence Society as “urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary incontinence (OAB-wet) or without (OAB-dry), in the absence of urinary tract infection or other detectable disease”.3 Urinary urgency is the “complaint of a sudden, compelling desire to pass urine which is difficult to defer”.4 Some women may also experience urine leakage during sex.5 It is a very common condition, affecting 16.6% of people in Europe; and in the US, estimates suggest a prevalence of up to 43% in women and 27% in men over 40. It is more common in women, and with increasing age.6 The prevalence of OAB Asian populations has been reported to be lower than that in other races in both men and women. The disorder reduces health-related quality of life (QoL) and results in a significant economic burden on society.1

 Reduction in caffeine and liquid intake  Pelvic floor exercises  Bladder retraining  Medication  Surgery  Botox Because urinary urgency and incontinence symptoms can be difficult to objectively characterise for research and clinical purposes, many studies of OAB treatments have used other measures (number of daily micturitions or incontinence episodes) to enable quantification of treatment response. Although highly variable (depending on sleep, fluid intake, and medical conditions, among other things), up to seven micturition episodes during waking hours is considered normal.

When a patient presents with troublesome symptoms of daytime and nighttime urinary frequency and urgency, this commonly leads to a diagnosis of OAB.4 OAB can be idiopathic or secondary to a neurological cause e.g. Multiple Sclerosis, Parkinson’s disease.4 Idiopathic OAB can be due to an obstruction or have no obvious contributing pathology.

Men are more likely to have OAB dry (without incontinence), and women are more likely to have wet (with incontinence). It is likely to be significantly underreported and therefore significantly undertreated.2 The guidelines and treatments discussed here generally refer to idiopathic OAB, excluding the management of neurological OAB.

Figure 1. Overactive bladder7

The following lifestyle changes and treatments may help with OAB:5  Losing weight if overweight

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42

CPD: Overactive Bladder

Diagnosis Often, patients have been living with OAB symptoms for substantial lengths of time, only seeking treatment when symptoms become particularly problematic.

Diagnosis of OAB is made based on symptoms of daytime urinary frequency and urgency, potentially occurring with urge incontinence (6). A simple 3-day voiding diary, completed by the patient, outlining voiding frequency, timing, and fluid intake can aid with quantifying frequency and nocturia. The identification of excessive or poorly timed fluid intake can guide behavioural recommendations.2 Haematuria and infection should be ruled out (by dipstick urinalysis initially). Taking a clinical history is important, i.e. symptoms, aggravating/alleviating factors, 24 hour incontinence pad use.

Physical examination of the genitourinary system, prostate assessment in men and vaginal examination in women should be performed.6 Imaging is not required unless a urinary obstruction is suspected. Urodynamic testing, to evaluate bladder function, is a technique that involves passing a thin tube into the bladder and another one into the rectum to measure bladder activity and episodes of urinary incontinence.

Patients often find this uncomfortable, and some people develop cystitis after the test.8 Detrusor overactivity identified through urodynamic testing tends to be more common in men and those with wet OAB (69% men in cases of dry OAB compared to 44% women; 90% men in wet OAB compared to 58% women).6 Urodynamic testing is an invasive procedure, and currently guidelines recommend that its use should be limited to those with refractory OAB. A clinical trial investigating the utility of urodynamics for advising on OAB treatment is ongoing.8 Treatment There are multiple guidelines for management of OAB such as those from the National Institute for Health and Care Excellence (NICE), European Association of Urology (EAU) and American Urological Association (AUA), which are generally in agreement with each other in terms of the type of stepwise approach to use.

This stepwise approach should

be tailored to the patient’s needs: they do not necessarily need to go through every step in the set order.6 Initial OAB management is conservative, including:2  Optimising the management of any potential contributing medical conditions (constipation, UTI, diabetes, heart failure, sleep apnoea)  Managing oral fluid intake overall and particularly in the evening. Consumption of diuretics like alcohol and caffeine should be minimised.  Timed voiding  Bladder retraining techniques  Reduction of excessive body weight  Smoking cessation Unexpectedly, not all studies show that discontinuing caffeinated beverages leads to an improvement in symptoms, but this is still commonly recommended. Where possible, the use of prescription diuretics, a known cause of incontinence in the elderly, should be avoided.Symptoms of OAB can also be significantly improved by limiting fluid intake by 25% (to up to 1.5 litres a day). Although pharmacotherapy is often more successful than behavioural, in all instances it is recommended that these be used in combination, as this is more effective than either one used in isolation.

Behavioural Therapy These therapies aim to increase the interval between urine voiding times, reduce nocturia and urgency, and prevent incontinence by providing tools to patients to interrupt/inhibit detrusor contractions.6 Compared with the recommended medications, especially antimuscarinics, behavioural therapy is associated with a lower risk of adverse events.

Pelvic floor training can be very effective, reducing leakage by 5080%, with up to 30% of patients becoming dry. Occasionally, a behavioural intervention and pharmacotherapy are used simultaneously to provide an additive effect for OAB treatment.

The following instructions describe briefly how to go about pelvic floor training:9

 The patient should sit, stand or lie with your knees slightly apart. The pelvic floor muscles should be slowly tightened.

They should try to lift and lift and squeeze as long as possible, followed by resting for 4 seconds. The contraction should be repeated, building up the strength to do 10 slow contractions at a time (holding for 10 seconds each) with rests of 4 seconds in between.  The pelvic floor muscles also need to react quickly to sudden stresses from coughing, laughing or exercise that puts pressure on the bladder. Quick contractions should also be practised, i.e. drawing in the pelvic floor and holding just for one second before relaxing.

People should aim to achieve a strong muscle tightening with up to ten quick contractions in succession.

These should be performed 3-4 times daily. It takes time for the exercises to strengthen the muscles: at least 3 months should be allowed before the muscles gain their full strength.

Bladder training in OAB helps control urgency through diverting attention, by e.g. performing mental arithmetic or pelvic floor muscle contractions, and/or relaxation e.g. with deep breathing activities, and gradually prolonging the voiding interval by 15 minutes.1 Eventually, the patient may be able to void every three to four hours without the frequent urge to urinate.

There is currently no agreed or standardised definition, but bladder training includes the following:  Patient education about the mechanism of bladder action and voiding function provide patients with a better understanding of their excretory function.  Scheduled voiding at fixed voiding intervals while awake, progressively lengthening as successful control is achieved.  Positive reinforcement through psychological support to patients, encouraging them to continue the practice.

Bladder training is occasionally combined with other therapies, such as pelvic floor muscle training and pharmacotherapy, for an additive effect. In clinical practice,

bladder training and pelvic floor muscle training are prescribed in combination. Currently a Cochrane review (1) is being undertaken to assess the effects of bladder training for treating adults with OAB in more detail.

Initial Pharmacotherapy Pharmacological treatments for OAB have traditionally included antimuscarinic medications as the first line choice. Oral oxybutynin was one of the first medications used, but subsequent formulations of anticholinergics have been developed to improve compliance through the use of extended release (ER) formulations and minimising the associated adverse effects.2 Table 1 summarises some of the main medications available for treatment of OAB. Antimuscarinics (available as transdermal and oral preparations) are still the first line treatment for OAB, and are effective in reducing major symptoms in 65-70% of patients. In some cases, the side effects of dry eyes and mouth, blurred vision and constipation may be an issue for patients; and central antimuscarinic effects like impaired cognition may contribute to adverse events in older people such as falls, cognitive impairment and delirium.

These side effects reduce patient compliance.6 Anticholinergics reduce the amplitude of bladder contractions which improves bladder capacity and involuntary detrusor contractions, meaning less urgency and frequency.2 The use of the oxybutynin transdermal patch vs oral administration leads to fewer side effects. The most common adverse reactions from the patch were application site pruritus (16.1%), application site erythema (7.0%), dry mouth (7.0%), and constipation (2.1%). Dry mouth was the most common adverse event from oral ER oxybutynin (68% of patients).

Tolterodine is often better tolerated than oxybutynin, but should be used with caution if there is any known history of QT prolongation or with concomitant use of certain antiarrhythmics. The most common adverse events reported by patients receiving tolterodine ER were dry mouth (23%), headache (6%), constipation (6%), and abdominal pain (4%).

Click here for Prescribing Information Legal classification: POM (S1B). Further information is available in the Summary of Product Characteristics or on request from Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555.

March 2021 BET_2021_0027_IE

43 Table 1. Summary of pharmacotherapy for overactive bladder2 Medication

Dosage and administration

Muscarinic receptor affinity

Side effects

Oxybutynin ER oral (e.g. Lyrinel XL) 5-40mg daily M1, 2, 3, 4

Dry mouth +++ Constipation ++ Cognitive ++

Oxybutynin patch (e.g. Kentera) 1 patch changed twice weekly, M1, 2, 3, 4

3.9mg/day

Dry mouth + Constipation + Cognitive: no effect Application site pruritus/erythema

Solifenacin (e.g. Vesitirim) 5-10mg daily M3

Dry mouth + Constipation + Cognitive: no effect

Fesoterodine (e.g. Toviaz) 4-8mg daily M1, 2, 3, 5

Dry mouth + Constipation + Cognitive: no effect

Tolterodine ER (e.g. Detrusitol SR) 2-4mg daily M1, 2, 3, 5

Dry mouth ++ Constipation + Cognitive: no effect Prolonged QT interval (dose ≥8 mg/d)

Trospium (e.g. Regurin) 20mg bd M1, 2, 3, 4, 5

Dry mouth ++ Constipation + Cognitive: no effect

Mirabegron ER (e.g. Betmiga) 25-50mg daily β3 adrenergic receptor agonist

All low incidence • Hypertension • Tachycardia • Urinary tract infection • Constipation or diarrhoea • Nasopharyngitis

Botulinum toxin A (e.g. Botox) 100–200 U idiopathic OAB Presynaptic motor neuron

• Urinary retention (elevated PVR ± need for CIC) • Hematuria • Urinary tract infection

Tricyclic antidepressant Starting doses Imipramine: 10mg bd Central action and direct action

Amitriptyline 10-20mg/day on detrusor

• Anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) • Tremor • Arrhythmia • Nausea

Desmopressin

• Hyponatremia • Cardiac failure • Hypertension

Fesoterodine has minimal effect on cognition, and the most common adverse event reported in trials was dry mouth, reported in 19% taking 4 mg daily, and 35% on 8 mg daily.

Trials comparing fesoterodine to

0.1–0.2 mg daily Concurrently reduce Renal collecting fluid intake to avoid hyponatremia/ duct/aquaporin-2-mediated water intoxication

tolterodine demonstrated that fesoterodine was superior across multiple outcome measures (patient-reported cure or improvement, leakage episodes, frequency, urgency episodes).

However, fesoterodine showed a

comparatively higher risk of dry mouth, and withdrawal due to adverse effects.

Solifenacin is selective for M3 receptors. Although the 10 mg dose is more effective in OAB treatment, it has a higher rate of

side effects. These include dry mouth (10.9% with 5 mg vs 27.6% with 10 mg), constipation (5.4% with 5 mg vs 13.4% with 10 mg), and blurred vision (3.8% with 5 mg vs 4.8% with 10 mg). A Cochrane review concluded that there were

Click here for Prescribing Information Legal classification: POM (S1B). Further information is available in the Summary of Product Characteristics or on request from Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555.

March 2021 BET_2021_0027_IE

44

CPD: Overactive Bladder

significantly less reports of dry mouth rates with solifenacin than with tolterodine ER, and better QoL improvements.

intermittent catheterisation for post voiding residuals at times may not be acceptable to some patients, however.6

Trospium is equivalent to oxybutynin in terms of improvement of urinary outcomes.

The two most common adverse reactions were dry mouth (20.1%) and constipation (5.8%). Dry mouth led to discontinuation in 1.9% of treated patients.

Additional Pharmacotherapy Treatments

Mirabegron facilitates bladder detrusor relaxation through the alternative mechanism of beta 3 adrenoceptor agonist action.

Detrusor relaxation is mediated mostly through noradrenaline action on beta 1, 2 and 3 receptors. The beta 3 receptor subclass is thought to be most important in mediating detrusor relaxation, and this receptor is preferentially expressed on urinary bladder tissues. Mirabegron causes a dose-dependent relaxation of the detrusor muscle, inhibiting overactivity. This mechanism of action means that there are no anticholinergic adverse effects. In theory there may be a risk of hypertension in patients taking mirabegron, but this has not been observed when treatment is compared to placebo. One large UK study found that persistence with and adherence to pharmacotherapy with mirabegron is higher than with the older antimuscarinic drugs used in OAB.2, 6 Combination therapy of an antimuscarinic and beta agonist (e.g. solifenacin 5mg with mirabegron 25 or 50mg) can be considered if monotherapy does not work. This does not appear to cause any increase in adverse effects, but has been reported to significantly reduce incontinence and micturition when compared to monotherapy with each agent alone. The use of mirabegron along with solifenacin 5mg may offer more benefit than an increase in solifenacin dose to 10mg due to fewer adverse effects.

A novel selective beta 3 agonist, virabegron, has shown significant improvement in OAB symptoms in trials although is not yet approved for use in Ireland.

Injection of Botox (botulinum toxin A) into the bladder wall has, in clinical trials, shown significant improvement in symptoms for patients who have not responded to behavioural or conventional pharmacotherapy. The need for repeated administration every 6-9 months, risk of UTIs, and

Tricyclic Antidepressants (TCAs) are potent inhibitors of muscarinic, a-adrenergic, and histamine H1 receptors, and inhibit noradrenaline and serotonin reuptake at nerve terminals.

They have been shown to reduce bladder contraction and increase the bladder volume required to initiate reflex voiding in animal studies. They may be considered as second or third line therapy in “off label” use.

Desmopressin is a synthetic form of the antidiuretic hormone vasopressin used for the treatment of nocturia and nocturnal enuresis in children and adults. The main risk of desmopressin treatment is hyponatremia.

Hormone Replacement Therapy (HRT) has shown a statistically significant improvement in symptoms of frequency, urgency and incontinence episodes, with both topical and oral formulations demonstrating these benefits.2 Phosphodiesterase inhibitors (PDE1 and PDE5) have been observed to lead to improvements in urodynamic measures. PDE5 medications (sildenafil, tadalafil) are licensed in some countries for lower urinary tract symptoms and erectile dysfunction management in men, but not specifically in OAB. Recent research has indicated that low dose tadalafil has been found to be effective in treating OAB in women but it is not licensed for this use.6 In general, ER formulations of anticholinergics lead to better QoL improvements than immediate release formulations. Long term patient compliance may be an issue due to the requirement of long term therapy and occurrence of side effects. Treatment persistence was better with solifenacin than with other agents.2 Non-Pharmacological Treatments Sacral neuromodulation (SNM) is a process in which an electrode is placed in the sacral foramen to stimulate S3/S4 nerve roots.

This is tested, and if symptoms improve, implanted. It has similar reported success rates to the use of Botox injections, ~69%.

Posterior tibial nerve stimulation (PTNS) involves electrical stimulation of the sacral micturition centres using a fine needle placed just above the medial ankle. It aims to alter the abnormal stimulation of the nerves that supply the bladder.

No long term data (over 6 months) is yet available for this, although a 71-79.5% patient reported response to improvement has been observed. Treatment requires 12 sessions lasting about 30 minutes, usually once a week. There is at the moment no consensus regarding the use of PTNS among the clinical guidelines.

Augmentation cystoplasty, also known as bladder augmentation, is a type of surgery to make the bladder larger. This is generally a last resort. Intermittent catheterisation may be required after the procedure, but for some patients with severe intractable symptoms, this is preferable to the symptoms of OAB.6 OAB is a syndrome with no cure, rather than a disease, and patient education about treatment, adherence and outcomes is important. The most up to date clinical guidelines should always be consulted to advise about the most current treatment recommendations. Pharmacists can play an important role in the management of OAB. Because of the accessibility of pharmacies, this can put pharmacists and pharmacy teams in a good position to recognise and advise OAB patients.11 Pharmacists can further assist by providing additional evidence based information to patients about their therapy and other treatment options.

Furthermore, at the point of dispensing and supply, pharmacists have an opportunity to further educate patients about treatment, provide advice on any side effects, and reinforce the need for longterm adherence, which is important for successful management of any chronic condition.

References 1. Funada, S., Yoshioka, T., Luo, Y., Sato, A., Akamatsu, S., & Watanabe, N. (2020). Bladder training for treating overactive bladder in adults. The Cochrane Database of Systematic Reviews, 2020(4).

2. Jayarajan, J., & Radomski, S. B. (2014). Pharmacotherapy of overactive bladder in adults: a review of efficacy, tolerability, and quality of life. Research and reports in urology, 6, 1.

Berghmans, B., Lee, J., ... & Schaer, G. N. (2010). An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction.

Neurourology and Urodynamics: Official Journal of the International Continence Society, 29(1), 4-20.

4. Lightner, D. J., Gomelsky, A., Souter, L., & Vasavada, S. P. (2019). Diagnosis and treatment of overactive bladder (nonneurogenic) in adults: AUA/SUFU guideline amendment 2019. The Journal of urology, 202(3), 558563.

5. Health Service Executive. (n.d.). Overactive Bladder/Urge Incontinence. Available https:// www.hse.ie/eng/services/list/2/ primarycare/community-fundedschemes/continence/public/urgeincontinence-leaflet.pdf 6. Fontaine, C., Papworth, E., Pascoe, J., & Hashim, H. (2021).

Update on the management of overactive bladder. Therapeutic Advances in Urology, 13, 17562872211039034.

7. Bladder Health UK. (2022).

Overactive Bladder. Available https://bladderhealthuk.org/page/ index/306 8. Abdel-Fattah, M., Chapple, C., Guerrero, K., Dixon, S., Cotterill, N., Ward, K., ... & Norrie, J. (2021). Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms. Trials, 22(1), 1-18.

9. Bladder and Bowel Foundation.

(2008). Pelvic Floor Exercises For Women Available https:// www.nhs.uk/planners/ pregnancycareplanner/documents/ bandbf_pelvic_floor_women.pdf 10. Madhuvrata, P., Cody, J. D., Ellis, G., Herbison, G. P., & HaySmith, E. J. C. (2012). Which anticholinergic drug for overactive bladder symptoms in adults.

Cochrane Database of Systematic Reviews, (1).

11. Stewart, K., McGhan, W. F., Offerdahl, T., & Corey, R. (2002).

Overactive bladder patients and the role of the pharmacist. Journal of the American Pharmaceutical Association (1996), 42(3), 469-478.

3. Haylen, B. T., De Ridder, D., Freeman, R. M., Swift, S. E.,

Click here for Prescribing Information Legal classification: POM (S1B). Further information is available in the Summary of Product Characteristics or on request from Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555.

March 2021 BET_2021_0027_IE

50mgs once daily

50mgs once daily

Her 10th shopping trip since the day she started BETMIGA1

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

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

This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors. Hepatic impairment: Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving

Date of preparation: June 2019

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

Pharmacokinetic interactions involving the potential for mirabegron to affect exposures to other medicinal products: Inhibition of CYP2D6: Moderate and time dependent inhibition of CYP2D6 by mirabegron may result in clinically relevant drug interactions. CYP2D6 activity recovers within 15 days after discontinuation of mirabegron. Caution is advised if mirabegron is co-administered with medicinal

products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established.

Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines.

Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections.

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

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

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

References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. https://doi.org/10.1080/03007995.2017.1419170.

are grouped by MedDRA system organ class. Infections and infestations: Common: urinary tract infection Uncommon: vaginal infection, cystitis Psychiatric disorders: Not known: Insomnia*, confusional state* Nervous system disorders: Common: headache* dizziness* Eye disorders: Rare: eyelid oedema Cardiac disorders: Common: tachycardia Uncommon: palpitation, atrial fibrillation Vascular disorders: Very rare: Hypertensive crisis* Gastrointestinal disorders: Common: nausea*, constipation*, diarrhoea* Uncommon: dyspepsia, gastritis Rare: lip oedema Skin and subcutaneous tissue disorders: Uncommon: urticaria, rash, rash macular, rash papular, pruritus Rare: leukocytoclastic vasculitis, purpura, angioedema* Musculoskeletal and connective tissue disorders: Uncommon: joint swelling Renal and urinary disorders: Rare: urinary retention* Reproductive system and breast disorders: Uncommon: vulvovaginal pruritus Investigations Uncommon: blood pressure increased, GGT increased, AST increased, ALT increased (*observed during post-marketing experience). Reporting of suspected adverse reactions: see below. Legal category: POM (S1B) Marketing Authorisation number: EU/1/12/809/003 - 25mg EU/1/12/809/010 - 50mg. Marketing Authorisation holder: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Further information is available from: Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555. Summary of Product Characteristics with full prescribing information available upon request. Job number: BET_2019_0002_IE Date of preparation of API: 27 May 2019.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance Astellas Pharma Co. Ltd Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555 Tel: +353 1 6764971 E-mail: Irishdrugsafety@astellas.com Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie.

Approval code: BET_2019_0004_IE

46

Awards

Deirdre Dominating the Role of Pharmacy Technicians Deirdre Doherty, O’Donnells totalhealth Pharmacy, Gweedore: Winner of the Paolo Iacovelli Community Pharmacy Technician of the Year Award

Awards The Irish Pharmacy

2022

The first accolade at the Irish Pharmacy Awards was given out in memory of Paolo Iacovelli, one of the first ever sponsors of the Community Pharmacy Technician of the Year category. It went on the night to Deirdre Doherty of O’Donnells totalhealth Pharmacy, Gweedore.

Laura Romero Iacovelli, PharmaConex with the winner of the Paolo Iacovelli Community Pharmacy Technician of the Year Award Deirdre Doherty, totalhealth Pharmacy, Gweedore, Tracey Barry and Manuela Cavaliere, both PharmaConex

One of the most relied-upon members of staff, Deirdre is regularly described as dedicated, adaptable, reliable, motivated, and hard-working. She has impeccable people skills and is a true teamplayer. She leads by example within the team, she never seems to stop working trying to find ways we can operate more efficiently.

Deirdre works longer hours than the normal shop day. She continues after work and often on days off when duty calls.

The pharmacy is located in a community hub premises, that serves as a meeting place for locals to congregate and connect, part of what community pharmacy is all about.

She has proud community spirit and puts everyone else’s needs before her own, especially the customer and patient.

“Deirdre joined the pharmacy team at O’Donnell’s totalhealth Pharmacy 25 years ago in 1997 as a trainee OTC assistant. Her passion for community pharmacy was evident from the beginning, and she continued to progress her knowledge and her career,

O’Donnell’s totalhealth Pharmacy lies in the Donegal Gaeltacht and is primarily Irish-speaking.

Her Supervising Pharmacists says, “Deirdre is regarded by her colleagues, customers and patients as very passionate and genuine person. Her commitment and contribution to the business is exceptional on so many fronts.

PHARMACYNEWSIRELAND.COM

being promoted to Front of Shop Manager, lending her support and knowledge to staff and customers.

“At her core, Deirdre is the patient advocate, the person who goes to the ends of the earth 24/7, often following up queries for them on her days off and very often after hours.

Her approach is consistently personcentred, with our patients and with her teammates.”

“Deirdre completed the IPU Pharmacy Technician course in 2013 and acts as the pharmacy’s senior technician in conjunction with her front of shop manager duties. Her commitment to both roles knows no bounds. She is respected and admired by patients and team mates alike, and is relied upon for her dedication and effort daily. Deirdre’s commitment to her professional development is evident by the number of training courses she has completed with distinction to improve her knowledge and competency in her pharmacy role.”

These courses include:

• totalhealth First Aid

• totalhealth Medicine Counter Assistant

• Lipotrim Training for monitored weight management.

• totalhealth Vitamins & Natural Remedies • NPA Medicine Counter Assistant Course • Retail Training with Skillnet Ireland

47 Deidre also continues to add to her knowledge of retail and management and is always the driving force behind new initiatives and services.

“Deidre is an incredibly competent pharmacy technician, consistently looking for new ways to improve the workings of their dispensary.

She is innovative and adapts to new processes and procedures quickly and effectively.

“Deirdre was instrumental in setting up our very successful Covid-19 vaccination service.

She organised local tradesmen to carry out necessary works to the pharmacy so that we had proper areas available to carry out vaccinations and antigen testing, and developed an efficient manual booking system which we used until we adopted a walk in service. Deirdre quickly became an expert on the HSE Covid platform and spent a lot of time chasing up certificates for our patients, often in her own time.

Watching her in action during the recent unprecedented demand for vaccination and testing truly shone a light on the potential for technicians to play a more prominent role in services like these. We couldn’t have managed without her.”

At her core, Deirdre is the patient advocate, the person who goes to the ends of the earth 24/7, often following up queries for them on her days off and very often after hours. Her approach is consistently person-centred, with her patients and with her teammates.

She attends clinical meetings in the local nursing home where she brings an incredible amount of value helping to solve medication issues at the home, as well as going to great lengths to ensure the nursing staff and their patients are looked after as best as possible.

“Deirdre Doherty is the heart and soul of everything we do in O’Donnell’s as part of a very happy team, many of whom have been with us for 25 years or more. She is a natural leader, who leads by example, always striving for excellence and inspiring others to do the same.”

Throughout Covid, as the entire team excelled and gave selflessly of their time and energy, Deirdre went that extra step to ensure the pharmacy was always run safely and efficiently and that everyone in the team was happy in difficult circumstances, and that patients and customers were kept safe and informed.

As new staff members come on board, Deirdre makes sure they feel welcome and part of the team. She

Community Pharmacy Technician of the Year Award winner Deirdre Doherty takes responsibility for ensuring the new staff member is trained up appropriately. She is the first to volunteer for anything new and works hard to bring others along.

In addition to her pharmacy technician role and managing the front of shop, Deirdre also manages to find time to do the accounts. She is also the totalhealth Ambassador for her pharmacy and integrates all the learnings from the totalhealth and CommCare group into her work and the work of all at the pharmacy.

“Everybody benefits from Deirdre’s work, especially our patients.

“As a technician, Deirdre is as strong as anyone I’ve ever worked with. She is incredibly organised – she has implemented processes in our dispensary to ensure the most efficient workflow, making sure that patient needs are met effectively, and that every member of the dispensary team can work to full potential. This has included a queuing system for waiting prescriptions, methods of taking patient information more efficiently, a repeat prescription service, and ways of identifying prescriptions that require additional counselling or advice. New patients are welcomed to the pharmacy, and she makes sure they are confident and comfortable taking their medicines to aid adherence.

working trying to find ways we can operate more efficiently. Deirdre works longer hours than the normal shop day. She continues after work and often on days off when duty calls.

“She has proud community spirit and puts everyone else’s needs before her own, especially the customer and patient. She brings everyone along when we try new things in the pharmacy.

Most recently with everything Covid, Deirdre was central to sourcing essential supplies and following up on orders at a time of great uncertainty.”

“Deirdre recently identified the need for us to automate some of our dispensing process and spearheaded research into new blistering solutions so we can meet the needs of our patients and the demands of our business.

Deirdre embodies the traits and values that make for an excellent pharmacy technician. She consistently strives to improve the patient journey, making service effective and efficient, as well as being patient-centred and focused on health promotion and optimal health outcomes. As a natural leader, she inspires others to achieve the highest standards possible. She is innovative and creative, as well as being extremely proactive about finding solutions, and implementing new initiatives and improvements, always with the patient at heart. Patient safety is of utmost importance to Deirdre; she always ensures that we have up to date and valid prescriptions and that patients are suitably counselled and supported. Dispensary paperwork and admin is kept constantly up-to-date, ensuring correct reimbursement and rejects prevention. She is of incredible support to the entire dispensary team and works to use her skills and knowledge to develop others, as well as continuing to improve her own expertise.

“She leads by example within the team, she never seems to stop

She embodies everything that is good about community pharmacy

“We benefitted greatly from Deirdre’s organisational skills during Covid-19, as she quickly implemented remote ordering of prescriptions and a delivery service. High risk patients were identified and contacted to make sure their needs were met.

“Deirdre single-handedly arranged an ongoing charity fundraiser using our loyalty points system.

Customers can elect to donate their points to our local Donegal Cancer Bus, a charity that helps lessen the burden of travelling to Dublin for cancer patients when they are getting their treatment.

Deidre came up with the idea, liaised with the charity, promoted it within the pharmacy and to the wider community and it has been continued to be extremely successful.

and the values that the team has learned from Evelyn O’Donnell MPSI (RIP) our founder.

Deirdre embodies the traits and values that make for an excellent pharmacy technician. She consistently strives to improve the patient journey, making service effective and efficient, as well as being patient-centred and focused on health promotion and optimal health outcomes.

As a natural leader, her team say she inspires others to achieve the highest standards possible.

She is innovative and creative, as well as being extremely proactive about finding solutions, and implementing new initiatives and improvements, always with the patient at heart. Patient safety is of utmost importance to Deirdre; she always ensures that we have up to date and valid prescriptions and that patients are suitably counselled and supported.

Dispensary paperwork and admin is kept constantly up-to-date, ensuring correct reimbursement and rejects prevention. She is of incredible support to the entire dispensary team and works to use her skills and knowledge to develop others, as well as continuing to improve her own expertise. She embodies everything that is good about community pharmacy and the values that the team has learned from Evelyn O’Donnell MPSI (RIP), the pharmacy’s founder.

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Awards

Laura Scoops Pharmacist of the Year Title Laura Dowling – winner of the Precision Biotics Community Pharmacist of the Year Award 2022 The Fabulous Pharmacist by name and nature, Laura Dowling was crowned the PrecisionBiotics Community Pharmacist of the Year 2022.

Awards The Irish Pharmacy

2022

TM

Group

Laura Dowling pictured with Gerard Murphy, National Sales Manager, Pamex Limited

“This is a huge honour for me to receive this Award, all the finalists in this category are outstanding pharmacists” One nominee describes Laura as an outstanding, inspirational leader. She is an incredible ambassador for the pharmacy profession in Ireland. Throughout her 20 years in the profession, Laura has bravely sought to progress her career in so many ways, above and beyond the simple ‘day job’ duties as a pharmacist manager.

A pharmacist and scientist by training, Laura graduated from the School of Pharmacy, Trinity College Dublin in 2002 and for over twenty years, she has been on a mission to optimise wellness by educating and empowering people to achieve sustainable, healthy lifestyles.

“I have always aimed to put the customer first. My dedication to the role was recently recognised -

I was delighted to be awarded the prestigious 2022 Pharmacist of the Year Award.”

Online, Laura is well-known as “The Fabulous Pharmacist”.

Her Instagram channel @fabulouspharmacist is dedicated to sharing relatable and passionate advice about health, family, self-care and wellbeing.

She continues, “I strive to give my 52k+ followers the tools to live a balanced, sustainable, and healthy lifestyle without resorting to short-term crazes or fads. Whether talking about skin concerns, constipation, female incontinence or mental health, I aim to educate my followers and shine a light on topics that others often tend to shy away from.”

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Of note, Laura’s social media following grew exponentially (doubled) over the time of the covid pandemic, as she sought to reassure and inform the public about covid and other pressing healthcare concerns. Laura did not just ‘stay in her lane’ by restricting herself to pharmacy store work.

She actively ramped up her social media content, and went above and beyond her day job duties by giving sound advice to tens of thousands of Irish people on a daily basis.

Many people were afraid to come into the pharmacy or visit their GP for fear of picking up infection.

She witnessed first-hand many people (young and old) that were worried and frightened. Laura used her high visibility on social

media to give them comfort remotely. Her advice is always up-to-date and evidenced-based using the latest WHO, CDC, HPSC, HSE guidelines. She conveys information in an upbeat, engaging and straightforward manner. She is not afraid to shy away from topics that others may be embarrassed to talk about such as vaginal dryness in menopause and urinary incontinence.

Laura has also appeared on national and local radio and in national and local newspapers.

Topics addressed include covid vaccine safety, pharmacists administering covid vaccines, pharmacy services, antigen tests, flu vaccines, covid vaccine in adults in children, pain relief for hangovers and healthy living

49 The Fabulous Pharmacist, Laura Dowling

“It’s vital community pharmacists are recognised for all that they do and the help they can give, from dispensing medicines, offering medicines advice and just being that ear to listen to problems and issues when customers come in and out of the pharmacy”

during covid. She has appeared on RTE, Newstalk, Cork FM, WLR FM, LMFM Drogheda and was quoted extensively in The Irish Times, the Irish Independent and online publications such as, RSVP magazine.

Working in the pharmacy every day helps Laura see what peoples’ real-time concerns are. She uses this knowledge to address issues and perform demos on her social media channels which resulted in these posts going viral.

Some examples of these health campaigns are: How to do an antigen test 146K views Difference between antigen and PCR tests - 120K views Hayfever/ allergy/ congestion 80K views Thanks to Laura’s high level of public profile, Laura has been in a unique position to provide educational and informative material to tens of thousands of people on a daily basis. One of the challenges with social media nowadays is the high level

of ‘misinformation’ available online. Laura has provided comfort and reassurance to many by providing a strong, levelheaded counter balance to various misinformation movements.

Laura has been described as an outstanding, inspirational leader.

“She is an incredible ambassador for the pharmacy profession in Ireland. She is not your typical pharmacist. Throughout her 20 years in the profession, Laura has bravely sought to progress her career in so many ways, above and beyond the simple ‘day job’ duties as a pharmacist manager,” says her nominee.

“Laura shines a light on topics that others shy away from. She has consistently spoken out about the shortage of HRT products and how this affects women in menopause who experience a myriad of problems as a result of not being able to obtain their medications.

This type of issue is usually not publicised by mainstream media, which is why Laura feels that it is so important to speak out about it.

“Her engagement throughout with the local community has been exemplary. Laura personally administered over 580 flu vaccines in her local community between October and December 2022.

Incredibly, she runs one of the busiest vaccine services in her company (Lloydspharmacy Ireland), despite her store being one of the smaller pharmacies in

the company. The high-quality training that she provided to her floor staff enabled Laura as pharmacist manager to focus on the most important aspect of her role – administering vaccinations and checking prescriptions.

“Public fear and covid fatigue often meant that many people quite unhappy and stressed when they came into the pharmacy, but Laura always tried to keep their spirits up and offer them as much help as needed.

“There were issues with her elderly and vulnerable patients not having the support that they were used to due to family staying away.

She personally offered delivery of medicines, blister packing of medicines and visited the homes of these patients. She even did the lotto for them but only if they agreed to split the winnings!

Regular phone-calls to patients who could no longer come into her for the weekly chats helped them to feel less isolated.

“It was a huge challenge to deliver a meaningful and impactful flu and covid vaccine program, being the only pharmacist in a very busy pharmacy. However, Laura could see that these programs were hugely beneficial to the public health of her community and trained all her staff in receiving patients, preparing the care room and input of data so that Laura was free to just vaccinate and check prescriptions.”

Laura said after receiving her Award, “This is a huge honour for me to receive this Award, all the finalists in this category are outstanding pharmacists. The Irish Pharmacy Awards are so important to the industry, as it’s vital community pharmacist are recognised for all that they do and the help they can give, from dispensing medicines, offering medicines advice and just being that ear to listen to problems and issues when customers come in and out of the pharmacy. It is amazing to be part of something that highlights the crucial role pharmacy plays to the general public in Ireland.”

Gerard Murphy, National Sales Manager, Pamex Limited said, “Never more so than over the past two years, have Community Pharmacists shown their relentless commitment, and dedication to our local communities. PrecisionBiotics Group are honoured to recognise the effort, and contribution they have made towards people’s health and quality of life and most importantly honoured to present this Award to Laura tonight.

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Awards

Identifying New Heights in Independent Pharmacy Slane Pharmacy – Winners of the United Drug Business Development (Independent) Award 2022 Slane Pharmacy took home the United Drug Business Development (Independent) Award on the night.

Awards The Irish Pharmacy

2022

Dermot Smyth, Pharmacist and Owner, Slane Pharmacy with Michael Taylor, Head of Sales and Retail Solutions at United Drug

The pharmacy team have overcome numerous challenges during the last year, including vaccination provision and an increased reliance on community pharmacy by patients which has resulted in the team having to react quickly and decisively to retain and grow the current business.

With the support of the pharmacy team and their dedication and hard work, they have been able to survive the obstacles thrown up by the pandemic, grow the business and place it on a sound footing for the future.

2021/2022 provided many challenges for Slane Pharmacy.

The Covid-19 pandemic led to fundamental changes in how the pharmacy operated. Key challenges included:

• Staffing levels

Dermot Smyth, Pharmacist and Owner told us, “With so many challenges and so much change we had to react quickly and decisively to retain and grow our current level of business, preserve and enhance our service levels and modify our core retail sales and services to meet customer needs. With the support and hard work off our staff we have managed to survive the choppy waters of the pandemic, grow the business significantly and place it on a sound footing for the future.

• An increased reliance by patients for their healthcare and medical needs

“The key to surviving and thriving over the past 18 months to two years has without doubt been

• Electronic prescribing • Social distancing/Infection control • Vaccination provision • Lockdowns leading to changes in retail patterns

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“With so many challenges and so much change we had to react quickly and decisively to retain and grow our current level of business, preserve and enhance our service levels and modify our core retail sales and services to meet customer needs”

having a supportive family, staff who have responded terrifically to challenges presented to them and finding good people/partners to support everything we have been trying to do here in Slane. Good relationships with customers and local voluntary organisations has also been key. As challenges arose they were dealt with.”

51 Dermot told us more about the key stakeholders the team worked with:

Dermot Smyth, Pharmacist and Owner, Slane Pharmacy

Staff - Communication, honesty and empathy were the key to getting staff buy in and cooperation. Their flexibility, patience, courage and strength have shone out throughout the pandemic Their input to the design of our website was terrific and still Is. Their input into the shop extension and refit we undertook means we have a store fit for pandemic purpose and one which is fit for future growth and needs United Drug were always helpful and supportive.

Local GP surgeries - We had many teething problems with Healthmail and our local GP practices were instrumental in helping keep patients right.

Drogheda Web design - They were excellent to work with on website design and with our launch.

The Local enterprise office gave us support with grant funding for our website development.

The HSE are often criticised, but we found them really helpful particularly with our vaccination queries and issues as were the IPU who were particularly helpful with our staff issues regarding Covid and vaccinations.

Furthermore, the Pharmaceutical Society of Ireland were very helpful, empathetic and supportive during our temporary relocation for shop fit and also when applying for our website licence.

year that Dermot’s passion for community pharmacy and helping people was nurtured.

Dermot says “I learned so much during that pre-reg year about how to treat people well and the positive effect that has in our place of work. Hence, I have carried 5 key principles throughout my professional life which I have now incorporated into the Five Star Pharmacy brand: • To treat our customers well and give them a Five Star service – you put the shirts on our backs.

• To earn our customers’ trust so that in return they will listen to our advice.

• To be honest with our customers.

Refill Assistant - They were excellent support with our vaccinations and allowed us to schedule and cope with the volume of vaccines efficiently.

• To help our customers – most of our customers are poorly, sick or have a problem they need help with. Hence, our aim at Five Star Pharmacy is to help make you feel better before you leave.

McLernons provided excellent support during the initial phase of Covid. They provided additional terminals to comply with social distancing and secure VPNs during our contingency planning.

• To be grateful of our own health, after all, Your health is your Wealth.”

John Downey Shopfitting completed a brilliant job on our pharmacy refit. The team kitted out our temporary unit and completed the extension and full refit of our original unit ahead of time.

Founder of Five Star Pharmacy Dermot Smyth has over 25 years of community pharmacy experience behind him, having come a long way since doing his pre-registration in Belfast in 1995. It was during that formative

As a pharmacy owner for 16 years now, Dermot has seen technology make numerous, positive changes, not just to the pharmacy profession, but to the way people live and shop.

Dermot shares that “In all my time in pharmacy I have always tried to improve myself, my pharmacy team and my business. I am looking forward to the challenge of creating a retail pharmacy online – I think the principles I learned all that time ago in Belfast of how to run a successful community pharmacy will hold for

online pharmacies as well. The 5 key principles will certainly be the foundation of what we are trying to achieve here with Five Star Pharmacy. So, I invite you all to stop by, shop our five star range of products, give us your feedback, let us earn your trust and let us help to keep you healthy and well.

After all, as I’m still learning, your health is your wealth.”

Dermot adds, “Entering this Award we felt was hugely important.

Firstly, to be able to reward our staff for all the hard work and input they have into the success of the business.

“Furthermore, these Awards highlight brilliantly how a small Community Pharmacy Business can be developed and grown through review, planning, reacting to change and implementing new ways of working.

“The project highlights the importance of staff buy -in, collaboration with key stakeholders putting patients and customers at the heart of the process. This Award showcases a source of pride for the locality of Slane and highlights the role pharmacies have to play in vaccination.

“Everyone here tonight, not just the winners of the different categories, but the finalists as well, are at the top of their game and therefore they are all a fantastic showcase to demonstrate what pharmacy does within communities all across Ireland.”

Michael Taylor, Head of Sales and Retail Solutions at United Drug commented, “On behalf of United Drug, I am honoured to represent the Business Development Independent category at the Irish Pharmacy Awards 2022. Following an exceptionally challenging two years for the industry, we are delighted to be back to celebrate and recognise the outstanding work from Pharmacies across Ireland who have been working tirelessly through the pandemic.

“On behalf of everyone at United Drug, we applaud the dedication, commitment and resilience of the Pharmacy teams who have stepped up and provided exceptional patient care. It has been a tremendous opportunity to reflect on the challenges that have past, and recognize the achievements and successes of our amazing pharmacy community.”

“It is also a great way to reward the resilience, ingenuity and adaptability of the pharmacy and the team.”

Dermot commented after winning the Award, “I really feel that this Award is a great reward for all my staff on reflection of the amount of work they have put into helping us take the business forward. Great reward for all the work and for all the staff and the work they have put in.

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Awards

Claire - Giving that Extra Care Claire Tierney, CarePlus Pharmacy Mulingar – Winner of the Avène Counter Assistant of the Year Award Claire Tierney has worked as a counter assistant for over 16 years in Enfield, almost 7 of which were with the Keane’s CarePlus group.

Awards The Irish Pharmacy

2022

Claire Tierney Keane’s CarePlus Pharmacy Mullingar with Julian Bush, Sales Director UK and Ireland with Pierre Fabre

“Throughout the pandemic, Claire played a leading role in ensuring that our most vulnerable patients had access to their medication” Claire became the front of shop supervisor as her result of her high service levels and dedication to the pharmacy. This is evident from her hard work and commitment over the years.

As a result of the high service levels, Claire has built a fantastic rapport with the customers within the community. She was served them over the 16 years and has seen babies grow into young adults.

Over the years, Claire has undertaken a number training courses including the IPU counter assistant course, training with key brands and most recently, started

the IPU technician course. Similar to her attitude towards her work, Claire goes above and beyond in her continuous learning approach.

When the Keane’s Group took over from the previous owners and transitioned to the CarePlus model, Claire was instrumental in the change. With the transition, came significant change. Claire spearheaded the change in store layout, products stocked and communicated with suppliers to ensure that the transition was as smooth as possible.

Her Supervising Pharmacist Robert Keane comments, “Over the years Claire has organised

PHARMACYNEWSIRELAND.COM

many different events for patients and members of the community.

This has ranged for charity bingo nights, first-aid training sessions for new parents and arranging for suppliers to come and talk to our customers on site. In addition to this, Claire played an important role in implementing the changes that were necessary for achieving approval from AsIAm as being autism friendly.

“Throughout the pandemic, Claire played a leading role in ensuring that our most vulnerable patients had access to their medication. Although there was no formal delivery system before the pandemic, Claire set up and

physically delivered the medication herself. This helped to reduce the stress and anxiety that these customers were experiencing.

On her travels to the vulnerable patients, Claire always made sure that the patients also had the basics such as bread and milk!”

In 2015, when the Keane’s Group took ownership of the pharmacy in Enfield, the store underwent a complete rebrand. The shop underwent a major remodelling, all while maintaining normal service levels. Claire was instrumental in ensuring business as usual.

Robert continues, “Claire was tasked with training all other

53 members of staff on new till systems, planograms and ordering systems.

“The transition was difficult on top on her daily duties but Claire took all of this in her stride. The transition was a success and the store operates efficiently with thanks to Claires hard work and determination.

“The current covid-19 pandemic has presented a number of major challenges. The main challenge for our team was ensuring that our patient still had access to their medication. Claire implemented a number of solutions that allowed patient to avail of what they needed. Claire made sure that all of our vulnerable patients still receive the high levels of care that they had become accustomed to.

The pandemic was particularly hard on the elderly, but Claire went above and beyond to help in any way that she could.

“Claires dedication, professionalism and exceptional levels of care make her an ideal recipient of the Avene Counter Assistant Award.”

Talking about her win, Claire Tierney commented, “I love my job and everything that it entails so to be recognised for that means a great deal to me. I would encourage anyone considering it, to enter these Awards as they have truly shone a spotlight on all that is positive about pharmacy and the pharmacy teams whom serve their communities every day.”

Julian Bush, Commercial Director, Dermo Cosmetics Division, Pierre Fabre UK and Ireland congratulated both Kathleen and Claire saying, “It is a privilege to welcome you the 2022 finalists for the Counter Assistant of the Year.

The support they provide through the recommendation of products, to best meet the needs of the

Claire Tierney Keane’s CarePlus Pharmacy Mullingar

consumer is second to none, and is key to ensure that pharmacy customers receive their most appropriate DermoCosmetic products.

“We know and appreciate that the past 2 years have been a huge strain and challenge on community pharmacy, as counter assistants continuously and tirelessly worked to support their communities with ongoing help, support and care, and for that we offer our utmost respect and sincere thanks.”

High Commendations for Kathleen Kathleen Donnelly, Foster’s Pharmacy, Cavan – Highly Commended Avène Counter Assistant of the Year Award The Avène Counter Assistant of the Year Award proved very difficult for the judging panel who felt they had no choice but to award a Highly Commended as well as a Winner - Highly Commended went to Kathleen Donnnelly of Foster’s Pharmacy, Cavan.

Kathleen Donnelly is and has been a well-respected, kind and caring member of the Arva community for over 46 years. Originally from Ballinamuck, Co. Leitrim, Kathleen finished school and began working for Mrs. Doherty in Doherty’s Chemist in 1975. Kathleen initially worked closely alongside Mrs Doherty as a counter assistant, eagerly absorbing all of the information imparted to her and very quickly became Mrs. Doherty’s right-hand woman.

Kathleen and Mrs Doherty worked alongside one another day in and day out as the only two members of staff in the chemist.

Her Superintendent Pharmacist says, “Kathleen often talks of the changes she has seen over the years and we are lucky to still possess some of the old prescription books which herself and Mrs Doherty used to record all their dispensing’s.”

In 1992, Mrs Doherty sold the Chemist to John Foster, again Kathleen worked alongside Mr. Foster in the now Foster’s Pharmacy for 13 years, As the business began to expand another employee was hired and the team began to expand. The current

owner, Paul O’Donnell, took over in 2005. Paul and Kathleen have worked closely together often as a duo dispensing up to 400 items, just the two of them, on their “best days” as they are described

by Kathleen.

Kathleen Donnnelly, Foster’s Pharmacy, Cavan

Foster’s Pharmacy serves a large catchment area and customers come from near and far, from three counties and three provinces to avail of the pharmacy’s services with a large majority of them requesting Kathleen’s attention specifically.

“We are extremely blessed to have such wonderful clientele and even more fortunate to have such a dedicated team. We have seven other staff members who have been with us for more than 15 years something which we pride ourselves on. I know that Kathleen has been the glue within the business and the reason why these members of staff are still employed with us today. Kathleen also plays a huge role in the success of the business over the years.

“During the pandemic Kathleen made sure that all of our customers were accommodated and personally delivered scripts and sundries to those who

were too nervous to visit the pharmacy and to those who were unable to get lifts in to collect their prescriptions as they had been restricted. She took the time to contact anyone who she thought may require some extra assistance during these difficult times and made sure that no one went without.”

Kathleen said on winning the Award, “Our entire team has received so much positivity from just being shortlisted for this Award. It has given us an opportunity to demonstrate to the public what it actually is that we do and the services we can provide.

I am hugely grateful to have been awarded this accolade.”

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Awards

Seamless Communication from David Dodd Pharmacy David Dodd Pharmacy, Greystones – Winners of the McLernons Innovation in Community Pharmacy (Indepndent) Award 2022 The McLernons Innovation in Community Pharmacy (Independent) Award for 2022 was won by David Dodd Pharmacy in Greystones.

Awards The Irish Pharmacy

2022

David Dodd, Pharmacist and Owner, David Dodd Pharmacy with Robin Hanna, Sales Director, McLernons

the area surrounding the ordering of prescriptions, or checking if a new prescription has been received by Healthmail into the pharmacy or on the pharmacy system. From here the process of preparing the prescription and lettering the customer know it is ready for collection is done in a very seamless way using the App solution.

“The app has been built to start communication with the customer from the moment the Healthmail arrives. The order can be seamlessly populated from the patients Healthmail and sent through the app so the customer can confirm the order and be informed of collection time, price, any extra information about the prescription and make payment through the app.

The McLernons Innovation in Community Pharmacy (Independent) Award for 2022 was won by David Dodd Pharmacy in Greystones.

David Dodd Pharmacy consulted with and developed a brief for the creation of a pharmacy app to be a seamless communication tool supporting all aspects of the patient pharmacy journey.

From Healthmail to prescription collection, the app development brought a next-generation standard in an easy-to-use communication tool for ordering, housing patient information, twoway communication, payment and delivery.

David tells us, “It has cut phone time, customer in store time, removed stress from patients and has received five-star reviews from customers since we launched it.

“Since the late August 2021 launch of the David Dodd Pharmacy App platform has resulted in an overall enhanced positive experience for the customer. We expect to maintain our website but having a strong pharmacy app with our independent pharmacy brand to the gives us the basis to maintain a persistent and trusted digital connection with our patients and the platform to being more addedvalue offerings in the future.

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“With our agreement, our development team have comprised the app platform into ‘PharmacyConnect’, a whitelabelled app platform for other pharmacies who can avail of the same functionality as the David Dodd Pharmacy app. By providing a whitelabelled solution for many Irish pharmacies, we now benefit from ongoing development and maintenance at minimal cost.”

David explains how the need for this innovation came about. “The need is simple. The pharmacy sector in a time of great strain needed a more effective and convenient way of communicating with the pharmacy, in particular

“Prior to the PharmacyConnect App solution the delays and gap in the systems within the Pharmacy caused orders being processed unnecessarily and a drop in the communication with the customer which led to frustration on both sides. The additional pressure of managing Covid fears and Covid restricted numbers meant that the pharmacy became a high stress environment for staff and patients.

“In addition to single patient ordering and prescription management the App also informs the customer about the medicines they are on and allows them to manage their partners and dependants’ medical needs.

Their medicine shortlists are clearly listed under each family member linked with the account.

55 David Dodd, Pharmacist and Owner, David Dodd Pharmacy

This can be added to easily with a prescription or, in the case of OTC items, on request of the patient. This information remains in the app for them to refer to whenever they choose. Easy, convenient ordering, personal prescription information and a simple to use messaging system simplifies the ordering journey and communication to strengthen the customer relationship.”

The objectives were seven-fold: • A well-designed app with a great user experience for both patient and pharmacy • Easy to use communication solution for customer and pharmacist • Bridge the communication gap created by Healthmail • Ordering tool for patients • Patient information accessible by patients in a clear, easy to understand, dated format.

• Improve systems within the Pharmacy • Support patients The back end of the App took a year to build, design, test and roll out in a pilot scheme which launched in the David Dodd Pharmacy in Greystones in August 2021. The technical spec is second to none with objectives being met to ensure the highest possible technological advances are used. For example: • Saas: as a software as a service (‘Saas’) platform, as a PharmacyConnect client we benefit from continuous development and upgrades to the system by a dedicated team. This is particularly important in an app environment where operating system and app store policy changes are continually being introduced. Furthermore, as an Irish-based provider, we are well-placed to keep up with and indeed anticipate local market and regulatory developments.

• Tech stack: the platform is built on the latest tech stack (incl.

Laravel PHP and React Native) which is proven capable of building scalable applications of a quality that consumers expect today (for example, Instagram is built using React Native technologies). In contrast to browser-based apps that are then ‘wrapped’ into an app, these technologies give a user experience that is true to the potential of smartphones today.

• Training and Support: as part of the service, technical support direct to both consumer endusers and pharmacy end-users is provided along with training to each pharmacy at the outset. This gets staff up and running quickly and means they should only be handling pharmacy-related queries, not technical ones.

• Data, GDPR, and Security: all data in respect of client activity is of course owned by the pharmacy group and/ or its customers. As required by law, PharmacyConnect has put in place a comprehensive Data Agreement within advance of launching. This agreement outlines inter alia technical and operational measures which employed to keep data safe, and this can be customised if needs require it.

The platform is openly available to all Irish pharmacies and is a multi-use one which means it can be developed and redesigned

for any independent pharmacy or group to deliver a seamless communication tool for the future of pharmacy/patient relationships.

David adds, “I personally feel that the recognising of the need and bringing it to fruition in this excellent level is not something I would be seeking to win a category in an award for. In fact, I am I so overjoyed with the success of it within my pharmacy and for my patients and I wish to put it forward for an award to ensure others can hear more about this seamless app solution with PharmacyConnect.

“So, for me, it’s not about the winning but sharing the benefits that we have experienced in the implementation of the app and the potential benefits for the Irish pharmacy sector in the future.

I am really delighted to receive this Award. We put a lot of work into the development of our App and as a team we are hugely proud of it and the difference it has made to our working lives within the pharmacy. This Award category in particular was really interesting for me as it forced us to focus on specific aspects of our pharmacy business and services offered.

Robin Hanna, Sales Director with McLernons said, “Tonight we are celebrating and recognising outstanding achievements – not just of finalists in tonight’s awards but of every single person who was working in community pharmacy in the last two years – the delivery drivers, the associated service providers, the cleaners, the pharmacy assistants and the dispensing teams.

“McLernons have been supporting the recognition of excellence in community pharmacy since the inception of these Awards because we believe that they shine a spotlight on the hard work, dedication and professionalism of community pharmacies up and down the country. This Award could have been won by each and every pharmacy in Ireland as they upended old ways of working, extended their dispensaries, coped with reduced or non-existent footfall in their retail space, and found new ways to receive, dispense and deliver prescriptions. Congratulations to David Dodd Pharmacy.”

“The whole process has been great for us and tonight has been the icing on the cake, we have had a wonderful team-building networking evening and have thoroughly enjoyed watching colleagues and peers also receive recognition for their work.”

PHARMACYNEWSIRELAND.COM

56

News

Reducing treatment-resistant High Blood Pressure A clinical trial to evaluate a new treatment for patients with high blood pressure that cannot be controlled with medication (treatment-resistant or refractory high blood pressure) has started at the Mater Private Network in Dublin and four patients have already been enrolled and received a study treatment.

Professor Robert Byrne, Director of Cardiology at Mater Private and Professor of Cardiovascular Research

He explained that if successful, a patient would only have to undergo the procedure once as it appears to have a long-lasting effect. Patients would still have to continue taking medication for their blood pressure but the hope is that with this procedure it would then be controlled.

If this new treatment proves safe and effective it could also potentially be a step towards a time at some stage in the future when patients with high blood pressure may no longer need to take medication for their condition.

The new treatment which involves a procedure carried out under mild sedation is aimed at patients who have high blood pressure (more than 150-180 over 90 mmHg) that is uncontrolled despite being on up to five medications.

Professor Robert Byrne, Director of Cardiology at Mater Private and Professor of Cardiovascular Research at RCSI , is the principal

investigator leading the study at Mater Private Network.

Professor Byrne explained, “This new investigational technique for treating high blood pressure is a minimally invasive procedure and is carried out under mild sedation.

We use a special catheter which is inserted through a small incision in the groin and guided to the renal arteries using X-ray guidance. The

Developing a deeper understanding of Diabetes Care Irish Pharmacy News is pleased to announce partnership with Ascensia Diabetes Care; makers of the Contour Next blood glucose monitors for a national survey within retail Pharmacy.

The aim of this survey is to develop a deeper understanding of diabetes care, specifically blood glucose monitoring across Ireland in pharmacies.

We want your opinion on service provision within your practices and if there are any areas for improvement. The survey will also look at trends in consumer buying habits and what influences your recommendation to your consumers.

All pharmacists across Ireland can take part in the survey, which will be sent out to our entire mailing list from November 1st.

An analysis of the survey findings will be published in the January 2023 issue of Irish Pharmacy News.

Deadline for participation: Tuesday 1st November – 29th November For further information or if you have any questions, please email: amy@ipn.ie

PHARMACYNEWSIRELAND.COM

catheter then delivers a small dose of medical-grade alcohol to the area just outside the renal artery where the nerves that contribute to the increase in blood pressure are located. The alcohol has the effect of deactivating the over-signaling of the nerves and this, in turn, reduces the blood pressure.”

According to Professor Byrne, it is estimated that 10% of people with high blood pressure would have refractory high blood pressure.

“If the treatment were to prove successful in the group of patients that are resistant to medications, down the line, it might be an option for people who say listen, I just want to control my blood pressure with a single procedure rather than have to take a couple of pills every day. So that is a direction of investigation as well,” Prof Byrne said.

“It could be a step on the road… to eliminate requirements for blood pressure tablets, but we’re still a long way off,” he added.

The clinical trial for this new treatment for high blood pressure is underway in 100 hospitals in Europe and the United States.

CONTOUR®NEXT

Your guiding light for diabetes management

To order your FREE CONTOUR®NEXT meters and support materials contact your local territory manager: South East - Maria Purcell Ph: 086 8181834 maria.purcell@ascensia.com

North East - Denise Butler Ph: 087 166 0065 denise.butler@ascensia.com

West - Barbara Muldoon Ph: 086 0455125 barbara.muldoon@ascensia.com

South West - Mary Gavin Ph: 086 0455136 mary.gavin@ascensia.com

CONTOUR®NEXT is an easy-to-use system that supports diabetes management providing clear, accurate readings you can trust.1 • Highly accurate1 readings you can trust to guide your patients

• smartLIGHT® feature. Target range indicators have been demonstrated

to help improve HbA1c control compared to BGMs without a target range indicator*2

• 60-second Second-Chance® sampling can reduce the need to re-lance and can help save strips.3

• Connected with the CONTOUR®DIABETES app to support self-management *Patients should always consult their healthcare professional before setting or changing any target ranges.

1. CONTOUR®NEXT (connected) BGMS User Guide, Rev. 05/19. 2. Grady M et al. J Diabetes Sci Technol. 2018;12(6):1211-1219.

3. Richardson J et al. Clinical Relevance of Reapplication of Blood Samples During Blood Glucose Testing. Poster presented at the Diabetes Technology Meeting (DTM). November 12-15 2020. © 2021 Ascensia Diabetes Care. All rights reserved. Ascensia, the Ascensia Diabetes Care logo, Contour, Smartlight and Second-Chance are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG. Date of preparation: September 2022. HCPCNEXTad092022v1

58

Cancer Report

National Trends for Cancer Report The National Cancer Registry (NCRI) has just published a new cancer trends report entitled Breast, cervical and colorectal cancer 1994-2019: National trends for cancers with population-based screening programmes in Ireland. The report focuses on cancer incidence, mortality, stage and survival for patients diagnosed with female breast cancer, cervical cancer and colorectal cancer. All three cancers have population-based screening programmes in Ireland.

NSS Chief Executive Fiona Murphy

National screening programmes organised by the Health Service Executive’s National Screening Service began inviting participants in 2000 (BreastCheck), 2008 (CervicalCheck) and 2012 (BowelScreen). Screening programmes aim to prevent or detect cancers early, therefore ensuring better outcomes for patients.

Key Findings • All three cancers show favourable trends in incidence, stage, survival and/or mortality consistent with improvements in early detection and outcomes, with clear evidence for additional or more recent benefits of screening.

• Almost a third of cervical cancer cases and a quarter of female breast cancer cases diagnosed during 2017-2019 were detected as a result of screening. A smaller proportion of colorectal cancers were screen detected.

• The introduction of a populationbased screening programme would be expected to decrease incidence in cervical and colorectal cancers, but not breast cancer. The incidence trends seen in our report are consistent with this.

• Screen-detected cancer cases were, on average, detected at a substantially earlier stage

than other cases diagnosed at the same ages. Survival has improved for all three cancers, with the biggest improvements in seen in the age-groups targeted by the national screening programmes.

• Death rates of all three cancers have fallen significantly.

Decreases in the age-groups targeted for screening have been more substantial than the overall decreases for all three cancers.

Cervical Check CervicalCheck was introduced in 2008 and now uses HPV testing as the primary screening test to screen women aged between 25-65 years for cervical cancer.

• Overall, the rates of cervical cancer have shown a significant decreasing trend of 2.8% per year since 2009 following the introduction of screening, reversing the previous trend of a significant increase from 1999 to 2009.

• The proportion of cases diagnosed with early-stage cancers (Stage 1 and Stage 2) is much higher in women in the screening age group (88%) than in the non-screening group (52%) • There has been a significant decreasing trend in mortality by on average 1.1% per year over the 1994-2019 period.

PHARMACYNEWSIRELAND.COM

“This is the first time that the NCRI has undertaken an in depth analysis on those cancers that have an associated screening programme.

Internationally, there is clear evidence that programmatic cancer screening improves cancer outcomes and saves lives.

This report demonstrates that the trends in Ireland are consistent with these international findings which is reassuring for service users, providers and policy makers.”

BowelScreen BowelScreen was introduced in 2012 and offers free at-home screening (FIT test) for bowel cancer men and women aged from 60-69.

• Overall, the rates of colorectal cancer in men have shown a significant downward trend of 2.5% per year following the introduction of screening, with a smaller but still decreasing trend (0.3% per year) in women since 1994.

• The proportion of cases diagnosed with early-stage cancers (Stage 1 and Stage 2) is much higher in screened men (64%) and women (62%) compared to non-screened age groups of men (37%) and women (39%) • There has been a significant decreasing trend in mortality over the 1994-2019 period and particularly noticeable in the 70+ year male age group (3.7% per year since 2011).

BreastCheck BreastCheck began screening for breast cancer in the eastern half of the country in 2000 and then extended nationally from 2007.

Screening was offered initially every two years to women aged 50 to 64 years, with an extension of the age eligibility to 69 years starting in 2015.

• The trends in incidence show what would be expected following the introduction/ expansion of a screening programme • The proportion of women in diagnosed with early stage cancers (stage 1 and stage 2) is higher (93%) in women in the screened age group compared to the non-screened age groups of <50 (78%) and > 70 years (75%).

• Mortality rates show a significant decreasing trend (by on average 1.8% per annum).

NCRI Director Professor Deirdre Murray said, “This is the first time that the NCRI has undertaken an in depth analysis on those cancers that have an associated screening programme. Internationally, there is clear evidence that programmatic cancer screening improves cancer outcomes and saves lives. This report demonstrates that the trends in Ireland are consistent with these international findings which is reassuring for service users, providers and policy makers.”

NSS Chief Executive Fiona Murphy welcomed the report and added, “The NCRI report is the first of its kind to analyse the impact of population screening programmes on cancer trends in Ireland. It is agreed that since the 1990s there has been a collective improvement in better awareness of cancer symptoms, new treatments, improvements in care and changes in underlying risks for cancer which have all had a positive impact on improved survival. However, with the publication of this report and the detailed analysis of the various screened populations we can now confidently say that a portion of that improvement is directly attributable to CervicalCheck, BowelScreen and BreastCheck. The public can be reassured that our screening programmes are effective.”

60

Children’s Health

Have you got the Golden Ticket?

Sona Irish Vitamins launch ‘Golden Ticket’ campaign to support sick children and their families through Children’s Health Foundation On October 1st, Sona Irish Vitamins launched a search to find their Golden Ticket! Whoever finds the ticket, which is hidden in the packaging in one of Sona’s children’s vitamins range, will win an amazing €1,000! On top of that, when the ticket is found, Sona will donate an incredible €30,000 to Children’s Health Foundation to support sick children and their families who attend Children’s Health Ireland at Crumlin, Temple Street, Tallaght and Connolly.

Susie recalls the stressful moment when Rosie had to go for her MRI scan. She had to be sedated.

Susie waited outside, her heart in turmoil. Once the scan was completed, Susie got to hold little Rosie again. It was good news.

The MRI was all clear. You can imagine what a huge relief it was for her family. Behind every sick child’s story, a lesser-known story – the story of how generosity, like that of Sona’s, directly connects with little patients like Rosie. It is the story of the vital equipment and upgraded facilities that your donation makes possible. Crucial improvements that make every patient’s and family’s journey less stressful, more comfortable and more positive.

Children’s Health Foundation is the charity supporting the lifesaving work of Children’s Health Ireland hospitals and urgent care centres. Since 2018, Sona has donated over ¤52,000 to Children’s Health Foundation. The funds donated by Sona will be used to help sick children across Ireland – children like Rosie.

obviously, but the staff were incredible and doing their best to reassure us. I knew she was in good hands. The one-on-one care around the clock that Rosie got was just fabulous, it meant that me and my husband could leave her cot-side temporarily and know we weren’t leaving her on her own.”

One-week-old Rosie had suddenly begun to cry. She was in obvious distress. Rosie’s parents, Susie and JP knew she was in trouble. It was a bank holiday Monday, their GP wasn’t available, so they took Rosie straight to the Paediatric Unit in the A&E in Mullingar.

The diagnosis was a serious one – Strep B Bacterial Meningitis.

Rosie was immediately sent to Children’s Health Ireland at Temple Street by ambulance, with her parents following behind in their car, completely in shock. By the time they arrived in ICU, Rosie had already been seen and her treatment started. That night Susie and JP slept in two reclining chairs in the family room. Susie will never forget the experience.

“I use the word ‘slept’ but we didn’t. We were very worried

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And thankfully, Susie tells us that Rosie is doing great. “Rosie started 1st class this year and thankfully all is going well with her. She has been a very healthy girl since she recovered from her meningitis as a new-born. She never stops talking and is a great character, cracks me up!”

For more information on how to find Sona’s Golden Ticket, visit

https://www.childrenshealth.ie/ sona-golden-ticket/ Commenting on the launch of the Golden Ticket campaign, Ohan Yergainharsian, Managing Director of Sona Irish Vitamins said, “SONA, as an Irish company, are proud to support the Children’s Health Foundation who work tirelessly in helping sick children and their families across Ireland. We are also delighted with the enthusiastic support we have received from community pharmacies to help make our Golden Ticket campaign a success.”

Denise Fitzgerald, Chief Executive of Children’s Health Foundation said: “We are quite simply blown away by the incredible support that Sona have shown sick children and their families in Children’s Health Ireland since 2018. Their commitment to helping sick children is steadfast, and we’re excited to launch the Golden Ticket campaign with them today.

Best of luck to everyone looking for the Golden Ticket!”

IrISH vItamInS FIND THE

Hidden inside a product from the Sona children’s range

&

WIN €1000

T E K C I T N E D L O G ner u are the lucky win Congratulations, yo ize of the €1000 cash pr

PLUS Sona will donate

€30,000

to Children’s Health Foundation in support of Children’s Health Ireland at Crumlin, Temple Street, Tallaght, and Connolly.

The lucky winner of the Sona Golden Ticket will get to present the cheque to Children’s Health Foundation on behalf of Sona Nutrition.

Sona proudly SupportS

RCN: 20042462 CHY: 13534

The Sona Golden Ticket competition will run Oct / Nov 2022

62

News

McKesson Ireland proud to announce ISPCC as their new Charity Partner McKesson Ireland has today announced a new charity partnership with ISPCC to help support the children’s charity with their aim to provide children with the facilities to listen to them, empower them, strengthen their resilience and enable them to live their best possible lives. McKesson Ireland is Ireland’s leading fully integrated healthcare provider and includes companies – LloydsPharmacy, United Drug, Median Healthcare & TCP Homecare.

ISPCC was chosen as the new charity partner for McKesson after a companywide vote and a period of research and consultation with staff. The new partnership came into effect end of September.

This ISPCC partnership further highlights how McKesson Ireland is committed to looking after all customers regardless of age, gender or location.

Paul Reilly, Managing Director of McKesson Ireland said ‘’We are delighted to announce our new charity partner of ISPCC. Through our many fundraising initiatives across the McKesson network, we aim to help raise the muchneeded funds for the vital services ISPCC provides to children. Our colleagues at McKesson are always willing to go the extra mile for our charity partners, whether it’s running, walking or cycling the length and breadth of Ireland to raise funds. We look forward to further growing these activities as our ISPCC partnership comes into play.’’

Dervila McGarry, Head of Marketing, McKesson Ireland, John Church, CEO, ISPCC and Paul Reilly, Managing Director, McKesson Ireland John Church, CEO of ISPCC commented: “We are delighted to have been chosen by McKesson Ireland as their charity partner

for the next two years. Childline

by ISPCC is a national charity dedicated to enhancing the lives of children and young people; they are at the heart of everything we do. Our child-centred services, programmes and supports are focused on strengthening resilience and developing coping

competencies. By listening to, supporting and empowering children and young people, we strive to ensure they are better equipped to face life’s ups and downs and reach their full potential. We are here to listen to children and young people, to empower them, to strengthen their resilience and to enable them to live their best possible lives. The support from McKesson will enable us to enhance the lives of many children across Ireland.”

Research Network enhancing Dementia Care Dementia Trials Ireland (DTI), led by Trinity College Dublin, is an exciting new national dementia research network that will offer every person in Ireland living with or at risk of dementia, the opportunity to access clinical trials. Over 65,000 people in Ireland are living with the condition.

Dementia Trials Ireland (DTI) is developing a national infrastructure to develop, attract and conduct dementia clinical trials across the state. Involving both lay and professional members of Ireland’s dementia community, DTI aims to significantly increase the capacity and capability to successfully undertake clinical trials across the range of stages of dementia from preclinical to advanced stage and different types of dementia including Alzheimer’s disease, dementia with Lewy bodies, frontotemporal dementia, vascular dementia and others. The project is funded by the Health Research Board (HRB) for five years, Professor Iracema Leroi of the Global Brain Health Institute (GBHI), Trinity College and St James’ Hospital is principal investigator of the project;

Professor Seán Kennelly of Tallaght University Hospital is co-lead.

To date, only a few centres in Ireland have conducted dementia trials, meaning that only a tiny handful of people with dementia have had the opportunity to participate in a study and access a potentially important treatment.

This needs to change. Ireland must take its place at the international table of those changing the landscape for dementia treatment.

This is the only way that people in Ireland will have early access to new treatments when they at last start emerging.

DTI will support a range of trials: from social and creative arts interventions such as dance therapy to complex drug interventions. It will include all members of the dementia community, healthy volunteers, people with dementia and

PHARMACYNEWSIRELAND.COM

caregivers, working towards the common goal of improving the lives of Ireland’s residents at risk of, or living with dementia.

Professor Iracema Leroi, DTI lead, said, “In the past 25 years nearly all the clinical trials for new dementia drugs have not been successful.

In most fields this would cause profound nihilism. However, the overwhelming need for trials, and the high prevalence of Alzheimer’s disease and other dementias, demands that we in the dementia community continue seeking a solution. Giving up is not an option.

In Ireland, we talk a lot about ‘brain health’ and ‘dementia prevention’, however our ability to arrest progression of dementia remains inadequate. Hence, clinical trials must continue. We need more trials, more interventions to trial, and more people volunteering to participate in trials.”

Professor Seán Kennelly, consultant physician, Tallaght University Hospital, Clinical Associate Professor of Medical Gerontology and GBHI faculty member at Trinity College, Director of the Institute for Memory and Cognition and DTI co-lead said, “This is how cancer drugs have succeeded so well, and this is the only way we can move forward as a dementia community.’ National and regional infrastructures to support clinical trials for cancer have dramatically improved survival rates, showing that research works. ‘We are at a really important intersection where we’re learning more all the time about the biology that’s causing these dementia syndromes and as result are increasing the repertoire of agents to treat or even potentially prevent them happening in the future.”

HELP YOUR CUSTOMERS BENEFIT FROM SUPPLEMENTS Alongside the fundamentals of a healthy diet and exercise, over 25 million people in the UK are choosing to find additional support from within the vitamins, minerals and herbal supplements (VMHS) category. With a further 31% of the population open to buying, the category presents a valuable opportunity to pharmacies.

Turning key insight into action:

64% of global consumers say they are more conscious of their

immune health since the pandemic. Immunity accounts for 8.1% of the VMHS category and is the 4th largest sub-category1. Autumn is traditionally the time when people engage with immunity products.

Ensure best-sellers and exciting new innovations are clearly visible so customers cannot miss them.

IMMUNITY

Women’s Health accounts for 9.9% of total category value and is the 3rd largest segment2. An estimated 13.1 million women in the UK are menopausal or peri-menopausal3.

WOMEN’S HEALTH

85%

of menopausal women experience menopausal symptoms3.

Menopause is a trigger for women to take food supplements for the first time, driving new buyers into the category.

63% of shoppers said mental wellness was important to them in the

STRESS & SLEEP

next 12 months4. Ensuring customers have branded stress, sleep and relaxation products will be key to meeting these needs.

Three VMHS innovations your customers will love:

Solgar® Ultimate Calm

Solgar® Ester-C® Plus Effervescent

Solgar® MenoPrime

Carefully designed to provide support for mental wellbeing by helping to promote a positive mood. An ideal option for occasions when feeling under pressure or overwhelmed.

Great tasting orange flavoured drink to recharge the body and mind. Ensures the recommended dose of Vitamin C daily.

A single daily tablet of MenoPrime provides whole-body, hormone-free, plant-based support for women aged 45 and over.

An award-winning range of over 370 nutritional supplements. Solgar® has over 75 years of commitment to quality, health & wellness and remains at the forefront of nutritional science. We are proud to say that 98% of Solgar® consumers would recommend our brand5.

To find out more contact us at infoUK@bountifulcompany.com / 01442 821 819 / www.solgar.co.uk 1. FMCG Gurus Top Trends 2022 2. Euromonitor 3. https://menopausesupport.co.uk/?page_id=60 4. NielsenIQ 2022 Consumer Outlook Survey, Dec 2021 5. Global Praxis online shopper survey 2017 of 3,882 VMS consumers.

Solgar® is a registered trademark.

64

COPD

Pulmonary Hypertension in COPD Written by Dr Rosie Kelly, respiratory registrar and Professor Eddie Moloney, respiratory consultant Tallaght University Hospital

Chronic obstructive pulmonary disease (COPD) is a common, preventable, treatable disease that is characterised by persistent respiratory symptoms and airflow obstruction, usually caused by smoking.

Approximately 10 percent of individuals aged 40 years or over have COPD, with estimates of over 500,000 people in Ireland having COPD, most undiagnosed and half of whom have moderate to severe disease, and prevalence increases with age.

Dr Rosie Kelly

Disease course can vary from exertional breathlessness to progressive severe exacerbations requiring hospitalisation. COPD is diagnosed using spirometry with a measurement of forced expired air in one second (FEV1) over forced vital capacity (FVC), the total volume of air expelled in a forced effort. A persistent obstruction in airflow will result in FEV1/FVC ratio of < 70 percent with. FEV1 also used to measure the severity of disease. Pulmonary function testing in a pulmonary laboratory allows for measurement of lung volumes (air trapping and hyperinflation pattern usually seen in COPD) and diffusion capacity for carbon monoxide (DLco) between lung alveoli and pulmonary capillaries. DLco is usually reduced in COPD as a complication of alveolar destruction due to emphysema and maladaptive pulmonary vascular changes which result in pulmonary hypertension.

Pulmonary hypertension (PH) is a significant complication of COPD, seen commonly in moderate (FEV1 < 80 percent) to severe (FEV1 < 50 percent) disease, and the presence of PH has a significant impact on survival outcomes in COPD. Patients with PH are classified into 5 groups based on aetiology and classification, with group 3 pulmonary hypertension

Professor Eddie Moloney

due to chronic lung disease and hypoxaemia, including COPD. Hypoxaemia from COPD results in pulmonary vascular endothelial cell injury promoting pulmonary vasoconstriction to try and maintain ventilation and perfusion balance, cellular proliferation and thrombosis.

Given that the majority of COPD patients at risk of PH (moderatesevere disease) will experience breathlessness, a principal symptom of both COPD and PH, it is important to be vigilant in clinical examination of COPD patients for signs attributable to PH. Such findings include a loud second heart sound (P2), signs of right ventricular failure including a raised jugular venous pressure (JVP), an auscultatory third or fourth heart sound, a systolic murmur of tricuspid regurgitation, hepatomegaly, and peripheral oedema. If there is clinical suspicion, a number of non-invasive methods may give further clues. A six minute walk test will often show a rapid decline in oxygen saturations. A CXR may show right ventricular enlargement.

An ECG may show signs of right ventricular hypertrophy (right axis deviation, dominant R wave in V1, a peaked P wave in leads II/III/ AVF), or right ventricular strain (ST depression and - T wave inversion in leads V1-V3).

PHARMACYNEWSIRELAND.COM

Transthoracic echocardiography (TTE) remains the investigation of choice due to its wide availability.

While there is an agreed upon consensus for the definition of PH on pulmonary artery catheterisation (mean pulmonary artery pressure > 20 mmHg), definitions for PH on TTE are less well defined. TTE evaluates the probability of PH using the tricuspid regurgitant jet velocity (TRV). TRV along with right atrial pressure (RAP) can be used to estimate the pulmonary artery systolic pressure (ePASP). PH is suggested echocardiographically when the ePASP exceeds 35 mmHg, and/or when the right ventricular size, wall thickness, and function are abnormal.

However, due to variability in RAP, ePASP may poorly correlate with values obtained by right heart catheterization (RHC).Thus, we support guidelines issued by the European Society of Cardiology (ESC) and the European Respiratory Society (ERS) that propose use of the peak TRV together with echocardiographic findings of PH rather than ePASP to report the echocardiographic probability of PH. Regardless of whether the TRV or ePASP is used, these values should always be interpreted together with clinical suspicion and signs of RV dysfunction. When pulmonary dysfunction is severe enough to explain the degree of PH on echocardiography (eg, severe pulmonary dysfunction and mild PH), RHC is not indicated. RHC is usually reserved for those in whom the severity of PH on echocardiography is not explained by the severity of their underlying CLD (eg, moderate to severe PH with mild lung disease) or for those in whom an alternate aetiology is suspected. If PH is present in the setting of a relatively normal or mildly impaired FEV1, but DLco disproportionately low, a CT Thorax should be considered to check for co-existing interstitial lung disease with COPD, or pulmonary embolic disease.

Should a diagnosis of group 3 PH be established, it is essential that the underlying disease process is

managed as well as possible to prevent further progression. This includes smoking cessation and pharmacological therapy to reduce symptoms and reduce frequency and severity of exacerbations.

This will aim to optimise lung function and limit hypoxaemia. For specific therapies targeting PH, a recent systematic review showed minimal benefit in pharmacological therapies for COPD-PH. Vasodilator treatment resulted in reduction of measured PAH however this failed to translate into symptomatic improvement or survival benefit for patients with COPD. The only treatment option that showed both haemodynamic and clinical benefits was long term oxygen therapy (LTOT). Guidelines for commencing LTOT in patients with COPD recommend its use in those who show evidence of moderate hypoxaemia (Pa02 <8 mmHg) with pulmonary hypertension and/or polycythaemia (haematocrit >55 percent) or severe hypoxaemia (Pa02 <7.3mmHg). LTOT, when used correctly at a minimum of 15 hours per day, could slow progression of PH and reduce mortality.

Unfortunately, correction of hypoxaemia at this point is unlikely to reverse vascular remodelling.

COPD-PH is a significant complication with direct impact on outcomes in a disease that already has significant morbidity and mortality. Recognition of this complication requires vigilance in clinical examination and an awareness of clues on readily available investigations such as six minute walk test, ECG, CXR and pulmonary function testing.

Echocardiography can be used to diagnose PH but results should be interpreted in combination with the clinical picture, should results be incongruous referral for expert opinion for consideration of RHC should be sought. Management of COPD-PH remains focused on correction of hypoxaemia with targeted treatments to lower PAH showing minimal clinical benefits at this stage.

References available on request

- LIVING WELL WITH COPD What is COPD? Chronic Obstructive Pulmonary Disease (COPD) is a disease that makes it hard to empty air out of your lungs. This is because the airways get smaller leading to airflow obstruction. This can result in shortness of breath or tiredness because you are working harder to breathe.

COPD is a term used to include chronic bronchitis, emphysema or a combination of both conditions.

Having COPD often means that patients have to check their SpO2 levels regularly. The Medicare LifeSense® Bluetooth Pulse Oximeter monitors SpO2 levels and automatically uploads your readings to the Medicare LifeSense® app. The app also allows you to set reminders to check your SpO2 levels daily or to take your COPD medication.

Home Solutions for Respiratory Well-being Medicare Pulse Oximeter Our Medicare LifeSense® Bluetooth Pulse Oximeter is an easy to use, non-invasive, SpO2 monitor which gives quick and accurate results within 10 seconds.

Medicare LifeSense Bluetooth Pulse Oximeter ®

This device can be paired via Bluetooth to the Medicare LifeSense® App and the results can be shared quickly and easily with healthcare professionals.

Medicare Humidifiers Consider using a humidifier in your home to help manage your COPD symptoms. Moisture in the air can help reduce excess mucus and phlegm and can help with breathing difficulty.

Medicare Nimbus & Cirrus Humidifiers

Talk to your doctor before using a humidifier as increased humidity can either benefit or make symptoms worse. Use a humidity meter in your home to find out what your current level is.

Medicare Nebulisers One of the key benefits of inhalation is the fact that the medication is delivered directly into the respiratory tract, allowing for a high drug concentration in the target area.

Medicare V1 Compressor Nebuliser

Nebulising medication can even have a greater clinical effect compared to similar or larger doses delivered orally (tablets) or by subcutaneous injection. Studies have also shown that this can lead to better treatment results than using inhalers alone.

MEDICARE LIFESENSE® APP

Measure, Track and Share your Results

Scan to download our free Medicare LifeSense® App and Online Health Portal

All products are exclusively available through Fleming Medical.

Visit FLEMINGMEDICAL.IE or call 1800 307777

66

Finance

Taxation of Pension Benefits in Retirement – A Guide to the Advantages Tax and pensions in one headline! If I still have your attention don’t worry as this is a good news article with valuable information that will benefit you in retirement and give you peace of mind now.

Written by Colm Moore, CERTIFIED FINANCIAL PLANNER™, Moore Wealth Management

As part of our advice process, we offer full cashflow modelling that runs your financial future out to end of life and this factors in the tax you pay on your income in retirement. So, the first thing to clear up is that you do pay tax on your retirement income including the state pension, but the good news is that there are very generous allowances from revenue and with the proper advice and planning you can have an income of ¤73,600 per annum at an effective income tax rate of 10.15% State Pension -Your Entitlement The State Pension (Contributory) entitlement of an individual is calculated on their PRSI record and is then assessed under two methods (Yearly Averaging & Total Contributions Approach) with the individual’s entitlement being based on whichever provides the best outcome. In both cases it is a requirement that the individual has paid at least 10 years’ worth of PRSI. If you are unaware of your PRSI record, you can request this from your own www.mywelfare.ie login and is something you need to know. For a married couple with a full entitlement, this amounts to ¤26,343 per annum. If you wanted to buy that income in the open market via an annuity it would cost in the region of ¤700,000 so you can see the value of this.

Lump Sums The first major advantage of having a pension is the entitlement to a tax-free lump on retirement up to revenue allowed limits.

Currently you can take up to ¤200,000 completely tax-free and depending on your fund size and needs you can take the next

PHARMACYNEWSIRELAND.COM

¤300,000 at a tax rate of 20%. If you combine both you can extract ¤500,000 which was an initially tax-relieved contribution from your business into your hands at an effective rate of 12% which is less than the tax relief you obtained thus making it a near tax neutral transaction. While it is rare to see someone extract this much at retirement with the excellent post-retirement options available it is still a choice.

Where someone makes a lump sum contribution into their pension near to business exit/sale to extract cash (as no buyer is looking to purchase cash), the tax relief will have two treatments depending on several factors. Some will be offset in the year of the contribution thus reducing the corporation tax liability and what is less well-known is that some can be carried forward in the company as an asset which is factored into the sale of the business.

Post Retirement The balance of funds after the tax-free cash option in many cases goes into an Approved Retirement Fund (ARF). This is an extension of your pension planning that allows your accumulated funds to continue to grow tax-free and is drawn down as your needs dictate. To make sure that the funds do not sit indefinitely in your ARF revenue tax these under a practice known as Imputed Distribution. This means that from your 60th birthday onward they tax you under the assumption you have taken 4% of the fund from your ARF so you should a make withdrawal of at least this amount. From age 70 onwards this increases to 5%.

Planning Opportunity The fact you need to extract 4% from your fund can be used for those who retire early and will not have another source of income who wish to continue to accumulate PRSI credits for the state contributory pension and the valuable benefit outlined above. To ensure that a PRSI record accrues towards the State Pension (contributory) a withdrawal of at least ¤5,000 in the relevant year would be required.

That ¤5,000 withdrawal can be taken monthly, quarterly, half-yearly or as a single payment.

In all cases where the total withdrawal or withdrawals equal or exceed ¤5,000 then the individual will accrue 52 Class S PRSI contributions which are essentially a full year’s worth of PRSI contributions.

This is a different approach to that of a standard private sector employee who would pay Class A PRSI and would only receive one Class A contribution for each week of work. Therefore, one ARF withdrawal of ¤5,000 or more will accrue 52 weeks’ worth of a PRSI record which it would take a private sector worker a full year of working to match. Again, this is vital information in your retirement planning.

Taxing your Income With an ARF the plan is that you draw income from this in retirement to fund your lifestyle.

As you do this you are looking at two things; The level of withdrawals which you hope can be sustained from investment performance and the level of tax you pay when combined with any other income. You want to keep your taxation level as low as possible.

Allowances Between the personal, employee and aged tax credits a married couple will have ¤5,345 credits on top of an exemption from income tax that goes up to ¤36,000 which can give you marginal relief up to ¤73,600. The best way to illustrate this is with an example where we will take a couple where one spouse is age 66 and there are two pension funds with values ¤1.08m and ¤480k Income Tax

Liability

Tax as a % of Income*

Spouse 1 ¤45,800

¤5,515

12.10%

Spouse 2 ¤27,800

¤1,915

6.90%

Jointly

¤7,430

10.15%

¤73,600

* Note income is still subject to USC which is outlined below

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68

Finance

What you will see above is that a couple can earn up to ¤73,600 in retirement at an effective tax rate of 10.15% when you factor in all allowances and credits. While this is an illustration of ARF income this could also be a combination of state pension, rental income and ARF withdrawals. In my view, this is a very strong case for funding your pension for retirement living and dispels the notion we hear about the effects of tax in retirement.

Bear in mind that the income you are drawing down has accumulated and grown in the most benign and favourable tax environment that exists for investors in Ireland.

If the above example consists only of income from your ARF you will also have benefitted from two sizeable tax-free lump sums from your pension of circa ¤380,000.

USC and PRSI You must however add USC to the above tax computations but again this is a benign rate in the age ranges below Age 66 to 70 Band Tax Rate

Income of ¤60,000

Up to ¤12,012

0.50%

¤60.06

Next ¤9,263

2%

¤185.26

Next ¤38,749

4.50%

¤1,743.70

Effective Rate

3.32%

¤1,989.02

PHARMACYNEWSIRELAND.COM

Age 70+ Band Tax Rate

Income of ¤60,000

Up to ¤12,012

0.50%

¤60.06

Next ¤47,988

2.00%

¤959.76

Effective Rate

1.70%

¤1,019.82

An important point to note is that you cease PRSI contributions once you reach 66.

How do we work this into our advice We can run this backwards to your current starting position and see what level of pension funding you need to make now at conservative growth assumptions to get to for example the scenario above. By combining this with cashflow modelling which gives you an accurate picture of your financial future you can then invest with the appropriate amount of risk to achieve your goals. Our process is bespoke and comprehensive.

“The first thing to clear up is that you do pay tax on your retirement income including the state pension, but the good news is that there are very generous allowances from revenue” efficient vehicle for cash extraction and wealth accumulation that a growing number of people wish they had. If you have not maximised the opportunities this pension gives you it’s in your best interest to have a consultation with a suitably qualified person to explain this opportunity while the option still exists.

Important Update on Company Paid Pensions Changes

*Please note that all the above is subject to current tax rates and Budget 2023 has made the scenarios outlined above more favourable with the widening of tax bands. This should not be taken as tax advice, and you should always engage the service of your accountant and/or tax advisor when making your tax return.

In our last article we mentioned that there were significant changes to the typical pension a company director in Ireland operated. The Pensions Authority shut off new access to these schemes and as yet we do not have a viable alternative. This means anyone who currently has one of these schemes has in their retirement planning armoury a supremely

Colm Moore is a CERTIFIED FINANCIAL PLANNER™ with Moore Wealth Management.

They have been advising the Irish Pharmacy community for over 20 years. If you have any questions on the above or would like to talk with Colm on any aspect of Financial Planning, he can be contacted on 086-8603953 or colm@mwm.ie

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IBS

Considerations in Irritable Bowel Syndrome Pharmacy teams can play an essential role for patients with Irritable Bowel Syndrome (IBS) by helping them identify symptoms, discussing possible treatment options, and educating them about the disease.

Counter assistants and staff can help to recognize patients who likely have IBS and either attempt to self-medicate with various OTC products such as herbal supplements or have prescriptions for antidiarrheals or laxatives.

Some people have occasional mild symptoms. Others have unpleasant symptoms for long periods. Many people fall somewhere in between, with flare-ups of symptoms from time to time.

Proactive questioning of the patient will allow pharmacy staff to assess the appropriateness of the medications or identify a need for referral to other health care professionals for further evaluation.

Finally, it is also important to reassure the patient that IBS remains a manageable illness for the most part.

Diet

Irritable bowel syndrome (IBS) is quite common with as many as 1 in 5 people affected. It is twice as common in women as men and happens most often to people in their 20s and 30s.

IBS is a disorder of the gut whereby the function of the gut is disturbed. However there are no physical or structural abnormalities. It causes a variety of symptoms, which are discussed in further detail below. It usually first appears in teenagers and young adults.

Symptoms of IBS include loose, frequent stools, constipation, bloating, and abdominal pain and cramps. Patients may notice symptoms following the intake of specific foods or that symptoms, such as stool consistency or pain location, change over time. Patients may also present with headache, lethargy, nausea, bladder symptoms or faecal incontinence.

Most IBS sufferers believe that certain foods cause or exacerbate their symptoms and thus exclude these foods from their diet.

Insufficient evidence exists, however, to support exclusion diets or food allergy testing once lactose intolerance and celiac sprue are excluded.

Alternatively, some may find it helpful to keep a food diary to determine if gas-producing foods (eg, beans, cabbage, onions, broccoli), carbonated drinks, sorbital, lactose, or wheat aggravate their symptoms and then avoid or limit them to determine if symptoms improve.

Many IBS patients who seek medical care suffer from anxiety or depression and benefit from psychological therapies, including cognitive-behavioural therapy, hypnotherapy, and dynamic psychotherapy.

Pharmacologic treatment is aimed at relieving the predominant GI

Pain and discomfort may occur in different parts of the abdomen.

Pain usually comes and goes. The length, severity and timing of each bout of pain can also vary greatly.

The pain often eases when passing stools (motions or faeces) or wind.

Many people with IBS describe the pain as a spasm or colic.

Bloating and swelling of the abdomen may develop from time to time. Sufferers may pass more wind than usual. Other symptoms can sometimes occur and include: nausea (feeling sick), headache, belching, poor appetite, tiredness, backache, muscle pains, feeling quickly full after eating, heartburn, and bladder symptoms (an associated irritable bladder).

PHARMACYNEWSIRELAND.COM

symptom, but the goal should be to improve the overall or global symptoms, including altered stool frequency and consistency, abdominal pain and discomfort, bloating, and quality of life.

Antispasmodics may provide short-term relief of abdominal pain and discomfort in IBS, but support for long-term efficacy is not available. Antispasmodics are associated with adverse effects (eg, dry mouth, blurred vision, dizziness, urinary retention), which may limit their use and should be avoided in IBS-C or IBS-M, as they may worsen constipation.

IBS and Heartburn As many as 2 out of 3 people with IBS also have symptoms of GERD. GERD and IBS both impact segments of the digestive tract, but the connection between the two is unclear. Theories explaining the overlap include: • Pain sensitivity: Both conditions arise when nerves in the gut become over-sensitive (visceral hypersensitivity). This causes changes in the muscle contractions of the intestines and esophagus.

• Confusion over symptoms: IBS patients with GERD symptoms may actually have functional

dyspepsia (indigestion). This is a milder form of GERD. Tests such as ambulatory oesophageal pH monitoring can confirm a diagnosis of GERD. • The broad definition of GERD: GERD symptoms vary in severity. IBS-like symptoms may be part of the same spectrum of GERD, leading to patients reporting symptoms of both conditions.

Pharmacy Considerations: - Am I aware of guidance which states sufferers should try to eat at about the same time each day to help regulate bowel function?

- Am I aware of food triggers for IBS? - Am I aware of the associated conditions and appropriate OTC medications which may help?

- Ensure there is a discreet area within the pharmacy for customers to discuss their condition in a confidential manner - Diet and lifestyle changes can go a long way to minimise IBS flare-ups, am I confident in advising these changes to customers?

72

News

The Burden of Chronic Health Conditions Researchers at Trinity, along with colleagues in RCSI University of Medicine and Health Sciences and the Economic and Social Research Institute (ESRI) have found that patients with more than one chronic health condition are under a significantly higher financial burden with healthcare expenses than those without a chronic health condition. Their findings, published in the journal BMJ Open, are particularly pertinent in the current cost-of-living crisis.

Susan Smith, Professor of General Practice, Department of Public Health and Primary Care, School of Medicine, Trinity College Dublin, and Senior Author

Antimicrobial Resistance Among those hospitalised during the pandemic, both COVID-19 patients and those tested for SARS-COV-2 but negative, had higher rates of antibiotic-resistant bacterial infections compared to patients hospitalised before the pandemic, according to a study evaluating the pandemic’s impact on antimicrobial resistance (AMR) in 271 hospitals across the USA, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, Portugal.

The study also found that drug resistant infections were significantly higher in hospitalonset cases during the pandemic.

• Though data was collected in 2016, there have been few changes to the medical card entitlements system in Ireland since then.

Healthcare is a major source of expenditure for patients in Ireland. The majority of people (59%) in Ireland aged 50 years or over have more than one chronic health condition. Chronic health conditions are health issues that can last a long duration, generally progress slowly, and are not passed from person to person.

Examples include diabetes, arthritis, or depression. Individuals with more than one health condition are likely to have higher healthcare needs and higher out of pocket payments for healthcare.

These high costs can lead to people choosing not to buy their medicines or not attending their healthcare appointments.

The question researchers sought to answer was: How much more do people with multiple health conditions spend on healthcare, compared to those with no conditions?

The research team used data from The Irish Longitudinal Study of Ageing (TILDA) from 2016 to investigate the healthcare expenditure of a nationally representative sample of 5,899 adults aged 50 years or over.

Key findings: • People with two chronic conditions had an average annual expenditure of ¤806.80, and people with three or more

conditions spent an average of ¤885.80. This compared to ¤580.30 for people with no chronic conditions. Therefore, people with two chronic conditions on average spent 39% more on healthcare than people with no chronic conditions, and people with three or more conditions spent on average spent 53% more than people with no chronic conditions. These figures are likely an underestimate as household adaptations and travel costs to access healthcare were not included in the analysis.

• The biggest contributor to increased expenditure was medicines, accounting for approximately half of expenditure for people with two or more conditions.

• People with more than one condition had lower incomes, which means that some people with multiple conditions are spending a very large proportion of their income on healthcare.

For example, we found that almost 1 in 10 people with three or more conditions spent more than 20% of their income on healthcare.

• Having a medical card reduced healthcare expenditure by approximately half.

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James Larkin, PhD Scholar, Department of General Practice, RCSI, and lead author said, “What is particularly concerning is that people with more than one chronic condition, not only have to spend more on healthcare, they also have lower incomes on average, meaning they do not have the ability to pay for some healthcare costs. Increasing the income threshold for the medical card, would likely be beneficial to people with more chronic conditions, especially considering the threshold has changed very little in the last 8 years. Furthermore, we know from previous Irish research that 31% of those entitled to a medical card are not availing of it. So to reduce financial burden, barriers to medical card uptake should be addressed. These barriers include lack of awareness of entitlement, potential stigma, and large administrative burdens.”

Susan Smith, Professor of General Practice, Department of Public Health and Primary Care, School of Medicine, Trinity College Dublin, and Senior Author, added, “These results are concerning, especially when we consider the current cost of living crisis. People with multiple health conditions have higher healthcare expenditure and lower incomes. Inflation is leading to higher energy bills and fuel costs, meaning that the capacity for people with multiple health conditions to pay for their healthcare is shrinking even further.”

The COVID-19 pandemic presents many challenges for appropriate antibiotic use and stewardship, and there have been studies reporting that the pandemic was associated with AMR secondary infections, possibly due to the increase in the use of antibiotics to treat COVID-19 patients and disruptions to infection prevention and control practices in overwhelmed health systems.

While conclusive evidence is lacking, these signals underscore the importance of continued monitoring of the impact of COVID-19 on AMR rates.

To provide more evidence, researchers conducted a multicenter, retrospective cohort analysis of all adults (aged 18 years or older) admitted to 271 hospitals across the USA before and during the COVID-19 pandemic, who had spent at least one day in hospital and had a record of discharge or death.

All admissions with at least one AMR infection (defined as a first positive culture for select gram-negative or grampositive pathogens resistant to antibiotics) were recorded. The analyses found that the AMR rate was 3.54 per 100 admissions before the pandemic and 3.47 per 100 admissions during the pandemic. However, patients who tested positive or negative for COVID-19 had higher levels of AMR than patients before the pandemic—4.92 per 100 admissions and 4.11 per 100 admissions, respectively.

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from

Topic Team Training – Acute Pain A community pharmacy environment that fosters teamwork ensures high levels of consumer satisfaction.

This series of articles is designed for you to use as a guide to assist your team in focusing on meeting ongoing CPD targets and to identify any training needs in order to keep the knowledge and skills of you and your team up to date. insensitive to mechanical stimuli, but can be sensitised by the chemical mediators produced during inflammatory reactions.

Neuropathic: this type of pain generally serves no purpose.

It is commonly described as nerve injury or impairment and is associated with allodynia (central pain sensitisation). Nerve neurochemistry can be damaged after compression, stretching, or hyperexcitability propagated from other peripheral nerves.

Following on from the October issue Continuing Professional Development on the Management and Treatment of Acute Pain, this Team Training Module is designed to enhance the community pharmacy team understanding and ask further questions as to how you can support and advise patients.

Pain is a distressing sensation, as well as an emotional experience.

The International Association for the Study of Pain (IASP) defines pain as an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.

In pain perception, three main stages generally occur, firstly pain sensitivity, then pain transmission from the periphery to the DH, and finally, transmission of these signals to the higher brain, e.g cortex, through nerves in the central nervous system (CNS).  Transduction occurs initially. The painful stimulus is converted to chemical tissue events, then

chemical tissue and synaptic cleft events are converted into electrical events in the neurons, and finally electrical events in neurons are transduced as chemical events in the synapses.  Transmission then occurs, i.e. the propagation of electrical events along the neuronal pathways and across synapses.  Modulation then takes place at all levels of nociceptive pathways through the primary afferent neuron, DH and higher brain centres, up or downregulating the sensation.

Pain can be grouped into three different classifications: nociceptive, neuropathic, and inflammatory: Nociceptive: Aδ and C-fibres are mostly found in superficial organs, such as the skin, whereas deeper structures such as muscles and joints are mainly supplied with C-fibres. There is an additional nociceptor type called silent nociceptors. These are located in the viscera and are usually

Consider:

Inflammatory: This is a normal biological response to harmful stimuli that is required to start tissue repair. Neutrophils are usually the first cells to gather at the site of injury. Redness and swelling at the site of injury is due to the increased blood flow and increased vascular permeability, which can also induce pain.

Pain is strongly associated with self-care management and acute pain is responsible for consumption of large quantities of over the counter (OTC) non-steroidal antiinflammatory drugs (NSAIDS).

The aims of pain management should be discussed with each individual, but may include some or all of the following:  Reducing the intensity of pain

A Cochrane review investigating the effects of analgesics/analgesic combinations (given as single doses postoperatively) concluded that there is evidence supporting the efficacy of these OTC drugs that are available without prescription, with ADRs generally not different from placebo.

Paracetamol is a great first line choice for mild to moderate pain. It has no known GI, renal or cardiac adverse effects at the usual OTC and prescribed doses; however, the patient should be reminded of the maximum daily dose over 24 hours to reduce the risk of accidentally exceeding this.

Codeine and paracetamol combination products should only be offered for e.g. managing acute lower back pain if an NSAID is not suitable or has been ineffective.

Caffeine does not have any pain relieving effect itself, but rather is added as an adjuvant to ibuprofen, aspirin and/or paracetamol products to enhance their analgesic effects.

The most effective OTC drugs used were ibuprofen/ paracetamol combinations in 400mg/1,000mg and 200mg/500mg doses; respectively, providing relief to 70% of people, and with a NNT of less than 2.

 Enhancing physical functioning  Improving psychological functioning  Promoting return to work or school and/or role within family and society  Improving health-related quality of life Key Points:  The causes of acute pain, including the various types of injury

Actions: Ensure support staff understand the following key points:  The common types of acute pain  The characteristics of a good analgesic for OTC use in the treatment of acute pain  The benefits and limitations of OTC medicines  The importance of what outcome a patient presenting with pain wants

 Is the pharmacy team fully trained on the indications and benefits of all products for the treatment of acute pain?

 What types of pain can be considered for management in the pharmacy

 How are pain relief products (oral and topical) displayed in the pharmacy?

 Which customers should be referred to the pharmacist

 Lifestyle issues that may impact on pain recovery, and tips on improving lifestyle

 Do we make the most of the potential for linked sales (e.g. oral and topical analgesics, food supplements, complementary therapies, support bandages)

 The importance of not taking certain oral analgesics for longer than three days without referral

 What approaches are recommended by the World Health Organisation (WHO) analgesic ladder

 Questions to ask the customer

 When to refer customers to the pharmacist.

 Am I up to date with the latest guidance?  Am I aware which preparations are recommended first-line?

74 | PHARMACYNEWSIRELAND.COM

DON’T LET PAIN HOLD YOU BACK

ESSENTIAL INFORMATION *To verify contact verify@perrigo.com Solpa-Extra 500mg/65mg Soluble Tablets contains paracetamol and caffeine. For the treatment of mild to moderate pain. Adults and children over 16 years: 1-2 tablets dissolved in water every 4-6 hours. Max 8 tablets a day. Children 12-15 years: 1 tablet dissolved in water every 4-6 hours. Max 4 tablets a day. Not suitable for children under 12 years. Contraindications: Hypersensitivity to the ingredients. Precautions: Particular caution needed under certain circumstances and medical advice sought for renal or hepatic impairment, Gilbert’s Syndrome, chronic alcoholism, glucose-6-phosphatedehydrogenase deficiency, haemolytic anaemia, glutathione deficiency, malnutrition or dehydration, the elderly, patients weighing less than 50kg. Precautions needed in asthmatic patients sensitive to acetylsalicylic acid, patients on a controlled sodium diet and with rare hereditary problems of fructose intolerance. Patients should be advised not to take other paracetamol containing products concurrently. Immediate medical advice should be sought in the event of overdose even if the patient feels well because the risk of irreversible liver damage. Excessive intake of caffeine should be avoided while taking this product. Interactions: warfarin and other coumarin, other medicines following the same metabolic pathway, cholestyramine, probenecid, chloramphenicol, metoclopramide, domperidone, sedatives, tranquilizers and some decongestants. Pregnancy and lactation: Not recommended during pregnancy and breastfeeding. Side effects: Rare: allergies. Very rare: thrombocytopenia, anaphylaxis, bronchospasm, hepatic dysfunction, cutaneous hypersensitivity reactions, very serious skin reactions, TEN, drug-induced dermatitis, SJS, AGEP, sterile pyuria. Unknown: nervousness, dizziness, neutropenia, leukopenia. Further information is available in the SmPC. Legal classification: P. PA 1186/017/001. MAH: Chefaro Ireland DAC, The Sharp Building, Hogan Place,Dublin 2, Ireland. Date of preparation: 04/2022. RRP (ex. VAT): €5.07. SPC: https://www.medicines.ie/medicines/solpa-extra-soluble-tablets-33783/smpc IRE SOL1 2022 14

The Maternity-Pharmacy Axis- Caring for women before, during and after pregnancy

Dr Claire McCarthy is a Consultant Obstetrician/Gynaecologist with a special interest in managing medical conditions in pregnancy. Dr McCarthy is also involved with the Irish Medicines in Pregnancy Service (IMPS), a multidisciplinary service based at the Rotunda Hospital, which provides information and expertise to support safe and effective use of medicines before, during and after pregnancy and in lactation.

Written by Dr Claire McCarthy, Consultant Obstetrician/ Gynaecologist, Rotunda Hospital

Over 1 million women of child-bearing age live in the Republic of Ireland and at any point could be planning to conceive, be pregnant or in the postnatal period. While pregnancy and childbirth are normal physiological events, some women do require extra care to optimise their pregnancy outcomes. During a woman’s reproductive years, there are increased opportunities to engage and educate women on their healthcare priorities, as well as those of their families. It is thus imperative that all healthcare providers use any of these interactions for health promotion and protection.

At the heart of the community, a pharmacy and its’ staff are in the valuable position of being able to provide care to women and their families for both minor ailments and illnesses, but also provide advice, support and dispensing of medication to service users. Therefore, there can be innumerable opportunities to provide advice and support

for those pregnant or considering pregnancy.

Some of these elements are outlined in the Health Service Executive document “Healthy Ireland, the Framework for Improved Health and Wellbeing 2013-2025”, which underlines that early intervention before birth is as critical as ongoing early years support.

The National Maternity Strategy was formally launched in 2016 as a ten-year plan, with the aim to support the implementation of National Standards of Care. The National Maternity Strategy, along with the National Standards represent the essential building blocks to provide a consistently safe and high-quality maternity service. This is both hospital and community based, with input from the multidisciplinary team. The National Women and Infants Health Programme provides oversight and governance of maternity services nationally, with the aim to further improve the quality and standard of care that is received.

From a pre-conceptual perspective, it is advised that women have a healthy balanced diet, minimise alcohol consumption and take folic

76 | PHARMACYNEWSIRELAND.COM

acid (0.4mg once daily) for at least three months pre-conceptually. Some women (e.g. those with Diabetes Mellitus, family or personal history of a neural tube defect, taking anti-seizure medication or those with a Body Mass Index over 30kg/m2) should be prescribed higher dose folic acid (5mg) supplementation. Vitamin D supplementation is also recommended for women who are deficient, or at risk of being deficient. Women who are entering pregnancy with a medical condition can sometimes benefit from pre-conceptual counselling. This can provide an opportunity to optimise medication, achieve disease control and allow counselling on potential pregnancy complications or outcomes that may arise owing to their condition, or indeed medications that they are taking. It is essential that women who are taking prescribed medication do not suddenly cease or discontinue taking medication on finding out they are pregnant, as in some cases this can lead to a deterioration in their health, putting themselves and their pregnancy at a greater risk. It is essential that these women undertake a risk-benefit discussion with their

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Key Facts • Studies have shown over 70% of first time NTDs1, such as Spina Bifida can be prevented by taking 0.4mg of folic acid daily.

• Almost 50% of pregnancies are unplanned.

• It’s important to take 0.4 mg of folic acid every day for at least 14 weeks before you become pregnant and continue taking it for at least the first 12 weeks of pregnancy.

You actually need Folic Acid

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Clonfolic is contraindicated in cases of Vitamin B12 deficiency. Caution is advised for patients under therapy for folate-dependent tumours when taking folic acid. Women with pre-existing diabetes, obesity, family history of neural tube defects, or previous pregnancy affected by neural tube defect have an increased risk of having a pregnancy affected by a neural tube defect and higher doses should be considered. For women taking anti-seizure medication the requirement for folic acid may be different and they should be under the supervision of a physician while taking folic acid supplements. The tablet also includes lactose monohydrate.

A copy of the summary of product characteristics is available on request. Clonfolic 0.4mg tablets. PA 126/95/1. PA Holder: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co Tipperary, Ireland. www.clonmel-health.ie Medicinal product not subject to medical prescription. Supply through general sales.

References: 1. NTDs (neural tube defects). 2. Leading sales brand in pharmacy – IQVIA, IRLP audit, units, MAT Jan 20.

Date prepared July 2020. 2020/ADV/CLO/048H

prescriber and evaluate whether continuing to take the medication is of a greater benefit than the actual or theoretical risks that taking the medication might pose.

Smoking during pregnancy additionally is noted to be detrimental to the health of both the mother and the fetus. The national tobacco control policy document “Tobacco Free Ireland” provides specific recommendations for smoking cessation both in pregnancy, but also pre-pregnancy. It notes that frontline healthcare professionals should have formalised and documented training in smoking cessation.

Women may attend their community pharmacy for support in accessing nicotine replacement therapy if non-pharmacological methods have failed, which required a detailed discussion on the risks, benefits and alternatives.

MBRRACE-UK (Mothers and Babies: Reducing Risk through Audits and Confidential Enquires across the UK) is a report published annually which examines maternal deaths and morbidities over a rolling three-year period, critically analysing and evaluating care given to women and their families. It provides healthcare providers with essential information to allow us to continually strive for improved care in our maternity services. Closer to home, the NPEC (National Perinatal Epidemiology Centre) based in University College Cork also publishes reports documenting Ireland’s maternal morbidity and mortality findings. It has been noted in many of these reports that there is a rising cultural bias to medication use in pregnancy, particularly in the context of older mothers, and those with increasingly complex medical conditions. Recommendations from these reports can be seen to take a pattern over the years. Specifically, with respect to medication, the 2018 MBRRACE report noted that the “decision on continuing, stopping or changing medication in pregnancy should be made only after careful review of the benefits and risks of doing so, to both mother and infant”.

Antenatally, the National Maternity Strategy aims is to create three dedicated pathways for women to access care. The Supported Care pathway is intended for normal-risk mothers and babies with midwives leading and delivering care within the multi-disciplinary framework. The Assisted Care pathway is intended for mothers/babies considered to be at medium risk, and for those who chose obstetricled care. This care is provided by obstetricians and midwives, as part of a multi-disciplinary team. For those women who are high-risk, the Specialised Care pathway provides obstetricled care, with input from other medical specialities, again delivered in partnership with midwifery services. These women may require a multi-disciplinary, multi-speciality approach to care and care planning.

Currently, from an obstetric perspective, families can opt for consultant-led care, or combined care. This is facilitated through the Maternity and Infant Care Scheme, available to every woman who is pregnant and ordinarily resident in Ireland, sharing care between the family doctor and hospital service. A number of maternity units also provide a suite of midwifery-led care, as well as midwifery-led units, a DOMINO (Domiciliary In and Out) service, Early Transfer Home and homebirth services. The HSE also facilitates a homebirth service through a number of registered self-

employed community midwives. Community pharmacists are an important resource during the antenatal period. Women may need support and resources in the management of both pregnancy-related and pre-existing complications. It is essential that pharmacists are empowered and supported in providing this, but also referring to the patients’ primary care or maternity care provider where necessary.

Postnatally, women are eligible for postnatal care both in hospital, but also in the community. Ideally, this should be a seamless transfer, either through hospital follow-up (i.e. community midwifery, early transfer home schemes), or through public health nurses and community care, in liaison with a primary care service. In this period, women may access the pharmacy for postnatal medications, or medical equipment/devices to support their recovery and rehabilitation.

Vaccination is also a key public health innovation to afford protection from severe forms of a condition but also to prevent disease.

Some pharmacies offer vaccination against a variety of diseases to their communities, and thus knowledge on vaccination during pregnancy is important. The Irish Immunisation Guidelines for Pregnant Women recommend that all rubella seronegative women of childbearing age should be offered a dose of the MMR postnatally. All pregnant women should be offered the influenza vaccine throughout the influenza season. The pertussis vaccine should be offered between 16 and 36 weeks gestation in order to allow passage of antibodies to the fetus. More recently, vaccination against COVID has predominated healthcare advice.

It is essential that pharmacists and their staff are proactive in supporting and recommending vaccination. There are helpful Decision Aids and Infographics available through the Royal College of Physicians of Ireland website to support and assist women in their decisionmaking surrounding COVID vaccination.

Breastfeeding is important for the health of both mothers and infants. From the maternal perspective, it reduces risk of cardiovascular disease, breast and ovarian cancer, as well as more short term conditions such as postpartum depression. For infants, breastmilk provides improved protection from acute infections and respiratory illnesses, as well as reduced childhood obesity. Despite this, breastfeeding rates in Ireland are amongst the lowest in the OECD. Public consultations have noted that some of the factors in these low rates are lack of breastfeeding supports in the hospital, community and home setting, as well as inconsistent and contradictory poor quality information on breastfeeding. In that context, support from all healthcare professionals, including pharmacists, is essential to improve our breastfeeding rates and support mothers who wish to successfully breastfeed. This can include on medication use in lactation, but also the provision of correct knowledge and support surrounding challenges women may experience and attend for advice (such as thrush, painful feeding, low supply) for both medical reasons, but assistance with medical supplies such as nipple shields and breast pump supports.

It would be remiss not to mention contraception when discussing women’s health and maternity services. In July 2022, the Minister for Health announced the introduction of a

78 | PHARMACYNEWSIRELAND.COM

free contraception scheme for women aged 17-25 years of age. From 2023, this will be extended to 16 to 30 year olds. The community pharmacy will be at the crux of the provision and dispensing of medications, along with the primary care teams. Going forward, it may be possible for women to access some hormonal contraceptive options in the community pharmacy, which will continue the precedence set by the successful provision of emergency contraception in the pharmacy setting. While this is a significant undertaking by the community pharmacy sector, it has revolutionised contraception provision, underpinning the centrality of the role of the community pharmacist and their team in the community.

Finally, it is known that one in six couples may experience difficulties in conceiving and may attend for advice both prior to attending for assessment, as well as during treatment. The community pharmacy can again play a key role in the support of couples through their subfertility journey, as well as the supply of medications that may be prescribed during this period of time. The Assisted Reproductive Technology journey can be fraught with emotional challenges, and can pose financial difficulties to couples which is important to acknowledge and help support as much as possible.

The community pharmacy as a location at the hub of a community has the unique ability and position to influence and promote positive healthcare changes in their clientele. Their knowledge of both their patients, but the wider factors surrounding prenatal, antenatal and postnatal care will be crucial going forward in the success of the National Maternity Strategy but also the healthcare of the population at large. Through continued engagement with education and increased provision of funding to the sector, the community pharmacy will continue to remain an essential part of the multidisciplinary healthcare team caring for generations of pregnant women.

References Health Service Executive. Healthy Ireland, the Framework for Improved Health and Wellbeing 2013-2025.

Department of Health/Health Service Executive.

National Maternity Strategy: Creating a Better Future Together 2016-2026 Health Information and Quality Authority.

National Standards for Safer Better Maternity Services. 2016.

Department of Health. Tobacco Free Ireland: Report of the Tobacco Policy Review Group.

Oct 2013.

Knight M, Bunch K, Tuffnell D, Jayakody H, Shakespeare J, Kotnis R, Kenyon S, Kurinczuk JJ (Eds.) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers’ Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2014-16.

Oxford: National Perinatal Epidemiology Unit, University of Oxford 2018 https://www.hse.ie/eng/health/immunisation/ pubinfo/pregvaccs/ https://www.rcpi.ie/news/releases/informationfor-women-who-are-pregnant-or-breastfeedingabout-the-covid-19-vaccine-update/

80

News

United Drug Documentary: United We Stand United Drug have been waiting to tell a very special story, one that will be a remembered forever as one of their greatest achievements in the history of their business. Finally, after a long and challenging period of lockdown, the business has been able to produce an incredible documentary called; United We Stand.

David Keyes, Distribution and Hospitals Director

Paul Reilly, Managing Director “We are all extremely proud of what we have achieved, and our efforts and commitment has helped to save lives.” - Catherine Cummins, Operations Director of United Drug

The documentary details the unprecedented time in history and through a series of intimate interviews with some of the company’s senior leaders, coupled with behind-the-scenes footage, the viewer will learn first-hand what it took to set up the operation for the storing, handling, and distribution of the COVID-19 vaccine across Ireland.

All McKesson Ireland staff were invited to the United Drug HQ on

September 15th for a premiere style event, to not only watch the first showing of the “United We Stand” documentary but also to finally stand together in one room after 3 years, united in celebrating their colleague’s success and this incredible achievement. Managing Director Paul Reilly and Catherine Cummins, Operations Director addressed the audience before the showing to reiterate how proud they were of their teams and all involved. The energy was electric!

The collaboration and trojan work of the United Drug teams during the Covid Crisis has proven to impact not just their business but the entire nation. Their tireless efforts, including long days and nights, and commitment to an incredibly complex project has benefitted nearly each and every individual in our country.

view it on the United Drug website or check it out directly here by scanning the QR code below:

Not all heroes wear capes, and they are thrilled to finally be able to share their story.

If you haven’t had a chance to see the Covid-19 Documentary, you can

www.united-drug.com

McKesson and United Drug are shortlisted with the Irish Pharma Awards 2022 Health & Safety Award: McKesson Ireland are delighted to have been shortlisted for the Health & Safety Award in the Pharma Industry Awards. In February 2019, the McKesson Ireland Health and Safety team began their discussions around the potential dangers of Covid19 to the business. Because McKesson plays such a pivotal role in the Irish Healthcare system, it was absolutely critical that whatever challenges lay ahead with Covid19, would not impact the supply of vital medicines across the Irish Health system and that every Pharmacy would where possible remain operational.

COVID-19 Crisis Response Award: United Drug were also shortlisted for the COVID-19 Crisis Response Award. As the global pandemic placed continuous and relentless pressures on the Health care sector, United Drug set about to prepare their business and teams for the challenges to come. They critically evaluated the risk at hand and implemented innovative processes, and protocols to receive, store, handle and distribute Covid19 Vaccinations. Their efforts ensured that vital medications, vaccines, and services could continue to be provided and maintained to the Irish Public throughout the entire Pandemic.

With this in mind, the Covid19 Task Force Team was formed.

The main objectives were to proactively put measures and processes in place to minimize risk to employees, customers, and most importantly patients.

Wishing the McKesson and United Drug teams all the best in the upcoming awards!

Shortlists can be viewed on the Pharma awards website: www.pharmaawards.ie.

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News

Budget 2023: Huge Help for Cancer Patients The abolition of hospital charges announced in the Government Budget will be a huge help for patients at a tough time financially, according to the Irish Cancer Society.

Rachel Morrogh, Irish Cancer Society Director of Advocacy

Society welcomes today’s momentous announcement that hospital in-patient charges are to be abolished. This will come as a huge relief to patients who are struggling to make ends meet in the current cost of living crisis.

Each time a patient without a medical card attends hospital for treatment they are currently charged ¤80 per visit, up to an annual cap of ¤800.

Irish Cancer Society Director of Advocacy Rachel Morrogh said, “After many years of campaigning to reduce the costs carried by cancer patients, the Irish Cancer

“This has been a central plank of our advocacy and we thank every patient who shared their story about how charges levied by the Government was adding to their financial misery. We will write to Minister Donnelly in the coming days to thank him for successfully negotiating this important measure, alongside his Government colleagues who supported it.

“The Irish Cancer Society is pleased that the National Cancer Strategy has been funded for the third successive year and that money has been made available to reduce waiting times. We will stay engaged with patients and clinicians over the winter period to monitor this and to ensure the funding is making a measurable difference.

“Finally, Government’s commitment to funding a catch-up programme for HPV (human papillomavirus) vaccinations for boys and girls in secondary school and for women up to the age of 25 who may have missed vaccinations, as campaigned for by the Irish Cancer Society and other groups, is further welcome news.

“We will continue to campaign on the measures that did not get funded in Budget 2023, such as reductions in the cost of hospital car parking and the entitlement of every cancer patient to a medical card.”

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Cold and Flu Film-Coated Tablets contain:

Professionally recommended for: Colds and Flu Runny Nose A triple combination of antihistamine, analgesic and stimulant

Pain Relief Congestion

Caffeine strengthens the analgesic and antipyretic effects of Paracetamol*

A therapy for the management of the symptoms of upper respiratory tract infections

Please consult the summary of product characteristics or contact the marketing authorisation holder for full product information. Name of product: Ilvico Cold and Flu film-coated tablets. Active Ingredient: Paracetamol 325 mg, Caffeine 30 mg, Brompheniramine maleate 3 mg. Supply classification: For supply through pharmacies only. Name and address of the marketing authorisation holder: P&G Health Germany, GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany Licence Number: PA22703/001/001. Indication: For the relief of symptoms associated with the common cold, influenza and upper respiratory tract infections. Method of administration: For oral use. Adults and children older than 12 years: One or two tablets taken orally with water three times daily and the maximum dose of 6 tablets daily should not be exceeded. Not recommended for children under the age of 12 years. Please refer to the SmPC for posology instructions for the elderly or those with renal or hepatic impairment. Potential Side effects: thrombocytopenia, leucopenia, agranulocytosis, pancytopenia, haemolytic-anaemia, palpitations, arrhythmia, ventricular depression, bradycardia, hypertention, hypotension, transient vasodepression, sedation, drowsiness, ataxia, headache, restlessness, insomnia, somnolence, impairment of cognition, tremor, dizziness, mydriasis, blurred vision, dry eyes, bronchospasms, dyspnoea, nausea, dry mouth, fatigue, increased level of aminotransferase, jaundice, urinary retention, urinary hesitation, erectile dysfunction, skin reactions, quinke’s oedema, sweating, acute generalised exanthematous pustulosis (AGEP), stevens-johnson syndrome (SJS), toxic epidermal necrolysis (TEN). Special warnings and precautions: Paracetamol should be administered with caution under the following circumstances: hepatic impairment; chronic alcoholism; renal impairment (GFR≤50ml/min); gilbert’s Syndrome (familial non-haemolytic jaundice); concomitant treatment with medicinal products affecting hepatic function; glucose-6-phosphate dehydrogenase deficiency; haemolytic anaemia; glutathione deficiency; dehydration; chronic malnutrition; weight less than 50kg; the elderly. Contraindications: Must not be used if patient: has hypersensitivity to the active substances or to any of the excipients listed in section 6.1; has the presence of narrow-angle glaucoma; has brain damage or epilepsy; is less than 12 years old; has tachyarrhythmias; has peptic ulcers; has severe renal impairment; has severe hepatic impairment (including viral hepatitis); has haemophilia; has vesical neck obstruction, symptomatic prostatic hypertrophy or urinary retention. Reviewed: November 2021. *Summary of Product Characteristics, Ilvico Cold and Flu film-coated tablets.

P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824, Schwalbach am Taunus, Germany

Further information is available on request from PRL on +353 1 257 4650 or pgsales@prl.ie

84

Erectile Dysfunction

Management and Treatment of Erectile Dysfunction Erectile dysfunction (ED) is a common condition occurring in males over 40 years of age, although it can occur earlier. It is estimated that at least 150 million men globally have ED. It is difficult to obtain accurate values for the true prevalence of erectile dysfunction however, as many patients fail to seek medical attention, and many clinicians are reluctant to ask patients about their sexual health.

An interview with Theresa LowryLehnen (PhD), CNS, GPN, RNP, South East Technological University

evidence now suggests that more than 80% of cases have an organic aetiology. While most patients with ED have organic disease, some do have a primary psychological cause, particularly younger men.

Even when ED is organic in nature, there are almost always psychological consequences regarding relationship issues, cultural norms and expectations, loss of self-esteem, shame, and anxiety and depression related to sexual performance.”

Erectile dysfunction is multidimensional in nature, and Theresa says it can be broadly divided into endocrine and nonendocrine causes.

We recently spoke to Theresa Lowry Lehnen, RGN, GPN, RNP, BSc, MSc, M. Ed, PhD Clinical Nurse Specialist and Associate Lecturer South East Technological University to understand more about this condition and its impact on males in Ireland.

ED can have a substantial negative impact on a man’s quality of life, Theresa reflects.

She says, “Erectile dysfunction is the inability to achieve or maintain an erection for satisfactory sexual performance, and affects a considerable proportion of men at least occasionally. It is often treatable, however, if left untreated, ED can be a source of severe emotional stress for both the man and their partner.”

Theresa notes that erectile dysfunction is often an under recognised, yet important, cardiovascular risk factor. She says, “Owing to its strong association with metabolic syndrome and cardiovascular disease, cardiac assessment is warranted in men with symptoms of ED.” Aetiology of Erectile Dysfunction Although most men will experience periodic episodes of erectile dysfunction, it tends to become more frequent with advancing age.

“Many factors can contribute

to sexual dysfunction in older men, including physical and psychological conditions, comorbidities and polypharmacy,” she adds. “Aspects of an ageing man’s lifestyle behaviour and androgen deficiency, most often decreasing testosterone levels, can affect sexual function.

“Studies have shown that the percentage of men who engage in some form of sexual activity, decreases from 73% in men aged 57–64 years to 26% for men aged 75–85 years. The aetiology for this decline in male sexual activity is multifactorial, and is in part related to female partners menopause at approximately 52 years of age, leading to a significant decline in female libido and desire to engage in sexual activity.”

While ED is associated with ageing, many studies and largescale surveys have concluded that ED is a major health concern among young men.

Theresa adds, “One study in 2013 reported that 1: 4 men seeking medical help for erectile dysfunction in the real-life setting, is < 40 years of age. Another study in 2016 concluded that 22.1% of men < 40 years of age had low (<21) Sexual Health Inventory for Men (SHIM) scores.

“In the past, erectile dysfunction was almost always considered a psychogenic disorder. However,

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“The condition can be caused by any disease process which affects penile arteries, nerves, hormone levels, smooth muscle tissue, corporal endothelium, or tunica albuginea. It is closely related to cardiovascular disease, diabetes mellitus, hyperlipidaemia, hypertension, and endothelial dysfunction,” she explains.

“Erectile dysfunction and vascular disease are thought to be linked at the level of the endothelium.

Endothelial dysfunction, results

in the inability of smooth muscle cells lining the arterioles to relax and prevents vasodilatation. The endothelial cell is known to affect vascular tone and impact the process of atherosclerosis and impacting ED, CVD and peripheral vascular disease. Cardiovascular disease and hypertension are very significant risk factors for erectile dysfunction.”

Besides cardiovascular disease, there are strong correlations between ED and hyperlipidaemia, diabetes, hypogonadism, obesity, smoking, alcoholism, benign prostatic hyperplasia (BPH) with lower urinary symptoms (LUTS), depression, and premature ejaculation. Diabetes is a common aetiology of sexual dysfunction, because it can affect both the blood vessels and the nerves that supply the penis. Men with diabetes are four times more likely to experience erectile dysfunction, and on average, experience it 15 years earlier than men without diabetes.

“Obesity is also correlated to the development of several types of dysfunction, including a decrease in sex drive and an increase in episodes of ED,” she

Date of Birth __________________

86

Date Completed: _______________ Erectile Dysfunction

Sexual Health Inventory for Men (SHIM)

continues. “Neurogenic erectile dysfunction is caused by a deficit in nerve signalling to the corpora cavernosa. Such deficits can be secondary to spinal cord injury, multiple sclerosis, Parkinson disease, lumbar disc disease, traumatic brain injury, radical pelvic surgery and diabetes.

Men being treated for prostate cancer with treatments such as radical prostatectomy, radiation therapy or the use of lutenising hormonereleasing hormone (LHRH) agonists and antagonists often experience ED.” Numerous medications are listed with erectile dysfunction and/ or a decreased libido as a side effect. Drugs that can cause ED include hydrochlorothiazide’s and beta-blocking agents.

Medications used to treat depression, particularly the SSRIs such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline, can also contribute to ED. The severity of erectile dysfunction is often described as mild, moderate or severe according to the five-item International Index of Erectile Function (IIEF-5) questionnaire, with a score of 1–7 indicating severe, 8–11 moderate, 12–16 mild–moderate, 17–21 mild and 22–25 no erectile dysfunction.

The International Index of Erectile Function (IIEF-5) Questionnaire The IIEF is a multidimensional validated questionnaire with 15 questions in the five domains of sexual function (erectile and orgasmic functions, sexual desire, satisfaction with intercourse and overall sexual satisfaction), and there is also an abbreviated format of five questions in the Sexual Health Inventory for Men (SHIM).

Investigations and Diagnosis Theresa continues, “A thorough medical history, detailed sexual history, and physical examination are required before commencing treatment or further investigations.

It is important to distinguish between psychological and organic causes of ED, as well as to ensure that the patient has erectile dysfunction and not another disorder. History that points towards a psychological aetiology include, sudden onset of erectile dysfunction especially if it is related to a new partner or a major life-changing event, situational ED, normal erections with masturbation or a different partner, presence of morning

Over the past 6 months: 1. How do you rate your confidence that you could get and keep an erection?

Very low 1

Low 2

Moderate 3

High 4

Very high 5

2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration?

Almost never/never 1

A few times (much less than half the time) 2

Sometimes (about half the time) 3

Most times (much more than half the time) 4

Almost always/always 5

3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?

Almost never/never 1

A few times (much less than half the time) 2

Sometimes (about half the time) 3

Most times (much more than half the time)4

Almost always/always 5

4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?

Extremely difficult 1

Very difficult 2

Difficult 3

Slightly difficult 4

Not difficult 5

5. When you attempted sexual intercourse, how often was it satisfactory for you?

Almost never/never 1

A few times (much less than half the time) 2

Sometimes (about half the time) 3

Most times (much more than half the time) 4

Almost always/always 5

IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items.

22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction

Total Score __________ erections and high daily variability in erectile rigidity.

“The main differential diagnosis for erectile dysfunction is hypogonadism, loss of libido, depression with low mood, and other psychological conditions. It may also be the first manifestation of diabetes or cardiovascular disease as well as depression.

It is important to differentiate between true erectile dysfunction and other sexual disorders such as premature ejaculation, and this is usually assessed by obtaining a good sexual history.

“A complete medication list including supplements should be checked with the patient. ED can be a result of prescription or other medications. Prescription drugs that can cause ED include, antidepressants especially SSRIs, cimetidine, ketoconazole, spironolactone, sympathetic blockers, thiazide diuretics, and other antihypertensives. ACE inhibitors and calcium channel blockers are the least likely to cause ED. Beta-blockers are only a minor contributor, while alpha-blockers can improve erectile function.”

Vascular risk factors such as hypertension and diabetes and lifestyle factors such as smoking, activity level, alcohol intake, and the use of any recreational drugs should be assessed, Theresa adds. A full general and cardiovascular examination

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should be undertaken, as erectile dysfunction can be the first symptom of underlying vascular disease. Peripheral pulses should be checked and blood pressure measured. The genitalia should be carefully inspected for hypogonadism, signs of infection, the presence of penile fibrosis or plaques, and phimosis.

Theresa continues, “The role of testosterone replacement therapy (TRT) as a potential to improve erectile function in ED remains an issue for clinicians who are comfortable treating androgen deficiency. Androgens are known to have a significant impact on the function of the smooth musculature within the corpus spongiosum.

“Testosterone supplementation is more effective as a treatment for low libido than for ED. For most men with both ED and hypogonadism, oral PDE5 inhibitors alone are recommended as the initial therapy. Testosterone supplementation is reasonable in men with proven hypogonadism and ED who have already failed PDE5 inhibitor therapy or who also have low libido. Hypogonadal patients with borderline erectile rigidity are most likely to benefit from testosterone supplementation.

“Testosterone replacement therapy may cause increased levels of haemoglobin or haematocrit which is associated

with an increased risk of heart attack, stroke and blood clots.

Testosterone treatment can also cause an enlarged prostate or other prostate disorders. During TRT treatment, the prostate specific antigen (PSA) will be measured to monitor for any changes and this is particularly important in men over 45 years of age.

“As a result of using testosterone replacement, natural production of testosterone may be reduced. This may lead to a reduction in sperm production and fertility. Other side effects of TRT include: weight gain, increased appetite, hot flushes, acne, depression, restlessness, irritability, aggression, tiredness, general weakness and excessive sweating. Lifestyle modifications are considered first-line therapy for ED, and men should be encouraged to make the necessary changes to benefit both their sexual function and their overall health.

“PDE5 inhibitors are highly effective and have an overall success rate of up to 76%. PDE5 inhibitors are contraindicated in patients taking nitrates, but otherwise are safe and effective.

When PDE5 inhibitors are co-administered with nitrates, pronounced systemic vasodilation and severe hypotension can occur.

“PDE5 inhibitors and α-adrenergic

87 receptor blockers, often used for treatment of BPH, need to be taken at least 4 hours apart.

Among second-line therapies, external vacuum devices (VCDs) are a good, non-surgical option for patients with ED. VCDs are clear plastic chambers placed over the penis, tightened against the lower abdomen with a mechanism to create a vacuum inside the chamber. This directs blood into the penis. If an adequate erection occurs inside the chamber, the patient slips a small constriction band off the end of the VCD and onto the base of the penis. An erection beyond 30 minutes is not recommended.

While cumbersome, these devices are considered safe.

atropine, which work alone or in combination to elicit an erection. Response is dose related, usually occurs within 10– 15 minutes, and does not require stimulation. A concern with ICI use is priapism, and if this occurs the patient will need to seek urgent medical attention.

Bruising can also occur, due to it being an injected medication. The intraurethral suppository consists of a tiny pellet of prostaglandin E1 inserted into the urethral meatus.

Response is dose related, and onset usually occurs within 10–15 minutes. Patients need to be trained on the technique of the IUS before use, and should be advised that pain or burning may occur with this medication.

Outlook

“Other second-line therapy includes the use of either intracavernosal injection (ICI) or intraurethral suppositories (IUS). A small needle is used to inject the ICI medication into the lateral aspect of the penis through a small-gauge needle.

These vasoactive agents include prostaglandin E1, papaverine and phentolamine and sometimes

“In men who fail to respond to first or second-line therapy, or who are not interested in conservative therapies, penile prosthesis implantation is available. Penile implants include malleable and inflatable devices, although most implants used are of the inflatable variety. Adverse effects including malfunction and infection are rare, and patient satisfaction is high.”

“Stem cell studies may also provide advancements in the treatment of ED in the future. The mechanism of action of stem cells is to generate angiogenesis with subsequent increase in cavernosal smooth muscle cells within the corporal bodies.

Theresa told us that future Therapies for ED Clinical studies in gene therapy are looking towards replacing proteins that may not be functioning properly in the penile tissue of men with erectile dysfunction.

She says, “Replacement of these proteins may result in improvement in ED. Experimental animal models have demonstrated improvement in erectile function with gene therapy. Human studies may demonstrate success with this therapy in the future, however, gene therapy in humans is controversial, and can take a long time for regulatory approval and public acceptance.

“The clinical studies published to date provide encouraging

results, with improvement of sexual function reported with no side effects. Although pioneering, stem cell studies to date are small scale, with a short follow up period, various aetiologies of ED and without a control group.

Melanocortin activators are drugs that act through the central nervous system, and have been shown in animal studies to produce an erection. Initial studies in humans suggest that the drug (PT-141) can be effective if given intranasally in men with psychological rather than physical causes, and mild to moderate ED. “Larger studies are necessary, however, to demonstrate the safety and overall effectiveness of these drugs. Another potential new treatment for ED, is penile low intensity shock wave lithotripsy.

This consists of 1500 shocks twice a week for 3–6 weeks. The purpose is to stimulate neovascularisation to the corporal bodies with improvement in penile blood flow and endothelial function. The use of low-intensity shock wave lithotripsy may convert PDE5 inhibitor non-responders to responders.”

Pharmacy Role in ED Care Background of ED Erectile dysfunction is defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance.

Erectile dysfunction is one of the most common health conditions affecting men. EAU guidelines from 2020 indicate a prevalence of 52% of men aged 40-70 years with erectile dysfunction (ED).4 ED is very common in Ireland, one in 5 Irish men experience this regularly.

Causes of ED There are many causes of ED which can result from both physical and psychological conditions Physical Causes • Conditions such as heart disease, atherosclerosis, high blood pressure diabetes, metabolic syndrome, parkinson’s disease and multiple sclerosis • Obesity • Certain Prescription medication (10-25% of ED causes are drug induced)* • Treatment for prostate cancer • Tobacco Use

• Excessive substance abuse such as alcoholism • Sleep Disorders

Written by Lisa Byrne, Superintendent Pharmacist, McCabes Pharmacy Group

• Low Testosterone Psychological Causes • Depression, anxiety or other mental health conditions • Stress • Relationship problems * Common medicines that cause ED are antidepressants, antihistamines, high blood pressure medicines and diuretics of which thiazides are the most common cause of ED following by beta blockers. Other classes of medications include Parkinsons disease medicines, chemotherapy and hormonal medicines, opiate analgesics and recreational drugs.

We would always advise men who are unsure of the reason behind their ED to speak confidentially to their pharmacist, we always recommend a visit to a GP to ascertain underlying conditions that might cause this.

Lifestyle changes Modifiable risk factors that can help improve symptoms of ED include losing weight, exercise daily, stop smoking, eat a healthy diet and reduce stress and anxiety.

Treatment of ED Sildenafil has been licensed for the treatment of ED since 1998 and is available in three different strengths on prescription.

Sildenafil 50mg (Viagra Connect) is available without a prescription to those over 18 from the pharmacy, following consultation with a pharmacist which can be done in the privacy of a consultation room.

Studies have reported that patients sought out online platforms for accessing ED treatments citing convenience, shame and discretion as treatment barriers.2 Pharmacists have a key role to allow customers access to medication in an environment that encourages them to seek treatment, be afforded counselling, and thus building a trusting relationships.3 At McCabes Pharmacy there is the option to Click & Collect. The customer completes an online

consultation form on the website and collects their medication in store from the pharmacist, after answering a few questions to ascertain if it is indeed the most appropriate medication for their needs. This has proved to be a very popular service, by nature of its discretion.

Referenc es vailable on request

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88

(ACEI) Angiotensin Receptor Blockers (ARBs)



Lithium Management

Up to fourfold increase in lithium level.



Most likely to cause lithium toxicity within a month of starting.

the elderly 

Consider alternative anti-hypertensive



If combination necessary, increased monitoring of lithium level and renal function required.

Lithium Therapy: a national patient safety and quality N: improvement initiative Non- Steroidal

Diclofenac: up to 23% increase in lithium level  From 10% to  Ibuprofen: up to 25% increase in Antimore than lithium level inflammatories four-fold  Patients should be advised Product: Formulation: Recommended Lithium levelto avoid (NSAIDs) increase in OTC NSAIDs and use Paracetamol if dosing: sampling time: lithium level.

OTC analgesic required.

Lithium Carbonate.

Once daily: 12 hours post-dose Priadel Tablets: at night-time 200mg+400mg  Unpredictable  Thiazides  Thiazide diuretics should only be used T: 400mg tablet contains (acceptable 10-14 hours) reduce renal where unavoidable and with strict Thiazide 10.8mmol/L Lithium.

(Prolonged Release) (200mg tablet may be halved to clearance of monitoring  Up to fourDiuretics facilitate 100mg dose ) lithium and fold increase levels can rise in lithium  Loop diuretics may be safer.

Once daily: 12ishours post-dose Camcolit tablet EMP level. Lithium Carbonatewithin a few Furosemide probably the safest at night-time diuretic to use with lithium but days 400mg (acceptable 10-14 hours)  Usually frequent monitoring required.

(Prolonged Release) EMP: Exempt Medicinal Product apparent in the 

Priadel Liquid EMP Written by Audrey Purcell B(Sc) Pharm. MPSI. MSc. Psych Pharm.

Chief 2 Pharmacist, Saint John of God Hospital, Stillorgan, Co Dublin.



Sodium

Honorary Senior Clinical Lecturer,

Switching lithium products: Royal College of Surgeons in Ireland.



Variable: a few days to several months.



first 10 days Twice daily: Pre-morning dose Any effect will morning and night be apparent in 520mg/5ml : equivalent the first month. to Lithium Carbonate (Immediate Release) Excess Sodium  Consider high Sodium content OTC 204mg/5ml can reduce preparations and recommend suitable lithium levels alternatives (calculate as 200mg/5ml)

Lithium Citrate 

520mg/5ml

S:

Unpredictable

Sodium  Care with Sodium content in restriction can effervescent formulation lead to lithium Priadel tablets are recommended for routine use. The tabletstoxicity. have score- lines therefore they can be divided Pharmacy NHS Lithium Citrate Twice daily:  Refer to SPS Pre-morning dose Li-Liquid EMP 509mg/5ml “Considering Sodium content of accurately to provide smaller dosage requirements. If a patient is unable to swallow tablets a liquid may be morning and night medicines”; particular care with 509mg/ml:by equivalent to prescribed.

It is essential that a switch from tablets to liquid is prescribed their Doctor, and calculation confirmed products > 17mmol Sodium in 1. BACKGROUND AND Lithium Carbonate (Immediate Release) maximum daily dose CLINICAL INFORMATION:

by Pharmacist.

200mg/5ml https://www.sps.nhs.uk/articles/consi Lithium Indications: dering-sodium-content-of-medicines/ 200mg/5ml) Example: Switching patient from Priadel tablet (Carbonate) 800mg(calculate nocte toasPriadel liquid (Citrate) = 400mg (10ml) • Bipolar Disorder: mania, hypomania prophylaxis Example: Sodium Bicarbonate in antacids BD morning and and night.

Lithium of level to be checked 5-7 days post- switch.

Bipolar Disorder (Gaviscon); recommend Maalox instead. 

• Recurrent Depressive Baseline work-up: Disorder: used to augment antidepressants

Example: patient from concomitant • Serum Creatinine+/-estimated Prescribing: •• Reduction ECG : if of cardiac history, forSwitching QTc prolongation, medicines that prolong QTc intentional self- risk factors Priadel tablet (Carbonate) 800mg Glomerular Filtration Rate (eGFR) harm and suicidality.

• Weight and height Starting dose may usually range nocte to Priadel liquid (Citrate) = • Adjusted Calcium Switching lithium products: from 400mg-800mg OD (nocte) in 400mg (10ml) BD morning and • Urea and Electrolytes adults, depending on indication. night. Lithium level to be checked Priadel tablets are recommended • Thyroid Function Tests (TFTs): •for routine Serumuse.

Creatinine+/-estimated Glomerular Filtration Rate (eGFR) Elderly patients, those with renal 5-7 days postswitch.

The tablets have include Free T4 and Thyroid impairment or those below 50kg lines therefore they can •scoreAdjusted Calcium Baseline work-up: Stimulating Hormone (TSH). in weight, often require lower be divided accurately to provide Patient should be euthyroid starting •smaller Thyroid Function Tests (TFTs): include Free T4 and Thyroid Stimulating Hormone (TSH).Patient should dose be (eg 200mg), and • ECG : if cardiac history, risk dosage requirements. If a before initiation maintenance doses. factors for QTc prolongation, patient is unable to swallow tablets euthyroid before initiation concomitant medicines that a liquid may be prescribed. It is • Full Blood Count Plasma levels: •essential Full Blood Countfrom tablets prolong QTc that a switch • Pregnancy test and review of to liquid is prescribed by their • Pregnancy test and review of •contraception (in women of childbearing age).

Weight and height Lithium plasma level should be contraception (in women of Doctor, and calculation confirmed

by Pharmacist.

• Urea and Electrolytes

childbearing age).

checked 5-7 days after starting, after every dose change, and after addition/discontinuation of medication that can affect level.

Target levels:

The minimum effective plasma level for prophylaxis in adults is 0.4mmol/L; optimal range is 0.60.8 mmol/L. A level of 0.4mmol/L may be effective in unipolar depression; 0.6 -1 mmol/L in Bipolar Disorder, and levels at the higher end of the range in mania (0.8-1mmol/L).

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90

Lithium Management

Name:

Magnitude:

Timescale:

Additional Information:

Name: A:

Magnitude:

Timescale:

Additional Information:

ACE Inhibitors A: (ACEI) ACE Inhibitors Angiotensin (ACEI) Receptor Angiotensin Blockers (ARBs) Receptor Blockers (ARBs)

N:

Non- Steroidal N: AntiNon- Steroidal inflammatories Anti(NSAIDs) inflammatories (NSAIDs)

T:

Thiazide T: Diuretics Thiazide Diuretics



Unpredictable



Unpredictable Up to fourfold increase Uplithium to fourin fold increase level. in lithium level.





  



Unpredictable





Unpredictable From 10% to more than From 10% to four-fold more than increase in four-fold lithium level. increase in lithium level.

Unpredictable





  

Unpredictable Up to fourfold increase Uplithium to fourin fold increase level. in lithium level.

 

  



S:



Sodium Sodium

 

Excess Sodium can reduce Excess Sodium lithium levels can reduce lithium levels Sodium





cause lithium Most likely to a toxicity within cause lithium month of toxicity within a starting. month of starting.



Variable: a few days to several Variable: a few months. days to several months.



 

  



S:

Develops over several weeks Develops over several weeks Most likely to

Thiazides reduce renal Thiazides of clearance reduce renal lithium and clearance levels can of rise lithiumaand within few levels can rise days within a few Usually days apparent in the Usually first 10 days apparent the Any effectinwill firstapparent 10 days in be Anyfirst effect will the month. be apparent in the first month.

restriction can Sodium lead to lithium restriction can toxicity. lead to lithium toxicity.

   

    

Sevenfold increased risk of hospitalisation for lithium toxicity in Sevenfold the elderlyincreased risk of hospitalisation for lithium toxicity in the elderly Consider alternative anti-hypertensive Consider alternative anti-hypertensive If combination necessary, increased monitoring of lithium level and renal If combination necessary, increased function required. monitoring of lithium level and renal function required.

Diclofenac: up to 23% increase in lithium level Diclofenac:up upto to25% 23%increase increasein in Ibuprofen: lithium level level lithium Ibuprofen: up tobe 25% increase in Patients should advised to avoid lithium level and use Paracetamol if OTC NSAIDs Patients shouldrequired. be advised to avoid OTC analgesic OTC NSAIDs and use Paracetamol if OTC analgesic required.

Thiazide diuretics should only be used where unavoidable and with strict Thiazide diuretics should only be used monitoring where unavoidable and with strict monitoring Loop diuretics may be safer.

Furosemide is probably the safest Loop diuretics safer.but diuretic to use may with be lithium Furosemide is probably the safest frequent monitoring required. diuretic to use with lithium but frequent monitoring required.

Consider high Sodium content OTC preparations and recommend suitable Consider high Sodium content OTC alternatives preparations and recommend suitable alternatives Care with Sodium content in effervescent formulation Care with Sodium content in effervescent formulation Refer to SPS Pharmacy NHS

“Considering Sodium content of Refer to SPS particular Pharmacycare NHSwith medicines”; “Considering Sodium content products > 17mmol Sodium inof medicines”; particular maximum daily dose care with products > 17mmol Sodium in https://www.sps.nhs.uk/articles/consi maximum daily dose dering-sodium-content-of-medicines/ https://www.sps.nhs.uk/articles/consi dering-sodium-content-of-medicines/ Example: Sodium Bicarbonate in antacids 

(Gaviscon); recommend Maalox instead.

Example: Sodium Bicarbonate in antacids (Gaviscon); recommend Maalox instead.

Monitoring frequency: TFTs, renal function, Calcium level, and weight check, recommended every 6 months; or every 3 months in at-risk patients.

• Renal impairment (eGFR<60ml/min) • Impaired Thyroid function at last test

Once stable, serum lithium levels recommended every 3 months for the first year, then every 6 months; or every 3 months in at-risk patients.

• Raised Calcium level (adjusted) at last test

At risk patients include: • Elderly (> 65 years)

• Significant change in patient’s sodium or fluid intake

• Have received less than 12 months treatment

• Last serum lithium level >0.8mmol/L

• Poor symptom control or suspected poor adherence

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• Interacting medicines. Key interacting medicines include: ACEI, ARBs, NSAIDs and Thiazide diuretics. (See summary below and BNF/Stockley’s for exhaustive list).

Discontinuation: If a decision is made to discontinue lithium, the risk of relapse may be reduced by reducing the dose gradually. It is recommended to reduce the dose slowly over at least 4 weeks or longer, and preferably up to 3 months in Bipolar Disorder; except in medical emergency or overdose.

ALARM BELL INTERACTIONS: THINK “ANTS” (SEE TABLE LEFT) ADVERSE EFFECTS : ( NOT AN EXHAUSTIVE LIST) Cardiac: Lithium may cause cardiac arrhythmia, including bradycardia, sinoatrial dysfunction (SA block), abnormal T waves on ECG (T-wave inversion), and STsegment depression.

Dermatological: Lithium may cause acne vulgaris and/or psoriasis (including exacerbation of both) in patients with and without either condition at baseline.

GI: Lithium may cause dyspepsia, diarrhoea, nausea, vomiting, dysgeusia (metallic or salty taste), gastritis and abdominal pain.

Some effects (e.g. nausea) may occur early in treatment. Other effects may take longer to develop.

Supratherapeutic lithium levels should be suspected with severe nausea, vomiting and diarrhoea.

Hypothyroidism: Lithium has varied effects on Thyroid Hormone production and regulation, including inhibition of Iodine uptake in the Thyroid, inhibition of Thyroid Hormone synthesis and release, and hepatic conversion of free Thyroxine. Patient may present with typical hypothyroidism symptoms including lethargy, impaired cognition, weight gain, dry skin, and cold intolerance. Risk factors include females, older adults, family history of hypothyroidism, and presence of anti-thyroid antibodies.

Hyperparathyroidism and hypercalcaemia: Hypercalcaemia has been reported with Lithium therapy, which may or may not be related to drug-induced hyperparathyroidism. While lithium has been observed to affect Parathyroid Hormone levels after a single dose, long -term exposure is likely required to observe clinically relevant alterations in Calcium homeostasis.

Polydipsia and polyuria: Common adverse effects associated with lithium. Patients may notice increased urinary frequency (> 3 L in 24 hours) due to poor urine concentration; and increased thirst, which is independent of dry mouth effects of lithium.

Renal effects: Up to one-third of patients may develop some degree of decreased kidney function during the course of lithium therapy, with approximately 5% developing significant kidney impairment/failure.

Sexual dysfunction: Studies report rates of the various effects of 5-40 %. Effects can include decreased libido, impaired sexual arousal, and

91 About this booklet

6. What happens if lithium level in my blood is too high?

If you have too much lithium in your blood, this is called lithium toxicity (or lithium poisoning). This can make you very ill.

There are two parts to this booklet: • an information section, and • a record book.

The Lithium Record book is on page 19.

Read the following list very carefully. If you get one or more of these problems at any time, talk to your doctor straight away.

Information section

Symptoms if there is too much lithium in your system

Page number 1. What is lithium and what is it used for? ................................3 2. What checks are needed before starting lithium? ................4 3. How do I take lithium? ..........................................................5 4. What blood tests do I have when I take lithium? ..................8 5. What side effects can lithium cause? .................................10 6. What happens if lithium level in my blood is too high? .......13 7. What can make lithium blood levels too high? ...................14 8. Pregnancy and lithium: what do I need to know? ...............16 9. Alcohol and lithium: what do I need to know? ....................17

• • • • • •

Severe hand shake (tremor).

Vomiting or severe nausea and persistent diarrhoea.

Muscle weakness.

Being unsteady on your feet.

Muscle twitches.

Slurring of words so that it is difficult for others to understand what you are saying.

• Blurred vision.

• Confusion.

• Feeling unusually sleepy.

A small number of people may not have any immediate symptoms of toxicity when the lithium in their blood is too high.

This is why it is important to have regular checks. Regular checks can prevent long-term problems.

Appropriate information and monitoring is imperative to ensure best outcomes for patients on lithium therapy and reduce likelihood of harm.

• The booklet has been reviewed and endorsed by Ciara Kirke, HSE Clinical Lead, National Medication Safety Programme, and the national print supported by the HSE’s National Quality and Patient Safety Directorate.

• It has been edited and reviewed by the National Adult Literacy Agency and has successfully been awarded the plain English mark by NALA. • It has been reviewed and endorsed by Saint John of God Hospital Drug and Therapeutics Committee, Irish Medication Safety Network, Irish Pharmacy Union, and the College of Psychiatrists.

The Lithium booklet contains: • Essential clinical and safety information for patients

1 23 Lithium therapy record book – your healthcare

Date

Daily Dose (mg):

Lithium Kidney blood Checks level (eGFR/ (mmol/L) Creatinine)

Thyroid checks

+ Ref Range

TSH (mlU/L): + Ref Range

Example 1: 600mg 2/3/22

0.8

eGFR 85

2.59 (0.27-4.2)

Example 2: 600mg 2/3/22

0.8

✓

✓

Thyroid checks

Free T4 (pmol/L): + Ref Range

Adjusted Weight/ Calcium BMI: (mmol/L): + Ref Range

• Information on side-effects and signs of toxicity

Date of next blood test:

• Advise on appropriate OTC medicines and contra-indications • A programme of monitoring to ensure safe and appropriate monitoring • A record book to record lithium levels and essential blood test results.

13 (12-22)

2.25 (2.1-2.6)

67kg

6/6/22

Healthcare Professionals provide essential support and are recommended to:

✓

✓

67kg

6/6/22

• Ensure patients have a lithium booklet • Reinforce essential information verbally • Refer patient to the booklet to be aware of potential side-effects and signs of toxicity

1

• Ensure the patient understands their own programme of monitoring

2 erectile dysfunction. Sexual dysfunction can negatively impact a patient’s quality of life.

3 Tremor: Lithium can cause tremor in up to 25% of patients, making it one of the most common adverse effects. This is commonly a bilateral, symmetrical hand tremor, which 4 spontaneously decrease over time as may compensatory mechanisms develop within the patient. Course tremor and muscle twitching may be observed in lithium toxicity.

5

Tremor commonly begins early in treatment, but can develop later in treatment, with or without a dose increase. Risk factors include: higher 6 doses/serum levels, medicines that can increase lithium level, medicines known to induce tremor (e.g. antipsychotic, antidepressants), caffeine and older adults.

7

Weight gain: Increases of 4 to 7 Kg within the first year have been reported in the literature.

Effects on central mechanisms related to weight gain, satiety and metabolism are 8 possible. Increased consumption of highcalorie, sugary beverages from increased thirst with lithium could contribute.

Symptoms of toxicity: For patients with symptoms of toxicity (eg diarrhoea, vomiting, coarse tremor, mental state changes or falls): Withhold lithium, refer to GP/Clinic/Hospital for urgent lithium level and U+Es, and seek specialist advice.

Referral to secondary care may be required depending on the severity of symptoms.

LITHIUM THERAPY : A BLUE BOOK FOR SAFETY • The national patient information booklet has been produced by Audrey Purcell, Chief 2 Pharmacist, Saint John of God Hospital, and supported by Professor Dolores Keating, Chief Pharmacist, and Saint John of God Drug and Therapeutics Committee.

• This initiative is intended to provide and promote safer lithium therapy, and empower patients to engage with their Healthcare Professional to discuss all aspects of lithium therapy, monitoring, and side-effects.

• Support patients to engage in appropriate blood test monitoring: keep their record book up to date, and have available at consultations with GP, Consultant, Pharmacist, Nurse.

National launch of the Lithium booklet: • Saint John of God Hospital, the HSE National Medication Safety Programme and the Irish Pharmacy Union have collaborated to implement a national launch of the booklet.

• Lithium booklets will be distributed from the HSE directly to Hospital Pharmacies, and to Community Pharmacies via the IPU Review.

GPs may sign-post patients to Community Pharmacists to avail of a booklet.

• Booklets can be ordered from Saint John of God Hospital: hospital.pharmacy@sjog.ie Acknowledgements: Many thanks to Aoife Carolan, Senior Pharmacist, Saint John of God Hospital, and Ciara Kirke, HSE Clinical Lead, for article peer-review.

References available on request

19

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92

Bone Health

Exercise for Bone Health in Women Osteoporosis and Fracture Risk: Osteoporosis is a disease characterised by low bone mass which affects both men and women but with a higher prevalence among women. It is estimated that 1 in 3 women over age 50 will experience fractures due to osteoporosis, as will 1 in 5 men. With people living longer, the lifetime risk of a fracture related to bone fragility is heightened.

Caitriona Cunningham is an Associate Professor at UCD School of Public Health, Physiotherapy and Sports Science. A Chartered Physiotherapist, she and colleagues at UCD cofounded UCD’s Better Bones programme in 2012, which focused on empowering individuals (age 55+) to adopt positive bone building and fracture prevention behaviours

Bone Health across the Lifespan Childhood and adolescence represent a critical period for the development of strong healthy bones with peak bone mass usually achieved between age 25 to 30. Bone density remains relatively stable until age 50 but begins to decline thereafter. Adopting and sustaining healthy lifestyle behaviours including exercise, a healthy diet (adequate calcium, Vitamin D, Protein intake) and getting sufficient sun exposure (Vitamin D) are advocated to promote bone health across the lifespan. At menopause bone loss may accelerate significantly in women due to the reduction in oestrogen, a key regulator of bone metabolism. Women should actively seek a DXA scan at that time. Where bone loss issues are identified, pharmacological therapy may be required which is based on a number of factors including DXA findings, prior fragility fracture and the risk of future fracture.

osteoporosis in healthy populations whereas exercise prescription for individuals with osteoporosis requires risk stratification.

What type of exercise is optimal to build bone?

Bone responds to mechanical stimuli with adjustment of skeletal mass and architecture in response to changing mechanical environments. The best types of exercise to build bone (osteogenic exercise) are impact (involves running, hopping and jumping) and resistance (strength) training with a combination of both the most effective. Strength training is also critical to slow down age related loss of muscle mass and function.

Walking is a form of impact exercise but higher impact, more unusual activity will likely induce

Exercise and Bone Health Exercise for bone health should start in the childhood years with the goal of optimising peak bone mass. In the middle years maintaining bone mass is the goal and in later life, the emphasis is more on slowing down bone loss.

As for all exercise programmes achieving an effective exercise dose is critical with consideration of frequency, intensity, type and time (FITT). Some bone health exercise programmes aim to prevent

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an even better bone formation response. Recent research places more emphasis on the need for higher loads to enhance bone when engaging in resistance training. Most of the studies regarding exercise interventions focusing on enhancing bone have been conducted in post -menopausal women. Mixed loading programmes (impact+ resistance training) conducted two to three times per week for approximately one hour for over six to nine months have shown positive changes in bone mineral density (BMD) on DXA scan.

However, the minimal effective exercise dose to enhance BMD has not been established to date.

Exercising if have osteoporosis Maintaining an active lifestyle is always positive and it is important that individuals with osteoporosis do not become fearful about exercise participation but adapt their exercise as required. ‘Bone building’ may continue to be a key goal of exercise for people with osteoporosis. However, when osteoporosis is more severe the main focus switches to improving muscle strength and balance to maintain and enhance function and reduce the risk of a fall and fracture, rather than aiming for an improvement in bone density.

For example, where a person has severe osteoporosis of the spine and/or a history of a

fragility fracture, exercises which involve lifting heavier weights with twisting of the spine are to be avoided, consistent with manual handling principles. In addition, higher impact exercises may not be appropriate. A risk benefit assessment and exercise prescription by a physiotherapist is recommended, bearing in mind that maintaining cardiovascular fitness through exercise is always important for health.

Key Messages • Exercise for bone health should start in the childhood years and continue through all life stages • A combination of strength and impact exercise is optimal for building bone • A DXA scan is recommended for women around the time of menopause, with repeat scans thereafter.

• Consultation with healthcare professionals is critical to decide on the need for initiation of pharmacological therapy to enhance bone, a decision which is based on a number of factors including DXA findings, prior fragility fracture and the risk of future fracture.

• Exercise continues to be very important for women with osteoporosis and consultation with a physiotherapist is recommended

Migraine

93

Migraine in Women Introduction: Migraine is a neurological disorder characterised by recurrent bouts of severe headaches with autonomic and neurological symptoms. Scientific advances in recent decades have provided us with a clear understanding of the pathophysiology of migraine and enabled the development of migraine specific acute and preventative therapies. Migraine occurs in 10-12% of the population and there is a 3:1 female to male ratio. It is particularly common, in women of all ages, and female preponderance begins around the time of the menarche. The World Health Organisation Global Burden of Disease study ranked migraine as the 2nd leading cause of disability and the leading cause in women under the age of 50 years.

Diagnosis: The International Headache Society has standardised the diagnosis of migraine using universally accepted diagnostic criteria (ICHD3) and these guidelines have provided us with a uniform approach to diagnosis in clinical practice (Fig 1,2,3,4).

Migraine Without Aura: 1.1 A. At least 5 attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) C. Headache has > 2 of the following characteristics 1. Unilateral Location

D. Not better accounted for by another ICHD-3 diagnosis, and TIA excluded.

Fig: 2 Chronic Migraine: 1.3 A. Headache (TTH-like and /or Migraine-like on >15 d/mo for > 3 month and fulfilling criteria B and C.

3. Moderate or severe pain intensity

2. Criteria B and C for Migraine With Aura

4. Aggravated by or causing avoidance of routine physical activity.

3. Believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative

2. Photophobia and Phonophobia

Medical advisor to the Migraine Association of Ireland

C. On > 8 d/month for > 3 month fulfilling any of the following: 1. Criteria C and D for Migraine Without Aura

1. Nausea and or vomiting

General Practitioner in Cork

B. In a patient who has had > 5 attacks of fulfilling criteria B-D For 1.1 Migraine Without Aura and /or criteria B and C for 1.2 Migraine With Aura

2. Pulsating Quality

D. During Headache > 1 of the following.

Written by Dr Edward M. O’ Sullivan, Clinical Director Headache Migraine Clinic Department of Neurology Cork University Hospital

D. Not better accounted for by another ICHD-3 diagnosis Fig: 3

the post-menopausal years. The average patient gets 2-3 attacks per month and for 10% of sufferers migraine is a progressive disorder leading to Chronic Migraine (>15 days per month) at a time in life when individual demands and commitments are greatest.

E. Not better accounted for by another ICHD-3 diagnosis Fig: 1

A. Attacks fulfilling criteria for 1.2 Migraine With Aura and criterion B below.

Migraine and Women: Throughout a woman’s life hormonal factors have a significant influence in the threshold, susceptibility, risks, and management of migraine (Fig:5).

Migraine With Typical Aura: 1.2.1

B. Aura consists of both of the following

1. Migraine and the menstrual cycle

A. At least 2 attacks fulfilling B and C B. Aura of visual, sensory and /or speech /language symptoms, each fully reversible, but no motor, brainstem or retinal symptoms.

C. > 2 of the following 4 characteristics 1. > aura symptom spreads gradually over 5 minutes and /or > 2 symptoms occur in succession.

2. Each individual aura symptom lasts 5-60 minutes 3. > 1 aura symptom is unilateral 4. Aura accompanied by or followed in < 60 minutes by headache

Hemiplegic Migraine: 1.2.3

1. Fully reversible motor weakness 2. Fully reversible visual, sensory, and or speech / language symptoms Fig: 4 Many migraine patients also experience other symptoms which are disabling but are not incorporated into the diagnostic guidelines. These symptoms vary and include vertigo, dizziness, cutaneous alloydynia, tiredness and psychomotor slowing.

The natural history of migraine in women is that it begins around the time of the menarche and early teenage years, peaks in the 30’s and declines rapidly in

2. Migraine and the oral contraceptive 3. Migraine and Pregnancy 4. Migraine and HRT / Menopause Fig:5 1. Migraine and Menstrual Cycle: Women are vulnerable to migraine attacks at the time of menses and less commonly around the time of ovulation. Attacks, however, are not exclusive to these times and many other migraines may occur either spontaneously or on exposure to a trigger (e.g. diet factors, alcohol, stress and lifestyle factors). Menstrual migraines most frequently occur between days -2 to + 3 of menses. Attacks are more likely to be migraine without aura

and are longer in duration (> 72 hours). It is also considered more disabling and more difficult to treat. In the perimenstrual period, and to a lesser extent at the time of ovulation, oestrogen levels decline and fluctuate. This decline activates the trigeminovascular system resulting in an acute attack. Many patients are able to anticipate menstrual migraines enabling them to treat early, particularly with longer acting triptans (e.g. frovatriptan 2.5mg or naratriptan 2.5mg) with or without an NSAID (e.g. naproxyn 500mg).

2. Migraine and Oral Contraceptive: The combined oral contraceptives are ethinyloestradiol / progestogen preparations (COCP). The newer versions contain lower doses of the oestrogen component.

The combined pill is a risk factor for cardiovascular and cerebrovascular disease and careful consideration needs to be given when prescribing in migraine patients. Migraine With Aura is an independent risk factor for stroke as are the COCP, cigarette smoking and hypertension. This risk is accumulative and migraine patients need to be advised to stop smoking. The use of a headache diary is invaluable in this supervision as the pill is known to:

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94

Migraine 3. Migraine and Pregnancy: Pregnancy is a positive time for migraine patients and up to 6070% of migraneurs improve during pregnancy, particularly after the first trimester, with many achieving a remission. This is due to the sustained high levels of oestrogen, which no longer fluctuate, providing a preventative benefit to triggering attacks. After childbirth the migraine pattern tends to re-emerge within the first month.

Breast-feeding may delay the re-emergence in the puerperium.

7% of women, however, experience their first migraine attack during pregnancy and women who present with new onset headache may have other causes such as cerebral venous thrombosis (CVS), preeclampsia or subarachnoid haemorrhage.

• Trigger headache and first attack of migraine without aura.

• Trigger aura symptoms for the first time in patients already diagnosed with migraine without aura.

• Worsen and increase the frequency of migraine in patients with an established diagnosis.

• It can improve migraine or in others it has no impact on the frequency, severity and duration attacks.

• Continuation of the pill without break through 3 cycles may prevent menstrual migraine attacks.

In patients with an established diagnosis of Migraine With Aura the combined pill is contraindicated and patients who develop aura symptoms after commencing the COCP need to discontinue the pill immediately due to stroke risk.

The headache diary will identify those patients in whom the COCP worsens their migraine and for whom it must be stopped or is contraindicated in the first place.

The diary, paradoxically, will also demonstrate those patients in whom the COCP has benefited their migraine and reduced the frequency of attacks.

The protestrogen-only-preparations are an alternative in women for whom the COCP is contraindicated.

The POP’s are safe and do not trigger or worsen migraine.

Many of the acute and preventative therapies are contraindicated during pregnancy due to their potential for harm. These include the triptans, paracetamol / codeine preparations, topiramate, sodium valproate and the latest preventative therapies the CGRP monoclonal anti-body antagonists.

Patients are limited to the use of simple analgesics such as paracetamol combined with metoclopramide for the treatments of acute attacks.

4. Migraine HRT and the menopause: The perimenopausal years frequently sees a rise in the frequency and disability of migraine attacks with many women progressing to chronic migraine (> 15 headache days per month) along with the vasomotor symptoms of the menopause. This can be a very challenging time and it is due to the fluctuating and erratic oestrogen levels during this time.

The use of hormone replacement therapy (HRT) is NOT contraindicated in either Migraine With Aura or Without Aura .

Oestrogen replacement therapy administered transdermally (with progestogen) in physiological doses can be very efficacious as a preventative migraine therapy and also for the troublesome menopausal vasomotor symptoms.

The natural history of history of migraine is that migraine prevalence goes into a rapid decline after the menopause. It is rare, but not unheard of, for the elderly to continue to complain of migraine in their advancing years.

Management of Migraine: The guiding principles in the management and treatment of migraine are outlined in fig:6.

3. Preventative Therapies.

4. Non Drug Therapies.

Fig:6 1.Use of a Headache Diary: Migraine is a recurrent disorder and a headache diary is a useful guide and aid memoir in chronicling the frequency, severity, duration and impact of attacks. It helps identify trigger factors and evaluate the efficacy of acute and preventative therapies.

1. Acute Therapies: One third of migraine patients can effectively manage their acute attacks with over-the-counter simple analgesics such as soluble aspirin, paracetamol or ibuprofen. Prescribed medications, the triptans, are now the gold standard in the management of the acute attack and these include: sumatriptan, zolmitriptan, almotriptan, eletriptan, frovatriptan and naratriptan. Ideally patients should get meaningful relief from their headache and most bothersome symptoms within 2 hours. These medications can be combined with anti-nausea medication and NSAIDS (e.g. naproxyn) which may enhance efficacy. Acute therapies which provide no relief within 4 hours are deemed to be lacking in efficacy.

Compound analgesics (e.g. paracetamol / codeine, tramadol) should be avoided or prescribed with caution due to risk of developing Medication-OveruseHeadache.

Newer treatments, the small molecule ‘’gepants’’, CGRP antagonists, are on the horizon and soon to be approved. They will add to armamentarium for the treatment of acute attacks and also as a preventative therapy.

2. Preventative Therapies: Preventative therapies are indicated when patients experience 4 or more migraine days per months, and are poor responders to acute therapies.

The conventional preventative therapies are listed in fig:7 1. B-blockers: propranolol, metoprolol, atenolol.

2. Anti-depressants: amitriptyline, venlafaxine.

3. Anti-epileptics: topiramate, sodium valproate.

4. Anti-hypertensives: candesartan.

5. Flunarizine.

6. Pizotifen.

1. Use of a Headache Diary.

7. Botulinun Toxin.

2. Acute Therapies.

Fig: 7

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The benchmark in evaluating the efficacy of preventative therapies is the achievement of at least a 50% reduction in the frequency of headaches in 50% of patients. To determine this end point patients need to remain on their medication for 3 months before a determination is made. Many patients in clinical practice discontinue their preventative therapy within weeks either due to side-effects or a perceived lack of efficacy.

New Preventative Therapies: C.G.R.P. (Calcitonin Gene Related Peptides) Monoclonal Antibody Antagonists: The CGRP monoclonal antibody antagonists are the first specifically developed migraine preventative therapies targeting the underlying mechanisms of migraine (Fig:8).

1. Erenumab 70mg or140mg s.c monthly injection.

2. Fremanezumab 225mg s.c monthly or 3 monthly 3. Galcanezumab s.c monthly 4. Eptinezumab 100mg or 300mg IV every 3 months (awaiting approval) Fig: 8 Erenumab, fremanezumab and galcanezumab are approved by the HSE on the Hi-Tech hub for patients who have Chronic Migraine (>15 headache days per month) and have failed to benefit from 3 previously prescribed conventional preventative therapies. They are licenced for patients aged between 18 and 65 years. In clinical trials benefits and efficacy are seen within 1 week and 25% of patients achieve up to 75% reduction in the frequency of headaches.

Conclusions: Migraine is a common disabling disorder which significantly impacts on the quality of life of women at pivotal times throughout their adult lives.

In the past, it has traditionally been underdiagnosed and undertreated. Many patients have fatalistic expectations regarding the management of migraine as they have had to endure migraine attacks for many years. Others may have witnessed a family member such as a parent or aunt or uncle suffer and endure a similar fate.

Today we are much better at diagnosing, understanding and treating migraine. Migraine specific acute and preventative are now available enabling us to better manage migraine. On going research is developing additional treatments (small molecule ‘gpants’ and ditans) which will further advance our ability to manage migraine and improve the quality of life for many migraneurs.

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96

Clinical Profiles

HELPING THOSE WITH ALLERGIES Over 60 delegates from Danish pharmaceutical company ALK (Allergology Laboratory Kopenhagen) arrived in Dublin recently for a three-day meeting entitled “Helping more people with allergy get better care”.

This was a briefing meeting for the Irish, UK and Benelux teams for the rest of 2022.

ALK is a global, research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. A world leader in allergy, ALK specialises in allergy immunotherapy; which not only reduces allergic symptoms but also treats the underlying cause of specific allergies. ALK has approximately 2,000 employees with subsidiaries, production facilities and distributors worldwide.

This was the first time the teams from these areas have met since 2019 due to Covid travel restrictions. The meeting was also attended by ALK Executive Vice Presidents Søren Niegel and Søren Jelert and Sean Connor, Regional General Manager Northern Europe.

Danish Ambassador to Ireland, Lars Theusen, who recently moved from the UK, opened the meeting and welcomed the delegates to

Mark Kneen and Mary Martin, ALK with Danish Ambassador to Ireland, Lars Theusen and Sean Connor, ALK

Dublin. ALK has had representation in Ireland since 2015, however, in recent years the sales team has expanded. This growth has come as the company successfully secured marketing authorisation for 3 new allergy immunotherapy treatments in Ireland, including one for the treatment of adult allergic asthma. Asthma prevalence in Ireland is among the highest in the world. It is the most common chronic disease affecting children and the most common chronic respiratory disease in adults. There is one death per week from asthma in Ireland.

ALK has also committed to increasing allergy education through the support of an educational grant to University College Cork. The emphasis will be on education through the support of postgraduate allergy training courses. ALK was also one of a small number of companies to sponsor the European Academy of Allergy and Clinical Immunology Summer School on Food Allergy.

This event was hosted in University College Cork recently with approximately 150 delegates from across Europe in attendance.

Sean Connor, UK General Manager of ALK says, “ALK is committed to improving the health of people suffering with allergy across the globe and ensuring that health inequalities are minimised. In Ireland, we see large numbers of people who do not have access to life-changing allergy medications when compared to the rest of Europe. ALK intends to change this injustice and have over the last couple of years registered three

new products for which we are actively seeking reimbursement so that all patients can access these medicines.”

For more information about ALK visit https://www.alk.net.

HSE LAUNCHES POLICY AND PROCEDURE FOR SAFE SURGERY The HSE has launched the revised National Policy and Procedure for Safe Surgery. The policy endorses the principles of the World Health Organisation (WHO) Surgical Safety Check 2008 and the HSE Patient Safety Strategy 2019 – 2024 to ensure that all patients undergoing surgical procedures do so safely.

The policy provides guidance for safe practice throughout the surgical patient pathway and introduces key safety steps that can be incorporated into the operating theatre. The critical safety steps proposed are intended to support the development of a safety culture for operating departments and teams.

Mr Kenneth Mealy, Joint Lead National Clinical Programme in Surgery, HSE said, “Safe patient care should be central to everything that we do in surgery.

Understanding that surgical error often arises from both system and individual failure, the HSE National Policy and Procedure for Safer Surgery 2022 defines ‘best practice’ at an organisational level in order to support surgical teams in their work. While the original WHO Surgical Safety Checklist forms the basis of this policy,

the COVID-19 pandemic has reminded all of us for the need to periodically update and adapt all healthcare policies to reflect local use and changing circumstances.

I urge all peri-operative governance groups to disseminate this updated Safer Surgery Policy to all those working with patients along the surgical pathway.”

The HSE is committed to supporting services to maintain safe practices of care within high risk environments such as surgery, to ensure that the correct procedure is performed on the correct patient and on the correct site on every occasion. Every member of the healthcare team involved in the patient pathway has a role to play in ensuring patient safety.”

The policy and procedure outlines the minimum safety steps to be included in the Safe Surgery Checklist based on best practice and evidence. It applies to all patients undergoing surgery in the Irish hospital setting and all healthcare staff involved in the patient pathway. In line with WHO guidance. The policy now includes 5 stages for safer surgery including briefing and debriefing to accompany sign in, time out and sign out. It can also be adapted for all clinical interventions in clinical areas outside of the operating department.

The Safe Surgery Checklist plays a key role in improving communication and teamwork in the operating department. It can also assist in changing the culture in operating departments by emphasising the importance of listening to all team members and valuing their contribution.

This review was coordinated by the National Clinical Programmes for Anaesthesia in collaboration with the National Clinical Programme for Surgery, the National Clinical Programme for Trauma & Orthopaedic Surgery, Stakeholders and Patient representatives.

The revised National Policy and Procedure for Safe Surgery is available to view at https://www. hse.ie/eng/about/who/cspd/ncps/ anaesthesia/resources/ EUROPEAN COMMISSION APPROVES UPADACITINIB FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERELY ACTIVE ULCERATIVE COLITIS



This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA pharmacovigilance website www.hpra.ie . Reporting suspected adverse reactions

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97 after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product.

AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval of Upadacitinib (45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.* “Our years of experience and longterm investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face, and a deep understanding of the ongoing need for additional treatment options to help those still suffering,” said Andres Rodrigo, General Manager of AbbVie in Ireland. “We celebrate the approval of Upadacitinib by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”

The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance.2 Statistical significance was achieved for the primary endpoint and all secondary endpoints with Upadacitinib 45 mg in the two induction studies and both Upadacitinib 15 mg and 30 mg in the maintenance study.

Clinical Remission† • During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 percent and 33 percent of patients treated with Upadacitinib 45 mg achieved clinical remission at week 8, the primary endpoint, compared to 5 percent and 4 percent of patients who received placebo.2,11,12 • During the U-ACHIEVE maintenance trial, 42 percent and 52 percent of patients treated with Upadacitinib 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo.2,13 • Additionally, 57 percent and 68 percent of patients receiving Upadacitinib 15 mg or 30 mg, respectively, achieved corticosteroid-free remission, defined as clinical remission (per Adapted Mayo Score) and corticosteroid free for ≥90 days immediately preceding week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 percent of patients on placebo.2,13

Clinical Response & Mucosal Healing‡§ • Seventy-three and 74 percent of patients treated with Upadacitinib 45 mg achieved clinical response (per Adapted Mayo Score) at week 8 compared to 27 and 25 percent of patients receiving placebo during the U-ACHIEVE and U-ACCOMPLISH induction trials, respectively.1,2,11,12,14 • In both trials, a significantly greater proportion of patients experienced clinical response per partial Adapted Mayo Score (symptomatic response) as early as week 2 (U-ACHIEVE: 60 percent vs 27 percent and U-ACCOMPLISH: 63 percent vs 26 percent).1,2,11,12,14 • Mucosal healing was observed in 36 percent and 44 percent of patients treated with Upadacitinib 45 mg in U-ACHIEVE and UACCOMPLISH, respectively, at week 8, compared to 7 percent and 8 percent of patients, respectively, who received placebo.1,2

The demand for Vitamin D3 has grown strongly in recent years due to the Covid pandemic and the need for bone health in elderly patients.

• In the maintenance study at week 52, mucosal healing was observed in 49 percent and 62 percent of patients treated with Upadacitinib 15 mg and 30 mg, respectively, compared to 14 percent who received placebo.1,2,13

The product range is now available in all pharma wholesalers and listed on all software prescribing systems nationally.

THE LAUNCH OF SOLFEROL CAPSULES, A PRESCRIPTION RANGE OF VITAMIN D3 MEDICINES Windzor Pharma Ireland Ltd is please to announce the launch of SOLFEROL Softgel Capsules, a range of Vitamin D3 medicines, for the treatment of Vitamin D deficiency.

This brand offers the widest range of presentations on the market 5 different strengths,, including two unique strengths, 400iu for the treatment of pregnant and breast feeding women, and 20,000iu for patients who are severely deficient in Vitamin D3.

Solferol Softgel Capsules were developed in Ireland and are sold all across Europe.

All five presentations are available on the reimbursement schemes, with a better price for all pack sizes.

The full range is as follows: SOLFEROL Softgel Capsules 400iu x 90 SOLFEROL Softgel Capsules 800iu x 30 SOLFEROL Softgel Capsules 800iu x 90 SOLFEROL Softgel Capsules 1000iu x 28 SOLFEROL Softgel Capsules 20000iu x 4.

Full prescribing information available on www.windzorpharma.com.

RUN ‘N’ ROLL FAMILY EVENT Pictured above are participants at the Irish Wheelchair Association (IWA) Run’n’Roll 5km, proudly supported by Liberty Insurance #MovedByValues.

In excess of 380 participants competed in the family fun run (Sunday, 4 September) in Saint Annes Park, Raheny, Dublin 5. The event was designed to support and promote a more inclusive society for people with disabilities.

Participants included disability advocates Joanne O’Riordan and Pharmacist Jack Kavanagh.

Liberty is committed to greater equity, diversity and inclusion within society, and central to this commitment is greater support and allyship with people with functional disabilities. Due to Liberty’s support, 100% of race registration fees went to the IWA. The event raised over ¤17,000 for the IWA including an additional donation of ¤10,000 from Liberty.

HALEON LAUNCHES CENTRE FOR HUMAN SCIENCES Haleon (LSE/NYSE: HLN) has launched the Haleon Centre for Human Sciences (“HCHS”), bringing together the expertise of practising health professionals and scientists, to address the behavioural challenges impacting everyday health.

Unveiled at the International Pharmaceutical Federation (FIP) congress in Seville, the Centre will operate as a community of health professionals and specialists in behavioural science, health psychology and the social sciences. This collaboration will aim to solve some of the most pressing everyday health challenges.

The HCHS is the first major initiative for health professionals since Haleon’s launch as an independent, global leader in

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Clinical Profiles

consumer health. Its mission is to support practicing health professionals - pharmacists, pharmacy assistants and dental professionals - in serving their patients and communities.

Leveraging Haleon’s competitive advantage of combining trusted science with deep human understanding, the Centre will bring expertise in physiological science together with human sciences to deliver real world-solutions and tangible interventions, resulting in measurable improvements in health outcomes through sustained behavioural change.

The launch of the HCHS comes at a crucial time. A recent survey undertaken by Haleon revealed that 90% of pharmacists across Europe and the US believe that the role of the pharmacist has changed, requiring them to have greater expertise in influencing human behaviour and choices in patients’ health.

How It Works The HCHS community will design, pilot, implement and evaluate solutions in real world settings. It will tackle issues one at a time, starting with pain management for the inaugural programme.

Pain is the most common reason people seek healthcare and is the leading cause of disability in the world [Lancet 2021].[i] Haleon has long championed the role of pharmacists and pharmacy services in pain management and strongly believes that with the right support, an enhanced role would be of great benefit to patients and healthcare systems more broadly.

Facilitated by Robert Horne, Professor of Behavioural Medicine at UCL School of Pharmacy, pharmacists can expect to see the first solution from the HCHS delivered in 2023.

easily accessible way. 91% of pharmacists would like more support to develop strategies for helping patients adopt new and sustainable health behaviours.

With the launch of our Centre for Human Sciences, we are committing to removing this barrier so they can focus on improving everyday health outcomes in the communities they serve.”

“Through a deep understanding of the human factors behind health decisions and behaviours, and the development of practical solutions, the Centre’s community can tackle some of the very real challenges pharmacy professionals experience. This is just one example of how Haleon is delivering on its purpose and raising the bar in the level of support for health professionals, patients, and everyday health.”

The Lancet , Series - Chronic pain. Available here: https://www. thelancet.com/series/chronic-pain

[i]

BEACON LIMERICK OFFICIALLY OPENS Limerick’s most advanced private Cardiology, diagnostic imaging and health screening centre, Beacon Limerick, was officially opened last week by Limerick’s Senior Hurling Manager John Kiely.

John Kiely, Limerick’s Senior Hurling Manager with Helen McCormack, Beacon Director Limerick

Tess Player, VP Global Head of Expert/Health Professionals at Haleon, said, “As a global leader in consumer health, Haleon’s purpose is to deliver better everyday health with humanity. We know that some of the barriers to that are behavioural. The potential for the application of human sciences to help improve people’s health by influencing behavioural change, is astounding. The key to unlocking this lies with health professionals.

While primarily students of medicine, their changing roles requires them to become experts in influencing patient behaviour.

This is where we can help.

We have long heard from practising health professionals that they would benefit from greater opportunity and resources to upskill themselves in behavioural and social sciences in an

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Beacon Hospital is renowned for its dedicated teams of highly skilled medical professionals, and its world leading technologies and equipment.

The new satellite clinic on Barrington Street offers stateof-the-art healthcare services including a comprehensive Cardiology Service, Diagnostic Radiology, Vascular Services, HealthCheck, Endocrinology and a minor surgical day unit.

The Team of Consultant Cardiologists at Beacon Limerick provide comprehensive cardiac consultation and diagnostics services including, ECG, Echocardiograms, Stress ECG, Pacemaker Checks and Holter Monitoring.

Beacon Limerick offers an extensive diagnostic imaging service using the most technologically advanced radiology equipment in Ireland. It is run by a team of experienced Limerick-based Consultant Radiologists and Radiographers offering cardiac CT (only centre in the Mid-West), general CT, Ultrasounds, DEXA Scans, vascular scanning and X-Rays.

Additionally, Beacon Limerick’s HealthCheck offers a premier health screening service enabling patients to take a proactive approach to their health in order to help identify and make any changes necessary to stay well.

Michael Cullen, CEO of Beacon Hospital said, “We’re delighted to

officially open Beacon Limerick today. The clinic is equipped with state-of-the-art modern medical and surgical equipment.

Our consultants, nurses, radiographers, physiologists and administrative staff are top of their field and will bring leading patient care to the people of Limerick and the Mid-West.

This marks a significant milestone for Beacon Hospital as we continue to invest and expand in both our Dublin campus and our regional satellite clinics, with Beacon Limerick a key part of our future.”

CROÍ WELCOMES MEASURES IN BUDGET 2023 TO IMPROVE DIAGNOSTIC SERVICES FOR HEART VALVE PATIENTS Following the announcement of Budget 2023, Croí, the cardiac and stroke foundation, has welcomed measures that will improve access to diagnostic services, such as echocardiography, for patients with structural heart conditions, including heart valve disease. The announcement comes following a Croí report which highlighted inequalities in the availability of echocardiography services and making clear and achievable recommendations to improve access.

The report published by Croí earlier this month also outlined the need to meet additional demand through recruitment, training, and upskilling of the workforce. Specifically, a structured postgraduate

99 programme in echocardiography aimed at the 35% of cardiac physiologists not yet trained in this important test.

In a positive move, the Government has allocated ¤47 million to facilitate GPs in accessing diagnostic tests, with major implications for access to radiology tests as well as up to 266,500 tests across areas such as echocardiography, spirometry and natriuretic peptide blood tests.

The current budget estimates do not include provision for workforce planning however, which will make it more challenging to achieve the best outcome from the funding allocated by the Department of Health.

The charity launched the report, based on data from the National Survey on Echocardiography Services in Leinster House to an audience of TDs, Senators and political staff. The report highlighted enormous disparities in terms of access to echocardiography services for public and private patients, and recommended GP direct access, via resourced community diagnostics, as a means to address them, reduce waiting times and lower the burden on hospital services.

Neil Johnson, Croí Chief Executive responded: “Croí believes that all patients requiring echocardiography services should have equitable and timely access.

Our report provided an evidence base to uphold our values and advocate on them, for the benefit of heart patients. We wish to thank Minister Donnelly for taking on board our recommendations, and also his Oireachtas colleagues who listened so intently to our presentation the week before last. We will continue to work constructively with both the Department of Health, the Department of Further and Higher Education, and their respective Oireachtas committees to deliver the best outcomes for heart and stroke patients.”

MATER PRIVATE NETWORK TO DELIVER IRELAND’S MOST ADVANCED ELECTRONIC HEALTH RECORDS SYSTEM Mater Private Network (MPN) has embarked on delivering Ireland’s most ambitious and comprehensive Electronic Health Record (EHR) platform, MEDITECH Expanse. Backed by an investment of €26m, Mater Private Network will integrate MEDITECH Expanse across its entire Irish network, including its flagship Dublin and Cork hospitals, the Mid-Western Radiation Oncology Centre, Limerick, both Day Hospitals and clinics in counties Limerick, Offaly, Meath and Louth.

John Hurley, CEO, Mater Private Network, said “This investment of €26m demonstrates a significant level of commitment from our shareholder, Infravia, to the integration of transformational technology across the full scope of our network. The ultimate beneficiaries of our investment in digital transformation are our patients. The EHR will facilitate clinical integration across our network, enhance access and patient participation in their own care. Seamless personalised care across our network will further improve our excellent clinical outcomes and patient experience.”

Eric Neville, Chief Information Officer, Mater Private Network, outlined his vision saying “Having recently launched the Mater Private Network patient portal/ app, this significant investment in the latest EHR technology is a major leap forward in our Digital Transformation and one we are all very excited about.

Being a fully digital Network will be a gamechanger not only for us but for our patients and other healthcare institutions with which we collaborate”.

Lead clinician on the project, Dr. Róisín Ní Muirceartaigh, Consultant Anaesthesiologist and Chief Medical Information Officer, said “Every step in the transfer or communication of medical and healthcare information is a significant contributor to clinical efficiency. EHR is about introducing a single, unified patient record which will encompass the entirety of the patient’s journey with us. It also ensures any information brought in from other institutions has a single, safe, easy to find, digital location in

the patient’s new e-Chart, quickly and easily accessed by every professional involved in their care.”

Working with their chosen provider MEDITECH, a large multidisciplinary team drawn from across the Mater Private Network will collaborate to deliver Meditech Expanse across its entire hospital network by 2024.

The scale of the investment demonstrates MPNs’ commitment to cultivating a sustainable digital connection with its patients and ambition to lead digital transformation in the Irish Healthcare market, which will improve both data accessibility and, through that, will optimise patient care.

TECHNOLOGY LEADING THE WAY Together, VIGO Health and Abi have developed unique subscription-based virtual health services for the first time in Ireland.

Prioritizing your health can be inconvenient and time-consuming, with many young adults admitting they do not have health coverage.

To address the gap in the digital healthcare market, VIGO Health has introduced two new, first-ofits-kind* digital health solutions developed with Abi and introduced to the Irish market to provide fast and easy access to healthcare.

The Abi proprietary Artificial Intelligence and machine learning architecture powers the VIGO Health telemedicine services including on-demand GP, messaging a doctor, mental health messaging and online prescriptions.

CEO of VIGO Health, Ruth Bailey says of the technology, “The Abi

CEO of VIGO Health, Ruth Bailey and Kim Schneider, CEO, ABI

Natural Language Processing & Understanding technologies parse, recognise and classify user requests. While, the matching, distribution and optimisation algorithms select the best available HCPs based on a range of factors.

Together VIGO Health and Abi are bringing real telemedicine innovation to the Irish market to break down the barriers of accessing immediate affordable healthcare advice.”

CEO of ABI, Kim Schneider said of the partnership, “We are delighted to partner with VIGO Health to bring these innovative digital health solutions to the Irish market. The Abi platform finds the most appropriate healthcare professional for the patient’s medical concerns. A series of algorithms prioritise in real-time our medical staff based on several inputs like the inferred medical speciality, predicted availability and past performance to optimize the patient experience.

An important focus of all our patient’s experiences is the privacy protection and security of our data, so we apply advanced techniques of de-identification / anonymization to remove or hide personal information as it flows through the platform. Working with VIGO Health, we are really excited to bring these innovative services to the Irish market for the very first time.”

For more information about VIGO Health and its new products visit www.vigohealth.ie

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IMPORTANT NOTICE: The World Health Organisation (WHO) has recommended that pregnant women and new mothers be informed on the benefits and superiority of breastfeeding – in particular the fact that it provides the best nutrition and protection from illness for babies. Mothers should be given guidance on the preparation for, and maintenance of, lactation, with special emphasis on the importance of a well-balanced diet both during pregnancy and after delivery. Unnecessary introduction of partial bottle-feeding or other foods and drinks should be discouraged since it will have a negative effect on breastfeeding. Similarly, mothers should be warned of the difficulty of reversing a decision not to breastfeed. Before advising a mother to use an infant formula, she should be advised of the social and financial implications of her decision: for example, if a baby is exclusively bottle-fed, more than one can (400 g) per week will be needed, so the family circumstances and costs should be kept in mind.

Mothers should be reminded that breast milk is not only the best, but also the most economical food for babies. If a decision to use an infant formula is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. •SMA LF® is a lactose-free milk based formula for babies and young children who are intolerant to lactose or sucrose, or who are experiencing symptoms such as diarrhoea, tummy ache or wind caused by temporary lactose intolerance. It is suitable as the sole source of nutrition up to 6 months of age, and in conjunction with solid food up to 18 months of age. The following products must be used under medical supervision. •SMA® Anti-Reflux is a special formula intended for the dietary management of bottle-fed babies when significant reflux (regurgitation) is a problem. It is suitable as the sole source of nutrition up to 6 months of age, and in conjunction with solid food up to 12 months of age. If the baby’s reflux does not improve within 2 weeks of starting SMA® Anti-Reflux, or if the baby fails to thrive, the family doctor should be consulted. •SMA High Energy® is a milk based formula for the dietary management of babies and young children with medically determined high energy requirements as identified by a healthcare professional. It is suitable as the sole source of nutrition up to 6 months of age, and in conjunction with solid food up to 18 months of age. SMA High Energy® is not intended for use with preterm babies, for whom fortified breast milk or a low birthweight formula such as SMA Gold Prem® 1 is more appropriate. •SMA® Comfort is a special formula intended for the dietary management of bottle-fed babies with colic and constipation. It is suitable as the sole source of nutrition up to 6 months of age, and in conjunction with solid food up to 12 months of age.

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