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September 2020 Volume 12  Issue 9 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

In this issue: NEWS: Pharmacists warn of online medicines risk Page 6 02-07-2017

PERSPECTIVES: Perspectives of Pharmacy Students Page 12

REPORT: Medicines for Ireland publish Policy Paper Page 19 DELIVERING CONSIS TENCY in QUALITY, VALUE and S UPPLY

FEATURE: livingahealthylife

KRKA Pharma Dublin Ltd. Unit 4A, Leopardstown Business Centre, Ballyogan Road, Leopardstown, Dublin 18. D18 YW 52 | Tel: +353 1 293 9180 | Email: info.ie@krka.biz

977-2017_KRKA-CORPO-adA4_IE.indd 1

10.7.2017 12:56:19

Top 10 Winter Conditions Page 24

CPD: Management of Acute Pain Page 39

TEAM TRAINING: Treatment of Heartburn Page 46

EDUCATIONAL: Chickenpox and Shingles Page 66


has Crohn's disease

"I was prescribed idacio

and Fresenius Kabi supported me all the way"

®

Mia, 54, has RHEUMATOID ARTHRITIS

® is an adalimumab biosimilar, is approved for the same indications as the IDACIO®IDACIO is an adalimumab biosimilar, whichwhich is approved for use in the same conditions as the reference product, including the treatment of moderately to severely Crohn’s biologicbiologic reference product, including the treatment of moderate to severe, activeactive rheumatoid 1, 2 1, 2 and ulcerative colitis in adult Patientsaprescribed IDACIO can access Patients prescribed IDACIO canpatients. access KabiCare, web-based resource developed arthritisdisease KabiCare, a web-based resource developed with a holistic approach to patient support. with a holistic approach to patient support.

The indications for IDACIO inIDACIO adults include, with methotrexate, the treatment of moderate to and severe, The indications for include in thecombination treatment of moderately to severely active Crohn’s disease active rheumatoid thewho response to DMARDs* has been inadequate and also the treatment severe, active ulcerativearthritis colitis inwhen adults have had inadequate response to conventional therapies or whoof are intolerant 1 and progressive rheumatoid arthritis without previous methotrexate treatment. IDACIO can be given as monotherapy 1 to or have contraindications to such therapies. Before prescribing IDACIO please consult 1the Summary of in case ofProduct intolerance to methotrexate, or when continued methotrexate treatment is inappropriate. Before Characteristics. Patients prescribed IDACIO should receive a patient alert card. For moreprescribing information IDACIO please Product Characteristics. Patients prescribed IDACIO should receive a patient aboutconsult IDACIOthe andSummary KabiCare,ofplease contact your local Fresenius Kabi representative. alert card. For more information about IDACIO and KabiCare, please contact your local Fresenius Kabi representative. References: References: 1. IDACIO Summary of Product Characteristics. Fresenius Kabi Ltd. 2. Humira Abbvie 1. IDACIO 40mg solution Summary for injectionofinProduct pre-filledCharacteristics. syringe and pre-filled pen.Ltd. Summary of Product Characteristics. Fresenius Kabi Deutschland GmbH. 2. Humira 40mg solution for injection in pre-filled syringe and pre-filled pen. Summary of Product Characteristics. AbbVie Deutschland GmbH & Co. KG. KabiCare is funded and developed by Fresenius Kabi. *DMARDs =IDACIO disease-modifying anti-rheumatic drugs, includingofmethotrexate and KabiCare are registered trademarks Fresenius Kabi. KabiCare is funded and developed by Fresenius Kabi. IDACIO and KabiCare are registered trademarks of Fresenius Kabi.

Abbreviated Prescribing Information. Consult the Summary of Product Characteristics for full information. Additional information is available on request. Idacio (adalimumab) 40 mg  This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See below for how to report adverse reactions. Idacio 40 mg solution for injection in pre-filled syringe Idacio 40 mg solution for injection in pre-filled pen Idacio 40 mg solution for injection in vial for paediatric use Presentation and method of administration: Each single dose 0.8 ml pre-filled syringe, 0.8 ml pre-filled pen or 0.8 ml vial contains 40 mg of adalimumab for subcutaneous injection. Indications and Dosage: Please refer to SmPC for full information. Idacio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Idacio is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio. Patients treated with Idacio should be given a patient alert card. After proper training in injection technique, patients may self-inject with Idacio if their physician determines that it is appropriate and with medical follow-up as necessary. During treatment with Idacio, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised. Rheumatoid arthritis (RA), adults: In combination with methotrexate (MTX) for moderate to severe, active RA with inadequate response to disease-modifying antirheumatic drugs (DMARDs) including MTX. In combination with MTX for severe, active and progressive RA when not previously treated with MTX. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Reduces rate of progression of joint damage on X-ray and improves physical function, in combination with MTX. Dosage:40 mg single dose every other week (EOW). Concomitant MTX should be continued. In monotherapy, patients may require 40 mg every week or 80 mg EOW if they experience a decrease in clinical response. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Consider need for dose interruption, e.g. before surgery or if serious infection occurs. Reintroduction after 70 days or longer of discontinuation gave same magnitudes of clinical response and similar safety profile as before dose interruption. Polyarticular juvenile idiopathic arthritis (pJIA), paediatrics 2 years and above: In combination with MTX for active pJIA with inadequate response to one or more DMARDs. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Dosage: 10 kg to < 30 kg 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Enthesitis-related arthritis (ERA), paediatrics 6 years and above: For active ERA with inadequate response to or intolerance to conventional therapy. Dosage: 15 kg to < 30 kg: 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. Ankylosing spondylitis (AS), adults: For severe active AS with inadequate response to conventional therapy. Dosage: adults: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), adults: For severe nr-axSpA with objective signs of inflammation (elevated CRP and/or MRI), and an inadequate response to or intolerance to nonsteroidal anti-inflammatory drugs. Dosage: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Psoriatic arthritis (PsA), adults: For active and progressive PsA with inadequate response to DMARDs. Reduces rate of progression of peripheral joint damage on X-ray in polyarticular symmetrical subtypes of the disease and improves physical function. Dosage: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Psoriasis, adults: For moderate to severe chronic plaque psoriasis in candidates for systemic therapy. Dosage: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment beyond 16 weeks should be reconsidered if no clinical response in that time (refer to SmPC). Paediatric Plaque Psoriasis, 4 years and above: For severe chronic plaque psoriasis with inadequate response to or if topical therapy and phototherapies are inappropriate. Dosage: 15 kg to < 30 kg: 20 mg dose initially followed by 20 mg EOW starting one week after initial dose. If ≥ 30 kg: 40 mg dose initially followed by 40 mg EOW starting one week after initial dose. Treatment beyond 16 weeks should be reconsidered if no

clinical response in that time. Hidradenitis suppurativa (HS), adults and adolescents from 12 years and above: For active moderate to severe HS (acne inversa) with inadequate response to conventional systemic HS therapy. Dosage: HS, adults: 160 mg dose initially at Day 1, followed by 80 mg two weeks later at Day 15. Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg EOW.HS, adolescents 12 years and above ≥ 30 kg: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. If there is inadequate response to 40 mg EOW, an increase in dosage to 40 mg every week or 80 mg EOW may be considered. Antibiotics may be continued if necessary. Concomitant topical antiseptic wash on HS lesions is recommended to be used on a daily basis. Treatment beyond 12 weeks should be reconsidered if no improvement in that time. Reintroduction of Idacio after treatment interruption as appropriate. Evaluate periodically the benefit and risk of continued long-term treatment. Crohn’s disease (CD), adults: For moderately to severely active CD with no response despite a full and adequate course of, intolerance to or contraindication for a corticosteroid and/or an immunosuppressant therapy. Dosage: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW. During maintenance, corticosteroids may be tapered in accordance with clinical guidelines. If decrease in clinical response, can increase dosage to 40 mg every week or 80 mg EOW. Patients with no response by Week 4 may benefit from continued maintenance therapy to Week 12. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Paediatric Crohn’s disease (CD), 6 years and above: For moderately to severely active CD with inadequate response to, intolerance to or contraindication for conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator. Dosage: < 40 kg: Induction: 40 mg dose at Week 0, followed by 20 mg at Week 2. For a more rapid response: 80 mg at Week 0, followed by 40 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 20 mg dose EOW from week 4. If insufficient response, consider an increase in dosing frequency to 20 mg every week. If ≥ 40 kg: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg dose at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW from week 4. If insufficient response, consider an increase in dosage to 40 mg every week or 80 mg EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Ulcerative colitis (UC), adults: For moderately to severely active UC with inadequate response to, intolerance to or contraindication for conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). Dosage: Induction: 160 mg dose at Week 0, followed by 80 mg at Week 2. Maintenance: 40 mg dose EOW. During maintenance, corticosteroids may be tapered in accordance with clinical guidelines. If insufficient response, consider an increase in dosage to 40 mg every week or 80 mg EOW. Treatment beyond 8 weeks should not be continued if no clinical response in that time. Uveitis, adults: For non-infectious intermediate, posterior and panuveitis with inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Dosage: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Idacio. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Paediatric Uveitis, 2 years and above: For chronic non-infectious anterior uveitis with inadequate response to or intolerance to conventional therapy, or in whom conventional therapy is inappropriate. Dosage: < 30 kg: 20 mg dose EOW in combination with MTX. Optional 40 mg (for patients < 30 kg) or 80 mg (for patients ≥ 30 kg) loading dose one week prior to start of maintenance therapy. No clinical data in use of loading dose < 6 years of age (see SmPC). If ≥ 30 kg: 40 mg dose EOW in combination with MTX. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Idacio may be available in other strengths and/or presentations depending on the individual treatment needs. Contraindications: Hypersensitivity to the active substance or to any excipients (see SmPC); Active tuberculosis (TB) or other severe infections such as sepsis and opportunistic infections; Moderate to severe heart failure (NYHA class III/IV). Warnings and precautions: Clearly record the name and batch number

of administered product to improve traceability of biological products. Infections: Patients taking TNF-antagonists are more susceptible to serious infections. Impaired lung function may increase the risk for developing infections. Monitor for infections, including TB, before, during and for at least 4 months after treatment. Treatment with Idacio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Idacio should be considered prior to initiating therapy. Evaluate new infections during treatment and monitor closely. Stop treatment if new serious infection or sepsis and treat appropriately. Exercise caution in patients with a history of recurring infections or who are predisposed to infections, including the use of concomitant immunosuppressive medications. Serious infections: Serious infections, including those associated with hospitalisation or death, were reported in patients receiving treatment. TB: Consult SmPC for details. Reactivation and new onset TB, both pulmonary and extra-pulmonary (disseminated), were reported. Screen all patients before therapy initiation for active or inactive (latent) TB. Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients. If latent TB is suspected, consult physician with appropriate expertise and follow local treatment recommendations for prophylaxis prior to initiation of Idacio. Despite prophylaxis, TB reactivation has occurred on adalimumab. If active TB is diagnosed, do not initiate Idacio treatment. Other opportunistic infections: Opportunistic infections were observed in patients receiving adalimumab. Stop treatment in patients with signs and symptoms of such infections. Consult with physician with appropriate expertise for diagnosis and administration of empiric antifungal therapy in these patients. Hepatitis B reactivation: Reactivation of HBV has occurred in chronic carriers (surface antigen positive). Patients should be tested for HBV infection before initiating treatment. HBV carriers should consult a specialist physician and be closely monitored for reactivation of HBV infection throughout therapy and for several months following termination of treatment. If reactivation occurs, stop treatment and initiate appropriate antiviral and supportive treatment. Neurological events: Caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. Discontinuation of treatment should be considered if any of these disorders develop. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to initiation of treatment and regularly during treatment, to assess for pre-existing or developing central demyelinating disorders. Allergic reactions: Reports of serious allergic reactions including anaphylaxis received. For serious allergic or anaphylactic reaction, stop Idacio immediately and initiate appropriate therapy. Malignancies and lymphoproliferative disorders: A possible risk has been reported of malignancy, including lymphomas and leukaemia, in all patients, including paediatric patients, treated with Tumour Necrosis Factor (TNF) antagonists. Examine all patients, especially those with a medical history of extensive immunosuppressant or PUVA treatment, for non-melanoma skin cancer prior to and during treatment; caution in COPD patients, and in patients with increased risk for malignancy due to heavy smoking. Consider the potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab (hepatosplenic T-cell lymphoma has occurred). Risk of hepatosplenic T-cell lymphoma cannot be excluded. Caution in patients with a history of malignancy. Risk of developing dysplasia or colon cancer is unknown. Patients with UC with increased risk of dysplasia or colon carcinoma, or history of dysplasia or colon carcinoma, to be screened for dysplasia before treatment and throughout disease course. Haematological reactions: Adverse events of the haematological system reported with adalimumab. Patients should seek immediate medical attention if signs and symptoms of blood dyscrasias develop while on treatment. Vaccinations: Patients may receive concurrent vaccinations, except for live vaccines. Bring paediatric patients up to date with all immunisations prior to initiating Idacio treatment. Congestive heart failure: See contraindications. Caution is advised with mild heart failure (NYHA class I/II). Discontinue treatment if new or worsening symptoms of congestive heart failure. Autoimmune processes: Autoimmune antibodies may form with Idacio. Stop treatment if development of a lupus-like syndrome with positive antibodies against double-stranded DNA. Surgery: Consider the long half-life of Idacio for planned

Fresenius Kabi Ireland Unit 3B Fingal Bay Business Park,

Fresenius IrelandIreland Balbriggan,Kabi Co.Dublin, Unit 3B (0)1 Fingal Bay Business Park, T: +353 8413030 Balbrigga, F: +353 (0)1Co.Dublin, 8496949 Ireland T: +353 (0)1 8413030 www.fresenius-kabi.ie F: +353 8496949 Date of (0)1 preparation: July 2020 www.fresenius-kabi.ie Job code: BIO/IDACIO/011.20 Date of preparation: 2020 Additional information isJuly available on request Job code: BIO/IDACIO/010.20 Additional information is available on request

surgical procedures. Monitor closely for infections. Elderly patients: Serious infections were higher in patients over 65 years of age, some of which had a fatal outcome. Consider risk of infections in these patients. Interactions: Antibody formation was lower when adalimumab was given together with MTX in comparison with use as monotherapy. Combination of Idacio with other biologic DMARDs (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended. Fertility, pregnancy and lactation: Idacio should only be used during pregnancy if clearly needed. Women of childbearing age should consider the use of adequate contraception and continue its use for at least 5 months after the last treatment. No administration of live vaccines (e.g. BCG) to infants exposed to Idacio in utero for 5 months following mother’s last Idacio treatment during pregnancy. Idacio can be used during breast-feeding. Adverse Reactions: Very common ≥ 1/10: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), leukopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, elevated liver enzymes, rash (including exfoliative rash), musculoskeletal pain, injection site reaction (including injection site erythema). Common ≥ 1/100 to < 1/10: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections, skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm, leucocytosis, thrombocytopenia, hypersensitivity, allergies (including seasonal allergy), hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration, mood alterations (including depression), anxiety, insomnia, paraesthesias (including hypoesthesia), migraine, nerve root compression, visual impairment, conjunctivitis, blepharitis, eye swelling, vertigo, tachycardia, hypertension, flushing, haematoma, asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome, worsening or new onset of psoriasis (including palmoplantar pustular psoriasis), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia, pruritus, muscle spasms (including blood creatine phosphokinase increased), renal impairment, haematuria, chest pain, oedema, pyrexia, coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased, impaired healing. Serious, including fatal, adverse reactions have been reported including infections/sepsis, TB, opportunistic infections, allergic reactions (including anaphylaxis), HBV reactivation and malignancies (including leukaemia, lymphoma and hepatosplenic T-cell lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome. Other less common and rarely reported adverse reactions are listed in the SmPC. Legal Category: POM. Marketing Authorisation Holder: Fresenius Kabi Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe, Germany. Marketing authorisation numbers: EU/1/19/1356/001, EU/1/19/1356/002, EU/1/19/1356/003 Package size and cost: UK / ROI - Idacio 40mg/0.8ml vial x 1: £316.93 / €309.31, Idacio 40mg/0.8ml pre-filled syringe x 2: £633.86 / €618.63, Idacio 40mg/0.8ml pre-filled pen x 2: £633.86 / €618.63 Further information: available from Fresenius Kabi Ltd., Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT. Tel +44 (0)1928 533 533 Date of preparation of PI: April 2020 001/API/IDACIO/FKUK-IRL Adverse events should be reported. Reporting forms and information can be found at: yellowcard.mhra.gov.uk www.hpra.ie/homepage/about-us/report-an-issue Adverse events should also be reported to Fresenius Kabi Ltd. Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT Tel +44 (0)1928 533 533


5

Contents

Foreword

Page 6: iTrolley Pharmacy launches in Ireland

Amongst our lead news this month, is the calls from pharmacists on the Minister for Health Stephen Donnelly TD to change legislation to allow them substitute expensive biological medicines for more cost-effective biosimilars.

Page 8: New research on flu vaccinations

In 2017, the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and IPU proposals showed ¤370 million in potential savings were possible if action was taken. Nearly three years later, there has been no action and those savings have not been made.

Page 10: Grays Pharmacy say a big ‘Thank You’

6

Page 12: Perspectives of Pharmacy Students Page 16: Biosimilars and the role of Pharmacy Page 18: Maintaining CPD whilst cocooning

Turn to page 8 for the full story.

10

Page 19: Medicines for Ireland’s policy paper on Lessons learned

PUBLISHER: IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562

19

ADVERTISING EXECUTIVE Amy Evans: amy@ipn.ie CONTRIBUTORS Caitriona Sheelin Peter Conry Rob Wood DESIGN DIRECTOR Ian Stoddart Design PHARMACYNEWSIRELAND.COM

@Irish_PharmNews

IrishPharmacyNews

In other news this month, our report on page 19 looks at a recent policy paper published by Medicines for Europe/ Medicines for Ireland. This examined ‘lessons learned from Covid-19’ for the pharmaceutical industry. Chair of MFI David Delaney says, “This document sets out a range of important national and European policy recommendations that illustrate the important role of the EU in relation to the supply of medicines and medical devices. This further illustrates the importance for Ireland of a pan-European response to many of the issues that have arisen due to the Covid-19 pandemic.” I think we can all safely say summer is officially over. Not that Ireland experienced a multitude of warm, sunny days but certainly the weather is only going to get worse. With that in mind, one of our leading clinical features looks at some of the most common winter conditions, which will be presenting in the pharmacy. Now is the time for community pharmacists and their teams, to be promoting the message that consumers should visit them first, for advice and treatment of common winter ailments.

MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie

“There are no clinically meaningful differences between a biosimilar and reference biological medicine and increased use of biosimilars would result in significant savings. Despite this, uptake has been extremely low in Ireland, with biosimilars representing less than 10% of the market share, which is far below the EU average,” says IPU Vice President Eoghan Hanly.

Research shows that 18% of GP appointments are for minor ailments. Community pharmacists are in fact, best placed to offer advice on these conditions and over-the-counter available and appropriate medications. Turn to page 24 for this overview.

52 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.

This issue also features analysis on winter skin, infant feeding, wet AMD and much more. I hope you enjoy the issue. Stay safe.

Regulars CPD: MANAGEMENT OF ACUTE PAIN P39 FEATURE: WINTER SKIN CONDITIONS P43 TEAM TRAINING: HEARTBURN P46 BACK2SCHOOL: DEALING WITH THE NEW NORMAL P64 CLINICAL PROFILES P74

PHARMACYNEWSIRELAND.COM


6

News

iTrolley Pharmacy Launched in Ireland “iTrolley Pharmacy” brand has been launched in Ireland iTrolley founder, Patrick Hogan, in partnership with the McCormack’s Pharmacy group. Patrick Hogan, MD, McCormack's Pharmacy Group

needs of our nation. This is the first iTrolley expansion since its launch, to help the people of Ireland during the Covid-19 pandemic. With 7 brick and mortar Pharmacies around Ireland, it will see the product line increase by over 6000 products within the first 3 months, to meet the medical

McCormack’s Pharmacy and online store is already seeing their focus change from instore purchases to contact-free, door to door deliveries over the last couple months and this will

continue to grow with the iTrolley Pharmacy brand. NRGStore.ie offers a large marketplace of 28,000 products and services which is the first of its kind in Ireland, offering so much in one place with products sourced from around the world. From places such as Tipperary in Ireland, New Jersey in the United States, Europe and the United Kingdom. The global pandemic has changed the world in the last 6 months; health and hygiene are at the front of everyone’s mind. From the founder Patrick Hogan, “The Irish market for medicine alone is worth ¤1.1 billion a year. It is a key area for online growth over the next five years.”

New research on Flu vaccine Less than half of Irish adults planning on getting flu vaccine says leading Pharmacy chain LloydsPharmacy StillorganPharmacist Laura Dowling

Amongst those who are planning to get the flu vaccine this year, but didn’t get the flu vaccine last year, almost 6 in 10 (59%) claim that this will be the first time they will get the flu vaccine. Each year the seasonal flu vaccine contains four common influenza virus strains. The flu virus changes each year and therefore a new flu vaccine must be administered each year. Seasonal flu vaccine helps a person’s immune system to produce antibodies to the flu virus.

Research by LloydsPharmacy shows, almost three quarters (74%) of adults claim that the Covid-19 pandemic has made them more aware of the importance of being vaccinated against viruses, such as the flu, with those aged 18-24 (93%) most likely to claim this to be the case. However, just under half (46%) of adults said that they are planning on getting the flu vaccine this year. The research shows that since the arrival of the COVID-19 pandemic there has been an increase (15%) of people who will visit their local pharmacy for advice. LloydsPharmacy’s highly trained colleagues are always on hand to support their communities and all

relevant precautions are in place in their 89 pharmacies making it a safe environment to get your flu vaccination. LloydsPharmacy research shows that washing hands regularly (92%), maintaining social distance from others (85%), practicing good coughing/sneezing etiquette (85%) and wearing a facemask (84%) are the measures most likely to be undertaken by adults to protect their health this Winter flu season. While these are all really important steps to take to protect from viruses, such as the flu and COVID-19, there are huge benefits to having your flu vaccine, reducing the potential risk of confusion with COVID-19 symptoms.

PHARMACYNEWSIRELAND.COM

Denis O’Driscoll, LloydsPharmacy Superintendent pharmacist says, “While it is really promising to see that almost three quarters of adults surveyed said that the Covid-19 pandemic has made them more aware of the importance of being vaccinated against viruses, such as the flu, there is a disconnect with just under half (46%) of adults said that they are planning on getting the flu vaccine this year. In order for the vaccine to be as effective as possible, we need as many of the population as possible to get vaccinated.” This year the flu vaccine will only be administered by appointment only. A short questionnaire, which is available in pharmacy or via lloydspharmacy.ie, is to be filled out in advance of appointments.

Hepatitis Day 2020 On World Hepatitis Day, which took place on Tuesday 28th July 2020, the HSE National Hepatitis C Treatment Programme highighted the new advancements in treatment for hepatitis C and encouraged people who think they may have been at risk to get tested. Previously, many people’s experience of hepatitis C treatment included weekly injections over a year with side effects that mimic the symptoms of the flu – with less than a 50% chance of being cured. Now, Hepatitis C treatment has been transformed by new, extremely effective, tablet-only medicines with minimal side effects. These new medicines, known as direct-acting antivirals (or DAAs) are very effective drugs, curing hepatitis C in more than 95% of cases. The HSE is committed to promoting widespread access to new and highly effective DAAs. Under the clinical leadership of Professor Aiden McCormick, the HSE National Hepatitis C Treatment Programme aims to provide everyone in Ireland infected with hepatitis C access to free DAA medicines. To date, over 5,000 patients in Ireland have been treated with highly effective DAA's for hepatitis C. Current data suggests that Ireland has reached the 2020 targets and is on track to achieve the 2030 WHO elimination targets. Professor Aiden McCormick, HSE Clinical Lead for the HSE National Hepatitis C Treatment Programme said, “For people with hepatitis C, the outlook has never been better. Our treatment programme provides free access to direct acting antiviral (DAA) tablets. DAA tablets are the safest and most effective medicines for treating hepatitis C. “They’re highly effective at curing hepatitis C in more than 95% of people. Traditional hepatitis C treatments came with a long list of side effects and were neither as quick nor as effective as these new drugs.”


News Medicine Shortages The Health Products Regulatory Authority has been notified of a shortage of the following products: • Hydromorphone hydrochloride 50mg/ml Solution for Injection/ Infusion – PA0549/030/002 • Kemadrin 5mg Tablet – PA1691/005/001 • Seretral 50mg Film Coated Tablet – PA0749/023/001 • Seretral 100mg Film Coated Tablet – PA0749/023/002 • Serimel 100mg Film Coated Tablet – PA0126/135/002 • Tradol SR 100mg Prolonged Release Tablet – PA0711/029/005 • Yasminelle 0.02mg/3mg Film Coated Tablet – PA1410/015/003 The following shortage has been resolved and supply has resumed to the Irish market: • Candist Plus 16mg/12.5mg Tablet – PA0126/207/002 • Celecoxib 100mg Capsule – PA0711/241/001 • Cimeldine 400mg Tablet – PA0126/077/002 • Emazole 40mg Tablet – PA0711/158/002 • Ezetimibe Simvastatin 10mg/10mg Tablet – PA0126/281/001 • Folinic acid 10mg/ml Solution for Injection (100mg/10ml presentation) – PA0822/198/003 • Galfer 305mg Tablet – PA0126/314/001 • Losamel 20mg Gastroresistant Tablet – PA0126/115/001 • Melfen 200mg Film Coated Tablet – PA0126/012/001 • Miramel 0.18mg Tablet – PA0126/173/002 • Neurontin 800mg Capsule – PA0822/015/005 • Nexium Control 20mg Tablet – EU/1/13/860/001-002 • Serlan 50mg Film Coated Tablet – PA0711/065/001

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Purchasing medicines online risk With more people than ever working from home the Irish Pharmacy Union (IPU) has issued a warning about the major health risks that can arise from purchasing medicines online. The IPU has also warned against those tempted to buy tests for the diagnosis of COVID-19. Community pharmacist and IPU Executive Committee member Caitriona O’Riordan said, “It is vitally important that all testing for COVID-19 is centralised under the direction of the National Public Health Emergency Team (NPHET) and conducted in the National Virus Reference Laboratory to ensure first and foremost that the test result is trustworthy, and also that we have reliable national data on case levels, and contact tracing can be carried out.” The IPU says the public must heed NPHET advice that members of the public should not purchase COVID-19 tests online or from any other retailer, as these tests may provide incorrect results. The ongoing problem with online medicines was highlighted by the seizure earlier this year of over 49,000 illegal medicine products by the Health Products Regulatory Authority (HPRA). The products, worth an estimated ¤175,000, were seized as part of Operation Pangea, an international week of co-ordinated action between

customs officers, health regulators and police from around the world, which targets the online sale of counterfeit and illegal medicines and medical devices. The most common items found in the packages seized were large volumes of sedatives and pain relievers, as well as anabolic steroids, erectile dysfunction and teeth whitening products. Ms O’Riordan said many of these products sold on websites and social media pages are falsely advertised; “While the people who purchased these products may feel like they are getting a good deal, the reality is that medicines and lifestyle products from unregulated online sources pose a major health risk to consumers. They sometimes contain none of the active ingredient, or sometimes too much or too little of some ingredients, which are also of questionable quality.” Previous HPRA laboratory analysis of seized medicines, unlabelled medicines, and lifestyle products has proven that they often contain harmful or completely different active ingredients.

Ms O’Riordan continued, “There are also other risk factors that people may not fully consider when purchasing medication online, including the importance of risk assessments. Your local community pharmacist is a medicines expert, who will ensure that any medicine you get from them is suitable for you and won’t react with any other medications you are taking. However, when purchasing medication online, all the established safety nets are bypassed.” “The dangers of purchasing medicines online have further been brought into focus following recent reports from Northern Ireland that unlicensed supposed anti-viral drugs are being bought online to treat COVID-19. There are huge dangers in purchasing unlicensed and unproven medicines from online sources that are unregulated and unaccountable. Anyone who has purchase these medicines online can and should instead consult with their GP or pharmacist, who can provide appropriate professional advice,” concluded Ms O’Riordan.

Supporting infection control in community A digital learning module, designed to support staff in community health services to implement safe practice in infection prevention and control and antimicrobial stewardship, such as appropriate antibiotic use, has been launched this month. The online module, from the Health Information and Quality Authority (HIQA), aims to support services to implement the National Standards for infection prevention and control in community services. Rachel Flynn, HIQA’s Director of Health Information and Standards, says, “Infection prevention and control is about supporting people to access care that is as safe as possible. The Covid-19 pandemic has further highlighted the importance of good infection prevention and control practices in all health and social care services to prevent the spread of infection. While overall responsibility for infection prevention and control and implementing the national standards rests with senior management, everyone working in health and social care services has a responsibility to provide care and support that is in line with good infection prevention and control practices.”

Rachel Flynn, HIQA’s Director of Health Information and Standards

Ms Flynn continued: “Preventing the spread of infection depends on everyone working within a service understanding their responsibilities and engaging in ways to reduce the risk of infection, such as ensuring hands, equipment and the environment are kept clean. It is also essential that antibiotics are used appropriately to reduce antibiotic resistance and ensure antibiotics remain effective. “We hope that people will use this digital learning module to strengthen and improve standard infection prevention and control practices in community services across the country.”

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News

Pharmacists prescribing Biosimilars could save Millions Pharmacists have called on the Minister for Health Stephen Donnelly TD to change legislation to allow them substitute expensive biological medicines for more cost-effective biosimilars. Eoghan Hanly, Vice President, Irish Pharmacy Union

in great shape and the ongoing pandemic will only make that worse. Analysis done for the IPU three years ago identified clear savings of hundreds of millions of euro but we are not able to use that money to support people in our health service today, because that opportunity was wasted. Will we be back here again saying the same thing in another three years?” Mr Hanly continued, “There are no clinically meaningful differences between a biosimilar and reference biological medicine and increased use of biosimilars would result in significant savings. Despite this, uptake has been extremely low in Ireland, with biosimilars representing less than 10% of the market share, which is far below the EU average.

In 2017 the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and IPU proposals showed ¤370 million in potential savings were possible if action was taken. Nearly three years later, there has been no action and those savings have not been made. Eoghan Hanly, Vice-President of the Irish Pharmacy Union said allowing pharmacists to substitute biological medicines for biosimilars “is the fastest and most effective way to ensure a rapid and

meaningful increase in the use of biosimilars, which could save the Irish State hundreds of millions of euro”. Commenting on the recently updated Guide to Biosimilars for Healthcare Professionals from the Health Products Regulatory Authority (HPRA), Mr Hanly called it a “massive own goal for the health service that we are not availing of hundreds of millions in potential savings”. Mr Hanly said, “The finances of the health service have never been

In 2013 pharmacists began facilitating Government policy on the use of generic medication. Consequently, the use of generic medicines in Ireland increased from 17% to over 40%, generating a total of ¤1.145 billion in savings for the State. As the experience of generic substitution demonstrated, allowing community pharmacists to substitute is the fastest and most effective way to ensure a rapid and meaningful increase in the usage of biosimilars. “An amendment to the Health (Pricing and Supply of Medical Goods) Act 2013 would allow pharmacists to substitute a biological reference product with a biosimilar, and the IPU is now calling on Minister Stephen Donnelly to legislate for this. Every week that the Government fails to implement this proposal is costing roughly ¤2 million in potential savings foregone”, concluded Mr Hanly.

PMI – Voice of Pharma Series The newest series from the Pharmaceutical Managers’ Institute will give 3 industry experts 120 minutes to discuss a particular topic including the opportunity for attendees to pose questions to the panel. The PMI will be hosting these sessions online initially in line with Covid19 policy to protect their members. The first session takes place on September 10th, where speakers will be discussing “How Innovation is Disrupting the Delivery of Healthcare” – this was particularly highlighted during the Covid19 pandemic this year with increased collaboration between Stakeholders and the entire healthcare industry. Speakers include Professor Derek O’Keeffe, Consultant Endocrinologist at University Hospital Galway and Professor of Medical Device Technology at NUI Galway; Professor Martin Curley, Director of the Digital Academy & Open Innovation, HSE and Dr Frank O’Donnell, Public Sector Lead, Microsoft. For further information visit https://www.thepmi.com/events/voices-of-pharma-series/

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Childhood Allergies A new research study from RCSI University of Medicine and Health Sciences and CHI Temple Street will examine if Ireland’s Covid-19 restrictions will result in an increase in allergies in infants born since March. Led by clinician scientists at RCSI’s Department of Paediatrics and CHI Temple Street, the study will investigate whether the lower rates of viral infections and improved air quality which resulted from the lockdown are going to make allergic conditions more or less common in children born to families who have experienced social distancing and isolation. Identifying non-acute consequences of Covid-19 is now a global research priority. Professor of Paediatrics at RCSI University of Medicine and Health Sciences Jonathan Hourihane, who is leading the study, said, “The lockdown presents a unique scientific opportunity to examine the early origins of often lifelong diseases, issues that constitute a major health and social burden in Ireland and other developed countries.” Allergic diseases like eczema, asthma, hay fever and food allergy have become more common over the last 30 years. This is thought to result from decreased exposure to infections, due to smaller family sizes, the introduction of effective immunisations against the most serious infections and community focus on hygiene. This is called the ‘Hygiene Hypothesis’. Air quality, which has also worsened in Ireland and in other industrialised nations over the last 30 years, also affects allergic conditions. “After birth, a baby’s immune system soon focuses on all the new challenges that life outside the womb brings, including fighting off infections and responding to immunisations. We want to see children playing on the floor, getting dirty, and being exposed to lots of people in lots of environments. The outcome of this is usually a stronger immune system, linked to a healthy population of gut bacteria, called the microbiome,” he added.


The Pelgraz® Patient App Find out how the Pelgraz® Patient App can help your patients to confidently self inject from home

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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 injector. Presentation: Each 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 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. Granulocyte-colony 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

www.accord-healthcare.ie

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. 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 x  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  x  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 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

Oncology & Haematology

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. This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 6 mg dose. Pelgraz contains less than 1 mmol (23 mg) sodium 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: Sickle cell crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile 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 injector with one alcohol swab, in a blistered packaging. Marketing Authorisation Number: 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-UK Ltd. via E-mail: medinfo@accord-healthcare.com or Tel: +44(0)1271385257. Date of Generation of API December 2019. IE-01454

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

May 2020. IE-01429


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News

No ‘Grey’ Days at Grays Pharmacy Community pharmacy teams across Ireland have been working tirelessly at the frontline during the Covid-19 pandemic. One such team, Grays Pharmacy in Castletroy, recently got in touch with Irish Pharmacy News to voice their gratitude at the outpouring of generosity they received. Pharmacist and owner Ruth Garahy told us, “I have been in pharmacy a long time, and I have never experienced anything like the world we are now in. From the endless shortages to the uncertainty over safety, to daily updated work practices; life will never be the same again. “In some ways it is better; Healthmail and the strengthened community bonds are tangible and won’t be forgotten. To watch our local GAA teams, along with all the community volunteers come together to help has been fantastic. For every major roadblock, a way round was found. “But our team has been at the coalface day in, day out, since before lockdown was announced and every day since. When we didn’t know how the virus was spread and were covered in

boiler suits and hedge cutting helmets, to days of keeling over from isopropyl alcohol fumes and working from home, a community pharmacy first! From not seeing our other team for 11 weeks, to taking WhatsApp video calls from Drs and Eircode’s becoming essential. “For every hard day and tearful encounter, for every petrol station meeting to gather masks, for every late night delivery and early morning shop clean, there has been a freshly baked tart, a box of our technicians’ favourite Lindt balls, a jar of specially picked decaf coffee, a hot Domino’s pizza, a bottle of red wine, a piece of jewellery for each member of the team from Chupi, a fantastic hamper box of biscuits from Lismore Food Co, a Butlers chocolate for break.

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“The generosity of our patients, local community and businesses has been incredible to witness. Knowing that our team is helping people and making a difference in these uncertain times has made it all worth it. All these tokens of appreciation bring such a smile our team during some of the toughest times we have ever faced.”


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"For every hard day and tearful encounter, for every petrol station meeting to gather masks, for every late night delivery and early morning shop clean, there has been a freshly baked tart, a box of our techniciansâ&#x20AC;&#x2122; favourite Lindt balls, a jar of specially picked decaf coffee, a hot Dominoâ&#x20AC;&#x2122;s pizza, a bottle of red wine, a piece of jewellery for each member of the team from Chupi, a fantastic hamper box of biscuits from Lismore Food Co, or a Butlers chocolate for break"

PHARMACYNEWSIRELAND.COM


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Perspectives

An Ireland ‘First’ for Pharmacy Student Experiences The APPEL Experiential Learning Placement Programme is a period of discovery, development and decisions. Edel Burton is an Intern Pharmacist and she recently collaborated with Senior Pharmacist Barry O’Sullivan from Mater Private Hospital in bringing Irish Pharmacy News readers their experiences during Covid-19. Intern Pharmacist Edel Burton and Senior Pharmacist Barry O’Sullivan discuss the impact of Covid 19 on intern placement

"Queues down the shop and out the door, constant requests for hand sanitizer and worried patients seeking reassurance epitomized the effects of COVID-19 on community pharmacy for me. As a student pharmacist, I strove to follow the example of my Pharmacist colleagues, remaining professional and offering reliably sourced information and advice."

“The Pharmacy Class of 2020 will forever be known as the first student pharmacists of the 5-year integrated Masters Programme. I never thought we would also be known as the student pharmacists of the 2020 COVID-19 pandemic. “I started my journey as a student pharmacist on 6th January this year. My experiential learning placement was a split placement between the Mater Private Cork, and McCauley’s Pharmacy, Mahon Point, Cork. This placement was unique, as the pharmacy serviced the Mater Private Cork. Thus I had the benefit of experiencing both the community and hospital settings on a weekly basis. “Queues down the shop and out the door, constant requests for hand sanitizer and worried patients seeking reassurance epitomized the effects of COVID-19 on community pharmacy for me. As a student pharmacist, I strove to follow the example of my Pharmacist colleagues, remaining professional and offering reliably sourced information and advice. It was a time when I had to rely on every skill, behaviour and competency I had learned during my pharmacy education. A time when I had to deliver care, empathy and understanding as always, but at a distance. “As of 30th March 2020 the Mater Private Cork opened its own Pharmacy Department. So, my experience of COVID-19 is now only from a hospital perspective. I

now wear scrubs and a mask each day on placement, I am in different locations to some of my Pharmacy colleagues and I avoid restricted areas of the hospital. I no longer interact with patients, I fill out a COVID-19 screening form each morning upon entering the hospital and have been trained in the donning and doffing of Personal Protective Equipment. A lot has changed in how we practice in the last few weeks. However the Core Competency Framework hasn’t changed, the Code of Conduct hasn’t changed, and my passion for pharmacy certainly hasn’t changed. Patient-centred care is still at the root of pharmacy. As my Senior Preceptor has taught me well; circumstances might change and you might have to adapt your processes, but the rationale, logic and goal behind them remains constant. “The hospital’s patient profile has changed. Pre-COVID it was an acute hospital, with a high turnover, mainly caring for surgical and cardiac in-patients. Now the Mater Private Cork is accepting patients with a range of conditions, requiring longer term care. That has affected the medications we keep and increased our transfers from other hospitals. I am trained in Basic Life Support, have worked with the Nursing Department to put together folders on critical care medicines for each ward, and am currently completing an online course in Critical Care Medications.

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“Some elements of my daily routine have been removed and replaced by other tasks, due to the current situation. This is a challenging time for our country and the world we live in. As a student pharmacist it is a challenge, but also a privilege to be able to work in this climate. I have truly seen that regardless of the situation, the health, wellbeing and safety of the patient is always our primary focus.” Preceptor Perspective Barry tells us, “As a Senior Preceptor, I believe our duty of care to oversee the professional development of the student pharmacist extends past the hours allocated and indeed past the experiential learning time with them. Senior Preceptors need to ensure we are fostering the next generation of Pharmacists to deliver a level of patient care and interdisciplinary support to our fellow Healthcare Professionals, better than we currently provide. We should always seek to be better at everything we do. Our patients deserve that. “The APPEL placement programme can be a potentially stressful time, away from their peers and familiar surrounds in University; student pharmacists must develop their skills quickly. Adding to this were two significant changes in the planned experiential learning program for Edel. A change in placement provider and a global pandemic were certainly

not in the placement training plan drawn up for Edel. “Like her peers, Edel, has been a crucial asset as the pharmacy profession tooled up for whatever COVID-19 may bring. Apart, but together, in their efforts. “During this time of flux and uncertainty, the Pharmacy Department of the Mater Private Cork was born. The transition period saw a lot of planning and an innumerable amount of tasks to be carried out to ensure turbulence between the end of the external contract and commencement of the internal function was kept to a minimum. Edel was central to all this. “Additional to CPD cycles, core competencies and associated study, it was prudent to add one more item to Edel’s daily workload. We called it her decompression time. Defined down time each day after work where she sets aside the notes and tends to her own well-being. Simple things like a family walk or Zoom with friends can very useful in dissolving the stress of COVID-19, PPE, infection control protocols and so on. “In some ways the current crop of student pharmacists are getting a learning experience far more complex than they could have foreseen at the outset, apart but together, they should be proud of their efforts.” Barry O'Sullivan MPSI MBA Senior Pharmacist, Pharmacy Department, Mater Private Hospital, Cork


For COPD patients on treatment with ICS/LABA and at risk of exacerbation*1 *A worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids in the past 12 months

It’s the things you do today that make a big difference 1-3 to their tomorrows TRELEGY Ellipta provides your patients with statistically superior improvements in lung function and health-related quality of life, and reduction in annualised rate of moderate/ severe exacerbations** vs. budesonide/formoterol***1–3 Fictional patient, for illustrative purposes only

Start your patients on TRELEGY Ellipta today, expect more from tomorrow 1,2

**Moderate exacerbation is a worsening of symptoms or a history of exacerbation treated with antibiotics or oral corticosteroids. A severe exacerbation is a worsening in symptoms that required hospitalisation.

TRELEGY Ellipta (FF/UMEC/VI) 92/55/22 mcg OD is indicated for maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LAMA and a LABA1

Today. Tomorrow. TRELEGY. 2-3

▼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. ***Co-primary endpoints were change from baseline in trough FEV1 and SGRQ at week 24 (n=1810). A subset of patients (n=430) remained on blinded study treatment for 52 weeks. Trelegy showed an improvement in trough FEV1 of 171mL versus budesonide/formoterol (p < 0.001, 95% CI 148,194) at week 24. Trelegy showed an improvement in health-related quality of life (SGRQ) of 2.2 units (p <0.001, 95% CI 3.5, 1.0) at week 24. At week 52 in a subset of patients Trelegy showed a 44% reduction in annualised rate of moderate/severe exacerbations versus budesonide/formoterol (95% CI 15,63, p=0.006, Absolute difference 0.16). TRELEGY Ellipta is generally well tolerated. Common adverse reactions include: pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain1 FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; UMEC, umeclidinium, VI, vilanterol References: 1. TRELEGY Ellipta SmPC 2019. 2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446. 3. Lipson DA et al.N Engl J Med 2018; 378:1671–1680. Trelegy▼ Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) Prescribing information. Please consult the full Summary of Product Characteristics (SmPC) before prescribing. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg), umeclidinium bromide (UMEC) 62.5 micrograms and vilanterol as trifenatate (VI) 25 mcg provides a delivered dose of 92 mcg FF, 55 mcg UMEC and 22 mcg VI. Indications: Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting ß2-agonist (LABA) or a combination of a LABA and a long acting muscarinic antagonist. Dosage and administration: One inhalation once daily at the same time each day. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Paradoxical bronchospasm, unstable or life-threatening cardiovascular disease or heart rhythm abnormalities, convulsive disorders or thyrotoxicosis, pulmonary tuberculosis or patients with chronic or untreated infections, narrow-angle glaucoma, urinary retention, hypokalaemia, patients predisposed to low levels of serum potassium, diabetes mellitus. In patients with moderate to severe hepatic impairment patients should be monitored for systemic corticosteroid-related adverse reactions. Eye symptoms such as blurred vision may be due to underlying serious conditions such as cataract, glaucoma or central serous chorioretinopathy (CSCR); consider referral to ophthalmologist. Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, old age, patients with a history of prior pneumonia, patients with a low body mass index and severe COPD. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Trelegy. Acute symptoms: Not for acute symptoms, use short-acting inhaled bronchodilator. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Systemic effects: Systemic effects of ICSs may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Interactions with other medicinal products: Caution should be exercised with concurrent use of ß-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products), hypokalaemic treatments or non-potassium-sparing diuretics. Co-administration with other long-acting muscarinic antagonists or long acting ß2-adrenergic agonists is not recommended. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, arthralgia, back pain. Uncommon (≥1/1,000 to

Find out more here:

www.trelegy.ie or request a visit from a GSK representative

<1/100): viral respiratory tract infection, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, dysphonia, dry mouth, fractures; Not known (cannot be estimated from the available data): vision blurred. Marketing Authorisation (MA) Holder: GlaxoSmithKline Trading Services Limited, Curabinny, Co. Cork, Ireland. MA No. [EU/1/17/1236/002]. Legal category: POM B. Last date of revision: June 2019. Code: PI-2093. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.

A full list of adverse reactions for TRELEGY Ellipta can be found in the Summary of Product Characteristics. Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255. TRELEGY Ellipta was developed in collaboration with ©2020 GSK Group of Companies or its licensor Trademarks are owned by or licensed to the GSK Group of Companies PM-IE-FVU-ADVT-200002 | February 2020


14

News

Pharmacists warned of Flu vaccine delay Pharmacists have received written communication from the HSE detailing a delay in supply of this years’ flu vaccine. It is believed the supply is delayed by two weeks due to the impact of Covid-19, pharmacists and GPs have been told.

Sanofi, which is making the vaccine, has “informed us that the release of this season’s flu vaccine will be delayed by two weeks.”

In a communication sent as Irish Pharmacy News was going to press, the Health Service Executive wrote that drug manufacturer

The HSE insisted that this is not a quality or production issue and Ireland will receive stock from the first batches released by Sanofi.

Speaking following an appearance by the HSE, NPHET and Minister for Health Stephen Donnelly at a Special Committee on Covid-19 Response, Irish Medical Organisation’s Dr Pádraig McGarry said that the winter season “will put unprecedented pressure on

our health system, which was already unfit for purpose prior to the emergence of Covid-19.” He said that waiting lists, which were already long, had increased further due to infection control and social distancing guidelines.

Calls for Support for Retailers Retail Excellence has written to Damien English, the Minister of State for Employment Affairs and Retail, looking for the government to step in and offer support for retailers who are struggling to pay commercial rents. The news came as it was revealed Boots Pharmacy Ireland became the latest major retailer to become embroiled in rental disputes with its Irish landlords. Boots Ireland confirmed it had stopped paying rent to some of its main Irish landlords as it was seeking new deals following the pandemic, according to the Irish Times. Boots joins a growing list of retailers in disputes including shoe brand Schuh; fashion retailer New Look and Topman. Duncan Graham, Managing Director of Retail Excellence said, “Sales across the retail sector in the first half of this year were down

30% with non-essential retailers closed for 3 months. City centres and shopping centres have been particularly badly affected, whilst we have seen a slight recovery during the summer the outlook for the rest of this year remains bleak. We are calling on the government to issue a code of practice and introduce an arbitration service to help with a speedy resolution of disputes between retailers and landlords. “We are also calling on commercial landlords to engage with retailers and move to a payment model based on paying a percentage of turnover whilst we remain in these uncertain times. “Failure to address these points urgently will result in further store closures and job losses in an industry that has already been decimated by Covid 19.”

Totalhealth Pharmacy Rugby Camps Some Connacht Rugby Skill Zone camps with totalhealth Pharmacy Group managed to survive Storm Ellen last month. Connacht Rugby Club & Community took the time to visit the local totalhealth Pharmacies in locations close to recent camps. The Pharmacy Group would like to say ‘Thank You’ for taking the time and thanks to the fab teams in store: McGuinness totalhealth Pharmacy, Roscommon Town, Marina Gorey of Riverstown totalhealth Pharmacy, Co. Sligo & John Feely of Feely's totalhealth Pharmacy, Tuam, Co. Galway.

PHARMACYNEWSIRELAND.COM


News

15

Answering Ireland’s call - Pharmacists on the Frontlines Pharmacist, Neassa Judge, MPSI

Irish Pharmacist Neassa Judge, MPSI recently signed up to the ‘Be on Call for Ireland’ initiative. Here, she give Irish Pharmacy News readers an overview of her experience. Like many others, my plans for 2020 were thrown out the window when the COVID-19 pandemic hit. Watching the news of Italy was harrowing, and as a healthcare professional I knew I wanted to stay in Ireland to help our health service during the unprecedented times ahead. I first heard about the HSE’s ‘Be On Call for Ireland’ initiative on the radio and immediately signed up online, eager to help in any way I could. A few weeks later I was contacted and asked to start a pharmacist role in Midlands Regional Hospital Tullamore (MRHT) to support the pharmacy team there, who were under pressure due to the pandemic. Working in a hospital pharmacy was a first for me. I qualified as a pharmacist back in 2016 and have worked across multiple community pharmacies and with a large pharmaceutical company in Dublin since. Moving into a hospital environment for the first time, especially during a global pandemic, was a daunting experience. However, to the credit of the pharmacy team in MRHT, it was so worthwhile both professionally and personally. The pharmacy team in MRHT are an incredibly supportive team and I learned so much during my time there. Despite being an extremely challenging and emotive time, there was such a great team spirit and I was inspired by how agile and hard-working the team were. Along with getting used to increased hygiene measures and the correct donning of PPE, my main learnings heading into a hospital environment were: 1) I had a lot of learning to do! Working in community pharmacy you rarely come

across IV antibiotics doses, therapeutic drug monitoring requirements or IV fluid management so there were a number of areas that required upskilling/further education when starting in the hospital. It was great to see increased availability of free online learning modules during the pandemic and there was a wealth of educational courses available online to upskill. I found the ASHP’s Critical Care pharmacy course particularly useful. 2) Access to patient information allows pharmacists to make more clinically significant interventions. Working in a community setting you rarely have access to a patient’s medical history, let alone their bloods to calculate hepatic or renal function. Having access to this information makes a huge difference in your clinical conversations and ability to optimise medication therapy. 3) There’s still some work to do on raising awareness on the role of the pharmacist. I think the COVID-19 pandemic has emphasised the importance of working together as multidisciplinary teams, sharing

experience and knowledge to enhance patient care. One of the biggest challenges faced during the pandemic was the lack of clinical guidelines or experience on how to treat patients and this required a real team effort. No one profession could tackle it on their own. We all had to try to keep abreast with new clinical developments and information on COVID-19 coming out daily. I believe this has helped raise awareness on the value pharmacists add to the multidisciplinary team. Pharmacists, as medication experts, have an important role to play on the frontlines, offering advice and information, and helping to optimise medication therapy. 4) Sourcing and ensuring adequate supply of medicines are critical tasks faced during this pandemic, in the midst of national and international shortages. These shortages aren’t a new phenomenon, however there has been a significant worsening in recent times due to the pandemic and bulk-buying of medicines. Pharmacists have an extremely important role to play in managing these shortages and obtaining alternatives.

"Despite being an extremely challenging and emotive time, there was such a great team spirit and I was inspired by how agile and hardworking the team were" Reflecting on my experience in the hospital, it was such a great learning and I feel grateful to have had the opportunity. I hope more pharmacists do get the opportunity to gain experience in the hospital environment and I hope to see it become an obligatory placement during the undergraduate degree, similar to other countries. Both community and hospital pharmacists can learn a huge amount from each other and I believe more information sharing between roles will bring our profession a lot further.

PHARMACYNEWSIRELAND.COM


16

News

Updated Guidance on Biosimilars The Healthcare Products Regulatory Authority has, just last month, updated their guidance on Biosimilars for Healthcare Professionals. The guide also outlines the current position on interchangeability and switching. In this regard, once approved, biosimilars can be used interchangeably with the reference medicine or with other biosimilars of that reference medicine, under the supervision of a physician. Once a biosimilar has been approved, it can be considered safe to switch to, should a prescribing physician wish to do so. Next month’s October issue of IPN will carry an exclusive report by a student pharmacist on her study findings into community pharamcists experience and understanding of Biosimilars. IQVIA Institute Scorecard on Biosimilar Medicines

This updated Guide came just shortly before community pharmacists across Ireland issued calls for change to legislation in order to allow them to substitute expensive biological medicines for more cost-effective biosimilars (see page 8). This guidance document provides information on the regulation, prescribing, dispensing, interchangeability and traceability of biosimilar medicines (‘biosimilars’) in Ireland.

The guide is primarily aimed at healthcare professionals for the purpose of informing and assisting their decision-making processes when prescribing, dispensing or administering biosimilars. It may also be of interest to those working in the area of manufacturing, medicines procurement, distribution and related activities. A separate Q&A for patients and an information video on biosimilars is also available on the HPRA website, www.hpra.ie.

Good biosimilar medicine policies balance the benefits of multi-source competition, volume uptake which increases patient access, and price discounts that generate savings. By acting decisively to tailor policies to local needs, governments and authorities can free up healthcare resources to improve access and make healthcare systems more sustainable. The Country Scorecards for Biosimilar Sustainability launched recently by the IQVIA Institute and the Biosimilar Medicines Sector Group of Medicines for Europe analyses the pros and cons of biosimilar policies in 12 countries – Denmark, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Romania, Spain, Sweden and the UK. Specifically, the scorecards assess the level of competition, price evolution and

volume development for seven key biologic molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each of the 12 countries. The project also includes a detailed sustainability check, in areas such as regulatory environment and clinical guidelines, awareness and education, incentives, pricing rules and dynamics, and purchasing mechanisms. Positive policy elements are specified for each country, as well as challenges and solutions. Furthermore, an ideal scorecard describes how effective policy measures can deliver a competitive and sustainable market. With numerous reports showing that patient treatment regimens for diseases such as cancer and arthritis have been disrupted by the COVID-19 pandemic, biosimilar medicines offer hope to deliver timely, standard of care to a broader group of patients. Commenting on the launch of the report Adrian Van Den Hoven, Director General of Medicines for Europe said, “This IQVIA Institute report is a helpful guide for policy makers to deliver sustainable access to biologic medicines. While the report shows that policy measures should be tailored to national contexts, the report provides clear recommendations on how measures can be combined and adapted to deliver effective results. Our ambition is to use this guide to improve sustainable access to biosimilar medicines across Europe.”

Accord commitment to ARC Cancer Support House Accord Healthcare has made a commitment to Cork ARC Cancer Support House, a support house and charity for Cancer patients and families to help them with their mission to help those who are dealing with a cancer diagnosis. Last month they donated 5000 face masks to them for them to continue their services. PPE is a key part of providing the support CORK ARC offers as CEO Aileen O'Neill highlights, “We expect that we will need substantial supplies of PPE as we need to assure our clients, many of whom are immunocompromised and some of the most vulnerable people in our community, for a very long time to come, that we are giving their safety the highest priority.

ARC Cancer Support House

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“Cork ARC is absolutely thrilled and so grateful to Accord Healthcare for the fantastic donation of 5,000 face masks, which are so vitally needed as we reopen our services to clients for face to face counselling. The costs of safely providing services are a huge consideration for everyone now and with the donation of protective equipment, Cork ARC has benefited yet again in such a significant way. “We are privileged to receive this donation from Accord.”


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18

Top 100: CPD

Maintaining CPD whilst cocooning: A Pharmacist’s Perspective

Pharmacy impact on immunisation

Catriona Sheerin is a community pharmacist, qualified since December 2016. She commenced employment as a Relief Pharmacist, then as a Support Pharmacist up until August 2019, after which she started working as a locum to gain experience of different pharmacy types.

Pharmacy’s impact on immunisation coverage is being made visible, with the publication of a new report. A total of 99 countries and territories participated in the survey by the International Pharmaceutical Federation (FIP), making “An overview of pharmacy’s impact on immunisation coverage: a global survey” the most comprehensive report published on this subject to date.

Catriona Sheerin, MPSI, Community Pharmacist

Catriona is currently unable to work due to the COVID-19 pandemic as she has cystic fibrosis, which places her in a higher risk category. She has been cocooning at home since March, but is hopeful she will get back to work soon. Here, she gives an overview of maintaining her Continuous Professional Development whilst cocooning. I love my work as a community pharmacist, I find it is a very rewarding career and I miss the problem-solving aspect of it and the interaction and communication with both patients and staff. I will be very happy to return! How are you maintaining your CPD whilst cocooning?

This led to the idea of setting up a medicines-information Instagram page - @thecocooningpharmacist. This gave me the purpose I needed and helped me to hold myself accountable for my learning. It enabled me to keep up to date with my knowledge, while simultaneously helping others which I had missed from not working. What differences (if any) have you encountered in maintaining your CPD whilst cocooning as opposed to in practice? The main difference has been having more time! On a more serious note, there has been a difference in how my CPD has been guided.

However, I found staying at home and the COVID-19 restrictions took their toll, and it was difficult to motivate myself to do any CPD especially as I wasn’t putting any of my learning into practice.

Normally, in practice, I would come across a medicine that I wanted to know more about e.g. ULM, I would discuss errors/near-misses with colleagues, I would learn a new skill such as administering the shingles vaccine or capillary blood testing, I would have a query regarding a prescription or a patient would ask me a question I needed to research further. These everyday pharmacy occurrences would form the basis of my CPD, as well as seminars or talks I attended.

I find for myself, it helps to have a goal or purpose for my learning.

Whilst cocooning, and after setting up the Instagram page, I have been

I initially viewed the cocooning period as a great opportunity to further my studies, and catch up on some CPD. I started working through some online learning modules with the best of intentions.

PHARMACYNEWSIRELAND.COM

guided by my environment and the people who follow the account. In the initial lockdown period I was focusing on online learning but I was lacking direction on which topics to focus on. After starting the online account, I made posts about seasonal topics such as hayfever and sun protection. I was forced to examine my surroundings and use what I could, so I made a post on how to administer an adrenaline auto-injector as I have an anaphylactic allergy myself and I had some trainer pens, and I did a post about seborrheic dermatitis as my partner was suffering with it. Now, I am also guided by the questions followers or friends ask me, or the topics they wish to know more about which help me to identify gaps in my knowledge. What advice would you give to other pharmacists in regards to documenting their CPD in these times? Find something or someone who will hold you accountable for documenting your CPD and learning. That was a key step for me, as I feel responsible to maintain my CPD for my online platform, and my friends and family who have loved asking me questions while I’ve been cocooning. If you are finding it difficult to maintain or document your CPD, examine why that is. I was lacking purpose and direction, and at times I would find online seminars and note-taking tedious, especially as I was sitting at home all day, so I needed to try different learning styles. Creating an online platform helped to create a purpose, and enabled me to explore my creative learning side through editing images and videos, which also encouraged me to examine my counselling skills as I was condensing information to teach others. This article first appeared in the Irish Institute of Pharmacy (IIOP) July 2020 Newsletter.

The work, which updates a survey conducted by FIP in 2016, evaluates different aspects of pharmacist-led immunisation, including advocacy activities, regulatory frameworks, vaccine administration, reimbursement models, training, vaccination records, and barriers to the expansion of pharmacy practice to include vaccine administration. Pharmacy-based vaccination is available in at least 36 countries and territories (covering nearly 1.8bn people) and has been proposed or is undergoing development in a further 16, according to the findings. The samples in the 2016 study and this new study are different (45 respondents in 2016), but there is a group of 40 countries and territories in common. In this group, there were 18 countries with pharmacy-based vaccination in 2016 and there are 23 in the 2020 survey, a 28% increase. “Pharmacists are medicines experts, first-line healthcare providers, and integral members of the healthcare team. Expanding their scope of practice as vaccinators will ultimately further their contributions to public health. I encourage countries currently without pharmacy-based vaccination to work with FIP and its member organisations to organise a strategy leading to the changes necessary towards health for all,” FIP CEO Catherine Duggan said. FIP and the General Pharmaceutical Council of Spain, have taken the decision to reschedule FIP’s 80th World Congress of Pharmacy and Pharmaceutical Sciences and Spain’s 22nd National Pharmaceutical Congress. The new dates for the 80th World Congress of Pharmacy and Pharmaceutical Sciences and the 22nd National Pharmaceutical Congress will be 12 – 16 September 2021, and 14-16 September 2021, respectively.


Report

19

Lessons learned for the Future After several months of crisis, Medicines for Ireland has compiled a new report which looks at some of the key lessons learned from Covid-19 for the future of pharmaceutical policy in Europe. As the supplier of the majority of medicines in Ireland to both the HSE and to patients directly, Medicines for Ireland (MFI) members are a critical and central stakeholder in the Irish health service. The COVID-19 outbreak in Europe has catalysed some long-standing issues in the functioning of pharmaceutical policy, as well as the impact this can have on patient access and hospital and pharmacy supply. The global Covid-19 outbreak lead to an acute shortage of essential supplies, including personal protective equipment, diagnostics, and medicines. During the crisis the EU Commission formally called on the pharmaceutical industry to increase production capacity for all medicines for which there is an increased demand as a result of Covid-19, and in particular for those for which there is a risk of supply shortages. In this context, Medicines for Ireland has worked pro-actively with Government, regulators and key policy makers to ensure round the clock continuity of supply in Ireland. Medicines for Ireland continues to work directly with the Department of Health and the Health Products Regulatory Authority (HPRA) as well as the HSE, EU Commission and all relevant EU institutions to ensure a solution focused approach is taken to secure a stable supply of medicines to the Irish market. Chair of Medicines for Ireland, David Delaney, told Hospital Professional News, “Medicines for Ireland (MFI) is the Irish pharmaceutical trade association and the supplier of the majority of medicines in Ireland to the HSE and patients directly. ‘Lessons Learned from Covid-19’ has been produced in conjunction with our sister organisation, Medicines for Europe. “This document sets out a range of important national and European policy recommendations that illustrate the important role of the EU in relation to the supply of medicines and medical devices. This further illustrates the importance for Ireland of a panEuropean response to many of the issues that have arisen due to the Covid-19 pandemic.

“The Covid-19 pandemic surge has brought unprecedented challenges to the pharmaceutical industry in Ireland and our members have responded to this challenge to ensure the supply of medicines to the patients who need them the most. It is worth noting that in manufacturing medicines in Ireland to supply to patients throughout the globe, MFI continue to support thousands of jobs throughout Ireland, through our significant role in maintaining Ireland’s ¤40bn annual pharmaceutical exports.” “There are a range of lessons learned that Medicines for Ireland have highlighted. They include: • Contingency plans are critical and should be integrated into the planning of all medicine manufacturers.

• EU and national coordination to ensure equitable supply of medicines is important for industry. Hoarding and other restrictions undermine our ability to supply patients in need.”

Lessons learned

Off-Patent Industry

• Government pandemic planning should exempt medicine manufacturing and logistics from lockdowns and other control measures.

The off-patent medicines industry mobilised all efforts to ensure medicines continued to be developed, transported and supplied, in collaboration with the European Institutions, throughout the crisis. Our industry notably massively scaled up production and put in place cooperation mechanisms to tackle the colossal surge in demand for medicine.

• Manufacturing contingency plans enabled a dramatic increase in supply during COVID-19.

• Avoiding shortages during a pandemic requires industry coordination, demand visibility and close cooperation between governments/regulators and industry for regulatory flexibility.

• Government pandemic planning should exempt medicine manufacturing and logistics from lockdowns. • Avoiding shortages during a pandemic requires industry coordination, demands visibility and close cooperation between governments/regulators and industry for regulatory flexibility.

David Delaney, Chair, Medicines for Ireland

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20

Report

Paul Neill, Director, Generic Products, Ireland, Teva says, “The Covid-19 pandemic was hugely challenging for everyone, but I’m proud of the way Teva and the wider pharmaceutical industry responded. As one of the largest suppliers of medicines to the State, we recognised early on during the Covid-19 crisis that we had a responsibility to make sure we kept medicines moving for the patients that rely on us. Our number one priority was making sure that patients continued to have access to the medicines that they rely on, which is why we worked hard to maintain supplies of our products to pharmacies across Ireland. “We also donated a consignment of more than 100,000 pots of Sudocrem® to the HSE, these were distributed to Healthcare staff across the entire HSE infrastructure - our small way of saying ‘thank you’ to all the healthcare professionals keeping the country safe during the pandemic. “As the Medicines for Ireland report shows, avoiding shortages during a pandemic requires industry co-ordination and close cooperation between the State and the pharmaceutical industry. There are important lessons to be learnt, and we look forward to having discussions with the HSE and the new coalition government to explore ways we can continue to work together in the future to ensure a robust and stable supply of medicines to the Irish market continues.”

• EU and national coordination to ensure equitable supply of medicines is important for industry. Hoarding and other restrictions undermine our ability to supply patients in need. • Disruptions to global supply chains did not cause any critical shortages during COVID-19 because Europe has a robust medicines and API manufacturing sector. The sector should be strengthened to increase Europe's manufacturing competitiveness and resilience. • Repurposing of medicines was essential in securing treatment options in a crisis. A fit for purpose regulatory and market framework is needed to encourage future repurposing developments.

Improving pandemic preparedness Although health systems adapted to the influx of COVID19 patients, both the European Union (EU) and Member States were slow to prepare for the outbreak including enacting effective control measures such as testing and contact tracing. This happened despite the WHO warning early on that there was a risk of COVID-19 spreading beyond Asia. Member States also adopted different and poorly coordinated measures which increased the difficulties to track and monitor the outbreak. Panic also set in regarding ICU medicine supplies which led many countries to hoard medicines at the expense of European solidarity and the efficient delivery of medicines to patients in need.

Paul Neill, Director, Generic Products, Ireland, Teva

This shows the need for an EU pandemic preparedness plan, which should integrate lessons learned from previous epidemics (SARS or H1N1) as well as COVID-19. An EU pandemic preparedness plan should address country coordination of confinement measures, including border closures and travel restrictions. The fragmentation in these measures in the early stages of COVID-19 led to major internal market disruptions, which challenged the manufacturing, packaging, testing and distribution of urgently needed medicines. The recognition of pharmaceutical manufacturing as essential production was critical for our industry response to the surge in demand for medicines brought on by COVID-19. Medicines for Europe members successfully

“In a market often fixated by high-profile high-cost drugs, the role of the generic medicines sector can be under-appreciated. However, its performance during the pandemic illustrates its importance and ability to respond to a series of challenges that threatened to derail the provision of healthcare.

• Maintain the integrity of the internal market so that critical manufacturing and logistics for medicine supply can continue during a health crisis. • Develop an EU epidemic/ pandemic preparedness plan to be implemented, where appropriate, for future communicable disease risks, led by the European Commission, with input from industry, with the technical support of the European Medicines Agency (EMA), European Centre for Disease Control (ECDC), and in coordination with Member States. Industry input would cover supply chain risks and how to plan for sudden demand surges, including logistical challenges requiring support. • Share best practices between EU countries on how to best treat patients during a pandemic.

Recognise the public health role of off-patent medicines in future industrial and pharmaceutical strategies

“While the sector experienced unprecedented demand on medicines coupled with unparalleled logistical challenges, and work place interruptions, it was evident that these challenges were surmounted as a consequence of the collaborative solution focused approach of manufacturers, wholesalers, pharmacists, and regulatory authorities. Our shared experience of the pandemic to date has educated us all, and it has highlighted the necessity that the industry must be pandemic-ready at all times.

PHARMACYNEWSIRELAND.COM

Recommendations:

• Foresee measures to ensure continuity of treatment for all patients during a pandemic, as well as continuing screening and diagnostic procedures. This is important to avoid disease worsening for chronically ill patients.

Padraic O’Brien is Associate Director Commercial with Accord Healthcare Ireland and is Vice-Chair of Medicines for Ireland. He told Hospital Professional News, “We are all aware that Frontline workers, clinicians, care workers and support staff are the heroes of Coronovirus; however generic suppliers like Accord Healthcare have played a vital role in ensuring these key professionals have the medicines available to do their job.

“Supply chain resilience from the industry coupled with regulatory flexibility from the HPRA ensured patients received the medicines they needed on time.”

implemented contingency production plans that reduced supply chain risks and enabled them to scale up production output during the outbreak. In some cases, border closures and heavy-handed state interventions undermined supply capabilities and limited industry efforts. Commission efforts and outreach to tackle these challenges were important to move medicines to where they were needed. A more rapid and coordinated approach to medicine demand and supply planning at Member State and European level would also reduce panic in hospitals and Member States that led to a lot of hoarding within and across countries to the detriment of equitable access to medicine.

Padraic O’Brien, Associate Director Commercial, Accord Healthcare Ireland

The pandemic showcased the essential role that offpatent medicines play in a large public health crisis, as the majority of medicine needs were covered by our industry. For example, in Germany, 97% of the medicines needed for Covid19 had a generic medicine option available on the market. Our industry was also able to massively scale up supply to meet the large-scale demand surge


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Choose INVOKANA – the only SGLT2i licensed to offer your T2D patients triple protection against renal events, CV events and elevated HbA1c1–4

INVOKANA® (canagliflozin) 100 mg & 300 mg film-coated tablets. PRESCRIBING INFORMATION. REPUBLIC OF IRELAND. Please refer to the Summary of Product Characteristics (SmPC) before prescribing. INDICATIONS: The treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes. DOSAGE & ADMINISTRATION: Adults: recommended starting dose: 100 mg once daily. In patients tolerating this dose and with eGFR ≥ 60 mL/min/1.73 m2 needing tighter glycaemic control, dose can be increased to 300 mg once daily. For oral use, swallow whole. Caution increasing dose in patients ≥ 75 years old, with known cardiovascular disease or for whom initial canagliflozin-induced diuresis is a risk. Correct volume depletion prior to initiation. When add-on, consider lower dose of insulin or insulin secretagogue to reduce risk of hypoglycaemia. Children: no data available. Elderly: consider renal function and risk of volume depletion. Renal impairment: for the treatment of diabetic kidney disease (DKD) as add on to standard of care (SOC) (e.g. ACE inhibitors or ARBs), initiate with 100 mg dose. The glycaemic lowering efficacy of canagliflozin is reduced in patients with moderate renal impairment and likely absent in severe renal impairment. If eGFR falls below 60 mL/min/1.73 m2 during treatment, adjust or maintain dose at 100 mg once daily. eGFR(mL/min/1.73m2) or CrCl (mL/min)

Total daily dose of canagliflozin

≥60

Initiate with 100 mg If tolerating 100 mg and needing additional glycaemic control, increase dose to 300 mg

45 to < 60a

Initiate with 100 mg If already taking Invokana – continue 100 mg

30 to < 45a,b

Initiate with 100 mg If already taking Invokana – continue 100 mg

< 30a,b

Do not initiate If already taking Invokana – continue 100 mgc

Consider addition of other anti-hyperglycaemic agents if further glycaemic control is needed With urinary albumin/creatinine ratio > 300 mg/g c Continue until dialysis or renal transplantation Hepatic impairment: mild or moderate; no dose adjustment. Severe; not studied, not recommended. Hepatic impairment: mild or moderate; no dose adjustment. Severe; not studied, not recommended. CONTRAINDICATIONS: Hypersensitivity to active substance or any excipient. SPECIAL WARNINGS & PRECAUTIONS: Not for use in type 1 diabetes.

a

b

Renal impairment: regardless of pretreatment, patients on canagliflozin had an initial fall in eGFR that attenuated over time. eGFR < 60 mL/min/1.73 m2: higher incidence of adverse reactions associated with volume depletion particularly with 300 mg dose; more events of elevated potassium; greater increases in serum creatinine and blood urea nitrogen (BUN); limit dose to 100 mg once daily. Not studied in severe renal impairment. Monitor renal function prior to initiation and at least annually. Volume depletion: caution in patients for whom a canagliflozin- induced drop in blood pressure is a risk (e.g. known cardiovascular disease, eGFR < 60 mL/min/1.73 m2, anti-hypertensive therapy with history of hypotension, on diuretics or elderly). Not recommended with loop diuretics or in volume depleted patients. Monitor volume status and serum electrolytes. Diabetic ketoacidosis (DKA): rare DKA cases reported, including life-threatening and fatal. Presentation may be atypical (blood glucose <14mmol/L). Risk appears higher in patients with moderate to severe decrease in renal function who require insulin. Consider DKA in event of non-specific symptoms. If DKA is suspected or diagnosed, discontinue Invokana treatment immediately. Interrupt treatment in patients who are undergoing major surgical procedures or have acute serious medical illnesses. Monitoring of (preferably blood) ketone levels is recommended in these patients. Consider risk factors for development of DKA before initiating Invokana treatment. Elevated haematocrit: careful monitoring if already elevated. Genital mycotic infections: risk in male and female patients, particularly in those with a history of GMI. Lower limb amputation: Consider risk factors before initiating. Monitor patients with a higher risk of amputation events, counsel on routine preventative foot care and adequate hydration. Consider discontinuing Invokana when events preceding amputation occur (e.g. lower-extremity skin ulcer, infection, osteomyelitis or gangrene). Necrotising fasciitis of the perineum (Fournier’s gangrene): post-marketing cases reported with SGLT2 inhibitors. Rare but serious, patients should seek medical attention if experiencing symptoms including pain, tenderness, erythema, genital/perineal swelling, fever, malaise. If Fournier’s gangrene suspected, Invokana should be discontinued, and prompt treatment instituted. Urine laboratory assessment: glucose in urine due to mechanism of action. Lactose intolerance: do not use in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Sodium: essentially “sodium-free”. INTERACTIONS: Diuretics: may increase risk of dehydration and hypotension. Insulin and insulin secretagogues: risk of hypoglycaemia; consider lower dose of insulin or insulin secretagogue. Effects of other medicines on Invokana: Enzyme inducers (e.g. St. John’s wort, rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may decrease exposure of canagliflozin; monitor glycaemic control. Consider dose increase to 300 mg if administered with UGT enzyme inducer. Cholestyramine may reduce canagliflozin

exposure; take canagliflozin at least 1 hour before or 4-6 hours after a bile acid sequestrant. Effects of Invokana on other medicines: Monitor patients on digoxin, other cardiac glycosides, dabigatran. Inhibition of Breast Cancer Resistance Protein cannot be excluded; possible increased exposure of drugs transported by BCRP (e.g. rosuvastatin and some anti-cancer agents). PREGNANCY: No human data. Not recommended. LACTATION: Unknown if excreted in human milk. Should not be used during breast-feeding. SIDE EFFECTS: Very common (≥1/10): vulvovaginal candidiasis, hypoglycaemia in combination with insulin or sulphonylurea. Common (≥1/100 to <1/10): balanitis or balanoposthitis, urinary tract infection (including pyelonephritis and urosepsis), constipation, thirst, nausea, polyuria or pollakiuria, dyslipidemia, haematocrit increased. Uncommon (<1/100) but potentially serious: necrotising fasciitis of the perineum (Fournier’s gangrene) (frequency not known), anaphylactic reaction, diabetic ketoacidosis, syncope, hypotension, orthostatic hypotension, urticaria, angioedema, bone fracture, renal failure (mainly in the context of volume depletion), lower limb amputations (mainly of the toe and midfoot. Refer to SmPC for details and other side effects. LEGAL CATEGORY: POM. PACK SIZES & MARKETING AUTHORISATION NUMBER(S): Invokana 100 mg film-coated tablets: 30 tablets; EU/1/13/884/002. Invokana 300 mg filmcoated tablets: 30 tablets; EU/1/13/884/006. MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. ® INVOKANA is a registered trade mark of Janssen-Cilag International NV and is used under licence. © 2020 Napp Pharmaceuticals Limited. Adverse events should be reported to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Adverse events should also be reported to Mundipharma Pharmaceuticals Limited on drugsafetyJNJ@mundipharma-rd.eu or by phone on 01 2063800 (1800 991830 outside office hours) FURTHER INFORMATION IS AVAILABLE FROM: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18. For medical information enquiries, please contact medicalinformation@mundipharma.ie UK/INV-18203(3) IRE/INVK-20206a Date of Preparation July 2020 References: 1. Invokana® Summary of Product Characteristics. Mundipharma 2020. 2. Dapagliflozin Summary of Product Characteristics. AstraZeneca 2019. 3. Empagliflozin Summary of Product Characteristics. Boehringer Ingelheim 2019. 4. Ertugliflozin Summary of Product Characteristics. MSD 2019.

CV: cardiovascular; HbA1c: haemoglobin A1c; SGLT2i: sodium-glucose cotransporter 2 inhibitor; T2D: type 2 diabetes. ® MUNDIPHARMA and the ‘mundipharma’ logo are registered trademarks of Mundipharma. Invokana® is a registered trademark of Johnson & Johnson. IRE/INVK - 20209


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Report on medicines procurement most economically advantageous tender (MEAT) criteria. An important step would also be to define “investment in manufacturing security of supply” as a tax credit under EU state aid law.

Martin Gallagher, Director of Marketing and Business Development said; “Throughout 2018/2019 when planning ahead for 2020, our main concerns were around Brexit and it’s impact on the supply of medicines in Ireland. “The company was working to ensure that we had sufficient stocks to maintain a stable market and continue to grow our business. At that point, we never envisaged a world where frontline workers would take such risks on our behalf, for which we owe them enormous levels of gratitude, where our population would be in lockdown, where the normal way of visiting your GP, hospital or pharmacist would change so dramatically. As a company, when the unprecedented catastrophic crisis of Covid-19 hit, it was extraordinary to see the response of staff and the company aligning itself with the demands placed by the behaviour in the Pharma market, particularly through the month of March. “As one of the largest suppliers of finished packed medicines in Ireland we managed to maintain continuity of supply to our patients, which was achieved by altering work practices so as to align ourselves with the pharmacists and other HCPs. There are key lessons to be learned from this crisis; contingency planning for the unforeseen, open lines of communication with our stakeholders and prioritising agility in the workplace.”

for medicines used in Covid19. This Covid19 experience typifies the central role of our industry in public health. Recommendations: • Future pharmaceutical or industrial policy strategies should take the following elements into consideration: • The generic, biosimilar and value added medicines industry is vital for public health in terms of access and sustainability. The crisis notably underlined the value of maintaining a strong medicines manufacturing sector that was able to adapt to a major global supply chain disruption and a massive demand surge to serve European patients.

resilience and competitiveness of the manufacturing chain in Europe. The strategy should introduce resilience criteria in procurement, reimbursement and state aid policies and better integrate API in the regulation of medicines. An EU Recovery Fund should provide investment in key value chains crucial for our future resilience, such as the medicines sector. In this context, the EU Green Deal and Digital Transformation can help to boost resilience. • Measures to stimulate investments in R&D need to be targeted and focused, with clear objectives to be achieved and factor in competition and equitable access policies.

• Looking forward, policies should be adopted to stimulate investments in: • A resilient and diversified manufacturing chain including a strong medicine manufacturing sector in Europe. This will improve rapid production scaleup together with an efficient and flexible regulatory framework to respond to demand surges. o sustainable policies that encourage companies to have resilient supply chains with mature quality, safety, environmental and supply chain reliability. o better planning and commitment from Member States on equitable access to medicines based on solidarity. • To increase strategic autonomy in medicines production, the EU should adopt an industrial strategy to strengthen the

PHARMACYNEWSIRELAND.COM

Martin Gallagher, Director of Marketing and Business Development, Clonmel

Building resilient supply chains The pandemic had a dramatic impact on demand surges that in some cases doubled or tripled relative to the normal annual consumption of medicines. Clearly no medicine stockpile could have covered these massive demand surges. Therefore, a key lesson of this crisis is the need to support the expansion of existing manufacturing capacity in finished dosage form and active pharmaceutical ingredient (API) during a crisis. This could be achieved with reform of market policies, implementing security of supply into national medicines procurement and purchasing policies, starting with the longawaited Commission guidelines

Supply chain resilience was challenged during COVID-19 by restrictions on exports from India and China but also by restrictions inside the EU by some member states. While it would be unrealistic to manufacture everything in the EU, steps can be taken to strengthen our manufacturing base in Europe. A new medicines trade policy agenda focused on regulatory cooperation and convergence could also reduce the risk of future trade disruptions in the global supply chain. In the EU, several Member States have put in policies to ensure medicines supply for their own populations. Most national measures targeted parallel exports of medicines due to concerns that speculation could undermine supply. Since 2013, the use of generic medicines and biosimilars have provided savings of ¤1.6bn to the Irish state. There is further potential to save much more and the members of Medicines for Ireland will continue to work with Government on behalf of patients and their families to ensure a sustained supply for patients in Ireland. Medicines for Ireland members include: Accord Healthcare, Clonmel Healthcare, Consilient Health, Fannin, Fresenius-Kabi, Mylan, Nasal Medical, Pinewood, Rowa and Teva.


V Vicks VapoRub relieves 4 cold symptoms* to help you have a good n night sleep sleep** eep** eep

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Cough due to colds

Sore Throat

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*Based on SmPC ** Santhi N, Ramsey D, Phillipson G, Hull D, Revell VL, Dijk D-J. (2017) OJRD 7: 83-101 Please consult the summary of product characteristics for full product information.Vicks Vaporub Inhalation Vapour, Ointment contains levomenthol, camphor, eucalyptus oil and turpentine oil.Indications: For the symptomatic relief of nasal catarrh and congestion, sore throat, also cough due to colds. Dosage and Method of Administration: Topical (Adults and children over 2 years): Rub the indicated amount onto the areas indicated (e.g. chest, back) and repeat up to 2-4 times a day as needed. Wear loose clothing to facilitate the inhalation of the vapours. Inhalation (Adults and children over 6 years): Place 1 – 2 x 5ml spoonsful as indicated into a bowl of hot (not boiling) water. Inhale the vapours for up to 10 – 15 minutes per time. Do not heat in the microwave or reheat this mixture. Children should always be supervised.Contraindications:Hypersensitivity to any of the ingredients. Do not administer to children < 2 years. Do not use as an inhalation for children < 6 years.Precautions: Patient groups with a history of airway disease or pronounced hypersensitivity of the airways / asthma should use with caution or consult doctor before use. Keep out of reach and sight of children. If symptoms persist, consult your doctor. Topical: Do not apply to broken skin, wounds or mucous membranes. Do not swallow or apply directly onto the nostrils, eyes, mouth or face. For external use only. Do not bandage tightly. Do not use with heat wrap. Inhalation: Do not use boiling water to prepare inhalations. Do not heat or re-heat the mixture in a microwave. Undesirable effects:Local effects: Redness, irritation of the skin, irritation of the eyes (by inhalation), allergic dermatitis. Irritations or allergic reactions are usually mild and occur rarely. General disorders and administration site conditions: Burns at application site – frequency not known. Systemic effects: Due to the recommended route of administration; systemic exposure is very low and undesirable effects due to systemic exposure have not been observed. Supply Status: Supply through non-pharmacy outlets and pharmacies.PA Number: PA2294/003/001PA Holder: WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH, Sulzbacher Str. 40, 65823 Schwalbach am Taunus, Germany. Text prepared: August 2020. Further information available on request.


The C-V of Winter Ailments

W

ith the winter season just around the corner, now is the time for community pharmacists and their teams, to be promoting the message that consumers should visit them first, for advice and treatment of common winter ailments.

Research shows that 18% of GP appointments are for minor ailments. Community pharmacists are in fact, best placed to offer advice on these conditions and over-the-counter available and appropriate medications. Furthermore, the winter months provide the perfect opportunity for pharmacy to drive home the self-care message and ease the pressure on GP surgeries and A&E departments. Pharmacists should be continuing to remind consumers not to take antibiotics for colds and flu, sore throat, coughs, vomiting and diarrhoea. Overuse of antibiotics in Ireland, and around the world, represents one of the most significant threats to long term public health. According to the IPU, health services are experiencing an increase in the levels of antibiotic resistant infections, and this is largely being attributed to the overuse and misuse of antibiotics.

The self-care agenda has been driven hard this year with the arrival of Covid-19, as more consumers take charge of their health and in booting their immune systems. However, selfmedication may not be appropriate for every patient in view of pre-existing medical conditions or because of interactions with other prescription and non-prescription medications. This reinforces the importance of pharmacists, who have been trained to ask the right questions so they can give appropriate advice. It has been previously revealed that treatment results for common ailments such as coughs and sore throats were equally good regardless of whether patients were treated at a pharmacy, A&E or GP practice, highlighting community pharmacy as a solution to the increasing burden on a stretched health service. Community pharmacy can have an extremely positive impact on the health of the communities it

24 | PHARMACYNEWSIRELAND.COM

serves due to the engagement pharmacy teams have with their patients every day. Pharmacists will offer advice on conditions and medications, and if appropriate, they will refer a patient to their GP if they feel it necessary. In this article, we take a look at the Top 10 conditions and issues which will present to pharmacy. 1. Common Cold The common cold is a condition that is prevalent in the community and is associated with a variety of symptoms. Typically, it is an acute, self-limiting viral infection of the upper respiratory tract that is most frequently caused by rhinoviruses. Symptoms commonly associated with the common cold include coughing, nasal congestion, low-grade fever, and fatigue, usually presenting 1 to 2 days after exposure. Generally, most symptoms subside within 7 to 10 days, although some symptoms can persist for up to 3 weeks.

2. Flu The common cold is often mistaken for the flu. The flu is caused by the influenza virus, classified as type A, B, or C. Types A and B affect humans, with type A generating more severe symptoms. The influenza virus can be dangerous in older people and in those patients who are immunocompromised. Nevertheless, people with influenza are sicker than those experiencing common cold symptoms and commonly manifest such signs and symptoms as temperatures greater than 102°F, chills, headaches, myalgia, and malaise. There are a number of simple health habits that can assist in preventing the spread of infectious pathogens like the influenza virus. This includes things such as avoiding close contact, staying home when you are sick, covering your mouth and nose when sneezing, cleaning your hands, and avoiding contact with your nose, eyes, or mouth.


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*class-specific comparison (topical vs systemic decongestant) Product Information. Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml nasal spray, solution (xylometazoline hydrochloride and ipratropium bromide). Indications: Symptomatic treatment of nasal congestion and rhinorrhea in connection with common colds. Dosage and method of administration: Adults: 1 puff in each nostril up to 3 times daily. 6 hours min. between 2 doses. Max. 3 puffs daily into each nostril. Max. 7 days use. Paediatric population: Not for use under 18 years of age. Geriatrics: Limited experience of use in patients above 70 years of age. Contraindications: Hypersensitivity to ingredients, atropine or similar substances. After surgical operations where dura mater may have been penetrated. Patients with glaucoma or rhinitis sicca. Precautions: Use with caution in patients with hypertension, cardiovascular diseases, long QT syndrome, hyperthyroidism, diabetes mellitus, hypertrophy of the prostate, stenosis of the bladder, pheochromocytoma and a sensitivity to adrenergic substances. Use with caution in patients predisposed to angle closure glaucoma, epistaxis, paralytic ileus and cystic fibrosis. Immediate hypersensitivity including urticaria, angioedema and rash may occur. Max. duration of use is 7 days to prevent rebound effect. Avoid spraying in or around the eye. Side effects: Epistaxis, nasal dryness, dysgeusia, headache, nasal discomfort, nasal congestion, dry throat, throat irritation, rhinalgia, dry mouth, parasomnia, dizziness, tremor, eye irritation, dry eye, palpitations, tachycardia, nasal ulcer, sneezing, dyspepsia, nausea, hypersensitivity. Overdose: May cause dry mouth, accommodation difficulties and tachycardia. Treatment is symptomatic. Legal category: Pharmacy Only. Product Licence Number: PA 0678/131/001. MAH: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Full product information is available in the SPC. Additional information is available upon request. Text prepared: May 2020. Trade marks are owned by or licensed to the GSK group of companies. PM-IE-OTRI-20-00011


Sore throat can also be caused by irritants such as air that is low in humidity, smoking, air pollution, excessive yelling, postnasal drip caused by allergies, and breathing through the mouth. Injury to the back of the throat and stomach acid backing up into the throat and mouth are other causes of sore throat. Sore throat symptoms are easily recognised. The throat hurts and is irritated, swollen, or scratchy. Pain increases when swallowing. Some sufferers may also have tenderness in the neck. Sore throat that is due to a virus should go away within 7 to 10 days. When a person has strep throat, however, throat pain starts out gradually and quickly becomes severe and constant.

Advising patients on good health habits and providing handouts is a simple way pharmacists can provide sound advice that is easy to follow. Former Minister for Health, Simon Harris TD, recently announced the government is to make the flu vaccine available to all children aged 2-12 and all at risk groups. The news follows a recommendation by the Irish Pharmacy Union for the flu vaccine to be made freely available to everyone who wants it during the coming flu season. Commenting on the announcement IPU Secretary General Darragh O’Loughlin said, “While we would have liked to see the scheme extended further, making the flu vaccination available to children aged 2-12 and to all at risk groups without charge is definitely a step in the right direction. It will help increase our capacity to combat seasonal flu and prevent it from overwhelming the health system during the winter.” Last year, over 1.1 million flu vaccines were delivered in Ireland, an increase of over 60% since pharmacies were first permitted to administer the vaccine a decade ago. Given that the convenience and availability of the vaccine has led to greater uptake, the IPU believes that pharmacists should be allowed to administer the vaccine to people in nursing homes and workplaces. 3. Cough Cold and flu season is the time of the year when pharmacists are more likely to see patients scanning the pharmacy shelves in search of the perfect remedy to manage a cough. Patients may be overwhelmed by the numerous OTC cough products, but

pharmacists are in an ideal position to evaluate and aid patients in selecting a cough product for self-treatment, as well as to encourage patients to seek further medical care when warranted. During winter, most coughs are caused by viruses such as colds and flu and can be safely managed at home using OTC remedies. Coughs are classified as “acute” or “chronic”. An acute cough is most common and lasts up to three weeks. It’s usually caused by a cold or flu virus and most improve after one to two weeks. Chronic cough lasts for eight or more weeks. The most common causes include acid reflux, asthma, TB, COPD, bronchitis and smoker’s cough. Red-flag signs include: • Coughing up blood • Unexplained weight loss • Night sweats • Cough worsening after three weeks • Shortness of breath • Voice changes • Lumps/swellings in neck • Chest pain Dry or chesty cough? A dry cough is caused by inflamed airways due to a viral infection such as a cold or flu. A chesty cough produces phlegm. This is caused by the lungs producing extra fluid due to an infection. It is important to get a detailed overview of the patient’s symptoms. Is their cough productive? How long have they had the cough and what action has been taken? Pharmacists should ask if a patient has any

26 | PHARMACYNEWSIRELAND.COM

medical conditions that may affect any treatment or product you recommend. The role of cough medicine is to ease symptoms while the body heals. There are many brands of OTC cough medicines. However, there are only three basic types: Expectorants help thin mucus, making it easier to cough up. The ingredient is guaifenesin. Suppressants help cut the number of times someone coughs. The active ingredient listed is usually dextromethorphan (DM). Other cough suppressants include camphor, eucalyptus oil, and menthol. Combination cough products have more than one active ingredient. They have both guaifenesin and dextromethorphan. Cough medicines may also contain ingredients to help coat and soothe the throat. Combination products may have medicines to ease other symptoms, that may include decongestants for stuffy nose, antihistamines for allergies or a runny nose, or painkillers. Cough drops can also help relieve a cough and may ease a sore throat (see below). 4. Sore Throat Sore throat is a hallmark symptom of both viral and bacterial infections of the upper respiratory tract. Sore throat is a self-limiting complaint, resolving within three days in 40% of sufferers and within one week in 85% of people - even in those cases with a bacterial aetiology. The key symptom of sore throat is pain at the back of the mouth, which can vary from localised mild discomfort to intense pain on swallowing.

Patients should be referred to their GP if they have a persistent fever of 38oC plus which doesn’t improve with analgesics, they have any difficulty swallowing or breathing or they are in severe pain. For sore throat sufferers presenting in pharmacy, regular use of paracetamol or ibuprofen-based products can be recommended to relieve pain (soluble analgesics can be gargled to provide targeted pain relief). Customers can also be advised to use simple mouthwashes at frequent intervals (e.g. warm, salty water) until the discomfort and swelling subsides. Sucking pastilles or lozenges stimulates saliva secretion, which lubricates the throat, and many throat sweets also contain soothing ingredients, such as glycerine and honey, to help relieve irritation. 5. Nasal Congestion Nasal congestion is a blocked, stuffy or bunged-up feeling in the nose. Depending on the cause, it can last a short while (a few days) or can be persistent. In adults and children it is usually an annoying symptom rather than a serious one. In babies, however, a blocked-up nose may make it difficult to breathe or feed. Some of the causes of nasal congestion include: • Infections: the common cold and other respiratory tract infections, including influenza (flu) and sinusitis • Allergies, including hay fever • Persistent rhinitis 6. Sinusitis The sinuses are small, air-filled spaces inside the cheekbones and forehead which drain into the nose. Sinusitis means inflammation of a sinus. Most bouts of sinusitis are caused by an infection. Most cases of sinusitis are acute (lasting 1-4 weeks) but some may go on to a more persistent (chronic) sinusitis.


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9. Vitamins & Supplements In the darker months, Vitamin D is one of the most important potential deficiencies to avoid. Vitamin D has several important functions within the body, including regulating the amount of calcium and phosphate needed to keep bones and teeth healthy. Deficiency carries with it a whole host of health problems including rickets in children, and osteomalacia, the adult equivalent, which causes bone pain and tenderness.

Pain and pressure in the face and head, as well as a stuffy or runny nose, are the chief complaints among those experiencing sinusitis. The location of this pain or pressure usually depends on which sinuses are affected, and head movement or leaning forward typically increases both the pain and pressure.

Prior to a breakout, there are certain sign to look out for such as:

Other symptoms may include postnasal drip, cough, sore throat, fever, fatigue, tooth pain, bad breath, and reduced sense of taste or smell. A yellow or green discharge from the nose or throat is also common. If an infection lasts more than 10 days without evidence of improvement, is accompanied by a fever with severe symptoms, or exhibits “doublesickening” (improves, then worsens), it is most likely bacterial and will require antibiotics.

• Swollen lymph nodes in the neck

Sinusitis is usually treated with painkillers and decongestants. 7. Cold Sores Cold sores are small blisters that develop on the lips or around the mouth. They are caused by the herpes simplex virus and usually clear up without treatment within seven to 10 days.

• Tingling lips • Sore mouth that makes eating, and drinking uncomfortable • Fever • Sore throat

Nothing can prevent an outbreak, however there are a number of treatments that work to reduce the duration of cold sore symptoms such as: • OTC antiviral creams can speed up the healing process • Cold sore patches containing hydrocolloid gel that ordinarily treats skin wounds. The patch is placed over the cold sore while it heals • In severe cases, the patient should be referred to their GP so that antiviral tablets may be prescribed.

Sufferers may not have any symptoms when they first become infected with the herpes simplex virus. An outbreak of cold sores may happen some time later. Cold sores often start with a tingling, itching or burning sensation around the mouth. Small fluid-filled sores then appear, usually on the edges of your lower lip. Those affected can seek a number of treatments from pharmacists that reduce the duration of cold sores when used at first sign of a break out. Symptoms of cold sores usually occur after something has triggered the virus, like a rundown immune system or cold, dry weather leading to dry, chapped lips.

28 | PHARMACYNEWSIRELAND.COM

8. Ear Infections Ottis Media is an inflammation of the middle ear and is often associated with sore throats, colds or other respiratory issues where the infection spreads to the middle ear. It is very common in children. The patient can suffer from temporary hearing loss and pain or discomfort in their ear. Patients can avoid ottis media by getting their annual flu vaccination. Ottis Media usually happens very quickly for a short duration. If the patient has had the symptoms for a few weeks or month it may be an acute ear infection and should visit their doctor. Antibiotics are usually prescribed as treatment. The pharmacy can offer pain relief with ear drops or antihistamines if the inflammation is causing discomfort. If customers are prescribed ear drops or use OTC products, it is important they are shown how to use them properly and reminded that ear drops should be discarded 28 days after opening.

Humans obtain vitamin D mainly from the action of sunlight on the skin, but in Ireland the sun is only strong enough for vitamin D production in the summer months. So, although a small surplus is built up over the summer, most people are probably vitamin D deficient in the winter. Add to that the fact that vitamin D is only found in small amounts in food – such as eggs, oily fish and fortified foods such as breakfast cereals – and it becomes clear why taking a supplement is recommended for ‘at risk’ groups. It is recommended that everyone takes a 10mcg vitamin D supplement daily, particularly in autumn and winter. All babies and young children aged six months to five years should be given a daily supplement containing vitamin D in the form of drops to help them meet the requirement for this age group of 7-8.5mcg of vitamin D a day. Breastfed infants may need drops containing vitamin D from one month of age if the mother has not taken vitamin D supplements throughout pregnancy. However, babies fed infant formula will not need vitamin D drops until they are receiving less than 500ml a day, as these products are often fortified with vitamin D.


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secretions. Inhalants, rubs and saline products can be used daily until symptoms are cleared. They can be used as an alternative by patients who cannot tolerate decongestants. Sore throat treatments - Most sore throats are caused by a viral rather than a bacterial infection, so don’t need antibiotics. Medicated lozenges or anaesthetic sprays can help relieve the symptoms of sore throat. Gargling regularly with an antibacterial mouthwash or warm, salty water can reduce any swelling and inflammation, while sucking pastilles or lozenges will stimulate saliva secretion to lubricate the throat and help relieve irritation.

Echinacea is probably the most common herbal supplement associated with the prevention and treatment of colds. This plant is promoted as an immunesystem stimulant. Elderberry, or Sambucus nigra, is commonly used for treating symptoms related to the flu. It is thought to have antioxidant and immune-modulating properties. There is evidence to suggest that elderberry does reduce symptoms of the flu. Elderberry is well tolerated and there are very few reports of adverse effects with usage. Those taking it should be warned not to eat raw or insufficiently cooked elderberries; cyanogenic glycosides are metabolized to cyanide in the GI tract, causing nausea, vomiting, dizziness and weakness. Vitamin C is a water-soluble vitamin that has an important role in various physiological processes. There have been a significant number of clinical studies completed to determine the efficacy of vitamin C treatment in the common cold. At doses used for daily supplementation, vitamin C is generally well tolerated. Zinc is a mineral that is considered an essential nutrient. Studies have shown that a mild zinc deficiency can elicit changes in the patient’s immune status, increasing their risk for infection. Vitamin E is most commonly known as a fat-soluble antioxidant. It is often put in oils to extend the shelf life of the product and prevent the oil from becoming rancid. Vitamin E is also similar to vitamin C in that it also plays a role in keeping the immune system healthy. Researchers are working hard to understand this role, but it appears that there are several mechanisms involved: 1. Reduction of PGE2 production by the inhibition of COX-2 activity

mediated through decreasing NO production 2. Improvement of effective immune synapse formation in naive T cells and the initiation of T cell activation signals 3. Modulation of Th1/Th2 balance. Higher natural killer cell activity and changes in dendritic function, such as lower IL-12 production and migration, were observed During the cold and flu season good nutrition and proper sleep is essential. Foods high in vitamin E are vegetable oils (especially wheat germ oil), nuts, kiwi, mango, spinach, broccoli, tomatoes, eggs, fish, and avocados. 10.The Paediatric Patient When temperatures start turning colder and kids are inside and interacting with each other in greater numbers, cold and flu season inevitably follows. Children under the age of 6, and particularly under age 2, are at an especially high risk during cold and flu season. Whilst it is known that antibiotics won’t help when it comes to clearing up an infection, there are steps pharmacists can advise parents to take to help their child feel better while their immune system battles the virus. Advise on keeping the child hydrated to help reduce cold and flu symptoms and make them feel better. Fevers can result in dehydration. Children suffering with the cold or flu may not feel as thirsty as they normally would, and they may be uncomfortable when drinking, so it’s important to encourage them to drink plenty of fluids. Medicated nasal sprays aren’t recommended for young children. Fortunately, there are several easy ways to clear up a stuffy nose without medication. Use a cool-mist humidifier in the child’s room. This will help break up mucus. Another option is using

30 | PHARMACYNEWSIRELAND.COM

a saline nasal spray or drops, which makes thin mucus easier to blow out or remove with a bulb syringe. This is especially helpful before feeding and bedtime. Medication Summary: Decongestants – These help to reduce nasal congestion by constricting the dilated blood vessels in the nasal mucosa. This reduces swelling and oedema of the nasal mucosa, making it easier to breathe. Decongestants are not suitable for pregnant and breast-feeding women and patients with hypertension. Nasal sprays and oral tablets should not be used concurrently. Oral analgesics - Analgesics and antipyretics help to reduce pain and fever associated with sore throats and colds. Ibuprofen also reduces inflammation, which can help if sinuses are inflamed. Paracetamol and ibuprofen can be used in conjunction with one another but should be taken two to three hours apart for maximum benefit. Combination products - Can contain ingredients such as a decongestant, analgesic, cough suppressant, antihistamine or an expectorant. These can be used up to their maximum dose for up to seven days unless they contain sedating antihistamines, when they should only be used for up to three days. Antihistamines work by drying up nasal secretions and should be used with a decongestant as they are relatively ineffective on their own. They can also cause drowsiness, so are often found in combination products to aid insomnia associated with having a cold. Inhalants, vapour rubs and saline products - Inhalants work by helping to clear the nasal passages, while steam inhalation will help ease nasal congestion by loosening mucus. Saline preparations relieve congestion by helping to liquefy mucous

Cold sore treatments - Cold sores usually clear up without treatment within seven to 10 days but antiviral creams, such as aciclovir or penciclovir, can be used to ease symptoms and speed up the healing time. Antiviral tablets are generally more effective than creams at treating severe cold sores, but are usually only prescribed in more intractable cases. Patches that contain a hydrocolloid gel can be placed over the cold sore to hide the affected area while it heals. Efficient Merchandising The cough and cold season could also provide the perfect opportunity to reorganise fixtures in your pharmacy with a clear merchandising plan featuring beacon brands in both the P and GSL sections. You really need to think about the winter season and make a proper planogram, that provides a merchandising tool on a tablet, so that any member of staff can scan the fixture and see what it should look like. Make sure that you feature the national bestsellers, as these beacon brands act as visual clues for customers and direct them to the products they are looking for. There needs to be some offers that make the pharmacy look competitive and it is crucial that staff are trained to provide advice on seasonal ailments and OTC products. Staff should also deliver public health messages by reminding customers to have a flu jab and, for example, when selling cough medicine finding out if the customer is a smoker and whether they would like help to quit. They won’t necessarily think the water tablets they are taking for their blood pressure are important but they could react with the decongestant in a cold remedy and cause problems. This could be a cue for the pharmacist to check through their medication records to ensure they are getting appropriate advice.


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Walk This Way

F

eet are often neglected; many people don’t pay their feet and legs much attention until they notice something isn’t quite right. Many people simply don’t know whether they have a wart, a verruca, a corn, or even know the source of the pain at all.

Despite the high prevalence of various foot ailments, because many are unable to distinguish the source of the problem, they may use the wrong products or don’t treat at all. So it is important that pharmacists are able to advise customers on key foot care issues, recommend the correct treatment solution and refer them to a GP or podiatrist if required. Pharmacies should ensure that they signpost the footcare section clearly within store and stock a comprehensive range of wellknown products for customers to choose from. With an ageing population, suffering from foot, knee and joint problems is seen as just part of getting older, but although to some extent that’s true, there are still warning signs that good pharmacists should take note of and refer on to a GP or podiatrist, along with effective support and treatment for feet and leg conditions.

Feet are often the most neglected part of our bodies with research showing that people are more likely to have their car serviced than have their feet checked by a Podiatrist. This is contrary to the fact that our feet are our main mode of transport and deserve equal amounts of care and attention. According to the HSE, during a lifetime, feet may walk the equivalent of four times around the world so it is essential that they are taken care of at all times. According to Podiatry Ireland, our feet are complex. They house a quarter of the bones in the body, as well as a network of muscles, ligaments and joints. They are also vulnerable to injury and disease with over 300 identified foot ailments. While our feet suffer wear by the age of fifty, they have also lost up to half of the shock-absorbing capability of the natural foot pad

34 | PHARMACYNEWSIRELAND.COM

which cannot be replaced like a pair of shoes. Some feet have special needs - children's feet, sporting feet, working feet, mature feet and feet affected by disease. There are many different types of foot ailments that Podiatrists treat including athlete’s foot, bunions, arthritis, and Achilles tendonitis. Many of these complaints may present at Pharmacy first and Podiatry Ireland has the following advice for pharmacists when advising their patients on foot care: 1. Advise patients to alternate shoes - they should not wear the same pair of shoes everyday. 2. Barefoot cautions - patients should avoid walking barefoot as their feet will be more prone to injury and infection. At the beach or when wearing sandals, patients should always use sunblock on their feet as well as the rest of their body.

3. Feet washing - patients should wash feet regularly, especially between the toes and they should always ensure to dry them completely. 4. Feet Inspection - patients should always inspect feet regularly. They should pay attention to changes in colour and temperature of the feet, look for thick or discoloured nails (a sign of developing fungus), and check for cracks or cuts in the skin. If there is peeling or scaling on the soles of feet it could indicate athlete's foot. Any growth on the foot is not considered normal. 5. Shoe fit - patients should make sure that shoes fit properly. It is important to purchase new shoes later in the day when feet tend to be at their largest and they should replace worn out shoes as soon as possible. Those at Risk Some people are more likely to experience pain in their feet and


fluticasone furoate

Allergic rhinitis relief

Relieving the symptoms of allergic rhinitis in patients over 6 years1

The incidence of epistaxis during long term treatment was higher than 10% but was generally mild to moderate in intensity1

www.avamys.ie

Prescribing Information (Please refer to the full Summary of Product Characteristics before prescribing) Avamys Nasal Spray Suspension (fluticasone furoate 27.5 micrograms/metered spray) Uses: Treatment of symptoms of allergic rhinitis in adults and children aged 6 years and over. Dosage and Administration: For intranasal use only. Adults and adolescents (12 years and older): Two sprays per nostril once daily (total daily dose, 110 micrograms). Once symptoms controlled, use maintenance dose of one spray per nostril once daily (total daily dose, 55 micrograms). Reduce to lowest dose at which effective control of symptoms is maintained. Children aged 6 to 11 years: One spray per nostril once daily (total daily dose, 55 micrograms). If patient is not adequately responding, increase daily dose to 110 micrograms (two sprays per nostril, once daily) and reduce back down to 55 micrograms daily dose once control is achieved. Contraindication: Hypersensitivity to active substance or excipients. Special warnings and precautions: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. Consider additional systemic corticosteroid cover during periods of stress or elective surgery. Caution when prescribing concurrently with other corticosteroids. A reduction in

growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year. Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control. It is recommended that growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Consider referring to a paediatric specialist. May cause irritation of the nasal mucosa. If a patient presents with visual disturbance they should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, central serous chorioretinopathy. Drug interactions: Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected. Co-administration should be avoided unless the benefit outweighs the increased risk. Co-administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate. Pregnancy and Lactation: No adequate data available. Recommended nasal doses result in minimal systemic exposure. It is unknown if fluticasone furoate nasal spray is excreted in breast milk. Only use if the expected benefits to the mother outweigh the possible risks to the foetus or child. Side effects: Very common (≥1/10): epistaxis. Epistaxis was generally mild to moderate, with incidences in adults and adolescents higher in longer-term use (more than 6 weeks). Common (≥1/100 and <1/10): headache, dyspnoea, nasal ulceration. Uncommon (≥1/1000 and <1/100): rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness. Rare (≥1/10,000 and <1/1000): hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria. Very rare (<1/10,000): Nasal septum perforation. Not known: transient ocular changes, vision blurred, bronchospasm, growth retardation.

Marketing Authorisation (MA) Holder: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. MA Number: EU/1/07/434/003. Legal category: POM B. Last date of revision: April 2020. Job Ref: PI-5555. Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Camp, Dublin 24. Tel: 01-4955000.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.



+285 ())(&7

Reference: 1. Avamys Summary of Product Characteristics, available on www.medicines.ie, accessed January 2020 PM-IE-FLF-ADVT-190007 Date of preparation: January 2020

Not actual size


lower leg than others. Risk factors include: • Age: Feet flatten and widen with age, the fat padding the sole of the foot wears down and skin becomes drier. Foot pain in older people may be an early sign of age-related illnesses such as diabetes, arthritis and circulation issues. Foot problems may also impair balance. • Gender: Women are more likely than men to suffer severe foot pain and this may be due to the type of shoes they wear. • Occupation: Foot problems, including arthritis in the foot and ankle, toe deformities, pinched nerves between the toes, plantar fasciitis, adult-acquired flat foot and tarsal tunnel syndrome, have been attributed to repetitive use at work – for example, in people whose job means they have to walk long distances or stand for many hours at a time. • Activity: Sports players and people who take part in vigorous exercise. Women are at higher risk of stress fractures than men. Common Foot Conditions Corns and Callouses - Corns (which usually appear on the tops or sides of toes) and calluses (found on the soles of feet) are areas of hard, thickened skin that develop when the skin is exposed to excessive pressure or friction. Problems can be prevented by wearing well-fitting shoes and using protective gel pads or strips to reduce pressure. Hardened skin can be gently removed with a pumice stone or foot file. OTC products containing salicylic acid are available to treat established corns or calluses, but severe cases or people with diabetes or circulation problems should be referred to a podiatrist. Cracked Heels - Cracked heels are often caused by open-backed shoes such as sandals or flip-flops striking the heel. Older people are most at risk of cracked heels, as well as those who stand for prolonged periods. Limiting unsupportive footwear can help to prevent the problem arising, while regularly applying a moisturising foot cream can help keep feet smooth and soft. A pumice stone or foot file can be used to remove hard skin; these are particularly effective when used after a bath or shower.

Athletes Foot - Athlete’s foot is contagious via skin to skin contact and indirectly if one uses the same towel as a person with the condition. Athlete’s foot, a common fungal infection that usually develops between the toes, most commonly affects teenagers and young adults. The infection usually clears up within days or weeks with antifungal treatment. Customers can choose between fungicidal products that kill the fungus and fungistatic products, which slow down its growth until it stops. A low-potency steroid cream may be recommended if the skin is very sore. Athlete’s foot is highly infectious, as the fungi multiply quickly in warm and humid environments, such as swimming pools, showers and changing rooms. Good foot hygiene can help to reduce the spread of an infection and involves drying the feet thoroughly, particularly between the toes, wearing clean cotton socks, rotating footwear and avoiding walking barefoot in changing rooms. Symptoms of Athlete’s foot include: • An itchy, red rash, which often starts in between the 4th and 5th toes, before spreading to the other toes. • Scaling or cracking of the skin may occur. • Blisters can occur. If these burst, they can cause pain & swelling. Verrucas - A verruca is a wart on the sole of the foot caused by infection with the human papilloma virus (HPV), which is picked up from contaminated floors in changing rooms or around swimming pools. The affected skin is usually white and may have a black spot in the centre. Verrucas may clear up naturally, but treatment is advisable to prevent the infection spreading. Several treatment options are available OTC, including salicylic acid gels, creams, plasters and paints, cryotherapy sprays containing dimethyl ether propane and silver nitrate. To make verrucas more susceptible to treatment, the affected area should be soaked in warm water for a few minutes and

gently filed with a pumice stone or emery board. Waterproof plasters are available to protect the verruca and prevent the infection from spreading. Tired Legs - Tired, aching legs are a common problem, especially in people who sit or stand for long periods. It could be a sign that leg veins are allowing blood to flow backwards and pool, rather than travel up towards the heart. Insole arch supports may provide extra support for the ankles, which can limit any swelling, while compression hosiery can improve the flow of blood, relieving the tiredness and aching sensation. Deep vein thrombosis (DVT) causes pain and swelling in the leg as a result of blood clotting while it is still inside the blood vessel. It usually affects one leg only. If DVT symptoms occur, they may include tenderness in one leg (usually the calf), a heavy ache in the affected area, warm skin in the area of the clot, and also red skin, particularly at the back of the leg below the knee. If customers are concerned about DVT, they should see their GP. Diabetic Foot Care Diabetes can cause nerve damage and blood vessel disease in the feet. This may cause skin and tissue breakdown, which can develop into non-healing wounds (ulcers), which are at risk of infection. This may even result in limb amputation. Structural deformity leaves bony prominences exposed to increased external pressure on the skin, leaving it at risk of being damaged. Identification of patients at risk of diabetic foot disease allows early intervention of preventative measures to be taken, and thus reduces the risk of further complications. As the number of type 2 diabetes (T2D) cases continues to escalate each year, pharmacists are likely to encounter patients inquiring about proper diabetic foot care. Foot problems are very common in patients with T2D, accounting for a significant portion of diabetes- related complications and health care costs. Pharmacists are in a pivotal position to educate patients with a new diagnosis of diabetes about their care. Pharmacists should remind patients about the importance of routine diabetic foot care to

36 | PHARMACYNEWSIRELAND.COM

prevent or delay complications, such as diabetic foot ulcers and amputations. Patients with diabetes, especially those with poorly controlled disease, are more susceptible to skin-related complications; therefore, patients should be reminded that many dermatologic conditions can be either prevented or effectively treated if identified early. Conducting a daily skin inspection and adhering to daily skin care, especially foot care, is imperative for all patients with diabetes. Pharmacists should seize every opportunity to stress the importance of maintaining tight glycaemic control and remind patients how proper and routine foot care is critical to decreasing the incidence of foot ulcers and amputations. It is estimated that nearly 85% of amputations are preventable with education and early intervention. The primary goal of diabetic foot care is prevention of diabetesrelated complications, such as changes in the skin (dryness and itching) and foot ulcers, which are often attributed to vascular disease, neuropathy, and relative immunosuppression. Strategies for preventing foot problems include patient education, patient involvement and adherence, maintenance of tight glycaemic control, and daily care and inspections of the skin, feet, and nails. Several OTC dermatologic products are marketed specifically for foot care in patients with diabetes. Prior to recommending any of these products, pharmacists should encourage patients with certain signs or symptoms to seek immediate medical care to avoid further complications. Examples of diabetic foot care products include antimicrobial lotions, skin moisturisers, and antifungal and callus treatments. Category Management Pharmacists should think beyond foot and leg care when it comes to making a sale. If someone picks up corn plasters, combination treatments may be required, and there is an opportunity for a link purchase such as insole supports to take the pressure off the area. Also, what about pain relief? This is precisely where community pharmacy can add value over and above its competitors – it’s an opportunity not to be missed. This category should be displayed next to or near the first aid category. This is where you will find antiseptic creams and plasters, so the link to the category is appropriate.


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NEW

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

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

ABBREVIATED PRESCRIBING INFORMATION Product Name: Emazole Control 20 mg Gastro-Resistant Tablets Composition: Each tablet contains 20 mg esomeprazole (as magnesium dihydrate). Description: Light pink oval film coated tablet. Indication(s): Proton Pump Inhibitor (PPI): Short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: Swallow tablets whole with liquid, do not chew or crush. Disperse in half a glass of non-carbonated water if difficulty in swallowing. Stir until tablets disintegrate, drink liquid with pellets immediately or within 15 min, or administer through a gastric tube. Do not chew or crush pellets. Adults: The recommended dose is 20 mg esomeprazole (one tablet) per day. It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Elderly (≥ 65 years old): As per adults. Paediatric population (< 18 years): Not recommended. No relevant use in this group in the indication: “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”. Severe impaired renal function: Caution. Severe liver impairment: 20 mg max daily dose. Contraindications: Hypersensitivity to esomeprazole, substituted benzimidazoles or any of the excipients. Not with nelfinavir. Warnings and Precautions for Use: On demand treatment: Contact a physician if symptoms change in character. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Absorption of vitamin B12 may be reduced due to hypo- or achlorhydria. Not recommended for long-term use as the following may also occur: Hypomagnesaemia; Risk of fracture. Consider stopping Emazole Control in cases of Subacute cutaneous lupus erythematosus (SCLE) accompanied by arthralgia. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Emazole Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Contains glucose and sucrose. Interactions: Effect of esomeprazole on other drugs: Co-administration with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Serum levels of cilostazol, cisapride, tacrolimus, methotrexate may be increased. An interaction is observed between clopidogrel and esomeprazole, but the clinical relevance is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. Gastric acid suppression by PPIs increase or decrease absorption of drugs with pH dependent absorption (decreased absorption of ketoconazole, itraconazole); esomeprazole inhibits CYP2C19 metabolising enzyme and could increase plasma concentrations of diazepam, citalopram, imipramine, clomipramine, phenytoin (monitor plasma levels of phenytoin), etc. resulting in need of a dose reduction; monitor INR when given with warfarin or similar. Caution as absorption of digoxin can increase. Effect of other drugs on esomeprazole: CYP2C19 and CYP3A4 inhibitors (clarithromycin, voriconazole) may increase the esomeprazole exposure. Dose adjustment not regularly required, except in severe hepatic impairment and long-term use. CYP2C19 and/or CYP3A4 inducers (rifampicin and St. John’s wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism. Pregnancy and Lactation: Caution in pregnancy due to lack of clinical data. No studies in lactating women, therefore, not recommended during breast-feeding. Ability to Drive and Use Machinery: Minor influence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported. If affected, patients should not drive or use machines. Undesirable Effects: Common: Headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign). Uncommon: Peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritis, rash, urticaria, fracture of the hip, wrist or spine. For other side effects refer to the SPC. Marketing Authorisation Holder: IQ Pharmatek Ltd., Gurtnafleur, Old Waterford Road, Clonmel, Co. Tipperary. Marketing Authorisation Number: PA 22777/001/001. Further information and SPC are available from: Rowex Ltd, Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417. E-mail rowex@rowa-pharma.ie Legal Category: Not subject to medical prescription. Date of Preparation: September 2019 Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing medsafety@hpra.ie or by emailing Rowex pv@rowa-pharma.ie


CPD: Acute Pain

Continuing Professional Development

CPD

39

This module is suitable for use by community pharmacists as part of their Continuing Professional Development. After reading this module, in the magazine or online, complete the post-test on our website at www.pharmacynewsireland.com and include in your personal CPD ePorfolio. AUTHOR BIO: Dr. Dominic A. Hegarty, BSc., BMedSc., MB., MSc. (Pain Management), PhD. FCARSCI, FFPMCAI, FIPP Dr. Dominic A. Hegarty is now practising as a Consultant in Pain Management & Neuromodulation at the Orthopaedic and Spine centre, Mater Private Hospital, Cork. Dr. Hegarty is recognized as one of the country’s foremost interventional pain management doctors who is constantly developing new pain techniques to deal with the most complex cases in this area. He is the holder of a doctrine degree (Ph.D., UCC), Master of Science (MSc., Edinburgh) a Fellowships in Ireland, USA (FIPP) and London (Royal College of Medicine) in the area of Pain Management. He has specialised in pain management over the last 2 decades and his expertise in this area is regularly sought by national media and in the High Court on medical legal matters. Dr. Hegarty has secured over ¤3 million in research grants and sponsorship over the last 3 years. He continues to collaborate with innovation centres and industry in order to provide the best solutions to help individuals who have to deal with chronic pain on a daily basis.

Supporting patients with acute pain in the Pharmacy 60 Second Summary Patients often use their pharmacy as the first point of call for advice on the management of acute pain. This article outlines how to conduct a patient-centred acute pain consultation using a shareddecision making approach. The range of over-the-counter analgesics can make it difficult for patients to select the appropriate medicine to self-manage their pain. Acute pain is defined as pain lasting less than three months or pain relating to soft tissue damage. It serves as a warning to alert the body to a problem, with the aim of preventing further tissue injury, and is often proportional to the severity of injury, often resolving when tissue healing is complete. A widely-recognised approach to patient consultations is the Calgary–Cambridge model, which is commonly used as the framework for healthcare professionalpatient consultations, with an emphasis placed on including patients in decisions about their care, the importance of active listening and use of open questions. As with any consultation, patients presenting with acute pain should be made to feel comfortable while discussing their symptoms. This could be through simple steps such as offering the opportunity to talk in the consultation room or, if possible, to speak to a member of the pharmacy team of the same gender or have a chaperone present. Pharmacy teams should be able to confidently support and work together with patients to help them make an informed choice, putting them at the centre of decisions about their treatment.

Patients often use their pharmacy as the first point of call for advice on the management of acute pain. This article outlines how to conduct a patient-centred acute pain consultation using a shared-decision making approach. With so many over-the-counter (OTC) analgesics available, it can be confusing for patients looking to self-manage their acute pain symptoms.[1] However, pharmacists and members of the pharmacy team can provide the expert advice and support that patients require to make an informed choice.[2],[3]

Reflection - Is this area relevant to my practice? What is your existing knowledge of the subject area? Can you identify any knowledge gaps in the topic area? Planning - Will this article satisfy those knowledge gaps or will more reading be required? What resources are available? Action - After reading the article complete the summary questions at www. pharmacynewsireland.com/cpdtraining and record your learning for future use and assessment in your personal log.

Key points:

Evaluation - How will you put your learning into practice?

• The range of over-the-counter analgesics can make it difficult for patients to select the appropriate medicine to self-manage their pain.

Have I identified further learning needs?

• Pharmacy teams should be able to confidently support and work together with patients to help them make an informed choice, putting them at the centre of decisions about their treatment. In 1998, the World Health Organization (WHO) stated that pharmacists have many different roles in self-medication and self-care, including:

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.

• Communication; • Provision of quality medication; • Training and supervising (support staff); • Collaboration (with the patient and other healthcare professionals); • Provision of health promotion advice.[8] The trusted and accessible nature of the community pharmacy team provides opportunities to support patients to make safe and appropriate choices on how best to selfmanage minor conditions.[9] Managing acute pain Acute pain is defined as pain lasting less than three months or pain relating to soft tissue damage.[11],[12] It serves as a warning to alert the

body to a problem, with the aim of preventing further tissue injury[13], and is often proportional to the severity of injury, often resolving when tissue healing is complete. There are a variety of OTC treatments available, including pharmacological options containing paracetamol, ibuprofen or aspirin and non-pharmacological treatment options, such as heat patches. The evidence base and guideline recommendations for first-line treatment vary based on the presenting complaint. Additional factors, such as clinical presentation, patient comorbidities and contraindications, need to be considered when supporting patients with the best options for self-care, in order to address misconceptions.

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40

CPD: Acute Pain

Treating Pain People will generally feel more positive if they can play a part in managing their condition, so pharmacy teams have a vital role in helping their customers make good lifestyle choices and advising them on how to choose OTC products to help relieve pain. Patients should be encouraged to self-care for the following acute pain conditions: aches and pains, bruising, colds, cuts, earache, fever, headache, period pain, recovery after a simple medical procedure, self-limiting musculoskeletal pain, sinusitis/nasal congestion, sore throat, sprains and strains, teething and toothache. However, self-care generally means that patients are presented with a broad range of oral OTC analgesics at different concentrations per tablet, alone or in combination with other ingredients, which makes appropriate medicine selection confusing. Pharmacists and pharmacy professionals should use guidelines supported by a review of the latest evidence as a basis for recommending OTC oral analgesics for acute pain. Ibuprofen is the first-line recommendation for a range of aches and pains, including lower back pain, period pain and toothache. Aspirin is also used for aches and pains, such as headache, migraine, toothache and period pain. It can be used to treat colds and ‘flu-like’ symptoms, and to bring down a fever (38°C and above). NSAIDs should not be sold to patients with active gastrointestinal (GI) bleeding or active GI ulcer; history of GI bleeding related to previous NSAID therapy or history of recurrent GI ulceration (two or more distinct episodes); a history of hypersensitivity/severe allergic reaction to an NSAID.

Aspirin is contraindicated in history of hypersensitivity to aspirin or any other NSAID, which includes those in whom attacks of asthma, angioedema, urticaria, or rhinitis have been precipitated by aspirin or any other NSAD Paracetamol is a suitable first-line choice for most adults with mild-to-moderate pain. Often combined with paracetamol in OTC preparations codeine can be offered for a variety of acute aches and pains. Topical analgesics are applied externally to the skin – either by rubbing or via patch or plaster formulations – and exert their effects locally. Effective skin penetration is key to their efficacy and certain products may boast advantages over others. The balance between lipid and aqueous solubility must be optimised and the delivery formulation is also critical. Creams appear generally less effective than sprays or gels and state-of-the art formulations such as micro-emulsions also appear to offer certain key advantages. Once through the skin barrier, topical nonsteroidal anti-inflammatory drugs (NSAIDs) – like their oral cousins – exert their therapeutic effects by inhibiting the cyclo-oxygenase (COX)2 enzyme, which is a key driver of prostaglandin production. It has been confirmed that topically applied NSAIDs reach tissue levels high enough to block COX-2. Their main effect is likely to be localised – reducing symptoms arising from periarticular and intracapsular structures in the joints and skeletal muscle. Topical NSAID gels, creams and ointments have shown improved efficacy compared with placebo in a number of short-term clinical studies of patients with joint pain, particularly knee osteoarthritis.

Over the counter (OTC) analgesics containing codeine or dihydrocodeine in combination with other analgesics, such as paracetamol or ibuprofen, are intended for short-term use (no longer than three days) to minimise dependence and addiction. Concerns that codeine or dihydrocodeine containing analgesics are being taken regularly should be discussed with the patient and the patient should be encouraged to seek medical advice and access appropriate services. Other interventions that community pharmacists can provide for patients with pain include: • Lifestyle advice, including diet and exercise, and supported self management of pain. • Improving protection against potentially harmful over-use of common analgesics such as paracetamol and NSAIDs available over the counter • Informing public understanding of what types of pain should be either accepted and ‘worked through’, or referred to GPs and/or specialists; • Opening the way to an extended use of assessment instruments to identify persistent pain risks, and cases; and • Signposting psychological and other care providers, or facilitating patient use of relevant computer based services. TOP TIPS: QUESTIONS FOR PATIENTS TAKING PAIN KILLERS Do you obtain adequate pain relief to allow you to function 'normally'? Do you experience any side effects? Have you taken more doses than prescribed?

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41 During the past month have you often felt subdued, depressed, or hopeless?

2. Gather information

TED

Ask open questions

The pain consultation

By asking open questions, the patient will feel encouraged to open-up about their history and acute pain experience[14], rather than simply asking questions that get a ‘yes’ or ‘no’ response (see Box 1). The pharmacist or team member should be conscious of their use of verbal and non-verbal communication. In addition, it is necessary to confirm understanding of what the patient has said.

T - Can you tell me why you have come into the pharmacy today?

A widely-recognised approach to patient consultations is the Calgary–Cambridge model, which is commonly used as the framework for healthcare professional-patient consultations, with an emphasis placed on including patients in decisions about their care, the importance of active listening and use of open questions.[14] Acute pain consultations can be conducted by any member of the pharmacy team, provided they are competent to do so. Steps in the Calgary–Cambridge model include: 1. Initiate the consultation and build rapport; 2. Gather information; 3. Shared decision making, including the discussion of treatment options alongside patient education (e.g. dosage, administration, what to expect in terms of symptom relief and relevant signposting); 4. Summarise and close the consultation.[14] Although every consultation will be different, these methods can be used to ensure the essential points of an impactful consultation are achieved. 1. Initiate the consultation and build rapport As with any consultation, patients presenting with acute pain should be made to feel comfortable while discussing their symptoms. This could be through simple steps such as offering the opportunity to talk in the consultation room or, if possible, to speak to a member of the pharmacy team of the same gender or have a chaperone present. Previous studies have shown patient preference towards having consultations in an environment where their privacy is protected.[15],[16] The pharmacist or team member should then introduce themselves and ask the patient the purpose for them visiting the pharmacy.[14] “Hello. My name is … what brings you to the pharmacy today?” Consultations in which the presenting patient asks for a specific medicine or product by name should be treated in a similar manner. It is important for the entire pharmacy team to be aware that, although the patient may be requesting a product, it may be inappropriate. In this situation, the patient may be unsure, or even irritated, as to why you are asking them further questions. Therefore it is important to communicate that these questions are being asked to ensure they receive the most appropriate and effective treatment for their pain. This aligns with the Calgary–Cambridge guide to negotiate the agenda with the patient.[14] “Before I can sell you this product, I would like to ask you a few questions to help ensure we are providing you with the best possible treatment. If you prefer, we can discuss this in the consultation room.”

Box 1. Consultation points for acute pain Pharmacy teams should focus on the following areas when discussing acute pain with a patient: Location - “Where does it hurt?” Duration / onset - “When did the pain start?”; “Do you have any ideas about what might have caused it?” Intensity - “How would you rate the pain?” (Use a rating scale to assess the level of pain). Description of pain - “Can you describe what the pain feels like?”; “Does it feel like a dull ache or sharp, stabbing pain?” Impact on day-to-day life - “Over the past two weeks, do you think your pain has been bad enough to interfere with your day-to-day activities?”; “Over the past two weeks, have you felt worried or low in mood because of this pain?”; “How does it make you feel?” Previous treatment - “What have you tried previously?”; “Do you think this helped?”; “How frequently are you using it?” Common mnemonics, such as WWHAM and ASMETHOD, can be used to help guide what questions to ask, but patients may feel that their scripted nature feels intrusive, especially if this takes place at the pharmacy counter.[17] WWHAM • W ho? • W hat? • H ow? • A ction? • M edicines? ASMETHOD • A ge/appearance? • S elf or someone else? • M edicines? • E xtra medicines? • T ime persisting? • H istory? • O ther symptoms? • D anger symptoms? - There are alternatives to this method that may feel less intrusive and encourage patients to share information, such as the TED and ICE principals:[18]

E - Can you explain who the medicine is for and what the problem is? D - Please describe your symptoms and how long you have had them? ICE I - What are your ideas about what may have caused it? C - What is a concern to you? E - What were your expectations from your visit to the pharmacy? Although exact questions do not need to be used prescriptively, these should act as a guide when asking patients open questions. It is important to establish any other medicine that the patient is taking or if they have any conditions that could influence treatment choice. In addition, there is a need to rule out red flags (see Box 2). Assess the level and location of pain Pain is a subjective experience; therefore, it can be difficult to determine the level of pain the patient is experiencing.[19] The Faculty of Pain Medicine has developed two questions as an early pre-screening tool that focus on quality of life and the effects of the pain experienced (see Box 1): “Over the past two weeks, has your pain been bad enough to interfere with your day-to-day activities?” “Over the past two weeks, have you felt worried or in a low mood because of this pain?”[20] Pain assessment scales, such as Numerical Rating Scales (NRS), Verbal Rating Scales (VRS) and the Wong-Baker FACES Pain Rating Scale, are an effective way for the patient to communicate just how bad their pain is and to measure changes in the intensity of the pain.[21] An example of a rating scale that uses various faces to depict pain, similar to the Wong-Baker FACES Pain Rating Scale, can be seen in the Figure. These are suitable for use in the community pharmacy setting to help determine the level of pain a patient is experiencing. The choice of assessment scale may be influenced by setting and the age of the patient, and their ability to communicate. For example, the Wong-Baker FACES pain rating scale is particularly useful for rating pain in children aged three years and over or for patients who have communication difficulties, such as language barriers.[21] A systematic review published in 2018 showed the visual analogue scale (VAS), VRS and NRS to be valid and reliable tools, with the NRS having good sensitivity to changes in the intensity of the patient’s pain.[22]

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CPD: Acute Pain

Box 2: Red flags for patients with acute pain These are general red flags associated with acute pain; however, this list is not exhaustive; professional judgement should be exercised based on potential causes of the pain. Bleeding; Pain from the central spinal pain region; Difficulty breathing or maintaining circulation; Dizziness; Fever; Gradual onset pain; Headache that worsens on standing or lying down; History of recent physical trauma; Impaired consciousness; Loss of physical function, particularly asymmetrical; Neck pain or stiffness with photophobia (i.e. sensitivity to light); Preceding recent head trauma (usually within past three months); Progressive or persistent headache or headache that has changed dramatically; Unexplained seizure; Severe, unremitting pain; Sudden onset severe headache, reaching maximum intensity within five minutes; Unexplained weight loss; Visual disturbance. Where a red flag is identified, the patient should be referred to an appropriate healthcare provider, such as their GP or hospital emergency department. Consideration should be given as to whether pain relief should be provided in the interim. Ask closed questions Closed questions can be used towards the end of the consultation to gather any specific points that may have been missed. 3. Shared decision making and discussion of treatment options In patients presenting with mild-to-moderate acute pain, in the absence of red flag referral criteria (see Box 2), the next step is to discuss potential treatment options. National guidance on medicines adherence suggests that patients are more likely to adhere to a medicine regime when they have been involved in the decision about what options are available and where there has been consideration towards how taking the medicine will fit into their daily routine.[26] Shared decision-making draws on the expertise of both the healthcare professional and the patient.[27] While the pharmacist understands the analgesics available and the associated evidence supporting their use, the patient can

tell the pharmacist what their preferences and values are; both sources of information are needed for high-quality decision making. Educate patients and manage expectations It is important to understand what the patient knows about their pain and what their expectations are in terms of recovery and the effect of any treatment recommended. Start by asking the patient open questions, such as: • “What do you know about the cause of your pain?”; • “What are you hoping treatment will do for you?.” When discussing treatment options, BRAN is a useful mnemonic to use: • B enefits — what are the benefits of the treatment? • R isks — what are the risks of the treatment? • A lternatives — what are the alternative treatments available? • N othing — what might happen if the patient does nothing?[28] It is important to ask the patient questions that will help to identify whether each option will suit their lifestyle, such as: “Would it be convenient for you to apply a cream throughout the day?”; “How would you feel about taking the medicine every four hours?” The management of acute pain can be likened to the principles of the WHO’s ‘Cancer pain ladder for adults’, with the initial OTC management targeted at the use of non-opioids (e.g. paracetamol or ibuprofen), before stepping up to low-dose opioids (containing codeine or dihydrocodeine).[29] Recommendations for the management of mild-to-moderate pain should follow local and national guidance, and the manufacturer’s product licenses.[30] An important consideration is whether the patient wants to be treated pharmacologically, if at all. It is an easy assumption to make that a patient presenting in the pharmacy is looking for medical treatment, but this may not be the case. The patient may only be seeking supportive advice or a diagnosis. Non-pharmacological management, such heat packs, may be beneficial to patients; therefore, training on the use of such products should be made available to the pharmacy team to help empower them during pain consultations.

information). Where necessary, a timeline for follow-up should be agreed and the patient reminded that they can return to the pharmacy for support should they need it[14]. Following the consultation, it is good practice to document and record the outcomes of interesting or particularly difficult or complex consultations, such as where additional intervention or referral may have been required, as this can be used to support reflective practice and annual performance reviews. It is important to remember that the patient’s experience is individual to them and that it is necessary to be sensitive when discussing their pain. Statements such as “that must be really frustrating” or “I am sure that it is difficult managing your pain everyday” can help show empathy and improve the patient’s willingness to open up and discuss their issues. Some patients may not want to take medicine to manage their pain in the hope that it may pass. If this is the case then you can outline the evidence base for acute pain management (see ‘Clinical guidelines and evidence base for acute pain management’) and explain that with suitable treatment they could achieve relief from their pain. There is a need to be aware of oversharing with the patient. Some pharmacy staff may feel that sharing their personal experience will help patients relate and open up; however, this should be avoided as it risks the patient simply mirroring what the staff member says or, due to the limited time available for a consultation, it may cause a lost opportunity for the patient to share their own experience. Although a consultation should feel natural - like a conversation - the entire pharmacy team must remember they need to gather information and educate the patient. Therefore, there needs to be a balance between being concise and encouraging the patient to contribute. When possible, opportunities for the patient to ask questions should be offered, because this will help clarify any misunderstanding and potentially improve patient engagement. References available on request

4. Summarise and close the consultation Once agreement has been reached on which treatment path to follow, the final step in the consultation is to utilise the ‘teach-back’ method; this is where the pharmacist or team member asks the patient to summarise what they are going to do.[31] This will confirm if the patient has understood what has been discussed. If needed, additional support can be provided (e.g. providing the patient with written

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Winter-proofing Skin Care in Pharmacy

W

inter plays havoc with skin, especially for customers with conditions such as eczema, rosacea and psoriasis. There is plenty of advice that pharmacy teams can offer customers so that their skin doesn’t suffer at this time of year. It is important to ensure that all pharmacy staff are well educated about the variety of different skin conditions prevalent in winter. Dry Skin If the skin’s water content drops below 10%, the enzymes responsible for corneocyte desquamation no longer function properly. The corneocytes shrink reducing levels of NMF and the lipid lamellae appears broken (analogous to crumbling mortar in an old brick wall). These will create breaches in the skin’s barrier, allowing for greater water loss. Clinically, xerotic skin appears rough and flaky, with white patches (which represent adherent corneocytes due to reduced desquamation) that is both uncomfortable and pruritic. Dry skin is commonly seen on the lower legs, the trunk, forearms, hands and face. The feet are normally less prone to dryness, being protected by socks and tights, but dryness can be problem for those who walk barefoot or wear sandals.

Left untreated, xerotic skin becomes red, dull and rough, and ultimately starts to crack. These cracks deteriorate over time and can bleed, providing an entry portal for irritants and bacteria that can lead to infections. To prevent dry skin, customers should be advised to maintain skin hydration through adequate fluid intake, avoid hygiene products that dry out the skin, reduce fullbody bathing to every other day, and avoid long, hot showers. To treat dry skin, there are several suggestions pharmacists can offer. Patients can apply oil-based emollients (eg, petrolatum and mineral oil) after bathing, or they may use colloidal oatmeal or bath oil while bathing to enhance skin hydration. Humectants, such as glycerin, draw water into the skin. More serious cases of dry skin may require a urea- or lactic acid containing product.

Eczema in Ireland Atopic eczema (also called atopic dermatitis) causes a dry, red, itchy rash; it may be scaly, weep, bleed or crust over. Eczema affects 1 in 5 children and 1 in 10 adults. The hallmarks of AE are intense itch, associated discomfort and pain, and skin inflammation. These symptoms interfere with sleep, the ability to perform day-to-day activities, school performance, ability to work and are associated with social stigmatization. Key findings released last year from the ISF’s ‘Living with Atopic Eczema Survey’iii, from four-hundred-plus participants, first highlighted the pronounced negative impact that living with severe atopic eczema can have on quality of life, revealing 86% of children and 84% of adults with the condition have ongoing sleep disturbanceiii.

Additional findings from the survey showed two-thirds (65%) of adults avoid exercise, activities and sportiii and more than half (52%) of adults surveyed avoid social activities altogether due to their conditioniii. The main symptom is an intense itch. Scratching only provides temporary relief, and leads to more itching and scratching (the itchscratch cycle), which can worsen eczema and make the skin more vulnerable to infection. Scratching in response to itch can cause some of the changes seen on the skin in eczema. The main aim is to improve symptoms and achieve longterm control. In atopic eczema, the skin’s protective barrier is weakened which allows moisture to be lost, and irritants and allergens to pass through the skin more easily. Some common everyday substances e.g. soap,

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others), so it is important sufferers visit their GP to establish a diagnosis. People frequently think that they will grow out of acne, but unfortunately for some people, it can continue for years and if left untreated may lead to scarring. Choice of treatment depends on the type of lesions and severity of acne. Treatment aims to reduce lesions and prevent scarring. An OTC consultation request for an acne product should be approached with empathy, as well as clinical knowledge, since acne is associated with significant psychological effects, including low self-esteem, social phobia, and depression. It is important when advising someone presenting to the pharmacy to dispel the myths associated with acne. It is not a condition of poor hygiene or diet, nor is it caused by stress, although severe stress may exacerbate the problem. It is just as important, though, to inform the patient that there are several factors that may cause or exacerbate acne: contribute to the weakening of the skin’s barrier and should be avoided. The ISF also say that it appears insufficient funding is being invested into innovative medicines and asked the HSE to ensure that saving delivered through biosimilar uptake or other savings are reinvested within the new medicine budget to ensure access to first-in-class treatments that have been proven to be effective and value for money. The organisation recently called on HSE management to reimburse a first-in-class drug (dupilumab) to provide access to hundreds of people living with severe atopic eczema throughout Ireland. The ISF says that these patients, who have exhausted other treatment options, urgently need access to the new treatment, which has been available to patients elsewhere in Europe for over two years. Professor Alan Irvine, Consultant Dermatologist at St James’ Hospital and Children's Health Ireland at Crumlin says, “Those living with severe eczema endure a huge burden to their quality of life, sleep is severely affected, itch and discomfort are a constant companion. Irish patients with severe eczema have been waiting for approval for dupilumab for 2 years since the UK’s NHS made this often life-transforming drug available in the North. They and those who care for adolescents and children with eczema are anxiously awaiting parity of access across the island of Ireland.” From the fourteen-country reference group, Ireland is among the very last countries (along with Greece) to provide patients

with access to dupilumab. The new treatment has been routinely available in the UK to people living with severe eczema since August 2018 (including Northern Ireland). “Many have been living their lives in a cruel limbo awaiting sign-off for this medicine. Health care systems across Europe have assessed cost benefits and made this drug available to their populations, following Germany’s lead in September 2017. Our patients are simply waiting too long now, their time has come,” Professor Irvine continued. Rosacea Gusty winds during the winter and the dry air in overheated rooms cause the skin of patients with rosacea to become more sensitive. Rosacea is defined as a chronic, relapsing, inflammatory condition that affects the central portion of facial skin. More frequently seen in fair-skinned individuals of Celtic or Northern European heritage, rosacea occurs more commonly in women (although men tend to experience more severe disease) and in those between 30 and 50 years of age. A system for classifying rosacea defines four sub-types although, in practice, aspects of each sub-type will be present to varying degrees in the same patient. Irrespective of the sub-type, a diagnosis of rosacea is made in patients having one or more of the following primary features:

Currently available treatments for rosacea are directed at managing sub-type 2 (papulopustular rosacea). Mild to moderate disease, defined as only a small number of papules and pustules, is normally managed with topical antibiotic agents such as metronidazole or azelaic acid. Other agents that have been used include topical clindamycin, tretinoin cream and benzoyl peroxide. The use of scarves or ski masks may help outdoors in cold winds. Although hot soups and drinks are tempting in the colder weather, these should be avoided or at least left to cool off before drinking, particularly if certain foods are a known trigger. It is important that patients are aware of the potential triggers for rosacea and try to avoid these wherever possible. It is useful for patients to keep a diary to help identify and therefore minimise exposure to potential triggers. All patients should use a high factor, broad spectrum sunscreen every day and those with very dry skin should be advised to experiment with hypoallergenic emollients to help relieve the dryness. Acne Acne is the eighth most prevalent disease in the world and this common inflammatory skin condition can affect 85% of teenagers and young adults.

• Papules and pustules

Acne commonly starts around 1214 years of age and peaks around 16-17 years in females and 17-19 years in males, and in some cases, may continue into adulthood.

• Telangiectasia (visible blood vessels).

There are different types of acne (non-inflammatory, inflammatory,

• Flushing (transient erythema) • Non-transient erythema

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• Hydration (high humidity, excessive sweating) • Occlusive clothing, headbands, helmets • Touching the face • Dirt, cooking oil, coal tar, petroleum • Oil-based cosmetics (those containing lanolin, mineral oil, and cocoa butter); also hair dressings used by African Americans • Severe or prolonged stress • Premenstrual flare-ups It is also important to educate those with acne on how to care for their skin. Initially, nonpharmacologic therapy should be addressed. Sufferers should cleanse their skin twice daily with warm water, which will remove excess sebum from the surface of the skin. Discourage vigorous washing and the use of soaps that contain oil or medications. Medicated soaps spend very little time on the surface of the skin and are of little clinical value. Individuals should also minimise exacerbating factors, including preventing friction-induced irritation by using water-based cosmetics and/or shampoos and by avoiding picking or squeezing lesions. When assisting in selecting an acne product, the various treatment vehicles available should be considered. Creams are suitable for patients with sensitive or dry skin; gels are more appropriate for patients with oily skin. Lotions may be used on any skin type and spread well over hair-bearing areas.


Chapped Lips Chapped lips can occur in any season of the year, although they are particularly common during the winter months. Chapped lips can be painful, embarrassing, and uncomfortable. They may sometimes cause difficulty in talking, eating, and drinking. Understanding the causes, treatments, and prevention can help pharmacy teams advise sufferers on how to reduce or avoid the occurrence of chapped lips. The skin on the lips is much thinner and more delicate than that on other parts of the body. The lips are also exposed to the elements, including the sun and cold, dry air, making them prone to dryness, cracking, flaking, and peeling. The lips lack oil glands and so cannot produce their own moisture, but natural moisturisers can help. Whilst the winter conditions most often cause chapped lips, there are other causes such as: • Smoking • Dehydration • Repeatedly licking the lips • Skin disorders such as eczema • Allergic reactions to certain skin care products or cosmetics • Use of certain medications such as anti-acne products Those with chapped lips may experience dryness, redness, tenderness and sensitivity, cracking, splitting, or peeling and pain.

A variety of OTC products are available for treating or preventing chapped lips. These products typically contain ingredients that assist in healing, such as skin protectants, moisturisers, pain relievers, and sunscreens.

• If possible, remove any rings before washing hands to avoid moisture and soap getting trapped under the rings

Reduce the risk of hand dermatitis

• After drying the hands thoroughly, apply an emollient (non-cosmetic moisturiser). Emollients are cheap and effective and provide a protective film on the hands

Frequent exposure to soaps, detergents and water can reduce the natural oils in the skin and can weaken the skin barrier, leading to the skin becoming dry, irritated and cracked. Increased hand washing and use of alcohol gels may trigger hand dermatitis. To reduce the risk of this happening, it is important to take care of our hands. Advise sufferers with the following tips: • Wash hands with warm running water

• If rings cannot be removed, try to dry underneath them

• Apply emollients frequently to prevent the skin from drying and to keep hands well moisturised • Consider applying a barrier cream to provide extra protection to the hands Merchandising Tips Pharmacy staff should have a thorough knowledge of the products available and which skin conditions most customers

want advice and products for. With the increasing trend for natural products, a good category should include some newer natural remedies alongside familiar brands. Customers need to be urged to use emollients regularly, particularly once symptoms are brought under control. Your range of products should be extensive as there is no-one-size-fits-all remedy. Consider incorporating regime into your category display. Regime is encouraged to help reduce and relieve symptoms on a long-term basis. Use health promotion displays that focus on a specific skin condition and are linked to a national promotion, such as National Eczema Week.

Protecting Summer Skin With everyone spending their summer holidays in Ireland this year, many could be fooled into thinking they don’t need to stock up on SPF. In fact, everyone who spends time outdoors is at risk of skin cancer, not just people who sunbathe. Statistics from the Irish Cancer Society reveal skin cancer to be the most common cancer in Ireland with over 11,000 new cases diagnosed in 2015. The National Cancer Registry of Ireland (NCRI) expects this number to double by 2040. LloydsPharmacy is reminding customers that whether or not they think it feels like summer, the sun’s damaging effects are still at work. People should use about a shot glass of sunscreen (35ml) for their entire body and apply it 20 minutes before going outside as this is approximately how long it takes before skin is completely protected from UV rays. Sinead McNabb, skincare expert with LloydsPharmacy says, ‘’Always choose a sunscreen that’s broad-spectrum because this type of sunscreen protects against UVA and UVB rays. UVA rays are the ones that can cause wrinkles, while UVB rays are the ones that can burn. Don’t be tempted to pick a lower SPF, you shouldn’t use less than SPF 30. If you’re unsure which suncare product will work best for you and your family, feel free to ask any of the highly trained LloydsPharmacy colleagues, who will happy to guide you.’’

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Heartburn Treatment Guide UNDERSTAND

RECOMMEND

2WHAM

Frequent Heartburn Typical symptoms (2+ times per week)

– Who is the medicine for?

1 Pill per day

– What are the symptoms?

Atypical or alarm symptoms (See below)

– How frequently do they occur? – Action already taken? – Medicines being taken?

Occasional Heartburn Typical symptoms

Symptomatic Antacid/Alginate for up to 7 days Multiple daily doses

Patient presents with Reflux Symptoms

What is Reflux?

PPI (eg. Nexium Control) for up to 14 days

LOS

Reflux is the backflow of acid from the stomach into the oesophagus (foodpipe) which may then become inflamed and painful.

LOS open, allowing reflux of acid

Heartburn is caused by the reflux of stomach acid into the oesophagus. It occurs when the lower oesophageal sphincter (LOS) does not close tightly allowing the backflow of acid out of the stomach into the oesophagus.

What are the typical symptoms of reflux? The normal symptoms of reflux are a painful sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Focus on frequency •

Occasional Heartburn - occurs sporadically – The cause is usually obvious often linked to

Frequent Heartburn - occurs 2+ times a week – More common after meals and at night - stress and

overeating, spicy foods, rich desserts or alcohol

food may be triggers but are not always the cause

PPI’s like Nexium Control® are a first-line treatment •

Why do people get these symptoms?

Initial treatment with a PPI is the current accepted practice for physicians treating heartburn¹ Response to treatment with a PPI demonstrates whether or not symptoms are acid related¹

Heartburn can be a result of eating too much, eating high fat food, eating too quickly and drinking alcohol. Customers may also notice that when they lie down, their heartburn gets worse.

PPI’s

Overweight people or those who smoke increase the probability of suffering from heartburn.

Symptoms return

Antacids

Atypical or alarm symptoms When should I refer customers to seek a doctor’s advice? – If they experience any of the following symptoms

• • •

lose a lot of weight for no reason.

• • • •

vomit blood, which may appear as dark coffee grounds in vomit.

problems or pain when swallowing. stomach pain or signs of indigestion such as nausea, fullness or bloating especially after food intake. pass black stools (blood-stained faeces). severe or persistent diarrhoea. over 55 with new or recently changed symptoms.

– Customers must talk to a doctor if they feel worse or they do not feel better after 14 continuous days of treatment. – Seek urgent medical advice if the customer experiences chest pain with light-headedness, sweating, dizziness or shoulder pain with shortness of breath.

Frequent Heartburn

If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor

The Nexium Control® benefit


CONTINUED SUPPORT Complete Heartburn Relief

Stop Treatment

Heartburn Returns

Patients satisfied with the results may repeat the treatment as needed, keeping to the labelled advice unless they have persistent or longstanding, frequently recurring symptoms even after treatment

Symptoms persist or worsen

Doctor referral Symptoms persist or worsen Symptom Relief

Stop Treatment

Heartburn Returns

Frequent Heartburn makes the oesophagus sensitive to acid such that it does not take a lot to trigger burning pain

Treating with a PPI such as Nexium Control® provides the 24 hour protection frequent heartburn sufferers want

Consider frequency of recurrence and re-evaluate patient

What lifestyle advice can I give my customers to help relieve their symptoms?

• • • • • • •

Eat healthy foods Try to avoid spicy and fatty foods and large meals just before bedtime. Avoid fizzy drinks, coffee, chocolate and alcohol. Eat slowly and eat smaller portions. Try to lose weight. Stop smoking. Log on to nexiumcontrol.ie for more information.

Nexium Control® is used in adults for the short-term treatment of reflux symptoms (for example, heartburn and acid regurgitation).

20mg gastro-resistant tablets and hard capsules Esomeprazole Name of product: Nexium Control 20 mg gastroresistant tablets and hard capsules. Active ingredient: Esomeprazole. Product licence numbers: EU/1/13/860/001; EU/1/13/860/002 and EU/1/13/860/003. Name and address of the company responsible for placing on the market and where additional information available: Pfizer Healthcare Ireland, Citywest, Dublin 24. Supply classification: Pharmacy Only. Indications: The shortterm treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Side Effects: Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/ vomiting, fundic gland polyps (benign). Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritus, rash urticaria. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, hyponatraemia, agitation, confusion, depression, taste disturbance, blurred vision, bronchospasm, stomatitis, gastrointestinal candidiasis, hepatitis with or without jaundice, alopecia, photosensitivity, arthralgia, myalgia, malaise, increased sweating. Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), muscular weakness, interstitial nephritis, gynaecomastia. Not known: hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia; hypomagnesaemia may also result in hypokalaemia, microscopic colitis, subacute cutaneous lupus erythematosus (SCLE). Precautions: Patients should be instructed to consult a doctor if: They have significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as treatment with esomeprazole may alleviate symptoms and delay diagnosis. They have had previous gastric ulcer or gastrointestinal surgery. They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks. They have jaundice or severe liver disease. They are aged over 55 years with new or recently changed symptoms. Patients with longterm recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals. Patients over 55 years taking any nonprescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. Patients should not take Nexium Control as a long term preventive medicinal product. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile. Patients should consult their doctor before taking this medicinal product if they are due to have an endoscopy or urea breath test. Coadministration of esomeprazole with atazanavir is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir. Esomeprazole 20 mg should not be exceeded. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole. The clinical relevance of this interaction is uncertain. The use of esomeprazole with clopidogrel should be discouraged. Patients should not take another PPI or H2 antagonist concomitantly. Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Nexium Control treatment should be stopped for at least 5 days before CgA measurements. If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of PPI treatment. Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. This medicinal product contains sugar spheres (sucrose). Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucraseisomaltase insufficiency should not take this medicinal product. Contra-indications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients. Esomeprazole must not be used concomitantly with nelfinavir. Dosage and Method of use: The recommended dose is 20 mg esomeprazole (one tablet or capsule) per day. It might be necessary to take the tablets or capsules for 23 consecutive days to achieve improvement of symptoms. The duration of treatment is up to 2 weeks. Once complete relief of symptoms has occurred, treatment should be discontinued. If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor. Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution. Dose adjustment is not required in patients with mild to moderate liver impairment. However, patients with severe liver impairment should be advised by a doctor before taking Nexium Control. Dose adjustment is not required in elderly patients. There is no relevant use of NEXIUM Control in the paediatric population below 18 years of age for the indication of “short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation)”. The tablets should be swallowed whole with half a glass of water. The tablets must not be chewed or crushed. Alternatively, the tablet can be dispersed in half a glass of noncarbonated water. No other liquids should be used as the enteric coating may be dissolved. The water should be stirred until the tablet disintegrates. The liquid with the pellets should be drunk immediately or within 30 minutes. The glass should be rinsed with half a glass of water and the water drunk. The pellets should not be chewed or crushed. The capsules should be swallowed whole with half a glass of water. The capsules must not be chewed, crushed or opened. Date: July 2018 For full product information please refer to www.medicines.ie ¹ NICE Clinical Guideline 184, September 2014.

PM-IE-NEC-20-00001


From Baby to Classroom

I

“ s my baby getting enough milk?” Explore first of all why this question is being asked. It can help to reassure that for the first month, while milk supply is being established, feeding 8-12 times daily is quite normal. It may also be reassuring to mention that feeds will become less frequent, and often shorter, as the baby gets older, which can be welcome news to a tired new mum. Also, breastfeeding takes time, and while it is difficult to define what is ‘normal’ because every baby is different, newborns can nurse for up to 15-20 minutes on each side (though sometimes less), so it can help to ask the mother how long she is feeding for before changing sides. Breastmilk starts off as quite watery foremilk to satisfy thirst, before changing in consistency to thicker hindmilk, with a higher fat content that satisfies hunger for longer. This means that changing sides too soon can mean the baby only getting the foremilk, so they may get hungry again much sooner than would otherwise be the case. That said, many health professionals advocate watching the baby instead of the clock. A satisfied baby will come off the breast when they have had enough. If they have had 6-8 wet nappies and are settled and content between feeds and gaining weight, then it is very likely that they are getting enough milk. If a mother is still worried, she should speak with her midwife if within the first 14 days or health

visitor after that, who will be able to provide 1-1 advice and assess technique etc. Formula feeding Bottle-feeding is currently the most common method of infant feeding. Formula milks are mostly based on modified cow’s milk (although some are based on soya, or goat’s milk), with additives e.g. vegetable oils, vitamins, minerals and fatty acids. The two main types of protein in breastmilk are whey and casein. Whey is more easily digested and is the type of protein contained in the liquid part of milk when it curdles. 60% of breastmilk protein is made up of whey protein. Casein is the type of protein in the solid part of curdled milk and makes up the remaining 40% of breastmilk. Casein protein remain in the stomach for longer, and hence are slower to digest. Cow’s milk is 80% casein and 20% whey. The whey: casein ratio in ‘first’ infant milks is more closely aligned to that of human breastmilk (60:40), which makes these formulae generally easier to digest, especially for new-born babies.

48 | PHARMACYNEWSIRELAND.COM

Hungry milks have a higher percentage of casein than standard first milk. Casein takes longer to digest so it can help babies feel fuller for longer. These milks are used to help to delay the onset of early weaning. Follow-on milks The main difference between follow- on milks and first infant / hungry milks is that they have a higher iron content. Babies are born with a natural store of iron which begins to deplete around 6 months. As babies are usually beginning to wean at 6 months there are only taking very small amounts of food and may not be eating enough iron rich food at this stage. Parents can choose to move to a follow-on milk at 6 months which contains higher levels of iron that standard first milks. These milks are for babies over 6 months, and as such they may be advertised direct to the public.

that up to 15% show symptoms of an adverse reaction to it. CMPA can induce both acute IgE immunoglobulin-mediated reactions (within 2 hours) e.g. rash or urticaria, wheeze, vomiting, and also non IgEmediated reactions which are more delayed, e.g. mild-moderate eczema, reflux. Management of the allergy necessitates the complete removal of CMP from a baby’s diet. For the breastfed infant, this means that the mother must follow a strict milk-free diet, and because of this, she also needs to take supplements containing 1000mg calcium and 10 micrograms of vitamin D daily. Bottle-fed infants need a formula which contains no cow’s milk, and there are two main options available to achieve this: Extensively Hydrolysed Formula (eHF)

Cow’s Milk Protein Allergy (CMPA)

In these milks the protein causing the allergy is broken up into smaller

Cow’s milk protein allergy affects approx. 2-7.5% of babies, although NICE states

fragments (peptides) that are less likely to illicit an immune response. Aptamil Pepti and SMA


IPN are now looking for your nominations for the Dynamic 100  The Covid-19 pandemic brought pharmacy professionals even further to the fore of healthcare provision. Do you know someone who went above and beyond during this time of huge challenge?  Who has inspired you this year?  Who deserves recognition for a special project they have executed this year?  Who has shown an ability to get things done during a period of change?  Who has developed something new and innovative within their organisation? The Dynamic 100 will represent Ireland's pharmacy industry's most inspiring and enthuiastic people - the industry's very best, nominated by you, the IPN readers, collegues and peers of these individuals. We would like you to nominate (up to 10) indiduals for this years' IPN's Dynamic 100. All we need is a short explanation for their nomination. Nominations are sought from right across the pharmaceutical proffesion in Ireland and may include (but is not limited to) Managing Directors, Commercial Directors, Pharmacists, Superintendents, Brand Managers, Group Representatives, Buyers or Owners - and anyone inbetween! Individuals featured in 2020's Dynamic 100 may be nominated provided that the reasons for nomination relate to a project undertaken during 2020. The Dynamic 100 is a not-to-be-missed 'who's who' of pharmacy in Ireland Please email your nomination(s) to kelly-jo@ipn.ie or editorial@ipnirishpharmacynews.ie before 12/10/20


There are many baby bottles on the market claiming to be ‘anti-colic’, yet it is important to recognise, that not all ‘anticolic’ bottles are the same and understand the physics behind the bottle mechanics. In conventional feeding bottles, negative pressure is generated both in the oral cavity and in the bottle, when fluid is removed by sucking. Consequently, the negative pressure retained inside the bottle causes the infant to suck excessively. Back to School Althera are whey-based eHF milks and Nutramigen and Similac Alimentum are casein-based ones. 90% of babies with CMPA can tolerate these formulae. If a baby is still showing symptoms after 2-6 weeks on an eHF formula, they may be switched onto an amino acid formula. Amino Acid formula (AAF) These are for the remaining 10% of babies whose symptoms do not resolve on an eHF, and who require the peptides to be broken up further, into amino acids. AAFs are quite expensive and are more likely to be needed for babies who have multiple allergies or a family history of CMP. Examples include Neocate LCP, Nutramigen Puramino and SMA Alfamino. CMPA usually resolves over time, and in most cases has completely resolved by 3-5 years. Guidance on how to gradually introduce food with increasing amounts of CMP in a controlled manner is laid out in the Milk Ladder4, and this process is managed by a paediatric dietician. Parents should introduce cow’s milk back into their child’s diet under medical advice. Lactose intolerance This is usually transient and often follows an episode of gastroenteritis, during which there is a reduction in lactase activity for a period lasting from a few days up to a few weeks. True lactase deficiency is extremely rare. Unlike CMPA, symptoms are usually limited to the gastrointestinal tract, e.g. diarrhoea, abdominal pain, flatulence and bloating. The 3 main types of lactose intolerance are: Congenital - an extremely rare condition where babies are born with a genetic defect resulting in the absence of the lactose enzyme. Primary - a genetically inherited condition uncommon before 2-3 years of age, normally becoming apparent after 5 years of age. Secondary - a temporary, more common, condition caused by damage to the gut (where lactase

is produced) e.g. following gastroenteritis. Usually resolves after a few weeks once the gut heals. If a baby has been diagnosed with temporary lactose intolerance breastfeeding mothers should be encouraged to speak to a healthcare professional about a lactose free diet. Babies who are bottle fed are usually recommended to move to a lactose free milk for 6-8 weeks. After this time the damage to the baby’s gut has usually resolved and they can move back to their usual milk. Milks for colic and constipation Types of milk are commonly known as comfort milks and are a specialised formula for the dietary management of colic and constipation. They should only be used under medical supervision. They are nutritionally complete from birth to 6 months and can be used as part of a weaning diet from 6 months. Dealing with Colic Pharmacists play a unique role in the assistance of families coping with colic. They are easily accessible to parents and may often be the first healthcare professional to turn to for advice on an inconsolable infant. There are several points of advice, including: • Advise parents that colic is not curable, but inform them of some popular soothing techniques that may help • Make them aware of the fact that colic occurs in both breastfed and formula-fed babies, and the cause is unknown • Reassure them that colic is temporary and is usually gone by the time the infant is 3 months old • Ask open-ended questions related to how the parents are coping Changes as simple as choosing the right baby bottle can help avoid the swallowing of air and thereby, put a stop to wind related colic in babies.

50 | PHARMACYNEWSIRELAND.COM

Back to school this year is going to feel very different from previous years as we navigate the Coronavirus Pandemic. Hygiene is always high up the parent shopping list, this year it will be even more important. Headlice Headlice are spread from head to head contact, the eggs (nits) are usually laid at the nape of the neck or behind the ears. Once an infestation is confirmed (and we only recommend treating confirmed cases) a suitable product can be selected for your customer. The longer a treatment is in contact with the hair, the more effective it seems to be. Treatment times range from 10 mins to 12 hours overnight. If a child suffers from asthma or eczema, some of the lice treatments can aggravate these conditions so it is important to choose the right one. Understanding a person’s preference, medical and drug history, the product’s active ingredient, how the active ingredient works, how the product should be used and if anything has been tried previously will allow pharmacists and pharmacy staff to recommend and help parents choose the right head lice product. Mechanical removal involves systematically combing the whole head of wet hair with a detection comb to remove the lice. The comb must be cleaned after each pass through the hair to remove lice and eggs, which is best done by wiping it on clean white paper or cloth. The process must be repeated every few days for two weeks. Products containing dimeticone or isopropyl myristate kill the lice through physical action. Dimeticone coats the surfaces of head lice and suffocates them, while isopropyl myristate dehydrates head lice by dissolving their external wax coating. The advantages of these products are that they are easy to apply, they have few side-effects, are odourless or have only a faint perfume, and the head lice are unlikely to become resistant to them.

The life cycle of the creature is around 21 days so treating again after a week will catch any newly hatched lice but hit them before they become mature enough to reproduce. We recommend using the same treatment - only change if there is a complete failure. This common condition happens to even the most hygienic families, so assure parents that they have not failed in any way if an infestation affects their child. Worms (Threadworms) As with head lice, this condition may be considered highly embarrassing, although it is usually harmless and not serious. Usually the first sign that parents notice is the child scratching his or her bottom. Sometimes parents will see thread like objects in faeces, eggs can sometimes be seen around the opening of the anus. This condition is easily treated with an over the counter product, with a second dose used after two weeks. Liquid and tablets are available for treatment from 2 years old. It’s recommended to treat the whole household as infection can be present without symptoms. After treatment, step up the hand hygiene, cut fingernails short, wear underwear at night, and ensure the bottom is washed daily. Omega 3 Fish Oil Half of the fat in the brain contains one of the Omega 3 fatty acids, docosahexaenoic acid (DHA). So we know that it plays a crucial role in brain development. Some studies also show that there is a positive effect on concentration levels. They’re found in oily fish like salmon, sardines and mackerel but these are not popular food choices with children. We recommend a supplement to ensure children are getting all the benefits of Omega 3. More back to school top tips: • Focus on nutrition - a healthy balanced diet will help boost immunity, help concentration and fight fatigue • Be alert to early changes of behaviour during term time that could flag potential bullying issues • Get an eye check organised, there’s lots of visual demands on a school goer - devices, books, whiteboards, etc. An optician will also check for general eye health • Apart from diet and exercise, sleep has a huge impact on performance at school. Around ten hours is right up to age 13


30 30

%

of infants experience symptoms of regurgitation1

For bottle-fed infants with frequent regurgitation

ESPGHAN

*

March 2018

RECOMMENDS

a stepped-care approach...

REVIEW the feeding history. REDUCE the feed volumes by trialling smaller,

more frequent feeds (while maintaining an appropriate daily total).

TRIAL a thickened formula. Aptamil Anti-Reflux is a thickened formula for the dietary management of reflux and regurgitation in bottlefed infants

Clinically proven to reduce infant regurgitation episodes by

78%

2

AVAILABLE IN RETAIL AND PHARMACY OUTLETS * European Society for Pediatric Gastroenterology, Hepatology, and Nutrition References: 1. Vandenplas Y et al., J Pediatr Gastroenterol Nutr 2015; 61(5): 531â&#x20AC;&#x201C;537. 2. Wenzl TG et al. Pediatrics 2003;111:e355-9. IMPORTANT NOTICE: Aptamil Anti Reflux is a food for special medical purposes for the dietary management of frequent reflux and regurgitation. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. This product should not be used in combination with antacids or other thickeners and is not suitable for premature infants. Suitable for use as the sole source of nutrition for infants from birth and as part of a balanced diet from 6 months.

Ireland: www.aptamilhcp.ie FOR HEALTHCARE PROFESSIONAL USE ONLY.

Northern Ireland: www.eln.nutricia.co.uk July 2020


52

Healthy Heart

Self Care for a Healthy Heart September is Irish Heart Month and this year the campaign is focusing upon stroke prevention. Over 2,000 people under the age of 65 have a stroke each year, but 80% of premature strokes are preventable. can be spread over two to three sessions in the day. Avoid other risk factors The more cardiovascular risk factors someone has, the greater the urgency in getting their blood pressure controlled. This is also the case for those with a history of a heart attack or stroke. Smoking Smoking and high blood pressure are two serious factors that can cause a heart attack or stroke.

Tackling Obesity The Irish Heart Foundation has urged the Irish Government to follow UK Prime Minister Boris Johnson’s lead through tough new actions to tackle obesity. By making small changes to their lifestyle, patients can reduce their chances of having a stroke now and in the future. Community pharmacists are ideally placed to offer advice and guidance on self-care to ensure a healthy heart. The vast majority of people believe in the importance of self-care and personal responsibility — pharmacists are able to help patients understand the choices available to them. These small steps or lifestyle changes may help to reduce blood pressure and can sometimes bring blood pressure that is mildly high to a normal level. Blood pressure level The first step to improving blood pressure is to know it. Advise patients to regularly have their blood pressure checked. Aim for a healthy weight. Keep weight at a level that is right for their height and build is important. For those who are overweight, even losing 10% of excess weight can help lower blood pressure.

of salt, including sea salt, iodised salt, garlic salt and onion salt all contain sodium and so they have the same effect on health as common table salt. To make sure that their blood pressure stays at a healthy level, advise patients to cut down – or cut out – adding salt to their food, and eat less processed foods which are high in salt. Drink less alcohol Drinking a lot of alcohol can increase blood pressure and may damage the liver and heart. Small amounts of alcohol may provide some protection against heart disease, but there is not enough evidence to recommend including alcohol as part of a heart healthy diet. Advise patients to not drink more than the recommended upper limits: 17 standard drinks (SD) a week for men and 11 standard drinks a week for women. Embrace activity

Diet

Everyone needs to be exercising at a moderate intensity for at least 30 minutes, 5 days a week. Increasing activities to 60 minutes brings even greater health benefits.

It is the sodium in salt which causes the problems associated with high blood pressure. All types

Activities such as walking, cycling, swimming and dancing are all excellent and the 30 – 60 minutes

PHARMACYNEWSIRELAND.COM

The need for decisive action has been made more urgent than ever by evidence that people living with obesity are at increased risk of severe disease if they contract Covid-19. The Irish Heart Foundation said there was clear evidence that measures to curb junk food marketing that feature in the UK’s new obesity strategy such as strict advertising restrictions on broadcast media and online, along with banning promotions such as buy-one-get-one-free, had a crucial role to play in combating our obesity crisis. However, the Irish Heart Foundation said that the Irish Government should now look at going even further than their UK counterparts, through a range of additional actions such as mandatory reformulation of unhealthy food and beverages, an extension of the sugarsweetened drink tax to items such as confectionery and an ambitious programme to create a healthier built environment. “It’s clear that being overweight or obese puts people at greater risk of serious illness or death from COVID-19. The more successful we are in limiting the impact of the virus the quicker we will be able to return to

Advise all smokers on the benefits to kicking the habit and direct them to the plethora of NRT products on offer in the pharmacy. People to choose larger sizes or multiple amounts of unhealthy food and drinks; 74 per cent support removing sweets and other unhealthy products from end of aisles and checkouts in supermarkets, and 71 per cent support a ban on the marketing and promotion of unhealthy food and drinks to under 18s.

some sort of normality, so the case for decisive action on obesity has never been more compelling,” said Irish Heart Foundation Head of Advocacy, Chris Macey. “While our primary focus has been on tackling childhood obesity – which the State’s own research estimates will result in the premature deaths of over 85,000 of this generation of children on the island of Ireland – it’s clear that a lot more should also be done to protect adults, 61 per cent of whom are living with overweight or obesity.” Mr Macey said that in addition to reducing exposure to junk food marketing, reformulation and portion size control are among the measures that can have the biggest effect in reducing high levels of fat, sugar, and salt in people’s diets. Mr Macey added that there was strong public support for many important measures to tackle obesity according to polls carried out for the Irish Heart Foundation by Ipsos MRBI, which found that: 75 per cent of adults support a ban on price promotions encouraging people to choose larger sizes or multiple amounts of unhealthy food and drinks; 74 per cent support removing sweets and other unhealthy products from end of aisles and checkouts in supermarkets, and 71 per cent support a ban on the marketing and promotion of unhealthy food and drinks to under 18s.


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54

News

Examining the Evidence in Heart Disease Each September the Irish Heart Foundation runs a public awareness campaign to support Irish people in living a healthier life. Heart Disease is one of Ireland’s biggest killers. Every day, hundreds of Irish people are diagnosed with heart disease. Every hour someone in Ireland suffers from a stroke. Community pharmacists are ideally placed to help patients with heart failure via a number of ways; Supporting medication adherence; Offering lifestyle advice, eg, regular exercise, smoking cessation, fluid and dietary recommendations and in providing guidance on recognising and responding to symptom deterioration. Heart failure is a common disease for which multiple effective drugs are available even though longterm outcomes remain poor. Over the last number of years, studies have evaluated the potential effects of Coenzyme Q10. Coenzyme Q10 (CoQ10) is a ubiquitous factor present in cell membranes and mitochondria, both in its reduced (ubiquinol) and oxidized (ubiquinone) forms. Its levels are high in organs with high metabolism such as the heart, kidneys, and liver because it acts as an energy transfer molecule but could be reduced by aging, genetic factors, drugs (e.g., statins), cardiovascular (CV) diseases, degenerative muscle disorders, and neurodegenerative diseases.

As CoQ10 is endowed with significant antioxidant and anti inflammatory features, useful to prevent free radical-induced damage and inflammatory signalling pathway activation, its depletion results in exacerbation of inflammatory processes. Therefore, exogenous CoQ10 supplementation might be useful as an adjuvant in the treatment of cardiovascular diseases such as heart failure, atrial fibrillation, and myocardial infarction and in associated risk factors such as hypertension, insulin resistance, dyslipidemias, and obesity. Results from randomised controlled trials with CoQ10 in heart failure have accumulated since the late 1980s and although encouraging, the studies have been underpowered to address major clinical endpoints. Q-SYMBIO was one such trial carried out in 2014 and was the first double-blind randomised controlled trial with adequate size, dosage of CoQ10 and duration of follow-up to evaluate the efficacy of CoQ10 on morbidity and mortality in heart failure. The study authors note, “Despite considerable improvements in pharmacological heart failure therapy, the supplementation of CoQ10 significantly reduced MACE and cardiovascular death by 43% in our study. Furthermore, CoQ10 supplementation

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improved the patients’ symptoms according to the NYHA functional classification after 2 years.” A 2020 study, ‘Coenzyme Q10: Clinical Applications in Cardiovascular Diseases’ and summarises the current evidences on the use of CoQ10 supplementation as a therapeutic approach in cardiovascular diseases through the analysis of its clinical impact on patients’ health and quality of life. The study authors found that, “Clinical evidence supports supplementation with high doses of bioavailable-CoQ10 (≥200mg/ day) to support heart health in patients affected by coronary heart disease and heart failure, partly modulating a number of risk factors for these conditions, and partly directly acting on myocardial cell metabolism. Long-term RCTs are still needed to confirm and better understand the effcacy and safety profile of this molecule in a large number of patients and CV diseases.” September is also International Heart Valve Disease Awareness Week, which runs from September 14-20. Ahead of this, the heart and stroke charity Croí has highlighted the need for those over the age of 65 years to ask their doctor to listen to their heart with a stethoscope, at least once a year.

The call comes against a backdrop of low public awareness of heart valve disease which can lead to death within two years of severe onset if not diagnosed and treated. Heart valve disease is a common, serious but treatable disease. The chances of developing the condition increase with age, especially after 75 years, with estimates suggesting that 13 per cent of people over that age will experience heart valve disease. There are over 2.7 million people across Europe age 65 and over thought to have heart valve disease with this figure set to rise to 20 million within the next two decades due to changing age demographics. Irene Gibson, Croí Director of Programmes and Cardiovascular Nurse Specialist, “We know that the outcomes for people who are not treated for heart valve disease are stark. More than half of those with severe aortic stenosis – the most common form of heart valve disease – die within two years of developing symptoms if not treated. We also know that some of the symptoms such as breathlessness, feeling older than our age, tiredness and weakness, are often ignored and dismissed as simply age catching up with us. “Our older generation makes a vital contribution to society and as highlighted by COVID-19 we need to proactively cherish and protect them. Heart valve disease is predominantly a condition of ageing, being most common in older age groups. With more and more people living longer, we need to ensure that they can enjoy healthy longevity. Early diagnosis is key and it is one of the few heart conditions that has almost curative treatment options through either heart valve repair or replacement.”


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56

DVT

Involvement of blood clots in Deep vein thrombosis (DVT) and cardiovascular disease pathway that functions in normal hemostasis; and the contact pathway, which seems to act in host pathogen defences can lead to pathologic thrombosis. These unwanted blood clots contribute to substantial disability and death in the developed world. The tissue factor pathway or Extrinsic Pathway is triggered by a cell-surface protein known as tissue factor (TF). When cells expressing TF are exposed to blood, it immediately triggers the clotting cascade and the formation of blood clots.

Deep vein thrombosis (DVT) takes place when a thrombus also known as blood clot forms in a deep vein, usually in the leg; it can cause swelling and redness or be asymptomatic. The cause of DVT can be found in certain medical conditions that affect the blood favouring the creation of blood clots, it can occur after surgery, due to long time repose in bed, or because of other cause that block the free blood flow in main veins. The majority of pulmonary thromboembolism results from blood clots that break loose from the main veins of lower limb affected with DVT and travel through the bloodstream to the lungs. The blockage of the blood flow there cause a pulmonary embolism (PE) accounting for 30% mortality rate within one month, is usually the main and most serious complication associated with DVT. Traditionally, a DVT was immediately treated using blood-thinning drugs. However, anticoagulants do not actively dissolve a blood clot; they just prevent new clots from forming. The body will sometimes dissolve a clot, eventually, but often the vein becomes damaged. DVT treatment options include the commonly used anticoagulants or blood thinners, which although do not break up existing blood clots, can prevent them from growing bigger and reduce the risk of developing more clots. Treatment with anticoagulation is the accepted standard of care for DVT involving the proximal leg veins, specifically, the popliteal,

femoral, and iliac veins. In order to be ideal, an anticoagulant has to be efficient, safe, and easy to administer; it should require minimal monitoring and have a low cost. There are currently a good number of anticoagulants used in clinic, including intravenous heparin; Lovenox, Fragmin, Arixtra or Enoxaparin, injectable under the skin; or injectable blood thinners followed by warfarin or Pradaxa. As warfarin which requires periodic checking blood tests, Xarelto, Eliquis or Savaysa can be administered as a pill. The protective system of blood coagulation to prevent excessive blood loss after injury in normal hemostasis is based in a cascade of enzyme activations proenzymes and procofactors initiated by serine proteases with limited proteolysis, which results in the polymerization of fibrin and the activation of platelets, leading to a blood clot formation. While hemostasis is the normal process by which the clotting cascade stops vascular damage by limiting blood loss after an injury, pathologic thrombosis triggers the clotting cascade in the lumen of a blood vessel, leading to the formation of a blood clot or thrombus that can obstruct the flow of blood. Furthermore, severe thrombosis can block the blood flow to a tissue, leading to ischemia and tissue death. The blood clotting system which can be triggered by two mechanisms: the tissue factor

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TF also known as thromboplastin, coagulation factor III, or CD142 is a glycosylated, integralmembrane protein that does not need proteolysis to be activated; it is present in adventitial cells surrounding blood vessels and organ capsules, and is particularly abundant at anatomic sites where hemorrhage can result in disastrous consequences, such as kidney and brain, but usually absents in circulating blood cells and endothelial cells. In atherosclerosis, only a thin monolayer of endothelial cells separate blood from TF. Since myocardial infarction is considered to be triggered by the rupture of an atherosclerotic plaque in a coronary artery, as a result of that burst, TF is exposed to the catalytic serine protease enzyme coagulation factor VIIa (fVIIa) within the blood. Myocardial infarction occurs if the process of coagulation activation is big enough to form an occlusive thrombosis within the coronary vessel. Epidemiologic studies suggest that elevated plasma fVII may be a risk factor for thrombotic disease; high levels of circulating fVIIa have also been found with angina, transient ischemic attacks, diabetes, uremia, and peripheral vascular disease. The contact pathway or Intrinsic Pathway is triggered when plasma meets some artificial surfaces like glass test tubes or finely ground clay. This pathway does not contribute to normal hemostasis, but it is thought to participate in thrombotic diseases.

Written by Dr Maria Benito

The role of contact activation pathway seems to involve the generation of bradykinin an inflammatory mediator involved in vasodilation, vascular permeability, pain, and neutrophil chemotaxis, the contribution to fibrinolysis, and the inhibition of thrombininduced platelet activation and angiogenesis. This pathway of coagulation is initiated by activation of factor XII (fXII) in a process involving kininogen (HK) and plasma pre-kallikrein (PK) producing active factor XII (fXIIa), which activates PK to kallikrein, leading to thrombin generation and blood clots. There is therefore a fine but complex relationship between hemostasis and pathological thrombosis. Classical anticoagulant drugs that interfere in both pathways too much anticoagulation presents the risk of bleeding, and to little have the risk of thrombosis are some of the most widely prescribed medications today. However, drugs that inhibit initiation of the contact pathway by using antisense oligonucleotides to inhibit the biosynthesis of fXI or with a monoclonal antibody targeting the active site of fXIIa may be more effective antithrombotics with little or no bleeding side effects. Inhibition of the contact pathway as a method of anticoagulation not only carries less risk of bleeding than current therapeutics, it also has the potential to reduce the often-damaging connections between coagulation and inflammation in human disease. References available on request


hYour Matters! Heart Health Matters!

Rudimentaries Rudimentaries

oronary heart disease is one of the leading causes of death in Ireland for both men and women. High cholesterol is one of the major risk factors associated with coronary heart disease. Shockingly, 4 out of 5 people over 45 years have high cholesterol, and 2/3 of these are untreated. Scientific research has shown that plant sterols included with a heart healthy eating plan is a safe and effective way to lower cholesterol naturally.

PLANT STEROLS TO LOWER CHOLESTEROL

Zerochol® is a food supplement containing natural plant sterols which is present naturally in fruits, vegetables, nuts, seeds and grains. Consuming five times the normal dietary amount contributes to a reduction in LDL cholesterol levels. Taking plant sterols CHOLESTEROL CHOLESTEROL daily should be your first step in PROGRAM PROGRAM lowering LDL (bad) cholesterol. They work by blocking the absorption of While Zerochol is While very Zerochol is very cholesterol in the small intestine, which effective at lowering effective at lowering contributes to a significant decrease in ng) mackerel, herring) onanchovies, its salmon, own, it cholesterol has on its own, been it has been the blood LDLcholesterol (bad) cholesterol level. tive provides the most beneficial and shown that following active a heart shown that following healthy a heart healthy Plant sterols help prevent cholesterol EPA fatty acids, commonly referred to as EPA diet and diet and contribute lifestyle may further contribute from being absorbed, which can lowerlifestyle may further and DHA.cholesterol to healthy to levels healthy cholesterol and levels and LDL ‘bad’ cholesterol without negatively improve your overall heart improve your health. overall heart health. impacting HDL ‘good’ cholesterol. New es “Very informative! daily updates easy, Changing habits isThe never Changing habits sois never we’re easy, so we’re research confirms that 1.6 g (2 tablets) ed were encouraging. I have introduced a delighted delighted to introduce new to introduce FREE a new FREE ® plant sterols can lower ies Zerochol more fruit and vegetables, nuts, berries online support program which online support provides program which provides cholesterol by 17% in 3 months, without ol and fish into my diet. My cholesterol daily and lifestyle tipsdailyto diet and support lifestyle tips to support any side effects. Zerochol®diet also reduced from 6.6 to 5.2! your cholesterol lowering efforts. your cholesterol lowering efforts. reduced Triglycerides by 17%, further Christine Whelan, Laois improving the overall lipid profile and

TAKE CONTROL TODAY TAKE CONTROL TODAY reducing risk of heart disease. ority The European Food Safety Authority Sign up for the free program Sign upto for thereceive free program to receive east (EFSA) state that adults require at least “I have reduced daily my cholesterole-mail updates with information daily e-mail updates with information y to from 6.6 to 4.7. I'm amazed and 250mg Omega-3 EPA and DHA daily to relating to heart health, cholesterol, relating to heart health, cholesterol, on. delighted with this 3 month result! maintain healthy heart function. healthy fats, sugar and how healthy it fats, relates sugar and how it relates vey The Daily email was very informative Surprisingly, an IPSOS/MRBI survey to high cholesterol, how to to high increase cholesterol, how to increase not and kept me on my toes ! I'm also found that 89% of Irish people are not fibre plus lifestyle tips, recipes fibre plus lifestyle and tips, recipes and heir taking Eskimo oil daily; it works consuming sufficient oily fish in their healthy snack ideas. healthy snack ideas. ons so unless you’re eating 2-3 portions nicely along with Zerochol inup - diet, Sign www.zerochol.ie/register Sign up - www.zerochol.ie/register ent oily fish a week, it is wise to supplement keeping your heart healthy and h as with a high quality supplement such as brain active.” Eskimo-3! Grainne Murphy, Galway hind There is more scientific evidence behind oil the cardiovascular benefits of fish oil ent. than any other nutritional supplement. WHOLEFOODS WHOLESALE WHOLEFOODS WHOLESALE aveLOVE YOUR HEART Thousands of clinical studies have 01-6262315 01-6262315 andWITH OMEGA-3! shown that increased intake of EPA and cidsOmega 3s support brain, eye, and heart DHA—the omega-3 essential fatty acids local Wholefoods Contact your local Wholefoods erallhealth throughout life.Contact in your fish oil—enhance overall The really Wholesale representative to Wholesale order representative to order -3simportant fatty acids are cardiovascular function. Omega-3s the “Essential window packs, leaflets, or to window organise packs, leaflets, or to organise ousfatty acids” considered have been found to improve numerous “essential” as the virtual training. virtual training. p tobody cannot make them and therefore heart disease risk factors. They help to ucethey must be obtained daily through diet reduce blood pressure, reduce oodor supplementation. Oily fish (sardines, triglycerides and improve blood circulation.

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58

Precision Medicine

Designer medicines, designer prices Written by: Oisín Kavanagh | @KavanaghOisin SSPC, The SFI research centre for pharmaceuticals, Bernal Institute, University of Limerick

The aspirin controversy The late 1950s saw various studies in top medical journals which reported conflicting results with the bioavailability and sideeffect profiles of buffered aspirin products1. Known as the aspirin controversy, it took almost ten years before a physicochemical basis was offered to explain the apparent statistical variations. Gerhard Levy later wrote, “The formulation of pharmacologically active substances (drugs) into therapeutically effective pharmaceutical dosage forms requires considerable scientific skill, one which is not shared equally by all manufacturers.”2 The aspirin controversy centred around the inclusion of a buffer (sodium bicarbonate) which changed the dissolution rate of aspirin from tablets.1 The addition of one component might be considered simple, but this highlighted the potential ramifications of potentially small changes to drug formulation. Fast forward half a century and now we can point to a single enzyme or biochemical pathway to explain a disease pathology. This diagnostic complexity allows us to create a specific and targeted approach to treatment, better known as Rational Drug Design.3 This strategy emerged to describe development of small molecule entities to target a particular receptor site and has now shifted to biologics with the emergence

of monoclonal antibodies4. Biologics have been completely transformative for the field of pharmacy. Indeed, the often cited examples transtuzumab (Herceptin®) and rituximab (Rituxan®) – and their biosimilars – have changed many thousands of lives. Precision medicine The concept of precision medicine is not new, in the clinic this is a familiar strategy which is used often. From changing the dose based on altered renal or liver function and in less complex situations where adjustments are made based on body surface area or weight. Today the field has evolved and the latest research illustrates attempts to utilise genetics to decide the treatment that is best for a patient, “the right drug at the right dose for the right patient.”5 Pharmacogenomics also has roots in the selection of antihypertensives e.g. ACE inhibitors are not suitable for those of afro-caribbean decent. We are also aware of drugs used in daily practice with variable metabolism such as codeine and tramadol, this knowledge can act as a prescribing deterrent. Ultimately, the field of pharmacogenomics seeks to deepen our knowledge of drug metabolism to understand the impact of genetic phenotypes on drug response. Specifically, we want to predict a patients response to medicine before we deliver it. Right now the field of pharmacogenomics is often studied in reverse i.e. a dose

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of a drug is given and the patient phenotype is determined after investigation of the drug pharmacokinetics.6,7 Clearly, precision medicine offers better outcomes for our patients but these formulations are complex and will require equally complex formulation strategies. As such, biologics and other precision modalities are intrinsically more expensive than small molecules due to the complexities in manufacture. This is perhaps best reflected by the rising price of drug development8 and healthcare systems are beginning to buckle under the increased economic pressure. Is this modern approach to therapy realistic? Precision medicine requires precision treatments – and unfortunately – it is not economically feasible for drug companies to personalise all medicines for specific patients. Despite pharmaceutical companies donating significant amounts of medicines each year to patients who need them most, they are still businesses and are driven by economic incentives. This is not for lack of scientific skill, but that for many medicines their price is dictated by the economics of scale. Widespread genetic testing programmes such as 23andMe are a welcome development which may develop into a rich source of genetic information. This data could be coupled with contemporary computational power to repurpose older medicines. This strategy has been utilised by the scientific

commmunity9–12 and has commercial potential via patent extension9,13, however, it is possible that these incentives are not enough. Within the pharmacy profession extemporaneous dispensing can meet this need. Particularly as it has been identified that triple therapy using small molecule entities could be more cost-effective than biologics in arthritis.14 One can imagine that a pharmacist could provide an additional level of dose tuning, utilising genetic and pharmacokinetic data to generate even better outcomes. However, this area of professional practice has receded in recent years as the importance of the solid form on physiochemical characteristics (solubility, stability and ultimately bioavailability) has been highlighted – and for good reason. In 2011, Professor Alexander T. Florence, author of the much loved undergraduate textbook, Physicochemical Principles of Pharmacy noted that the profession should make stronger efforts to ensure clinical translation of our scientific training.15 Indeed, this scientific training is what makes pharmacists, pharmacists. Recently, Professor Duncan Craig (UCL Pharmacy) warned, “If we lose the science, we lose our unique selling point”.16 This is compounded by the absence of accurate analytical equipment in the typical pharmacy environment which limits the potential of extemporaneous techniques to enable cost-effective, precision medicine. This has resulted in articles from our physician colleagues making reference to pharmacists living in the dark ages – and we can’t blame them.17 These analytical tools also need to be combined with a strong fundamental basis. As illustrated


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60

Precision Medicine

previously, even simple one molecule systems are complex to formulate. Indeeed, despite the previous attention no aspirin suspension exists on the market.18 Development here might have benefits beyond our own society. As pharmacists are the only profession with the ability to formulate medicines currently on patent. Here, these skills can enable the continuation of supply, in times of uncertainty (e.g. Brexit) or indeed enable high-quality care in war torn or poverty stricken environments. For example, across the spectrum of Neglected Tropical Diseases some patients – particularly children and the elderly – who might have swallowing difficulties, are forced to take oversized tablets which can cause them to choke. In 2016 Pfizer announced their device challenge to tackle this issue. This provided funding for researchers to develop

a formulation system which would enable pharmacists to deliver pharmaceutical precision without the safety concerns. Unfortunately it appears that a product is yet to be developed,19 perhaps this was again hindered by economics. However, this poses a new question, does the use of these recycled medicines mean that we are entering a time were latest (and most expensive) medicines are afforable for the few, but not the many?

A difficult choice Famously, the French impressionist Pierre-Auguste Renoir had Rheumatoid Arthritis. This forced him to change his painting technique as his disease progressed and he required an assistant to wedge a brush between his fingers.20 Despite advances in understanding and treatment of this condition, patients today face the same difficulties as Renoir, with many

unable to take pleasure in the things they love. It’s not difficult to imagine how complex it is for a physician faced with treating someone that has been stripped of their livelihood. Which option should they choose? Costeffective reformulations or the latest biologic? What should they try to achieve with drug therapy? Then again, the latest drugs don’t promise that you’ll be able to paint any better… References available on request

From left: Luncheon of the Boating Party (1882) and Madeleine Leaning On Her Elbow With Flowers In Her Hair (1918). Renoir, known for his detail saw a decline as his Rheumatoid Arthritis progressed. Adapted from Boonen et al.20

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62

Osteomalacia

Osteomalacia and Vitamin D Written by: Dr Sharon Cowley; Rheumatology Specialist Registrar, Mater Misericordiae University Hospital and Professor Gerry Wilson; Consultant Rheumatologist, Mater Misericordiae Hospital, St Vincent’s University Hospital, Conway Institute of Biomolecular & Biomedical Research, UCD.

Dr Sharon Cowley

Professor Gerry Wilson

SUMMARY: Osteomalacia is a metabolic bone disease characterised by impaired bone mineralisation. The primary defect is in the mineralisation of normally formed osteoid (organic matrix) at sites of bony turnover. Reduced mineralisation results in soft bones which are easily deformed and fractured. Symptoms, if present, are varied and consequently diagnosis is missed leading to delayed treatment. It is commonly misdiagnosed as hypothyroidism, inflammatory myopathies, multiple myeloma and even arthritis. The most common cause in Ireland is vitamin D deficiency. Diagnosis is made with a combination of clinical, laboratory and radiographic findings. Bone biopsy is the gold standard, but in practice is rarely performed. Treatment most commonly involves calcium and vitamin D supplements.

world's population is not getting an amount of vitamin D sufficient to maintain healthy bone mass and minimize the risk of fracture. The workshop members also agreed that vitamin D insufficiency decreases muscle strength and increases the risk of falls.1 Vitamin D deficiency is one of the most common nutritional deficiencies in Europe. A recent European study has identified 13% of its sample population from across 9 EU countries as having vitamin D deficiency (<30nmol/l).2 A Cork based Irish study completed in 2012 found the average prevalence of vitamin D deficiency to be 6.7%, increasing in winter to 7.5%.3 This is even more profound if we use the cut off of <50nmol/l which the Royal Osteoporosis Society uses to treat patients with additional risk factors4, based on the same Cork based cohort prevalence rises to 40.1% all year round and peaks at 55% in winter.

Introduction Osteomalacia is still an important metabolic bone disease. It is sometimes confused with rickets which is a disorder of defective mineralization of cartilage in the epiphyseal growth plates of children. Osteomalacia and rickets can occur together in children (open growth plates), but only osteomalacia occurs in adults (fused growth plates). Several different disorders cause osteomalacia via mechanisms that result in hypocalcaemia, hypophosphatemia, or direct inhibition of the mineralization process. The most common cause in the general population is vitamin D deficiency. Vitamin D Deficiency At an international workshop on vitamin D held in 2007, there was agreement that most of the

Vitamin D has a well-established role in calcium homeostasis and in maintaining bone health and preventing osteomalacia. Deficiency of this vitamin leads to inadequate skeletal mineralization and leaching of calcium from the skeleton and is the commonest cause of osteomalacia in Ireland.5 This can occur through many mechanisms. Deficiency can be a result of increased requirements such as during adolescence,

pregnancy and lactation. Decreased synthesis of vitamin D can also lead to deficiency. This can be caused by reduced sunlight exposure at higher latitudes as 90% is synthesised in the skin and only 10% found in diet. During winter periods we are particularly vulnerable as sun exposure in Ireland is only strong enough to provide synthesis from June – September. At risk also are indoor workers and those with increased skin pigmentation, as well as those who cover up for cultural or religious reasons. Another cause is inadequate absorption of vitamin D which can be due to gastrointestinal diseases including coeliac disease or inflammatory bowel disease. Impaired metabolism of vitamin D can also lead to deficiency. Hepatic failure limiting 25-hydroxylation of vitamin D or chronic renal disease resulting in inadequate 1α hydroxylation can be implicated. There are many less common causes of osteomalacia including hypophosphatemia, renal tubular acidosis and exposure to drugs that inhibit the mineralisation process such as fluoride, aluminium and possibly nitrogen containing bisphosphonates.6 Clinical Features The features of osteomalacia, if present, are often insidious in onset. Bone pain and muscle weakness are the most common symptoms and are present in over 90% of patients with bone biopsy proven osteomalacia.7 Pain is generally dull and exacerbated by weight bearing. Proximal muscle weakness is often a marked feature. Patients may have difficulty climbing stairs or getting out of a chair. Bony tenderness occurred in 88% of patients in one study with 7 biopsy proven osteomalacia and proximal medial femur. and 100% of patients in another

study with diagnosis made on clinical, laboratory and radiological grounds.8 Fractures can occur with little or no trauma and typically involve the ribs, vertebrae and long bones. Difficulty walking and waddling gait may also be a feature. It is likely that high levels of parathyroid hormone (PTH) and low levels of phosphate and calcitriol all contribute to the myopathy and similar findings occur in severe primary hyperparathyroidism. Muscle spasms, muscle cramps, a positive Chvostek's sign and tingling or numbness. Abnormal spinal curvature or deformity of the thorax or pelvis appears only in severe osteomalacia of long duration.9 As a result of its varied presentation it can often be misdiagnosed as hypothyroidism, inflammatory myopathy, multiple myeloma or even arthritis. Laboratory Features Laboratory features of osteomalacia secondary to vitamin D deficiency have been identified in retrospective reviews10 and include: • Alkaline phosphatase elevated in 95 to 100% • Serum calcium and phosphorus reduced in 27 to 38% • Urinary calcium low in 87% • 25-hydroxyvitamin D (25[OH]D, calcidiol) <15 ng/mL in 100% • PTH elevated in 100% It is worthwhile to note the majority of these patients had nutritional osteomalacia from either a gastrointestinal disorder or suboptimal nutrition and inadequate sun exposure. They have laboratory features consistent with may secondary True fractures occur through hyperparathyroidism.

the

Image 1: Osteopenia changes involving bony pelvis and proximal femurs. Multiple pseudofractures are seen involving the superior and inferior pubic rami bilaterally. There is also a transcervical fracture on the right side. Image from Radiopedia.org

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Image 1: Osteopenia changes involving bony pelvis and proximal femurs. Multip superior and inferior pubic rami bilaterally. There is also a transcervical fracture


severe vitamin D deficiency. These includes subperiosteal resorption of the phalanges, bone cysts, and resorption of the distal ends of long bones such as the clavicle and humerus. More severe osteomalacia can lead to shortening and bowing of the tibia, pathologic fractures, coxa profunda hip deformity. Coxa profunda is a non-specific finding and refers to a deep acetabular socket. Image 2: Coxa profunda (pincer type femoroacetabular impingement). Image from radiopedia.org

63

primary hyperparathyroidism. Consideration may be given to DXA, especially if the patient has other risk factors for bone loss. Conclusions

TEST

and they advise treating all Osteomalacia is a metabolic bone patients with vitamin D levels disease that can have profound below 25nmol/l and also those consequences especially on with levels between 25-50nmol/l the older population if fracture who have risk factors including ensues. Increased awareness of fragility fracture, osteoporosis, vitamin D’s role in metabolic bone symptoms suggestive of vitamin disease is a useful tool to prevent D deficiency, reduced UV this disease. It is clear the Irish exposure, raised parathyroid population have a significant risk of Image 2: Coxa Features profunda (pincer type femoroacetabular impingement). Image from radiopedia.org assessment. Transiliac bone biopsy Radiological hormone, on treatment with vitamin d deficiency due to many should be completed by a skilled anticonvulsants or glucocorticoids factors such as latitude, reduced X-ray remains the most important professional. It is preferred as it Histological Diagnosis or malabsorption.4 Vitamin D sunlight exposure and dietary imaging technique for metabolic 12 is a relatively accessible site. A levels should ideally be checked intake. Patients with a vitamin D bone disease. The most common definite diagnosis of osteomalacia one for month after replacement. If level Although routinely performed bone biopsy is the gold standard diagnosis of osteomalacia. It below 25nmol/l should have radiographicnot abnormality is cortical requires an osteoid volume of abnormalities persist with calcium replacement therapy and those thinning but this is a non-specific >10% along with evidence of may be useful if the diagnosis remains unclear after clinical, laboratory and radiological assessment. levels, rechecking PTH can be with a level between 50nmol/l finding and these are generally decreased mineralization as useful as often replacing vitamin should also be treated if they have Transiliac bone biopsy should be completed by a skilled professional. It is preferred as it is a not to be relied upon for definitive assessed by tetracycline double D can unmask concomitant risk factors. 5 diagnosis. Looser zones also Double-labelling of the labelling. relatively accessible site (12). A definite diagnosis of osteomalacia requires an osteoid volume of known as cortical infarctions, bone with tetracycline should be Vitamin D and Bone Health: >10% along evidence of decreased assessed by tetracycline double labelling milkman’s lineswith or pseudofractures completedmineralization before the bone as biopsy A Practical Clinical Guideline for Patient Management are lucencies that extend part is performed. This involves giving (5). Double-labelling of the bone with tetracycline should be completed before the bone biopsy is (for use in conjunction with full guideline) The quick guide way through the bone usually at two doses of tetracycline 10-14 performed. involves giving two doses of tetracycline 10-14 days apart. The amount of bone a right angle toThis the cortex. They days apart. The amount of bone • Patients with diseases with outcomes that may be improved with vitamin D treatment e.g. confirmed are a type of insufficiency fracture formed during that period osteoporosis formed during that period can be calculated from the can distance between theosteomalacia, double bands of that strongly favour the diagnosis be calculated from the distance • Patients with symptoms that could be attributed to vitamin D deficiency e.g. suspected osteomalacia, chronic widespread pain with other features of osteomalacia tetracycline labels during histologic evaluation (12). when they are fluorescence present bilaterally between the double bands of • Before starting patients on a potent antiresorptive agent (zoledronate or denosumab or teriparatide) in a symmetric pattern and in a tetracycline fluorescence labels classic location such as the axillary during histologic evaluation.12 25(OH) vitamin D (nmol/L) border of the scapulae, ribs, or 25-50 <25 Treatment of Vitamin D >50 posterior ulnae. Other frequently Deficiency involved sites include the superior

Society, Royal Osteoporosis. s.l. : Guidelines , 2019. 5. Osteomalacia - What the rheumatologist needs to know. al, Arya et. s.l. : Indian Journal of Rheumatology, 2007, Vol. 2; 1722. 6. O1. Osteomalacia: The missing link in the pathogenesis of bisphosphonate related osteonecrosis of the jaw? . al, Bedogni et. 2012, Oncologist, pp. 17(8);1114-9. 7. Osteomalacia revisited. al, Gifre et. s.l. : Clinical Rheumatology, 2010, Vol. 30; 639-45.

Histological Diagnosis

If one or more of following applies: • Fragility fracture/osteoporosis/ high fracture risk • Drug treatment for bone disease • Symptoms suggestive of vitamin D deficiency • Increased risk of developing vitamin D deficiency e.g. • Reduced UV exposure • Raised PTH • Treatment with anticonvulsants or glucocorticoids • Malabsorption

INTERPRET

References 1. Workshop consensus for vitamin D nutritional guidelines . al, Norman et. s.l. : Journal of Steroid Biochecmistry and Molecular Biology, 2007, Vol. 103; 204-5 2. Vitamin D deficiency in Europe: pandemic? al, Cashman et. s.l. : American Journal of Clinical Nutrition, 2016, Vol. 103(4); 957-8 3. Vitamin D status of Irish adults: findings from the National Adult. al, Cashman et. Cork : British Journal of Nutrition, 2012, Vol. 109; 1246-56 4. Vitamin D and bone health: A practical clinical guide for patient management.

Other radiographic changes can include those related to secondary hyperparathyroidism from severe vitamin D deficiency. These includes subperiosteal resorption of the phalanges, bone cysts, and resorption of the distal ends of long bones such as the clavicle and humerus. More severe osteomalacia can lead to shortening and bowing of the tibia, pathologic fractures, coxa profunda hip deformity. Coxa profunda is a non-specific finding and refers to a deep acetabular socket.

Maintain vitamin D through safe sun exposure and diet

Treat

Treat Rapid correction if:

TREAT

Although not routinely performed bone biopsy is the gold standard for diagnosis of osteomalacia. It may be useful if the diagnosis remains unclear after clinical, laboratory and radiological

25 hydroxycholecalciferol (25(OH-D)) although biologically inert until converted to 1,25 hydroxycholecalciferol remains the best measurement of overall vitamin D reserves as the half-life of the active form is <4 hours.13 The Endocrine Society classifies vitamin D deficiency as a level below 25nmol/l and vitamin D insufficiency as a level below 30nmol/l.14 They recommend that deficient adults are treated with 50,000 IU of Vitamin D2 or D3 once a week for 8 weeks or 6000 IU per day for the same time period. This is available in a variety of preparations. This should be followed by maintenance therapy of 1500-2000 IU/day. The aim is to achieve a blood level of 25(OH) D above 30nmol/l. In patients with obesity or malabsorption syndromes they suggest a dose two or three times higher for replacement and a maintenance dose of 3000-6000 IU/day.13 The Royal Osteoporosis Society give similar recommendations

HOW TO TREAT VITAMIN D DEFICIENCY

• Symptoms of vitamin D deficiency • About to start treatment with potent antiresorptive agent (zoledronate or denosumab or teriparatide)

CAUTION

• Approximately 300,000 IU vitamin D3 (or D2) orally in divided doses over 6-10 weeks • Commence maintenance vitamin D 4 weeks after loading as per elective correction*

Elective correction in all other instances

*

• When co-prescribing vitamin D supplements with an oral antiresorptive agent, maintenance therapy may be started without the use of loading doses.

FOLLOW UP

and inferior pubic rami, and proximal medial femur. True fractures may occur through these weakened sites.11

• 800-2,000 IU vitamin D3 daily or intermittently at higher equivalent dose

• Check serum adjusted calcium one month after treating with loading doses of vitamin D. Vitamin D repletion may unmask primary hyperparathyroidism • Routine repeat vitamin D testing is generally unnecessary Example regimens are given in Appendix 1 of the full guideline

Image 3: Royal Osteoporosis Society Guidelines on Vitamin D treatment. Published online in guidelines.co.uk by Royal Osteoporosis Society “ROS Vitamin D and Bone health Guideline” March 2019. 8. Aetiology and clinical profile of osteomalacia. al, Rajeswari et. s.l. : National Medical Journal of India, 2003, Vol. 16; 139-142. 9. al, Lips et. Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism. s.l. : John Wiley & Sons, 2013. 10. Osteomalacia due to vitamin D depletion: a neglected consequence of intestinal malabsorption. al, Basha et. s.l. : American Medical Journal, 2000; 296-300. 11. Resnick. Diagnosis of bone and joint disorders; 2670 12. Bone densitometry and bone biopsy. al,

Ralston et. s.l. : Best Practice Clinical Rheumatology, 005, Vol. 19; 487-501 13. Vitamin D deficiency. Holick. s.l. : New England Journal of Medicine, 2007, Vol. 357; 266-281 14. Evaluation, Treatment, and Prevention of Vitamin D Deficiency: an Endocrine Society Clinical Practice Guideline. al, Holick et. 7, s.l. : Journal of Endocrinology and Metabolism, 2011, Vol. 96; 1911-30 15. The Role of Vitamin D in Cancer Prevention. al, Garland et. 96(2), s.l. : American Journal of Public Health, 2006; 252-61

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64

News

Emerging Research in Back to School Peter Conry, Pharmacist and Managing Director of Nutricentric looks at the Back to School market, and working within the ‘new normal’, in this 'Back to school guide'. Other Japanese research showed that 4 layers of silk caught over 90% of micro-droplets. Obviously, if masks (of any sort) aren’t close to the skin, micro-droplets can escape through the gaps but they won’t be shooting towards the person you’re talking to. Tighter fitting medical masks – like the N95 type – reduce the gaps and increase protection of the wearer. My own preference is to adapt the ear-bands by cutting them and adding an elastic band top and bottom so I can tie them around my skull rather than around the ears.

We know that there will be schoolrelated cases. We also know the many reasons why schools needed to open. Parents will naturally worry, so we have to have a set of measures that can minimize risks and potential consequences for children, their friends, siblings, parents and grandparents. Anticipate an onslaught of trolling on social media so here’s a recap of the key messages for you and your customers. If anything, their importance has only been underlined by the ongoing tide of COVID research: 1. Total viral load Total viral load is a key determinant of the severity of infection. And that’s why wearing masks is so important. There is no 100% barrier, but every extra barrier makes a (big) difference. More of that anon. You can accumulate a large viral load via one or two big exposures or multiple small exposures over a relatively short time (e.g. on a bus). All our precautions are aimed at ensuring that little or nothing gets through. And if anything does get through, that the total viral load will remain low. Apart from masks, you’d look at more frequent washing of coats or anything else that could collect droplets. I have been trialling IgG antibody tests. I’ll cite two examples. One man in Co. Wicklow attended Cheltenham and he and 5 of his 6 companions ended up in hospital with COVID-19. He had probably the most severe case of anyone who survived the disease. Yet his wife – who had made him change clothes at the hall door when he arrived home from England, and dutifully used antiseptic wipes on door handles and anything he touched in the days before

he showed symptoms – tested negative. And another man in Dublin, who had been unable to smell the After-Shave his sister bought him for Christmas, was home sick for weeks. As this was December 2019, his treatment consisted of antibiotics. He ultimately made a recovery and was able to smell his Christmas gift by the end of January. His COVID-IgG antibody result was still strong in May. His wife, a nurse, was negative. He has required a coronary stent in recent weeks – possibly related to COVID. Why do I mention these? In both cases, the wives and children didn’t show any signs or antibodies against COVID-19. They were careful and took all reasonable precautions, but they weren't wearing HazMat suits. Although these are anecdotal cases, they support sticking to the normal precautions - hand washing, cleaning surfaces and others that we'll recap here.

Early in the pandemic, when masks weren’t universally required, I advised wearing N95 or better in pharmacies and other healthcare settings rather than mere surgical masks. With most people now masked, that is no longer as important. The graph (not specific to COVID) on mask-wearing versus mask efficiency shows that you can be as safe with a less efficient mask once nearly everyone is wearing one2. Dark blue is the safest zone.

the chin. We all have to do our bit. Visors are a physical barrier to expelled droplets (and protect others) but don’t filter inhaled air at all. The WHO August report on masks in schoolchildren recommends a differentiated approach. Small children are a law unto themselves and the WHO concludes that there’s generally no point in trying to make them comply with mask rules, but some children would be ok with them. From 6-12, they recommend a common-sense approach. There would be greater urgency, for example, if the child has greater health risks, or if there’s been a surge in local cases. From 12, they advise the same approach as in adults. 3. Personal space

The term social distancing is being deservedly replaced by physical distancing. We actually want to encourage social contact. Distance won’t completely eliminate exposure but drops will be well on their way to the ground by the 2 metre mark. Micro-droplets Outside the pharmacy, non-medical can be in the air longer but more masks of natural fibres, if there are micro-droplets. Obviously, masks (of anyjob sort) aren’t close to(and the skin, can space lessmicro-droplets people in the multiple layers, will ifdo a good escape through the gaps but they won’t be person you’re talking to. space)the allows dispersal – especially of preventing outward escape ofshooting towards outdoors (see below). droplets are washed Tighter fitting once medicalthey masks – like the N95(70 type – reduce the gaps and increase protection degrees or more, soap or detergent) of the wearer. My own preference is to adapt the ear-bands by cuttingit’s them and adding an to 4. Outdoors much harder at least daily. absorb elastic band top andThese bottom fabrics so I can tie them aroundaccumulate my skull rather than around the ears. a large viral load droplets so frequent washing is Early in the pandemic,they whenare masks weren’t universally required, I advisedmost wearing N95 or after key. However, much easier China analyzed patients better in pharmacies and other settings rather than mere surgical masks. With to breathe through andhealthcare that can’t the initial Wuhan outbreak and most now masked, thatisisonly no longer The graphthat (not only specific to COVID) bepeople forgotten. A mask as as important. concluded one of over on good mask-wearing maskwearability. efficiency shows that you can be as safewas withalmost a less efficient as its versus practical 7,300 cases certainly 2 mask once nearly everyoneifishanging wearing one . Dark bluepicked is the safest zone. up outdoors (neighbours). They’re all useless under

2. Masks work A few months ago there weren’t any. Now you can get them in your County colours. And designs are multiplying – some even have an antimicrobial surface. All are needed as they reduce potential viral load to others and to yourself. I’ve been trawling the latest research and here are some pointers. Multiple layers are better than one. Recent Japanese simulations found that a normal multilayer (nonwoven, polypropylene) surgical mask catches almost all of the droplets emitted by a cough. And even a mask with two layers of T-shirt cotton will catch close to 80%. Putting a couple of layers of paper tissue between the cotton layers would further close the gap.

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Outside the pharmacy, non-medical masks of natural fibres, if there are multiple layers, will do a good job of preventing outward escape of droplets once they are washed (70 degrees or more, soap or detergent) at least daily. These fabrics absorb droplets so frequent washing is key. However, they are much easier to breathe through and that can’t be forgotten. A mask is only as good as its practical wearability. They’re all useless if hanging under the chin.


65 And that’s very encouraging. Breeze and sunlight help dissipate and inactivate expelled droplets. But distance remains your friend. At the school gate, avoid the touchy-feely person like the plague. Civilized conversation is still perfectly possible when you keep a bit of distance and try to ensure any prevailing wind carries your droplets away from the person you’re chatting to. If you can tell what they had for breakfast, you’re too close. On the same basis, most outdoor sport is low-risk. But take care where you shout if, by any chance, you are allowed on the sideline. 5. Sugar, oh sugar It’s not all about the virus, a lot also depends on your immune system. There are helpful supplements, but one of the avoidable risk factors may be in your child’s treat bag: sugar. One statistic. Diabetics with good glycaemic control had one tenth the COVID mortality of those whose blood sugar was poorly controlled. You might worry about a child’s tendency to pick up colds and forget that what you lovingly put in his (or your!) treat bag also plays a role. There is some biochemical research that suggests the culprit is fructose rather than glucose. If you recall, sugar is an even mix of fructose and glucose. Fructose is responsible for most of the sweetness. So just keep an eye on the stuff you can control. 6. Re-infection You will have read that the virus has mutated and that several people have been re-infected. Mutation is normal and not always

Peter and staff at LloydsPharmacy Gorey harmful. Newer versions might be more infectious but less lethal (like COVID-19 compared to its cousin SARS). When the accumulated changes are sufficiently large, re-infection is possible. At this stage it’s not a major concern. Research in Singapore showed that people who had SARS in 2003 had neutralizing antibodies that worked against COVID-19. Your immune system makes multiple antibodies against an infection. Some of those may no longer be relevant if the virus mutates, but others should still be able to recognize and neutralize the infection. I’d put it like this. Imagine how you recognize a person – it might be the eyes, the hair, the mouth or the way they move. Even if they wear sunglasses or get a haircut, their other features will likely still be enough for you to identify them. And so hopefully out immune systems. One remaining concern is more that these re-infection cases (asymptomatic as you’d expect) might be able to infect others before the immune system kicks in. As of writing, that hasn’t been shown. My current take is that it’s way down on the list of “Things to keep me up at night”. COVID is still behaving like most viruses before it. Conclusion We know what to do. Research has strengthened the validity of standard approaches adopted

against airborne infections in the past, notwithstanding whatever daily theories circulate on Twitter or Facebook. An Australian Broadcasting Corporation medical podcast posed the question on everyone’s minds “Can a fart transmit the coronavirus?” After all, diarrhoea is a prominent COVID symptom and the virus has been isolated from air samples in toilets. A friend of mine, let’s call him M, was diagnosed and spent time in the COVID ward of Tallaght Hospital. His breathing had been ok, but the pounding head, muscle pain, lethargy and constant bloody diarrhoea led him to get tested. He tested positive and received i.v. fluids for 2 days. On the third, he sent me a WhatsApp pic of his first solid stool with the caption “Like winning the Lotto”. But, I digress. As I know you want to know, I’ve looked at (but wish I hadn’t) the

available research on flatulence and its role in transmission of infection. And the learning is that, again, the two intervening layers of fabric come up trumps. Wear a mask! References: 1. Advice on the use of masks for children in the community in the context of COVID-19 [Internet]. Who.int. 2020 [cited 30 August 2020]. Available from: https://www.who.int/publications/i/ item/WHO-2019-nCoV-IPC_MasksChildren-2020.1 2. Robinson JF, de Anda IR, Moore F, Reid JP, Sear RP, Royall CP. Efficacy of face coverings in reducing transmission of COVID-19: calculations based on models of droplet capture. arXiv preprint arXiv:2008.04995. 2020 Aug 11. 3. Do cloth masks work? Supercomputer Fugaku says yes [Internet]. Nikkei Asian Review. 2020 [cited 31 August 2020]. Available from: https://asia.nikkei.com/ Business/Technology/Do-cloth-maskswork-Supercomputer-Fugaku-says-yes 4. ABC Coronacast with Dr. Norman Swan “No bare bottoms” Dr. Norman Swan weighs in on Coronafarts

EMeRGe Conference 2020 EMeRGe, RCSI and HSE supported by HRB are hosting their first virtual conference this Autumn. The conference is titled, ‘Medication without Harm: Communicating and promoting safe medicines in Ireland.’ The event takes place on Monday, 28th Sep and will encompass a half day of exciting talks and presentations from approximately 9am – 1pm. Free to attend, all welcome (all healthcare professionals, patients & public), register your interest at: emerge.ie/conference

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66

Educational

Chickenpox and Shingles Also known as varicella zoster virus, chickenpox is often seen in children under eight years of age. Symptoms include an itchy rash (mainly on the chest and back) comprising of spots that resemble blisters. Discomfort is notably worse if the skin is too warm. Finally, scabs form where the blisters were, which may leave some slight scarring. It usually takes two to four weeks for the rash to completely heal. There is no cure for shingles, but treatment can help ease symptoms. For those who develop the shingles rash advise: • Keep the rash as clean and dry as possible. This will reduce the risk of the rash becoming infected with bacteria • Wear loose-fitting clothing. This may help sufferers feel more comfortable • Do not use topical (rub-on) antibiotics or plasters (adhesive dressings) as this can slow down the healing process

Chickenpox tends to last between 7-21 days. Paracetamol should be given in the case of fever and cooler baths. Calamine lotion is the traditional option for topical use but is drying in nature. Newer cooling gels/sprays are available to reduce itching and limit any potential scarring. Advise parents to keep their child away from others – especially pregnant women or immunosuppressed individuals. Ibuprofen is no longer advocated as it can make the lesions worse. Last year, calls were made to introduce a vaccination to prevent thousands of children catching the highly contagious chickenpox each year. The Varivax vaccine is not part of the national childhood immunisation programme at present, despite having been successfully rolled out in other countries. Both Sinn Féin and Fianna Fáil have called for the vaccination, which is currently available privately, to be rolled out as part of the public system. Sinn Féin health spokesperson Louise O’Reilly said she would support the roll-out of a chickenpox vaccine along with an information and education campaign.

Shingles Herpes zoster (HZ), also known as zoster or shingles, is caused by the reactivation of the varicella zoster virus. Community pharmacists have the opportunity to play a key role in the early detection and treatment of HZ. By knowing the signs and symptoms of HZ, pharmacists can help their patients identify it and seek immediate treatment. Early identification is critical.

is most common in people who are over 50 years of age. Among people who are over 80 years of age, about 11 people in every 1,000 have shingles each year. Shingles is much less common in children. It is unknown exactly why the shingles virus is reactivated at a later stage in life, but it may be due to having lowered immunity (protection). This may be the result of:

• Use a non-adherent dressing (a dressing that will not stick to the rash) if they need to cover the blisters, for example to prevent passing the virus to anyone else Calamine lotion has a soothing, cooling effect on the skin and can be used to relieve the itching. An antihistamine may also be useful for preventing itching at night. To ease the pain caused by shingles, analgesics may be used such as: • paracetamol • non-steroidal anti-inflammatory drugs (NSAIDs)

Most people have chickenpox in childhood, but after the illness has gone, the virus remains dormant in the nervous system. The immune system keeps the virus in check, but later in life it can be reactivated and cause shingles.

• being older

• opioids

• being stressed

• antidepressants

• a condition that affects your immune system, such as HIV and AIDS

• anticonvulsants

Shingles usually affects a specific area on either the left or right side of the body. The main symptoms are:

The shingles rash usually follows several days after the start of the pain. The rash appears on one side of the body and develops on the area of skin that is related to the affected nerve.

• pain • a rash, which develops into itchy blisters and then scabs over It is estimated that about 3 people in every 1,000 have shingles in the UK every year, so the figure for Ireland should be similar, according to the HSE. Shingles can occur at any age, but

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Rash

Initially, the shingles rash appears as red blotches on the skin, before quickly developing into itchy blisters that are similar in appearance to chickenpox. New blisters may appear for up to a week, but about three days after appearing they become yellowish in colour, flatten and dry out.

Chickenpox - When to Refer For most children, chickenpox is a mild illness that gets better on its own. However, some children can become more seriously ill with chickenpox and need to see a doctor. Advise referral to a GP if a child develops any abnormal symptoms, such as: • if the blisters on their skin become infected • if the child has a pain in their chest or has difficulty breathing


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68

Feature

Signposting Patients with Wet AMD Pharmacists cannot stop the progressive loss in central vision that comes with age-related macular degeneration, but they can help patients understand the treatment options. There are 2 types of macular degeneration: dry and wet. Dry macular degeneration, also known as the nonexudative form, is more common and found in approximately 90% of AMD patients. The onset of dry AMD is subacute. Management of dry AMD includes attempts to prevent progression to and frequent monitoring for the development of wet macular degeneration.

gene. While AMD can be inherited, many lifestyle choices can make progression of the disease worse.

Wet (also known as exudative or neovascular) macular degeneration occurs in about 10% of AMD patients. It is the more acute form and more likely to cause vision loss.

Because the exact causes of AMD are not yet known, some people may develop AMD even in the absence of these risk factors.

Wet age-related macular degeneration develops when abnormal blood vessels grow into the macula. These leak blood or fluid which leads to scarring of the macula and rapid loss of central vision. Wet AMD can develop very suddenly but it can now be treated if caught quickly. What are the symptoms? • Gaps or dark spots (like a smudge on glasses) may appear in their vision, especially first thing in the morning. Objects in front of them might change shape, size or colour or seem to move or disappear. • Colours can fade. • Sufferers may find bright light glaring and uncomfortable or find it difficult to adapt when moving from dark to light environments. • Words might disappear when they are reading. Age-related macular degeneration (AMD) is a chronic disease leading to progressive central vision loss. The symptom of central vision loss is due to the fact that the damaged macula is in the center of the retina. Patients with AMD may be unable to recognise faces, read, or drive a vehicle. AMD is the most common cause of sight loss in people over the age of 50 in Ireland and it's estimated that 7% of Irish people over 50 years of age are living with AMD. On account of our ageing population, the number of people in Ireland

affected by this condition is expected to increase. Symptoms of AMD include decreased central vision, central scotoma, and metamorphopsia. Scotoma is an area of partially diminished vision surrounded by a field of normal or well-preserved vision. Metamorphopsia is a visual defect that causes people to see objects in a distorted manner; straight objects appear wavy or curvy. Patients will complain of distorted vision, lack of bright colours, or blurred vision.

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• Straight lines such as door frames and lampposts may appear distorted or bent. Causes The exact cause of AMD is unknown. However, extensive research efforts over the last decade are playing an important role in uncovering some of the clues as to what may be causing the disease. Researchers know that certain genes can cause AMD, but they don’t know what triggers the

Some risk factors that are believed to increase the chances of developing AMD include being over the age of 50 and having a family history of AMD. Having high blood pressure, a poor diet or being overweight are also thought to be risk factors for this condition.

Age-Related Studies (AREDS1 and AREDS2) have shown that a combination of vitamins and antioxidants may help reduce the risk of progression of Early AMD to late-stage AMD. The recommendations include supplements containing vitamins C and E, zinc, copper, lutein and zeaxanthin. Treatment for Wet AMD is most often through a series of injections into the eye using a drug called anti-VEGF (anti-vascular endothelial growth factor). This treatment works by reducing the growth of new blood vessels. Response to this treatment is usually better in the early stages of Wet AMD, although even later stages can be stabilised. In some cases, individuals may notice improvements in their vision. Role of the Pharmacist It is important to remind patients at risk for AMD to have regular eye exams, even when they are symptom-free. Patients complaining of a recent or chronic loss or change of vision should be urged to see an ophthalmologist immediately. A healthy lifestyle may help prevent AMD. This includes not smoking, eating a healthy diet, and being physically active. Following the recommended guidelines and the use of appropriate pharmacologic agents may help patients with AMD slow vision loss progression, increase visual acuity, and experience a greater quality of life.


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70

Corneal Ulcers

Case Study: A Novel Treatment for Neurotrophic Corneal Ulcers Authors: Dr C Bourke, Ms S Chamney - Temple Street Children’s University Hospital INTRODUCTION: Neurotrophic keratopathy occurs when there is loss of trigeminal innervation to the cornea resulting in partial or complete anaesthesia. A loss of corneal sensation leads to intracellular oedema and epithelial breakdown resulting in persistent corneal ulceration. Causes include stroke, peripheral neuropathy, ocular disease (e.g Herpes simplex and Herpes Zoster keratitis) and tumours. Neurotrophic corneal ulcers present numerous treatment challenges in the ophthalmology clinic. The biggest one being improving corneal epithelialisation Current treatment options include: • Topical ocular lubricants • Protection of the ocular surface-taping of the lids, botox induced ptosis, tarsorrhaphy • Autologous serum drops • Amniotic membrane transplantation • Corneal neurotisation-sural nerve graft

Dr C Bourke, Temple Street Children’s University Hospital

Recent research has shown a benefit from Topical Insulin.

Case An 8 year old girl with a background of Neurofibromatosis Type 2 presented to Temple Street Children University Hospital in November 2018 for a review appointment of a left neurotrophic ulcer in a non seeing eye. The patient developed a left optic nerve meningioma in 2013. This was resected at the time causing damage to the trigeminal nerve and resultant corneal denervation. On presentation the initial examination showed an injected conjunctiva, hypopyon, quiet anterior chamber and a corneal infiltrate inferiorly 5mm x 2mm with central corneal thinning of 50%. She was admitted for intensive topical antibiotics (vancomycin and ceftazidime hourly to the left eye) for 7 days. During admission she underwent a lateral tarsorrhaphy in an attempt to protect the corneal surface and improve epithelial healing. On day one post tarsorrhaphy there was no hypopyon and the cornea had fully epithelialised; however it as noted to be very thinned. The patient was discharged home on g. Dexafree bd, occ. Vitapos nocte, g. Hyloforte tds and occ. Chloramphenicol bd. At her outpatient review one week later the corneal epithelium had once again broken down. At this point it was decided to commence Actrapid insulin in Systane 1 unit/ml once daily in the left eye. The patient was reviewed in the clinic one week later. Unfortunately the

Figure 1: photograph of the patient’s left cornea on presentation showing corneal infiltrate inferiorly

Figure 2. The left cornea post intensive topical antibiotic treatment

Figure 3. Left cornea one week post discharge-corneal epithelium has once again broken down as evidenced by marked fluorescein staining

lateral tarsorrhaphy had opened spontaneously. The family were not keen for a repeat tarsorrhaphy so it was decided to continue the Insulin drops.

A 2017 study4 recruited six patients ranging in age from 2 to 73 years who had developed neurotrophic corneal ulcers refractory to a range of medical and surgical treatments. Each patient was started on topical insulin drops with complete corneal re-epithelialization within 7 to 25 days. A further study in 20195 showed beneficial effects of topical insulin in one case of neurotrophic keratopathy with complete corneal epithelialisation in two weeks. Our case further demonstrates the beneficial effect of insulin on corneal healing. The insulin drops are aseptically compounded by our pharmacy department once weekly.

References:

On review in the outpatients department 4 days later the cornea remained in a stable condition even after the lateral tarsorrhaphy had opened. Insulin drops were continued four times daily as well as ocular surface lubricants. The corneal defect gradually healed over many weeks and the insulin drops were titrated slowly downwards and eventually stopped. Discussion: Insulin is a widely available, safe and effective medication. It has been shown to improve corneal re-epithelialisation in vitro and in vivo.1, 2 In diabetic mice, topical insulin has been shown to slow the loss of sub-basal plexus corneal nerves.3 Restoration of corneal nerves and/or improved epithelial cell migration may play key roles.

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Conclusion: Insulin is a simple and effective treatment for refractory neurotrophic corneal ulcers. Further studies are needed. This is the first documented case of this use of insulin in paediatric ophthalmology in Ireland.

1. Zagon IS, Klocek MS, Sassani JW, et al. Use of topical insulin to normalize corneal epithelial healing in diabetes mellitus. Arch Ophthalmol. 2007;125: 1082–1088. 2. Aynsley TR. The use of insulin in the treatment of corneal ulcers. Br J Ophthalmol. 1945;29:361–363. 3. Chen DK, Frizzi KE, Guernsey LS, et al. Repeated monitoring of corneal nerves by confocal microscopy as an index of peripheral neuropathy in type-1 diabetic rodents and the effects of topical insulin. J Peripher Nerv Syst. 2013;18:306–315 4. Wang AL, Weinlander E, Metcalf BM et al; Use of Topical Insulin to Treat Refractory Neurotrophic Corneal Ulcers. Cornea 2017 Nov;36(11):1426-1428. 5. Galvis V, Nino CA, Tello A et al; Topical insulin in neurotrophic keratopathy after resection of acoustic neuroma. Arch Soc Esp Oftalmol 2019 Feb;94(2):


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Breakthrough treatment trial for peanut allergy The world’s largest peanut allergy treatment trial has found that a new oral treatment can reduce sensitivity to peanuts. The findings could lead to new treatment approaches for people living with peanut allergy, the leading cause of food-related anaphylaxis. Professor Jonathan Hourihane, Professor of Pediatrics at RCSI University of Medicine and Health Sciences and CHI Temple Street led the immunotherapy trial in Ireland, which involved more than 30 Irish children in Cork and Dublin, with Dr Aideen Byrne, CHI Crumlin and Tallaght. The study has been published in The Lancet Child & Adolescent Health.

The ARTEMIS trial demonstrated that after undergoing a new immunotherapy treatment known as AR101, 67% of peanut allergic children could tolerate eating up to three peanuts after the treatment was administered over a ninemonth period. Researchers also found that the children who still experienced allergic reactions to peanuts after the treatment had much milder reactions and used

adrenaline injections far less often than those children who had been on a placebo treatment. Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful. Peanut allergy is one of the most common food allergies, which affects over 17 million people in Europe. Peanut allergy accounts

for the majority of food allergyrelated deaths. Peanut allergy usually persists into adulthood and there currently are no approved treatment options in Europe. Despite vigilance, accidental exposures may occur and cause reactions of unpredictable severity, leading to a lifelong risk of severe reactions.

New podcast ‘Gutcast’ launched to support IBD A new podcast ‘Gutcast’ has been launched by the Irish Society for Colitis and Crohn’s Disease (ISCC) in partnership with Janssen Sciences Ireland UC in response to national research, that shows the extent of mental health concerns among those living with Irritable Bowel Disease (IBD) and the need for accessible supports for stress, anxiety and depression, all of which are being compounded by COVID-19. The research conducted among people living with Crohn’s disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), has revealed that mental health issues have the highest impact on everyday life with 82% of people with IBD stating they have experienced stress, 74% experienced anxiety and 53% experienced depression due to their condition. In response to this research, ‘Gutcast’ has been developed to provide practical advice and information for people living with IBD in a digital format that can be easily accessed during and after the pandemic. Gutcast brings together healthcare professionals, sports

Amy Kelly, Crohn’s patient, Director of the ISCC and Gutcast host

stars and social media influencers living with the condition to give their opinions and advice on a variety of topics including mental health, fatigue, managing work and social life, sex and relationships and getting the most out of your healthcare appointments. Each Gutcast episode has been compiled in response to feedback from people living with IBD with the aim of providing practical advice and to address questions they may not feel comfortable openly discussing.

¤500,000 Health Research Board funding Researchers at University College Cork [UCC] have been awarded almost €500,000 in Health Research Board funding under two postdoctoral training schemes. One project aims to identify the women and infants at the highest risk of Iron deficiency during pregnancy and early childhood - one of the leading causes of diminished nuerolgical developmental potential worldwide. The other seeks to comprehensively research the oral health of people with Cystic Fibrosis (PWCF) over the next

three years to establish whether they have higher rates of oral diseases such as dental decay or gum disease. Dr Elaine McCarthy’s work on an Iron Deficiency Assessment for protection of the newborn brain received ¤241,040 as part of the Applying research into Policy and Practice Fellowships, while Dr Martina Hayes’ research on Oral Health in Adults with Cystic

Fibrosis, was awarded ¤236,183 under the Clinician Scientist Fellowships scheme. Dr Hayes is a Senior Lecturer in Restorative Dentistry at UCC, and expressed her delight at the award. “This will allow me to comprehensively examine the oral health of people with Cystic Fibrosis (PWCF) over the next three years. It’s not known whether or not people with CF have higher

rates of oral diseases such as dental decay or gum disease but at present dentists are not part of the multidisciplinary Cystic Fibrosis healthcare team. “If people with cystic fibrosis do have a higher risk of dental disease, inclusion of oral healthcare professionals such as dentists and hygienists, would allow for preventive and early intervention measures.”

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News

Living with a Rare Disease There are an estimated 6-8,000 rare diseases. They are chronic, progressive, degenerative, often life-threatening, and associated with multiple impairments including cognitive, developmental, intellectual, mental, physical and sensory. Around six per cent of the population in Ireland is estimated to have a rare disease, or approximately 300,000 people. At least four per cent of children born in Ireland in the year 2000 were diagnosed with a rare disease by age 17. Rare Diseases Ireland has called on the Government to ensure the provision of healthcare services for people with rare diseases, noting: “in our collective efforts to combat one disease, COVID-19, it is important that other diseases are not left behind”. Almost three quarters of respondents (73 per cent) to a Rare Diseases Ireland research report among the rare disease community are concerned that their condition, or that of their loved ones, may deteriorate due to the impact of COVID-19 on their treatment and care. More than half (53 per cent) have had scheduled medical appointments cancelled, while a quarter (26 per cent) indicated that they have encountered difficulty accessing medicines and medical supplies. Against this backdrop, it is perhaps unsurprising that almost two thirds (62 per cent) believe that COVID-19 is having a negative impact on their mental health. The report, Living with a Rare Disease in Ireland during the COVID-19 Pandemic, has highlighted how COVID-19 is hindering access to routine treatment and care for people with rare diseases, and is having a detrimental effect on their health and well-being. The research provides a snapshot into life today for people with rare diseases, with responses from 176 people living

with a rare condition, their family members and their carers, from across the island of Ireland.

confusion over the availability of the usual hospital consultant to provide care.

It was undertaken by Rare Diseases Ireland, the national alliance for rare disease voluntary groups, in the two-week period leading up to May 6.

Leave No One Behind

Key Research Highlights Impact on rare diseases: Three quarters (73 per cent) of respondents indicated that they were concerned about their own, or their loved one’s, rare disease. They are concerned about how the condition is deteriorating without access to the usual healthcare, and how an already complex health situation may be negatively impacted if infected with COVID-19. In such circumstances, they are worried how the rare condition may be perceived if ICU care is required. Three in five respondents (62 per cent) believe that COVID-19 is having a negative impact on their mental health. Medical appointment cancellations: more than half of respondents (53 per cent) responded that scheduled medical appointments have been cancelled. These included hospital appointments, such as diagnostic/ monitoring procedures, surgical procedures and in-patient/outpatient therapies, as well as the cancellation of appointments for physiotherapy, occupational therapy, and speech and language therapy. Accessing medicines: one in four respondents (26 per cent) noted that there were difficulties accessing medicines and medical supplies needed for the condition. Delaying seeking medical help: three in ten (31 per cent) respondents have avoided seeking care for complications related to the condition because of concerns over exposure to COVID-19 and

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According to Vicky McGrath, CEO of Rare Diseases Ireland, the Government needs to take into account the full range of people’s medical needs during this pandemic, including those with rare diseases: “Since COVID-19 arrived in Ireland, we have witnessed huge restrictions on hospitals for everything except COVID-19 and emergency care. The fact that rare disease care is routinely provided by hospital-based consultants within the hospital setting, has had particularly negative consequences for the care of rare disease patients during this pandemic. “Many respondents have expressed frustration and disappointment with the lack of communication from their health care providers. “They have been left to cope for themselves and are struggling to know how best to manage. For those who previously accessed private healthcare, they are now unsure as to who is managing their care, and are concerned that they will go to the bottom of public waiting lists. “More than half of those who responded to our research study indicated that scheduled medical appointments have been cancelled and I have no doubt that the experiences relayed are reflective of the wider rare disease community. It is extremely worrying for people and the cancellation of such a large number of appointments will inevitably lead to spiralling waiting lists and extensive delays. “Many people with rare conditions spend years pursuing a diagnosis in the hope of therapeutic relief, so it is particularly frustrating when we hear of empty hospital beds and under-utilised resources. In

our collective efforts to combat one disease, COVID-19, it is important that other diseases are not left behind. “Steps taken by the health authorities in our hospitals and community healthcare facilities at the outset of this pandemic were widely accepted and understood by the rare disease community. However, we are now calling for all hospital and community healthcare services to be reopened for all patients in a safe manner. In addition, urgent measures need to be put in place to ensure that such severe service curtailments do not have to be applied in the event of any possible future resurgence of the virus, and that treatment and care for rare diseases can co-exist alongside that for COVID-19.”

Key Statistics for Ireland • There are an estimated 300,000 people living with rare diseases in Ireland. • 72% of rare diseases are genetic in origin. A rare disease does not just impact the affected individual. A rare disease has implications for everyone in the immediate family unit and the wider family too; grandparents, aunts, uncles, cousins, second cousins. • 70% of rare diseases are exclusively paediatric onset. • At least 4% of children are diagnosed with a rare disease, a life-long condition, by age 17 in Ireland. • Approximately 2/3 of paediatric deaths in Ireland are associated with rare diseases


News Migraine Symptoms Worsening World Brain Day was held recently, on July 22nd, and the Migraine Association of Ireland (MAI), was raising awareness of the impact of Covid-19 on people living with migraine – a complex neurological condition which affects around half a million of the Irish population. The Neurological Alliance of Ireland (NAI) carried out a nationwide survey of over 600 people with neurological conditions and family carers to explore the impact of Covid-19. The survey findings reveal that over a quarter of people are experiencing significant challenges in accessing ongoing care due to the cancellation of appointments and the difficulty of scheduling routine treatments. One third of patients reported a significant impact on family life and relationships and on emotional wellbeing. The NAI findings echo MAI’s own research with migraine patients. A survey they posted on their Instagram channel confirmed that 72% of people’s symptoms has worsened since the lockdown. Speaking in advance of World Brain Day, Mr Patrick Little, MAI CEO, said, “Many households have come under financial stress or hardship, with pay cuts, jobs that have been furloughed, or jobs that have been lost entirely. In many respects, our information suggests that those with migraine may have been disproportionately impacted by the additional burden brought on by the pandemic, with additional physical and mental stressors, serving as triggering factors for worsening symptoms.” As stress is one of the main recognised triggers for migraine, the team at MAI quickly mobilised a response, by creating a ‘Frequently Asked Questions‘ section on their website to try to cover all the main areas of concern. MAI also called on the public to show their support on social media by using the hashtag #SAVEMYCHARITY, and to consider donating to Migraine Ireland at https://migraine.ie/donate.

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Positive impact of Pharmacy The positive impacts of pharmacists in supporting medication without harm are described in a new publication from the International Pharmaceutical Federation (FIP). FIP’s new reference document, entitled “Patient safety — Pharmacists’ role in ‘Medication without harm’”, provides information about what pharmacists can do to promote patient safety at an individual patient level, as well as at organisational and policy development levels. “Medication safety has become a global emergency and many nations are placing it on their national health priority agendas. Regardless of whether pharmacists provide direct or indirect patient

care, they all have a role in promoting safe and quality health care,” said Parisa Aslani, Professor in Medicines Use Optimisation at The University of Sydney, Australia, and co-editor of the document. Case studies of best practice from Australia, Canada, Finland, India, the Netherlands, Oman, Saudi Arabia, South Africa and the USA are to be found in the document. “The common challenges facing pharmacists include increasingly complex medicines, polypharmacy and ensuring optimal transitions of care for our patients in spite of

fragmented healthcare systems or models of service delivery. There is also the often-reported issue of being under-resourced and timepoor. We can learn a lot from each other, and this reference paper is a personal and professional challenge to all pharmacists to keep patient safety at the forefront of practice and to take new steps towards safer care. We all are advocates of patient safety. As pharmacists, we are particular advocates of medication safety,” Professor Aslani added.

Irish researchers to lead ¤3m study Researchers at RCSI University of Medicine and Health Sciences are leading a new €3m study to investigate the real-world effects of the newest cystic fibrosis medications as they become available for people with CF. Annabel Murphy (aged 8) who has cystic fibrosis pictured with Professor Paul McNally, Associate Professor of Paediatrics at RCSI, Respiratory Consultant in Children’s Health Ireland and lead researcher on the RECOVER study The research will look at how a new triple combination cystic fibrosis drug, Kaftrio, will affect people in their day to day lives, rather than in controlled clinical trial conditions. Kaftrio (known as TriKafta in the US) is a successor to Orkambi. The project, called RECOVER, has been awarded ¤2.85 m from Cystic Fibrosis Foundation (US), ¤112 thousand from Cystic Fibrosis Trust (UK) and ¤100 thousand from Cystic Fibrosis Ireland. “Our study will allow us to discover in detail how this powerful new treatment affects the health and everyday lives of people with cystic fibrosis, to understand why different people might respond differently to the drug and to gain insight into how this treatment might affect the very significant treatment burden that people with cystic fibrosis currently endure,” said Professor Paul McNally, Associate Professor of Paediatrics at RCSI, Respiratory Consultant in Children's Health Ireland and lead researcher on the RECOVER study. “Clinical trials occur under very controlled conditions and exclude many sick people with cystic fibrosis. 'Real-world' studies,

such as RECOVER, are essential to confirm the trial findings and examine in-depth effects on the everyday lives all people with cystic fibrosis.” Dr Lucy Allen, Director of Research at the Cystic Fibrosis Trust, said, “The data from the clinical trials have shown us that Kaftrio will make a significant difference to people’s lives. However, as cystic fibrosis is a complex condition affecting many parts of the body, it is important to understand the full impact of this drug. In the short term, the results of the RECOVER study may speed up access to Kaftrio around the world, in the longer term it will provide information on tailoring care for each individual with cystic fibrosis.”

“Patient-centred research is central to what we do at RCSI and the RECOVER project exemplifies research that can make a real impact on the quality of life for people living with chronic conditions such as cystic fibrosis. I am delighted to welcome the generous funding of the Cystic Fibrosis Foundation, Cystic Fibrosis Trust and Cystic Fibrosis Ireland in support of this vital research. I congratulate Professor Paul McNally and his collaborators on their funding success for RECOVER, which is a testament to their expertise in cystic fibrosis lung disease research,” said Professor Fergal O’Brien, Director of Research and Innovation at RCSI University of Medicine and Health Sciences.

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ACCORD HEALTHCARE LAUNCH INNOVATIVE PATIENT FOCUSED APP Following on from the successful launch of its patient-activated, pre-filled injector (PFI) to deliver pegfilgrastim (Pelgraz® ), Accord Healthcare are delivering another first, with the launch of their Pelgraz® support app in Ireland.

The app is designed specifically for patients who have been prescribed Pelgraz® PFI. “We appreciate that patients undergoing treatment for cancer can feel like they have very little control over their illness and we believe it is important to give patients back some sense of control. We have therefore developed our app to help give patients the confidence to self-administer their treatment from the convenience of their own home, while offering them the peace of mind that they are complying with their prescribed treatment regimen”, says Mr Tony Hynds, Managing Director, Accord Healthcare Ireland Ltd. The app supports patients to administer their medication at the correct time and in the correct way. It also provides relevant educational content and the ability to track side-effects along with highlighting how to report any sideeffects. The app allows a patient to set a reminder to administer their treatment, based on when their last chemotherapy session took place and when the clinician indicated to use the product. Once the reminder is opened, the app automatically presents the administration instructions, which includes an animated video and step-by-step instructions. The symptom tracker allows patients to log their side-effects and symptoms post-chemotherapy and track them over a given period, providing the patient with the tools and information to have an in-depth conversation at their subsequent meeting with their healthcare professional should they wish. The ethos behind Accord’s Pelgraz® PFI launch is to give patients the confidence to administer pegfilgrastim from the comfort of their own home. With pegfilgrastim administered at least 24 hours after cytotoxic chemotherapy, patients will often have to return to hospital or await a visit from a home care nurse to administer pegfilgrastim. “Evidence shows that travelling to and attending hospital visits are one of the major contributing factors that negatively impact the quality of life for people living with cancer. Reducing the number of times that a patient must visit the clinic or hospital, at a time

when they are living with the side-effects of chemotherapy and when their immune systems are compromised, must be a priority for patients and their healthcare team. Being able to offer the option of spending more time at home during chemotherapy treatment is something I know patients genuinely welcome and also means that the clinic could potentially make more effective use of nurse resources.” said Prof Hartmut Link, Professor of Medicine, external faculty at University Medical Centre, Hannover, Germany. Patients prescribed Pelgraz® can download the support app from the Apple App store and Google Play. TESTOSTERONE-CONTAINING MEDICINAL PRODUCTS – CAUTION IN PATIENTS WITH THROMBOPHILIA OR RISK FACTORS FOR VENOUS THROMBOEMBOLISM (VTE) Following a recent periodic review of oral, topical, and injectable testosterone-containing medicinal products*, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended an update to the product information for testosterone-containing medicinal products. These products are licensed in Ireland as testosterone replacement therapy for male hypogonadism. Based on a review of the literature, and in particular data from studies by Glueck et al.1,2, the PRAC considered that the existing warning in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) regarding clotting disorders should be amended to highlight the need for caution in patients with risk factors for venous thromboembolism (VTE). Similarly, a warning will be included to indicate that in patients with thrombophilia, cases of VTE have been reported, including some in those on anticoagulant treatment. Therefore, continuing testosterone treatment after a first thrombotic event in patients with thrombophilia should be carefully evaluated, and in the case of treatment continuation, further measures should be taken to minimise the individual VTE risk. Moreover, the PRAC considered it pertinent to specify risk factors for VTE in the Package Leaflet and additionally to include signs and symptoms of thrombosis in order to highlight these for patients. Advice to Healthcare Professionals • Topical, oral and injectable testosterone-containing medicinal products should be used with caution in patients

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with risk factors for venous thromboembolism (VTE). • In patients with thrombophilia, cases of VTE have been reported, including some in those on anticoagulant treatment. Continuing testosterone treatment in patients with thrombophilia requires careful evaluation after a first thrombotic event and implementation of measures to minimise the individual VTE risk. *Testosterone-containing medicines licensed in Ireland include Androgel, Nebido, Restandol Testocaps, Testarzon, Testim, Testogel, and Tostran. Further details on testosteronecontaining medicines are available at www.hpra.ie and www.ema.europa.eu. EUROPEAN COMMISSION CALL FOR DATA ON PROSTAGLANDINS AND THEIR ANALOGUES USED IN COSMETIC PRODUCTS The European Commission has issued a call for data on the safety of prostaglandins and their analogues as cosmetic ingredients in the framework of Regulation (EC) 1223/2009. The Commission has concerns about the use of such ingredients in cosmetic products. Several countries have recorded serious undesirable effects caused by the use of cosmetic products containing prostaglandins and/or its analogues for eyelash growth. The Commission will mandate the EU Scientific Committee for the Safety of Consumers (SCCS) to assess the safety of the abovementioned cosmetic ingredients. In preparation, interested parties have been invited to submit relevant scientific information on the safety of prostaglandins and their analogues. More information in relation to requirements for submission of data and the background of this topic, as well as a non-exhaustive list of the ingredients in question, can be found on the European Commission website.

States Patent and Trademark Office ("USPTO") has granted a patent on use and methods of treatment of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb). The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent will be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858. Recently, Tiziana also announced the issuance of the first-ever patent on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). The grant of this additional compositionof-matter and use patent further strengthens the Company's intellectual property, consisting of proprietary technologies on oral and nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases. Tiziana previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab on 9 January, 2020, which was designed to evaluate its safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women's Hospital, Harvard Medical School, Boston, Mass., and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose (https://www.tizianalifesciences. com/news-item?s=2020-0109-tiziana-reports-phase-1clinical-data-demonstrating-oraltreatment-with-foralumab-a-fullyhuman-anti-cd3-monoclonalantibody-is-well-tolerated-inhealthy-volunteers). The Company plans to move forward with a phase 2 trial in the 4th quarter of 2020 with orally administered Foralumab for the evaluation of moderate-to-severe patients with Crohn's Disease.

TIZIANA GRANTED A PATENT ON METHODS AND USE OF ANTI-CD3 MONOCLONAL ANTIBODIES FOR TREATMENT OF CROHN'S DISEASE

Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "We are delighted that this key patent on composition-of-matter and use for treatment of Crohn's Disease is granted. We are very excited about the continued development of the oral administration of Foralumab for the treatment of Crohn's disease because this alternative route of administration seems to minimize toxicity and we believe it would maximize clinical activity by acting topically in the gut to inhibit inflammation."

Tiziana Life Sciences plc, a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, has announced that the United

Additionally, Tiziana previously reported the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered stabilized solution of

The last date for submission of relevant information to the European Commission is 21 October 2020.


75 Foralumab on 28 November, 2018 (https://www.tizianalifesciences. com/news-item?s=2018-11-28tiziana-announces-initiation-ofphase-1-clinical-trial-with-nasaladministration-of-foralumab-afully-human-anti-cluster-definition3-monoclonal-antibody-anti-cd3mab-in-healthy-volunteers).

EVAPORATE Study" – presented on behalf of all authors by Matthew Budoff, M.D., The Lundquist Institute – August 29, 8:50-9:20 a.m. CEST (Central European Summer Time) Rapid Fire Abstracts and e-Poster Presentations

Additionally, a Phase 2 trial in patients with progressive multiple sclerosis will commence in the 4th quarter. Importantly, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.

• Session: Rapid Fire Abstracts

The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.

"REDUCE-IT: Total Ischemic Events Reduced Across the Full Range of Baseline LDL Cholesterol and Other Key Subgroups" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital – Available from August 30

LATEST CLINICAL RESEARCH EVALUATING VASCEPA® (ICOSAPENT ETHYL) Amarin Corporation plc have announced that new data that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) in patients at risk for major adverse cardiovascular events will be presented at ESC Congress 2020, the annual meeting of the European Society of Cardiology (ESC), being held virtually from August 29 - September 1, 2020. These new findings will be presented in one Late-Breaking Science presentation and four rapid fire abstract and e-poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin. "Cardiovascular disease is an ever-increasing global challenge commanding both attention and action," said Craig Granowitz, M.D., Ph.D., Amarin's senior vice president and chief medical officer. "Often devastating, cardiovascular disease demands new research to increase our understanding of how to address residual cardiovascular risk. Several scheduled presentations at ESC provide new data on VASCEPA and its potential to address heart health in at-risk patients." Featured Amarin-supported abstracts to be presented at ESC Congress 2020 include: Late-Breaking Science Presentation • Session: Late-Breaking Science in Lipids "Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: Final results of the

"REDUCE-IT: Accumulation of Data Across Prespecified Interim Analyses to Final Results" – presented on behalf of all authors by Brian Olshansky, M.D., University of Iowa – Available from August 30 • Session: Rapid Fire Abstracts

• Session: Rapid Fire Abstracts "Are the Results of Clinical Trials Relevant in The Real World? The Applicability of REDUCEIT to the FAST-MI Registry." – presented on behalf of all authors by Jean Ferrières, M.D., M.Sc., FESC, Toulouse Rangueil University Hospital – Available from August 30 • Session: e-Poster "REDUCE-IT: Outcomes by Baseline Statin Type" – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital – Available from August 28 Additional REDUCE-IT® and icosapent ethyl (EPA)-related topics will be presented at ESC Congress 2020 and can be found at https://www.escardio. org/Congresses-&-Events/ ESC-Congress. SANOFI AND GSK IN ADVANCED DISCUSSIONS TO SUPPLY UP TO 300 MILLION DOSES OF COVID-19 VACCINE Sanofi and GSK are in advanced discussions, with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine. The vaccine candidate developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK's established adjuvant technology. The doses would be manufactured in European countries including France, Belgium, Germany and Italy. This marks a key milestone

in protecting and serving the European population against COVID-19. "Today's announcement helps to ensure that millions of Europeans will have access to a potential vaccine protecting against COVID-19, once proven safe and effective. It has been our steadfast commitment to provide a vaccine that is affordable and accessible to everyone, and we are grateful to the European Commission for their ongoing engagement and shared support of this effort," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. "Together with GSK, we are working relentlessly to develop and produce a vaccine to address this global health crisis." Roger Connor, President of GSK Vaccines added "GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Europe. Both companies have significant R&D and manufacturing capability in Europe and are already working hard to scale up production across our networks. This announcement from the EC supports our ongoing efforts" Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/ 2 study to start in September, followed by a Phase 3 study by the end of 2020. If data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall. Sanofi and GSK are committed to making the vaccine available globally Sanofi and GSK recently signed agreements with the United States where they have longstanding partnerships with the Biomedical Advanced Research and Development Authority, and also with the UK Government. The partners plan to provide a significant portion of total worldwide available supply capacity in 2021/22 to the global initiative "Access to COVID‐19 Tools (ACT) Accelerator," a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. INTRAVACC'S CANDIDATE RSV VACCINE DEMONSTRATES SAFETY IN PHASE I TRIAL Intravacc, a global leader in translational research and

development of viral and bacterial vaccines, has announced the publication in the medical journal Vaccine, of a clinical phase I study with its candidate Respiratory Syncytial Virus (RSV) vaccine. The vaccine showed excellent induction of immunogenicity after nasal administration to healthy adult volunteers (18-50 years). In addition, the Live Attenuated Vaccine (LAV), constructed with reverse genetics, appears to be safe and well-tolerated. Intravacc is currently orienting on a suitable partner for further joint clinical development of this vaccine in a large pediatric setting. A pediatric vaccine against RSV would not only prevent morbidity and mortality in infants and young children but could also reduce transmission to the elderly. The RS virus is the most common cold virus in children under the age of five and poses a serious threat to the elderly as well. Many biotech and pharmaceutical companies have been developing an RSV vaccine since the 1960s, but to this day no vaccine emerged out of this. An estimated 120,000 children worldwide still die of the virus every year, especially in developing countries. The conducted trial was a randomized, placebo-controlled phase I study with a first administration in humans of a live attenuated RSV virus without the G (adhesion) protein to evaluate safety, tolerability, excretion and immunogenicity. In preclinical studies, RSV∆G showed decreased host cell binding and infectivity. Intranasal immunization of laboratory animals with the RSV∆G vaccine protected against replication of wild-type RSV, without aggravating the disease. An RSV lacking the G-protein is expected to be attenuated, but still able to elicit an effective immune response due to the presence of the surface protein F as the major antigen site and residual infectivity. Using reverse genetics, Intravacc constructed a Live Attenuated Vaccine against RSV from which the coding sequence for the attachment protein (G) was removed from the RSV genome (RSVΔG). Live attenuated vaccines can be administered intranasally, mimicking the natural route of infection and thereby stimulating both local mucosal and systemic immunity. Volunteers received one dose of vaccine intranasally, the control group a placebo. The side effects were mild and comparable to the placebo group. No measurable amounts of vaccine were excreted after administration, indicating sufficient attenuation of the vaccine.

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Clinical R&D

Since almost everyone is infected with the RSV almost every year, adults have a fairly high background immunity. That makes it difficult to evaluate efficacy in this group. Measured antibody levels were comparable before and after immunization and between vaccine and placebo groups. In a subsequent study it must be demonstrated whether the vaccine is immunogenic to children. SANOFI TO ACQUIRE PRINCIPIA BIOPHARMA Sanofi and Principia Biopharma Inc. a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). The Sanofi and Principia Boards of Directors unanimously approved the transaction. Principia's Bruton tyrosine kinase (BTK) inhibitors add to Sanofi's efforts to accelerate and build a portfolio of the next generation of transformative treatments for autoimmune diseases. BTK is present in the signaling pathways of key innate and adaptive cell types of the immune system. Being able to block or disrupt these signaling processes can help in stopping inflammation and tissue destruction related to autoimmune diseases and target some of the underlying pathophysiology. • BTK inhibitor '168: In a Phase 2b study in patients with multiple sclerosis, '168 reduced Gd-enhancing T1 hyperintense lesions by 85% compared to placebo. In June, Sanofi announced the first multiple sclerosis patient was enrolled in the Phase 3 program for the BTK inhibitor, comprising four pivotal clinical trials across the disease spectrum. The Principia acquisition will provide an opportunity to expand the development program to evaluate indications beyond central nervous system diseases. • Rilzabrutinib: This oral BTK inhibitor is currently being evaluated in a Phase 3 program for patients with moderate to severe pemphigus, a rare, debilitating autoimmune disease that causes blistering of the skin and mucous membranes. A Phase 3 program for immune thrombocytopenia, a disease that causes high risk for bleeding events, is expected to be initiated by the end of 2020, assuming no COVID-19 related

impact. The company also has an ongoing Phase 2 program for IgG4-related diseases, which is driven by chronic inflammation, immune cell infiltration, and fibrosis within organs that can lead to severe morbidity. • PRN473 Topical: This BTK inhibitor is a topical agent currently in Phase 1 trials and is being developed for immune-mediated diseases that could benefit from localized application to the skin. The Principia BTK inhibitor franchise is based on its proprietary Tailored Covalency® platform that has generated potential best-in-class clinical candidates. The platform allows the design of both reversible covalent and irreversible covalent small molecule inhibitors that are more selective with less off-target effects. The optimized target residence time has potential to deliver a desired efficacy with a stronger safety profile. In 2017, Sanofi formed a collaboration with Principia under which Principia granted Sanofi an exclusive, worldwide license to develop and commercialize BTK inhibitor '168 in multiple sclerosis and other central nervous system diseases. GENMAB ANNOUNCES EUROPEAN MYELOMA NETWORK AND JANSSEN ACHIEVE POSITIVE TOPLINE RESULTS Genmab A/S (Nasdaq: GMAB) has announced that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary endpoint of improving progression-free survival (PFS). Overall, the safety profile of daratumumab SC in combination with Pd was consistent with the safety profile for each therapy separately. "We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone. The corresponding intravenous regimen was previously approved by the U.S. FDA based on the Phase1

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single-arm EQUULEUS study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Janssen Biotech, Inc., which obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012, intends to discuss the data with health authorities in preparation for regulatory submissions and plans to submit the data for presentation at an upcoming medical conference. The APOLLO study was designed to confirm the results from the Phase 1 EQUULEUS (MMY1001) study, which investigated intravenous (IV) daratumumab plus Pd in the same indication. In June 2017, the U.S. Food and Drug Administration (U.S. FDA) approved the use of DARZALEX in combination with Pd for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a PI based on the results of the EQUULEUS study. VIIV HEALTHCARE ANNOUNCES DATA DEMONSTRATING THE FEASIBILITY OF DOVATO (DOLUTEGRAVIR/LAMIVUDINE) ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced findings from the STAT study, a phase IIIb, multi-centre, open label, single arm, 48-week study in the United States presented at the American Conference for the Treatment of HIV (ACTHIV) 2020. The study evaluated Dovato (dolutegravir/lamivudine) for rapid initiation of treatment after diagnosis in adults with HIV-1. Dovato was found to be effective and well tolerated in this setting, indicating the feasibility of its use in Test and Treat strategies. The STAT study followed a rapid Test and Treat model of care increasingly seen in clinical practice, with treatment initiated within 14 days of diagnosis before baseline HBV co-infection status, renal function and resistance test results were available. All study participants were tested for HBV co-infection prior to receiving Dovato, with results available after initiation of treatment. In the study, 92% (n=102/111) of participants with available data at 24 weeks, achieved a viral load of <50c/mL. This includes participants who stayed on Dovato and those who switched to alternative ART. Eight participants switched from Dovato to an alternative antiretroviral (ART) regimen; five of the eight due to HBV co-infection and one due to baseline resistance to lamivudine. Data were available for five of

these participants and showed that they all achieved a viral load of <50c/mL at 24 weeks, without developing HBV or HIV resistanceassociated mutations,1 indicating that rapid initiation of Dovato did not compromise outcomes for this subset of participants. 87% (n=97/111) of participants with available data at Week 24 and still taking Dovato* achieved a viral load of <50c/mL. At the start of the study, 8% (n=10) of participants had HIV-1 RNA >1,000,000 c/mL. At week 24, 80% (n=8) of these participants had HIV-1 RNA <50 c/mL. Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “The results from the STAT study reinforce the proven efficacy of Dovato and provide further evidence supporting its use in settings where rapid treatment initiation is the standard. The STAT study also shows us that this treatment can be initiated when the baseline HBV co-infection or resistance status is unknown, as appropriate therapy adjustments can be made once results become available without compromising patient safety. These findings represent an important step forward in our understanding of current treatment options that can be rapidly initiated after an HIV diagnosis and confirm the validity of this approach with Dovato.” At 24 weeks, 11% (n=15) of participants discontinued the study, including 9% (n=12) who were lost to follow-up or withdrew consent and 2% (n=3) due to physician decision. Data were not available at week 24 for 4% (n=5) of participants. The study found that Dovato was well tolerated, with low rates of grade 2-5 drugrelated AEs (2%, n=2) and serious AEs (2%, n=2). About Dovato (dolutegravir/ lamivudine) Dovato is a once-daily, singlepill, 2-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INI) dolutegravir (Tivicay, 50 mg) with the NRTI lamivudine (Epivir, 300 mg). Observed analysis, where missing patients were not included in the analysis Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) is authorised in the EU for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the INI class, or lamivudine.


Skin Superfood by Codex Beauty. Deeply hydrates, nourishes and smooths. â&#x20AC;˘ Contains BiaComplex, a patented blend of 5 native Irish plants, each hydrate, and lock in moisture in complementary ways. â&#x20AC;˘ Clinically proven to increase hydration - Stratum Corneum Hydration increases 42.5% - Trans Epidermal Water Loss decreases 13.4% - Improves smoothness Desquamation decreases 40.5% (2019 Derma test: 28-day independent clinical study involving 30 women) A non-greasy cream formulation that can be used in place of moisturiser to keep skin hydrated and smooth. Can be used anywhere on the body suits all ages and is perfect for use under a face mask. Every home should have one. For more information please contact Lorraine.morton@codexbeauty.com or see www.codexbeauty.com


Apivita Prickly Pear Moisturising & Revitalising Face Mask This moisturising and revitalising mask with creamy texture is suitable for all skin types. This EXPRESS BEAUTY face mask with prickly pear extract, a favourite summer fruit or the rural areas of the Mediterranean, moisturises and instantly alleviates the skin. It offers a unique experience of deep moisturisation while soothing the skin thanks to prickly pear, it alleviates, nourishes and softens even the most sensitive and dehydrated skin types thanks to aloe, shea butter and chamomile, it rejuvenates the skin with lavender essential oil, water in this composition has been replaced by an antioxidant wild rose infusion. Available in pharmacies nationwide and on www.cosmeticsonline.ie

Xemose Cream You may notice your skin becoming dryer than usual. We are now being encouraged to wear protective coverings to partially cover our face. Xemose Universal Emollient Cream will deliver long lasting comfort, soothe and protect dry irritated skin, suitable for both face and body. It has a lipid replenishing, moisturising formula that works to treat dry or atopy prone skin, delivering long lasting comfort. It has a non sticky texture that melts into the skin, helping to relieve irritation and itching associated with a dry skin condition. Its triple barrier action will help strengthen the cutaneous barrier with the addition of Uriage Thermal Water and Shea Butter to soothe hydrate and moisturise. Fragrance free, Hypoallergenic. Suitable for adults and children. Use in conjunction with Uriage Thermal Water.

Apivita Tonic Mountain Tea Shower Gel 300m Toning shower gel with essential oils, inspired by the principles of aromatherapy, which gently cleanses the skin without dehydrating it and at the same time provides protection from oxidative stress thanks to the Greek mountain tea. It improves the mood and leaves the skin lightly scented. Use it for your morning bath in order to kick start the day. Suitable for men and women. • The infusion of a combination of 3 organic sideritis species from the organic cultivations of APIGEA (Sideritis Scardica, Sideritis Perfoliata, Sideritis Raiseri), has replaced water, contributing to the anti-oxidant and moisturizing effect of the product. • The organic Malotira (Sideritis Syriaca) extract from Crete is a rich source of anti-oxidants. • Saponaria and mild cleansing agents gently cleanse and preserve the natural moisture of the skin. • The propolis extract has a mild antiseptic effect and enhances the radiance and health of the skin. • The organic bio-active aloe, the olive seed extract, panthenol (provitamin B5) and arginine moisturize the skin, leaving it smooth and soft. • The bergamot and eucalyptus organic essential oils improve the mood and grant optimism. Available in pharmacies nationwide and on www.cosmeticsonline.ie

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The Lepicol range BR Healthcare are delighted to announce that they will be managing the Lepicol range from the 1st of September 2020. Lepicol is a three-in-one combination of gentle psyllium husk fibre supplement, live bacterial cultures and probiotics. Lepicol is high in fibre & contributes to the maintenance of normal bowel transit. Lepicol contains five probiotic strains. Your digestive tract is home to trillions of gut bacteria that aid in digestion, help prevent a pathogenic bacteria over-growth, and have an impact on your immune system. Lepicol Plus has the same great three-in-one combination of gentle psyllium husk fibre, live bacterial cultures and inulin, however it also has the extra benefit of digestive enzymes. The digestive enzymes and digestive aids included In Lepicol Plus+ are Ginger root, Bomelain, Peppermint leaf, Fennel seed, Papain, Protease, Betaine HCL. The Lepicol range is available from BR Healthcare, United Drug & Uniphar. For more information please contact your local BR Healthcare representative or our office on 01-8850 800

As September reminds us of the reminds importance of eye health raisesofawareness As September us of the importance of eye health andand raises awareness AMD. As already of AMD. As already mentioned in this month’s issue,accounts dry AMD accounts for 90% of all AMD cases. mentioned in this month’s issue, dry AMD for 90% of all AMD cases. As we grow older our eye health comes under increasing pressure and in particular, the macula. It is As we grow older our eyean health comes under increasing pressure and in particular, the macula. It is an oval shaped pigmented area near the central retina, which can be damaged. The macula protects oval shaped pigmented area retina, which can be the light near sensitivethe cells incentral the back of the eye. The macula is responsible for damaged. the clarity of centralThe macula protects the It allows to see fine detail clearly and is essential for activities such as reading, writing, light sensitive cells in thevision. back of usthe eye. The macula is responsible for the clarity of central vision. It driving or even recognising faces. The macula pigment comprises of three carotenoids, Lutein, Mesoallows us to see fine detail clearly and isLutein essential forareactivities such reading, Zeaxanthin and Zeaxanthin. and Zeaxanthin important nutrients that as the body naturally writing, driving or even deposits in the macula of thecomprises eye to create a protective layer known as macular pigment. Lutein andMeso-Zeaxanthin and recognising faces. The macula pigment of three carotenoids, Lutein, Zeaxanthin are powerful antioxidants that work like internal sunglasses, protecting the macula from Zeaxanthin. Lutein and Zeaxanthin are important nutrients that the body naturally deposits in the macula the damaging effects of blue light and oxidative stress. The body does not produce Lutein and of the eye to create a protective layer macular pigment. Lutein are powerful Zeaxanthin. The macularknown pigment canas therefore become severely depleted in those withand a poor Zeaxanthin diet lacking in the right sunglasses, foods. Hence, why it could be advantageous to use supplementations as damaging effects of blue antioxidants that work like internal protecting the macula fromsuch the light and oxidative stress.MACU-SAVE. The body does not produce Lutein and Zeaxanthin. The macular pigment can MACU-SAVE’s one-a-day to swallow fooda supplement which provides advanced for therefore become severely depleted ineasy those with poor diet lacking in nutrition the right foods. Hence, why it the eyes. It is suitable for diabetics, gluten free, yeast free, lactose free and contains no artificial could be advantageous to use supplementations suchcarotenoids as MACU-SAVE. preservatives or sweeteners. All of the three macular in MACU-SAVE are of the highest quality grade and are harvested from the marigold plant Tagetes Erecta. MACU-SAVE contains

MACU-SAVE’s one-a-day easyLutein to and swallow food Zeaxanthin. supplement FloraGLO OPTISHARP National FloraGLO® which Lutein is theprovides most clinically advanced nutrition for lutein brand worldwide with over 90 human clinicallactose trials published. Clinically to the eyes. It is suitable forresearched diabetics, gluten free, yeast free, free andproven contains no artificial show bioavailability of FloraGLO® Lutein is similar to that obtained from foods that naturally contain preservatives or sweeteners. All of the three macular carotenoids in MACU-SAVE are of the highest these nutrients. FloraGLO® Lutein sets the gold standard for the lutein market. With proven efficacy, quality grade and are harvested fromOPTISHARP® the marigold plantis aTagetes Erecta. MACU-SAVE contains safety and credibility. Natural Zeaxanthin supplement ingredient for eye health that’s naturally-sourced from marigold flowers. FloraGLO Lutein and OPTISHARP National Zeaxanthin. FloraGLO® Lutein is the most clinically researched lutein brand worldwide with over 90 human clinical trials published. Clinically proven to show bioavailability of FloraGLO® Lutein is similar to that obtained from foods that naturally contain these nutrients. FloraGLO® Lutein sets the gold standard for the lutein market. With proven efficacy, safety and credibility. OPTISHARP® Natural Zeaxanthin is a supplement ingredient for eye health that’s naturally-sourced from marigold flowers.

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