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May 2020 Volume 12  Issue 5 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

In this issue: NEWS: Robust plans needed for Flu Page 4

PROFILE: McGreals display Innovation Page 10

REPORT:

Are you looking for a vitamin D supplement that is bioavailable and effective? Are you looking for a vitamin D supplement that is bioavailable and effective?

Pharmacy landscape during Covid-19 Page 16

Get the proven Get the proven benefits of benefits of sun exposure sun exposure Without worrying about your skin

FEATURE: Pain in Children Page 22

Are you looking for a vitamin D supplement that is bioavailable and effective?

NEWS:

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Without worrying about your skin As you know, it is important to protect your skin when the sun is most powerful. Still, sun exposure is necessary in order for our skin to synthesize vitamin D, which contributes to a normal immune defense.

If we avoid the sun or somehow prevent the UV rays from reaching our skin, it will reduce our ability to make vitamin D. It is difficult to get your full requirement of Vitamin D from As you know, it is important to protect your diet alone. Therefore, to maintain skin when the sun is most powerful. Still, sun a reasonable amount of exposure is necessary in order for our skin to vitamin D in your system it may synthesize vitamin D, which contributes to a be a good idea to consider normal immunelike defense. taking a supplement BioActive D-Pearls.

BioActive D-Pearls are small, soft gelatin capsules with 38, or 75 micrograms of vitamin D in each. This makes it easy for you to choose BioActive D-Pearls are small, soft gelatin the right dose for the time of year and for your capsules with 38, or 75 micrograms of vitamin personal level of sun exposure. D in each. This makes it easy for you to choose thefor vitamin BioActive the• vitamin Dthe in BioActive D-Pearls is your the• right dose timeD of in year and for dissolved in olive oil in forcoldbetter personal level of cold-pressed sun exposure. D-Pearls is dissolved absorption pressed olive D-Pearls oil for better • the vitamin D in BioActive is • small capsules that are easy – or dissolved in cold-pressed oliveto oilswallow for better absorption chew absorption •

Pharmacists' thoughts on Covid Page 26

CPD:

• small capsules that are easy to small capsules that are easy to swallow – or chew swallow – or chew

Vitamin D Deficiency in Ireland Page 29

Without worrying about your skin

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• the vitamin D in BioActive D-Pearls is www.pharmanord.ie dissolved in cold-pressed olive oil for better absorption

TEAM TRAINING: GB_D-Pearls_Ad_IrishPharmacyNews_148x297_0520

If we avoid the sun or somehow prevent the UV rays from reaching our skin, it will reduce our ability to make vitamin D. It is difficult to get your full requirement of Vitamin D from diet alone. Therefore, to maintain a reasonable amount of vitamin D in your system it may be

BioActive D-Pearls are small, soft gelatin capsules with 38, or 75 micrograms of vitamin D in each. This makes it easy for you to choose the right dose for the time of year and for your personal level of sun exposure. www.pharmanord.ie

Management of Cough Page 40


INVOKANA® (canagliflozin) 100 mg & 300 mg film-coated tablets. PRESCRIBING INFORMATION. Republic of Ireland Please refer to 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: not to be initiated with eGFR < 60 mL/min/1.73 m2. If eGFR falls below this value during treatment, adjust or maintain dose at 100 mg once daily. Discontinue if eGFR persistently < 45 mL/min/1.73 m2. Not for use in end stage renal disease or patients on dialysis. 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. Renal impairment: 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 and discontinue when eGFR < 45 mL/min/1.73 m2. Not studied in severe renal impairment. Monitor renal function prior to initiation and at least annually. Volume depletion: caution in patients for whom a canagliflozininduced 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). 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). 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. Necrotising fasciitis of the perineum (Fournier’s gangrene): postmarketing 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. 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): hypoglycaemia in combination with insulin or sulphonylurea, vulvovaginal candidiasis. Common (≥1/100 to <1/10): constipation, thirst, nausea, polyuria or pollakiuria, urinary tract infection (including pyelonephritis and urosepsis), balanitis or balanoposthitis, dyslipidemia, haematocrit increased. Uncommon (<1/100) but potentially serious: anaphylactic reaction, diabetic ketoacidosis, syncope, hypotension, orthostatic hypotension, urticaria, angioedema, necrotising fasciitis of the perineum (Fournier’s gangrene) (frequency not known), bone fracture, renal failure (mainly in the context of volume depletion), lower limb amputations (mainly of the toe and midfoot, incidence rate of 0.63 per 100 subject-years, vs 0.34 for placebo). 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 film-coated tablets: 30 tablets; EU/1/13/884/006. MARKETING AUTHORISATION HOLDER: JanssenCilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. ® INVOKANA is a registered trade mark of Janssen-Cilag International NV and is used under licence. © 2017 Napp Pharmaceuticals Limited. FURTHER INFORMATION IS AVAILABLE FROM: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18. For medical information enquiries, please contact medicalinformation@mundipharma. ie IRE/INV-19401 Date of Preparation November 2019

INVOKANA is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.1 Improvements in renal outcomes with INVOKANA are additional benefits only and not licensed indications.

Did you know...

“Kidney disease predominantly accounts for the increased mortality observed in type 2 diabetes”2 Improved renal outcomes 47% relative risk reduction in time to first adjudicated nephropathy event (doubling of serum creatinine, need for renal replacement therapy, and renal death) HR 0.53 (95% CI 0.33-0.84), compared with placebo and SoC. Absolute risk reduction: 1.3 fewer major adverse renal events per 1000 patient-years.3

27% reduction in the progression of albuminuria in patients with normo- or micro-albuminuria HR 0.73 (95% CI 0.67-0.79), compared with placebo and SoC. Absolute benefit: 39.3 fewer instances of albuminuria progression per 1000 patient-years.4

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). References: 1. INVOKANA SmPC www.medicines.ie November 2019. 2. Afkarian M, et al. Journal of the American Society of Nephrology. 2013;24(2):302-3082. 3. Perkovic V. et al. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. 4. Neal B. et al. N Engl J Med 2017; 377:644-657. INVOKANA® is a registered trade mark of Janssen Cilag International N.V. and is used under licence. MUNDIPHARMA® and the ‘mundipharma’ logo are registered trade marks of Mundipharma AG. Date of Item: February 2020. IRE-INVK-20062 Distributed in Ireland by: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland. Phone +353-1-2063800 www.mundipharma.ie

The recommended starting dose of INVOKANA is 100mg once-daily. SoC - Standard of Care

The renal reason to intensify


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Contents

Foreword

Page 5: Haven Pharmacy Duleek raise vital funds

We lead this issue of Irish Pharmacy News, with calls from community pharmacists for a robust plan to combat flu and prevent it from overwhelming the health system next season.

Page 6: Pharmacy struggling with increasing costs due to Covid Page 10: How McGreals Pharmacy Group are thinking with innovation

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“The flu season which just ended led to the hospitalisation of over 4,000 people in Ireland. Next year we must do everything in our power to reduce the impact of flu to preserve capacity in our health system, particularly as the uncertainty surrounding the impact of COVID-19 remains.”

Page 14: Allcare pharmacy launch new telehealth pilot Page 16: The landscape of medicines during coronavirus

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MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

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ADVERTISING EXECUTIVE Amy Evans: amy@ipn.ie CONTRIBUTORS Dr Kate McClelland Peter Conry Lucy Woolfe DESIGN DIRECTOR Ian Stoddart Design PHARMACYNEWSIRELAND.COM

@Irish_PharmNews

IrishPharmacyNews

In other news, our special report on page 16 looks at the medicines landscape, and potentil impact of Covid on shortages. Dublin GP and former president of the Irish Medical Organisation (IMO) Dr Ray Walley is increasingly concerned by the growth in the number of medicines in short supply here. He believes more should be done to raise awareness of and tackle the issue. He also maintains that shortages are a serious threat to patient safety. Turn to page 16 to read the full report. We have also gathered views of community pharmacists on both sides of the border in response to the pandemic. On page 19, CarePlus Pharmacist Steve Philips from Kildare reflects on how pharmacy is 'stepping up.'

EDITOR Kelly Jo Eastwood: 00353 (87)737 6308 kelly-jo@ipn.ie ADVERTISING DIRECTOR Debbie Graham: 00353 (87) 288 2371 debbie@ipn.ie

Media reports that Government will implement such a fight against were welcomed BUT 'more ambition is needed' to prevent hospitals being overrun with flu this winter, say pharmacists. “Providing the vaccine to at-risk groups is an important first step, but why stop there? Ireland’s flu vaccine strategy must be more ambitious. Official advice should recommend that all people over the age of six months get an annual flu vaccine, and it should be free – this is the best way to maximise uptake,” added My Hanley.

Page 25: Boots launch online prescription ordering

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

Speaking about the importance of planning, IPU VicePresident and community pharmacist Eoghan Hanly said, “As a society we have all learned a lot about epidemiology and health over the past few weeks. Previously alien concepts such as ‘social distancing’, ‘community transmission’ and ‘herd immunity’ are now well understood. We must now seize the opportunity presented by these greater levels of public understanding and step up the fight against the perennial problem of seasonal flu.

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.

“We can hardly believe the world we’ve had to adapt to and figure out how to do business in, over the past couple of months. Over the course of a couple of days in early March, the business changed drastically,” he says. While on page 26, well known Northern Ireland pharmacist Dr Kate McClelland talks us through her journey home from Ausytrlia and what the future of the profession might look like. As always, we are keen to hear your views and thoughts on the challenging times being faced by all. Drop us an email at: kelly-jo@ipn.ie

Regulars FEATURE: PAIN IN CHILDREN CPD: VITAMIN D TEAM TRAINING: COUGH FEATURE: GUT HEALTH FEATURE: SEXUAL HEALTH

P22 P29 P40 P42 P44


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News

Fight Flu now says Pharmacy Ireland needs to devise and deploy a robust plan to combat flu and prevent it from overwhelming the health system next season. Dr Tony Holohan, Chief Medical Officer 3. A public information campaign should raise awareness about the availability and importance of children receiving the flu vaccine.

This call was issued by the Irish Pharmacy Union (IPU), which says that the time for planning is now and that a central pillar should be making the seasonal flu vaccine available to everyone for free this autumn. Speaking about the importance of planning for seasonal flu, IPU Vice-President and community pharmacist Eoghan Hanly said, “As a society we have all learned a lot about epidemiology and health over the past few weeks. Previously alien concepts such as ‘social distancing’, ‘community transmission’ and ‘herd immunity’ are now well understood. We must now seize the opportunity presented by these greater levels of public understanding and step up the fight against the perennial problem of seasonal flu. “The flu season which just ended led to the hospitalisation of over 4,000 people in Ireland. Next year we must do everything in our power to reduce the impact of flu to preserve capacity in our

health system, particularly as the uncertainty surrounding the impact of COVID-19 remains. To achieve this is it vital that the planning starts now. The complex process of procuring adequate national stocks of seasonal flu vaccines will shortly begin and our public health officials must show ambition in this regard.” The Government’s Chief Medical Officer, Dr Tony Holohan, has outlined the need to vaccinate early and in more significant numbers for the upcoming 2020/21 influenza. Pharmacists will have a key role in delivering on this. The IPU has issued the following recommendations to fight the 2020/21 Flu: 1. Free Flu Vaccine should be made available to everyone from 6 months old; 2. Increase the efficiencies of the system by allowing pharmacists administer flu vaccines outside of the pharmacy setting in nursing homes and workplaces; and

Speaking about the recommendations Mr Hanly said, “As the world waits with hope for a vaccine against COVID-19 it should be seen as everyone’s responsibility to build collective immunity against flu. The best way to do this is through widespread vaccination. Ireland performs well by EU comparisons but we still fall short of the target of 75% of people over the age of 65 availing of the vaccine. Making the vaccine free for everyone and improving its accessibility would send a powerful message about its importance to public health.” “Last year there were over 1.1 million flu vaccines delivered in Ireland, which is up 60% since pharmacies were first permitted to administer the vaccine a decade ago. This shows that increasing the convenience and availability of the vaccine has yielded extremely positive results. Pharmacist vaccination services should now be extended by allowing pharmacists to administer the vaccine outside of pharmacies, for example in nursing homes, community centres or workplaces.” Mr Hanly concluded by reiterating the importance of fighting flu proactively: “Every year flu is cited as the reason for the annual challenges with our health system. We can and should do much more to prevent this. We can’t yet stop the coronavirus, but we can stop the flu.”

Reminder on Vaccinations Community Pharmacists should be advising parents of the need to continue to get their babies vaccinated on time during the Covid-19 pandemic as vaccine preventable diseases (such as measles, mumps, polio, whooping cough) continue to be reported, according to the Director of the HSE National Immunisation Office, Dr Lucy Jessop. “World Immunisation Week is a great opportunity to remind us all about the importance of getting vaccinated on time. We know people are worried about Covid-19 but other infectious diseases are also a threat and so vaccines for babies, pregnant women and people in at risk groups should continue at this time. “WHO and HSE advice has not changed, vaccines must be given

at their recommended time to provide maximum protection from vaccine preventable diseases. Delaying vaccines is putting children at unnecessary risk of vaccine preventable diseases at the time they are most vulnerable to the diseases. “The Health Protection Surveillance Centre continues to report cases of vaccine preventable disease during Covid-19, many of these

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cases could have been prevented by getting vaccinated on time,” she said. Vaccines for babies are recommended at 2, 4, 6, 12 and 13 months of age and protect against 13 vaccine preventable diseases. Pertussis vaccine is recommended for pregnant women from 16-36 weeks of pregnancy.

Medicine Shortages The Health Products Regulatory Authority has been notified of a shortage of the following products: • Atenomel 50mg Tablet – PA0126/169/001 • Beclazone 200mcg CFC-Free Inhaler – PA0436/021/001 • Candist 8mg Tablet – PA0126/206/002 • Cozaar 100mg Film Coated Tablet – PA1286/004/003 • Losamel 20mg Gastroresistant tablets – PA0126/115/001 • Lustral 50mg Film Coated Tablet – PA0822/001/004 • Mefac 500mg Film Coated Tablet – PA0074/015/002 • Nimbex 2mg/ml Solution for Injection/Infusion – PA1691/030/001 • Sildenafil 50mg film-coated tablets – PA0126/199/002 • Sildenafil 100mg film-coated tablets – PA0126/199/003 • Tipol 250mg Suppository – PA1684/002/003 • Tipol 500mg Suppository – PA1684/002/004 • Vedixal 37.5mg Tablet – PA0711/161/002 The following shortage has been resolved and supply has resumed to the Irish market: • Fluzac 20mg Capsule – PA0711/110/001 • Ipratropium Steri-Neb 250mcg/ml Nebuliser Solution – PA1986/083/001 • Marcain Heavy Steripack 0.5% w/v Solution for Injection – PA1691/024/003 • Olanzapine 10mg Tablet – EU/1/07/427/011-014 • Quetex 25mg Film Coated Tablet – PA0711/156/001 • Rispone 6mg Film Coated Tablet – PA0711/106/005 • Rivastigmine Sandoz 6mg Capsule – EU/1/09/599/013-016 • Zomacton 10mg/ml Powder and Solvent for Solution for Injection – PA1009/008/003


News Ireland suppressing Covid Ireland's highest number of weekly coronavirus tests conducted to date, as Irish Pharmacy News was going to press, found just 3.7% positive cases, a rate a senior health official said showed it was on a path towards suppressing the disease. Ireland, which plans to reopen its economy from May 18 at a more gradual pace than many European neighbours, carried out almost 62,000 tests over the past week, up from the 41,000 a week earlier that had given a positivity rate of 12.9%. Ireland reported 211 new cases on 5th May to bring its total to 21,983, with 1,339 deaths. The number of new cases marked the lowest daily rise since March 29, when the government introduced its most severe restrictions. The sharply lower number of positive confirmed cases gave an indication that there is “perhaps not as much disease out there as we might suspect,” Cillian De Gascun, the head of Ireland's national virus laboratory, told a news conference. “Combined with the high level of testing we are now undertaking, this gives us confidence that we are on a path towards suppression of the disease,” De Gascun added. Ireland's current testing capacity stands at 84,000, putting it on course to reach 100,000 by a target of May 18, De Gascun added. The health service has prioritised 550 nursing homes for sampling over the past two weeks and has tested 91% of all staff and residents, with the remainder to be completed in coming days. The number of positive cases among residents who had yet to be tested was also “reassuringly lower than we thought it would have been,” the Health Service Executive's Colm Henry said after a number of deadly initial outbreaks in retirement homes.

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Pharmacy circular details withheld drug A drug being used to successfully manage Covid-19 patients in hospitals is being withheld from patients in the community, including in nursing homes, Irish Pharmacy News has learned. A HSE circular to pharmacists, dated April 17th, refers to the “appropriate prescribing of azithromycin in the community”, and notes: “Letters have issued to GPs requesting that prescriptions for azithromycin should not be offered in the community for the management of Covid-19 in the home.Your co-operation and ongoing support is appreciated.”

There is a global shortage of the antibiotic azithromycin, which is also used to treat some sexually transmitted diseases, according to the Irish Pharmacy Union.

for the management of patients with confirmed Covid-19 disease should be restricted to hospitals only.”

The circular refers to a memo from Professor Michael Barry, HSE National Clinical Lead of the medicines management programme, dated April 10th. He says “prescribing of anti-virals

He adds that “careful” consideration of whether to prescribe azithromycin in the community “will support the safe use of this agent, and ensure continuity of supply.”

Haven Pharmacy raise over ¤4000 for ICU The pharmacy heroes in Haven Pharmacy, Duleek, recently raised ¤4,650 for the Intensive Care Unit in Our Lady of Lourdes Hospital in Drogheda. The money was raised over Easter by Kathy Maher and her husband Tom of Haven Pharmacy Duleek. Tom kindly, albeit bravely, agreed to have his head shaved on Easter Monday to raise money for this very worthy cause.

Update on Falsified Medicines Directive The Safety Features Oversight Group has been reviewing plans to end the FMD use and learn period on a phased basis in light of the COVID-19 pandemic. This Group comprises Irish Medicines Verification Organisation (IMVO), Department of Health, Health Products Regulatory Authority (HPRA), Pharmaceutical Society of Ireland (PSI), Health Service Executive (HSE) and Private Hospitals Association (PHA). A statement refletcs, "The Group recognises that this crisis has placed considerable strain on all parties involved in the medicines supply chain in Ireland – pharmacies, hospitals and wholesalers as well as manufacturers, MAHs and parallel importers/distributors – and acknowledges the excellent work being done by everyone to maintain the supply of medicines, while ensuring staff and public safety. “The obligation to move towards full compliance with the Falsified Medicines Directive (FMD) remains, however, given the unique circumstances in which we find ourselves, it has been decided to delay plans previously

notified to end the use and learn period for wholesalers in May and for pharmacies and hospitals in September.” The Irish Medicines Ceroficiation Organisation (IMVO) is operating as normal and has been closely monitoring FMD activity on the ground over the last few weeks as well as liaising with other national medicines verification organisations to see how they are being impacted by COVID-19. IMVO is also continuing to work in the background to reduce the number of avoidable alerts due to manufacturer and system issues and to prepare for the end of use and learn. The Safety Features Oversight Group will continue to closely monitor the situation over the next few weeks and new dates for ending the use and learn period will be notified in due course. In the meantime, the advice is as follows: 1. If you have any queries about your FMD obligations, please contact the PSI (Retail

Pharmacy Businesses), HSE FMD project team (public hospitals), HPRA (wholesalers, MAHs, manufacturers, parallel importers, parallel distributors). 2. Parallel importers and parallel distributors should continue to comply with the guidance issued to them by the HPRA on 7th February. 3. Please contact IMVO if you have queries about your connection to the national system (including new registrations, login queries, change of FMD software provider) or want to follow up on specific alerts or scanning issues. 4. If at any stage you have grounds for believing that a pack has been interfered with or could be falsified, please report this to the HPRA, by email to qualitydefects@hpra.ie or using the HPRA’s online reporting system https://www.hpra.ie/ homepage/about-us/reportan-issue (select the link called ‘Report an issue’, then ‘Medicine Quality Issue/Defect’).

PHARMACYNEWSIRELAND.COM


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News

Soaring costs and falling revenue hits Pharmacy Ireland’s 1,900 community pharmacies are struggling to cope with soaring costs and falling revenues. New research released by the Irish Pharmacy Union (IPU) reveals the extent of the severe cost increases being borne by pharmacies providing front line care during the crisis. The IPU Covid-19 Business Survey revealed that the vast majority of pharmacies have been hit by significant extra costs to enable them to remain open and to provide safe care. The costs associated with physical distancing are among the most significant, with over two thirds (68%) installing new counter screens to protect patients and staff, and significant costs highlighted for the implementation of other measures including signage and security pods. When Personal Protection Equipment (PPE) is included the average cost per pharmacy is ¤2,700 with some pharmacies spending up to ¤10,000. Day to day operating costs have also dramatically increased for pharmacies. The survey reveals staff costs, as well as additional security, delivery and sanitisation costs, are increasing by an average of ¤5,000 per month, equating to almost ¤10 million per month on average across the sector. The increase in costs comes at a time when retail sales in pharmacies have dropped dramatically due to the restrictions, with falls on average of 36% across

the sector, and three-quarters of pharmacies anticipate having to make additional investments to reconfigure their premises or otherwise prepare for when the current restrictions on movement are lifted. This is putting considerable pressure on pharmacies, the majority of which are small family run businesses. The survey showed that one in five pharmacies have laid off staff, while another two in five (38%) will be forced to so in the next two to three months. A quarter of pharmacies have reached their credit limit with medicine wholesalers, impacting their ability to purchase further supplies, while many more have had to defer payments to creditors, restructure loans, or expand overdraft facilities. Worryingly, 30% of respondents indicated that they had difficulty in ordering key medicines for patients due to reaching their credit limit. Speaking about the stark figures, IPU Secretary General Darragh O’Loughlin said, “Pharmacists are at the frontline of our healthcare system. As the various Covid-19 restrictions have been implemented, pharmacies have

remained open to provide their communities with an uninterrupted supply of medicines, service and advice, but this has come at an unsustainable cost to many. “Pharmacists are fully committed and none of them want to see staff laid off, but the reality is that there is little choice unless the situation changes. These pressures also could cause closures of some pharmacies, a situation that everyone wishes to avoid.” In conclusion, O’Loughlin said that while pharmacies continue to operate in extremely difficult circumstances they will make every effort to remain open. Minister for Health Simon Harris has said that he is looking at ways to support pharmacies in their work. However, no support has yet been provided, leading O’Loughlin to warn that, if the additional costs continue at the levels currently experienced and urgent Government support is not forthcoming, some pharmacies will have to dramatically curtail their opening hours or close completely. The survey was undertaken in the week beginning 20 April 2020 to establish to establish the impact of Covid-19 on pharmacy businesses and to get an estimate of the costs already incurred and the potential future costs when the public emergency measures are eased. There were 190 responses to the survey representing 430 pharmacies. • ¤10 million per month increase in operating costs • Retail sales down 36% while costs soar • One in five has laid off staff while a further 38% will do so in the next three months • Government supports urgently needed

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Psychology of Covid Researchers from the Trinity Centre for Global Health have released the first wave of the Irish COVID-19 Psychological Survey; a multi-wave study running throughout the COVID-19 outbreak to better understand how people are responding, understanding, and coping with the pandemic. The Trinity research team collaborated with researchers from Maynooth University, Ulster University, Edinburgh Napier University, and University of Sheffield. Over 1,000 adult citizens of the Republic of Ireland completed the survey, which was launched on 31 March; 31 days after the first confirmed case of COVID-19 was reported in the Republic of Ireland. The survey was launched 19 days after An Taoiseach Leo Varadkar announced sweeping restrictions on the movement of people, and two days after Irish residents were required to stay at home. Participants answered questions about their current circumstances of the COVID-19 pandemic, their mental health, and their views on COVID-19 vaccination. Initial results suggest that mental health problems are common; 41% of people reported feeling lonely, 23% reported clinically meaningful levels of depression, 20% reported clinically meaningful levels of anxiety, and 18% reported clinically meaningful levels of post-traumatic stress. Dr Frédérique Vallières, Director of Trinity College’s Centre for Global Health further added, “Despite encouraging results in terms of people’s knowledge on COVID-19, we further found that attitudes towards the uptake of a potential COVID-19 vaccine to be worryingly low, with only 65% of people indicating that they would accept a vaccine for themselves and their children. “One-in-four people did say however that they might accept a vaccine for themselves and their child, compared to one-inten people who said they would not. A better understanding of why people might be hesitant to accept a COVID-19 vaccine, if and when it is developed is required.”


THE FLEXIBILITY OF Q3W OR Q6W DOSING ACROSS MONOTHERAPY INDICATIONS1

KEYTRUDA® (pembrolizumab) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION KEYTRUDA 25 mg/mL: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. INDICATIONS KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. KEYTRUDA as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic HNSCC in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. DOSAGE AND ADMINISTRATION See SmPC for full details. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The recommended dose of KEYTRUDA as part of combination therapy is 200 mg every 3 weeks administered as an intravenous infusion over 30 minutes. KEYTRUDA must not be administered as an intravenous push or bolus injection. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. Treat patients until disease progression or unacceptable toxicity. Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. For the adjuvant treatment of melanoma, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued (a) For Grade 4 toxicity except for: endocrinopathies that are controlled with replacement hormones; or haematological toxicity, only in patients with cHL in which KEYTRUDA should be withheld until adverse reactions recover to Grade 0-1; (b) If corticosteroid dosing cannot be reduced to ≤10 mg prednisone or equivalent per day within 12 weeks; (c) If a treatment-related toxicity does not resolve to Grade 0-1 within 12 weeks after last dose of KEYTRUDA; (d) If any event occurs a second time at Grade ≥ 3 severity. Patients must be given the

Patient Alert Card and be informed about the risks of KEYTRUDA. Special populations Elderly: No dose adjustment necessary. Data from patients ≥ 65 years are too limited to draw conclusions on cHL population. Data from pembrolizumab monotherapy in patients with resected Stage III melanoma, from pembrolizumab in combination with axitinib in patients with advanced RCC, and from chemotherapy combination in patients with metastatic NSCLC, and from pembrolizumab (with or without chemotherapy) in patients receiving first line treatment for metastatic or unresectable recurrent HNSCC ≥ 75 years are limited. Renal impairment: No dose adjustment needed for mild or moderate renal impairment. No studies in severe renal impairment. Hepatic impairment: No dose adjustment needed for mild hepatic impairment. No studies in moderate or severe hepatic impairment. Ocular melanoma: Limited safety and efficacy data exist. Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 2: Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC. Paediatric population: Safety and efficacy in children below 18 years of age not established. CONTRAINDICATIONS Hypersensitivity to the active substance or to any excipients. PRECAUTIONS AND WARNINGS Assessment of PD-L1 status When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Immune-related adverse reactions Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. Immune-related adverse reactions affecting more than one body system can occur simultaneously. See SmPC for full details. Immune-related pneumonitis: Patients should be monitored for signs and symptoms of pneumonitis. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Refer to SmPC for information on management of immune-related pneumonitis. Immune-related colitis: Patients should be monitored for signs and symptoms of colitis, and other causes excluded. Consider the potential risk of gastrointestinal perforation. Refer to SmPC for information on management of immune-related colitis. Immune-related hepatitis: Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Refer to SmPC for information on management of Immune-related hepatitis. Immune-related nephritis: Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. Refer to SmPC for information on management of immune-related nephritis. Immune-related endocrinopathies: Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Hypophysitis has been reported in patients receiving pembrolizumab. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes. Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment. Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy. Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. Refer to SmPC for information on management of immune-related endocrinopathies. Immune-related skin adverse reactions: Patients should be monitored for suspected severe skin reactions and other causes should be excluded. Based on the severity of the adverse reaction, pembrolizumab should be withheld or permanently discontinued, and corticosteroids should be administered. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients


(pembrolizumab) Injection 25mg/ml FEWER INFUSIONS WITH Q6W DOSING The flexible dosing regimen with KEYTRUDA is an opportunity to reduce the frequency of treatments for your patients

Q6W dosing means as few as 8 infusions per year

CHOOSE THE APPROPRIATE DOSING REGIMEN FOR YOUR PRACTICE AND PATIENTS

3

Weeks

OR

Every

6

Weeks

200 mg

400 mg

Short-interval Dosing

Long-interval Dosing

receiving pembrolizumab. For signs or symptoms of SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued. Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune- stimulatory anticancer agents. Other clinically significant immune-related adverse reactions: The following additional clinically significant, immune-related adverse reactions, have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis. Refer to SmPC for information on management of significant immune-related adverse reactions. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT): Allogeneic HSCT after treatment with pembrolizumab: Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT after previous exposure to pembrolizumab. Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case. Allogeneic HSCT prior to treatment with pembrolizumab: In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT. Infusion-related reactions: For severe infusion reactions including hypersensitivity and anaphylaxis, stop infusion and permanently discontinue pembrolizumab. With mild or moderate infusion reactions, infusion may continue with close monitoring. Premedication with antipyretic and antihistamine may be considered. Overdose: There is no information on overdose with pembrolizumab. In case of overdose, monitor closely for signs or symptoms of adverse reactions and treat appropriately. INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. No metabolic drug-drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Corticosteroids can be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. FERTILITY, PREGNANCY AND LACTATION Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Pregnancy No data on use in pregnant women. Do not use during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Breast-feeding It is unknown whether pembrolizumab is secreted in human milk. A risk to newborns/ infants cannot be excluded. Fertility No clinical data available. SIDE EFFECTS Refer to SmPC for complete information on side effects. Pembrolizumab is most commonly associated with immune-related adverse reactions. Most of these reactions resolved with appropriate medical treatment or withdrawal of pembrolizumab. The most serious adverse reactions were immune-and infusion-related adverse reactions. Monotherapy: Very Common: anaemia, hypothyroidism, decreased appetite, headache, dyspnea, cough, abdominal pain, nausea, vomiting, constipation, musculoskeletal pain, arthralgia, asthenia, oedema, pyrexia, diarrhoea, rash, pruritus, fatigue. Common: pneumonia, thrombocytopaenia, lymphopaenia, hyponatraemia, hypokalaemia, hypocalcaemia, insomnia, neuropathy peripheral, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, hyperthyroidism, insomnia, dizziness, dysgeusia, pneumonitis, colitis, dry mouth, severe skin reactions, vitiligo, dry skin, alopecia, eczema, dermatitis acneiform, erythema,

over 30 minutes

myositis, pain in extremity, arthritis, influenza like illness, chills, AST and ALT increases, hypercalcaemia, increase in blood alkaline phosphatase, blood bilirubin increased, blood creatinine increased, infusion related reaction. Frequency not known: solid organ transplant rejection Combination with chemotherapy: Very Common: anaemia, neutropaenia, thrombocytopaenia, hypokalaemia, decreased appetite, dizziness, neuropathy peripheral, dysgeusia, headache, dyspnoea, cough, abdominal pain, alopecia, diarrhoea, nausea, vomiting, constipation, rash, pruritus, musculoskeletal pain, arthralgia, pyrexia, fatigue, asthenia, oedema, blood creatinine increased. Common: pneumonia, febrile neutropaenia, leukopaenia, lymphopaenia, infusion related reaction, hypothyroidism, hyperthyroidism, hyponatraemia, hypocalcaemia, insomnia, lethargy, dry eye, cardiac arrhythmia (including atrial fibrillation), hypertension, pneumonitis, colitis, dry mouth, severe skin reactions, erythema, dry skin, myositis, pain in extremity, arthritis, nephritis, acute kidney injury, chills, influenza-like illness, hypercalcaemia, ALT increase, AST increased, blood alkaline phosphatase increased. Combination with axitinib: Very Common: hyperthyroidism, hypothyroidism, decreased appetite, headache, dysgeusia, hypertension, dyspnoea, cough, dysphonia, diarrhoea, abdominal pain, nausea, vomiting, constipation, palmar-plantar erythrodysaesthesia syndrome, rash, pruritus, musculoskeletal pain, arthralgia, pain in extremity, fatigue, asthenia, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased. Common: pneumonia, anaemia, neutropaenia, leukopaenia, thrombocytopaenia, infusion related reaction, hypophysitis, thyroiditis, adrenal insufficiency, hypokalaemia, hyponatraemia, hypocalcaemia, insomnia, dizziness, lethargy, neuropathy peripheral, dry eye, cardiac arrhythmia (including atrial fibrillation), pneumonitis, colitis, dry mouth, hepatitis, severe skin reactions, dermatitis acneiform, dermatitis, dry skin, alopecia, eczema, erythema, myositis, arthritis, tenosynovitis, acute kidney injury, nephritis, oedema, influenza like illness, chills, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased PACKAGE QUANTITIES KEYTRUDA 25 mg/mL: 4 mL of concentrate in a 10 mL Type I clear glass vial. Legal Category: POM. Marketing Authorisation numbers EU/1/15/1024/002 Marketing Authorisation holder Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Date of revision: November 2019. © Merck Sharp & Dohme Ireland (Human Health) Limited 2019. All rights reserved. Further information is available on request from: MSD, Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 or from www.medicines.ie. Date of Preparation: April 2020. 11065_11080 Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to MSD (Tel: 01-2998700) Reference 1. Keytruda Summary of Product Characteristics, April 2020, available at www.medicines.ie.

Red Oak North, South County Business Park, Leopardstown, Dublin D18 X5K7 Ireland

IE-KEY-00261

Every

Both dosing options are administered as an intravenous infusion


10

Profile

Pharmacy Group employing Innovation during Pandemic "How can I implement guidance and best practice in response to COVID-19?" "How can I ensure the safety of my customers and my pharmacy team?" Kilian McGreal, Pharmacist and Managing Director, McGreals Pharmacy Group

These are just two of the many questions community pharmacists and pharmacy business owners across Ireland will have been asking themselves over recent weeks during a rapidly changing global pandemic landscape. In response to the virus many, if not all, have adopted new working regimes, such as allowing only one customer into the store at a time. Perspex screens have been constructed at dispensaries and consultation areas. Many are closing during lunch, opening later and closing earlier in order to allow for deeper clearning of the shop. Community pharmacies continue to stay open during the COVID-19 pandemic to deliver essential

medicines, health and wellbeing support and information to their customers. The resulting panic purchases and increased demand for OTC medicines has put them all under serious pressure. One local pharmacist has employed the use of innovative thinking in adapting his frontline service to meet demand. Kilian McGreal, Pharmacist and Managing Director of McGreals Pharmacy Group has recently installed a unique air disinfection system to safeguard his customers and his staff. It is also now available to businesses and the public through the McGreals Group, which is based in Wicklow.

any airborne viruses and bacteria. It is patented and has a unique design scientifically proven for airborne infection prevention.

This ground breaking device decontaminates the air and kills

It closes the loop in terms of the importance of disinfecting hands

PHARMACYNEWSIRELAND.COM

The Novaerus air disinfection system

and surfaces and now that third crucial element, air. By drawing air through the clinically proven and patented Air Plasma field it immediately destroys airborne viruses - all while using less energy than a 40 watt light bulb.


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"I firmly believe that the benefits go well beyond that. Post Covid 19, our team and our patients will have a much higher expectation of the hygiene measures they expect from their pharmacy" The product is designed and manufactured by local company Novaerus. The product which has been endorsed by Enterprise Ireland is being used in hospitals and health care settings around the world. Following increased interest and demand in Ireland from consumers and businesses, Novaerus approached the McGreals Pharmacy Group to bring the product to the Irish retail market. With no harmful by products, they are safe for use around children, the elderly, and the sick. They are simple to use, low maintenance and highly effective for rapid or continuous infection control, odour mitigation and particle reduction.

higher expectation of the hygiene measures they expect from their pharmacy. “With the amount of people coming into our pharmacies with colds, flus, chest infections and so on, having a Novaerus unit working away reducing the level of airborne viruses, bacteria and fungi makes perfect sense.” This innovative technology has also been at the forefront of fighting the coronavirus in China following donations of several units to two hospitals in Wuhan. The units have been tested in more than 30 independent laboratories across the world, testing against a range of viruses including MS2 Bacteriophage, a commonly used surrogate for SARS-CoV* (Coronavirus), which was shown to reduce the virus by 99.9% Michael Corr, Novaerus Director of Business Development, explains, “Due to the growing concerns over the coronavirus presence in Ireland and following a recent Irish Times article and interview on the RTE news highlighting our support against the virus in other countries including its origin in China, we received many requests for our devices from the general public and retail businesses.

To find out more about the Novaerus air disinfection units you can contact the McGreals Pharmacy Group directly on +353 45 397 202, email novaerus@mcgreals.ie or visit mcgreals.ie

“As an Irish company based in Dublin with our manufacturing in Portlaoise, our success is through channel partners across the world. We needed a partner to help us support the Irish public and retail businesses to receive our technology quickly and efficiently and that’s why I approached Kilian McGreal at the McGreals Pharmacy Group. We are now working with the McGreals Group to help both businesses and people in their own homes. It’s a real success story!” “We are delighted to be working with Novaerus to bring this product to the Irish retail market. With the devices installed in our pharmacies we know we are protecting the health of our team and customers by providing the safest environment possible,” adds Kilian.

Kilian told Irish Pharmacy News, “For me, installing Novaerus units in all our shops to help prevent the spread of Covid 19 was a no brainer. “However I firmly believe that the benefits go well beyond that. Post Covid 19, our team and our patients will have a much

McGreals Pharmacist and Healthcare Hero Duarte wearing all of the protective equipment the pharmacy team have available

PHARMACYNEWSIRELAND.COM


12

News

Rory gets on his Bike totalhealth Pharmacy Group have proudly been able to react and roll-out their totalhealth Pharmacy Group App in reponse to the coronavirus. The App has now been rolled out across Ireland to benefit and aid totalhealth Pharmacies and make life easier for teams, patients, and customers during the Corona Crisis. The App allows the patient/user to order a prescription, regular or repeat, they can order for themselves and their dependents without visiting the pharmacy. Users can also order other pharmacy shopping using the messenger area of the App, giving patients another way to contact and converse with their local totalhealth Pharmacy at this time of crisis and social distancing Meanwhile, Owner and Pharmacist at O'Donnell's totalhealth Pharmacy in Gweedore and Chair of totalhealth Pharmacy Group Rory O'Donnell as been getting onto his motorcycle to do his part in delivering valuable medicines to patients.

Medbot launches at mccabespharmacy.com

Emergency Pharmacist Restoration The Emergency Measures in the Public Interest (Covid-19) Act 2020 introduces responsive emergency provisions, including a mechanism to quickly restore health professionals to Statutory Registers where a previously registered individual wishes to assist and be available to work within the health system. In line with these measures, a new restoration route has been introduced to the Pharmacy Act, referred to as a Section 77 registration. This enables former PSI registrants, including pharmacists and pharmaceutical assistants, who either voluntarily withdrew from the register or were removed due to nonpayment of registration fees, to have their registration restored. Restorations to the Register made under COVID-19 Section 77 are temporary registrations and registration will automatically cease after the COVID-19 pandemic emergency has been declared to have passed by Government.

McCabes Pharmacy have become the first Irish pharmacy to launch the Covid 19 Medbot. The COVID-19 Medbot is an online consultation based risk assessment for coronavirus. Click on the Medbot icon and patients will be asked a series of questions, designed to assess their risk of contracting Coronavirus. The Medbot then provides a recommendation on whether they need to be tested and provides any follow up actions they may need to take.

To make an application under Covid-19 Section 77 Restoration, please download and complete the COVID-19 Restoration Application Form and submit it by email to section77@psi.ie.

Members of the public can also choose to have these recommendations emailed to them. The questions, analysis and results are based on the Health Service Executive (HSE), Centers for Disease Control (CDC) and World Health Organisation (WHO) guidelines on COVID-19.

Previous registrants can make an electronic application for Section 77 registration to re-join the Register by downloading the required application form.

The Covid-19 Med Bot was developed with the help of two Irish consultant doctors, Dr Oran Rigby and Dr Amy Hollingworth.

Applicant submits the completed application form by email to section77@psi.ie.

The #medbot is continuously updated with new information, is free and can be used as many times as needed.

Cosmetics Association Trade Show

The annual Cosmetics Association Trade Show has been cancelled for 2020. A statement says, "Due to the Government restrictions during this Covid 19 Pandemic and the situation with RDS as our venue, we are forced to cancel our Trade Show for this year. PHARMACYNEWSIRELAND.COM

“We have rescheduled the event in RDS for next year on the following dates: Saturday 15th May - Set Up; Sunday 16th May - Tuesday 18th May - Exhibit “We hope to see all our Buyers back in RDS next year and trust you are all safe and well at this time.”

PSI will consider your application and, if satisfied that restoration is appropriate, your name will be restored to the Register of Pharmacists and Pharmaceutical Assistants . Applicants who are restored to the Register will have “Section 77 Registration” stated after their surname on the PSI register. An email will be issued to the applicant to confirm their application has been successful and that their name is restored to the Register. Prior to 31 July 2020 (or a date as amended by the Minister for Health), the PSI will contact you to inform you of the date from which your Section 77 registration will cease and what options will be open to you.


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e in ยนCetrine Allergy7 1mg/ml Oral Solution, and available in 200ml bottle and launched 28 in November 2019. Cetrine Allergy 10mg FCT available in 7 and 30 packs, Lorat 10mg Tablets available in 7 and 28 C packs, or Rhinex Relief 50 micrograms/actuation to Nasal report spray, suspension, available as 1 x 60 doses. Medicinal products not subject to medical prescription. For further information, SPC or to report CF adverse drug reactions, No: contact the Marketing Authorisation 22863 Holder: Rowex Ltd., Bantry, Co. Cork. Ireland. Freephone: 1800 304 400. Fax: 027-50417. Date of preparation: (01-20) CCF No: 22863


14

News

First for Pharmacy Telehealth Pilot Allcare Pharmacy, the largest Irish-owned community pharmacy group, announced today the launch of Ireland’s first community pharmacy telehealth service in Ballincollig, Cork. Ballincollig Pharmacy under Pharmacist Shane Byrnes, are trialling a new telehealth pilot

The pilot has introduced the trialling of various video consultation technologies to established patients in the Allcare Pharmacy in Ballincollig. This enables patients to have a one-toone consultation with their pharmacist. This ability to access a clinical follow-up reassures the pharmacist that guidance is being followed, whilst bringing great comfort to patients. In recent weeks, the number of patients self-isolating has increased significantly. With medications being collected or delivered, the important faceto-face interaction between the pharmacist and patient has disappeared. This can be a cause for concern for many patients: for example, those who live with a chronic illness and need to discuss the implications of their immunosuppressant

therapies during Covid19; those with respiratory issues who need advice on inhaler use; or those who simply need the reassurance of a conversation with their pharmacist. Speaking about the pilot, pharmacist Shane Byrnes says, “‘Patients have responded very positively to the service which maintains access to their local pharmacist directly from the comfort of their own home. “A great use case that has emerged throughout this pilot is from patients currently on immunesuppressant drugs. Tens of thousands of patients around Ireland receive weekly, fortnightly or monthly injectable medications for conditions such as rheumatoid arthritis that work by supressing the immune system. Given the nature of their medication this is an incredibly worrying time for

them compounded by the fact that they may have restricted access to their normal healthcare support network. Utilising the telehealth service in the pharmacy we were able to intervene with patients who were planning to discontinue their long-term medication based on mis-information circulating on social media. Reassurance was given, and instead we were able to provide them with guidance on maintaining their current medication regimen and the increased importance of ‘cocooning’ or ‘stay at home’ recommendations depending on their risk category.” The pilot got underway in Allcare Pharmacy in Ballincollig, Cork six weeks ago and to date is proving to be extremely successful. With so many changes taking place in the way that patients access their healthcare, the Pharmacy Telehealth pilot is certainly an interesting proposition for future healthcare interactions. The pharmacy, as do most Allcare pharmacies, also provides a free local delivery service to its patients, of both medications and our full range of products. Customers are asked to contact their local pharmacy to arrange this with the staff.

Cinacalcet Clonmel Clonmel Healthcare is delighted to announce the launch of Cinacalcet Clonmel 30mg, 60mg and 90mg Film-coated Tablets. Adults Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyper-

-parathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Full prescribing information is available on request or alternatively please go to

PHARMACYNEWSIRELAND.COM

www.clonmel-health.ie. Product is subject to medical prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information. PA 126/306/001-003. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: April 2020. 2020/ADV/CIN/034H

Irish study awarded HRB-IRC funding Scientists and clinicians from RCSI University of Medicine and Health Sciences are leading a groundbreaking study funded jointly by the Health Research Board (HRB) and Irish Research Council (IRC) to develop new and innovative approaches to improve the clinical care of patients with COVID-19 pneumonia. The Irish COVID-19 Vasculopathy Study (iCVS) project has been awarded ¤199,000 as part of government funding announced today under the COVID-19 rapid response call. It is one of 26 projects that will receive ¤5 million funding under the newly-established national, coordinated research and innovation response to the COVID-19 pandemic, complementing the ongoing research work already underway in higher education institutions. The iCVS cross-disciplinary study is led by Professor James O'Donnell, Director of the Irish Centre for Vascular Biology, RCSI and a Consultant Haematologist in the National Coagulation Centre in St James's Hospital, Dublin. The study will investigate why patients with COVID-19 develop blood clotting abnormalities leading to micro-clots in the lungs. These micro-clots block normal blood flow throughout the lungs, which coupled with pneumonia, can result in the patient’s oxygen levels in the blood falling to dangerously low levels. “The mechanisms through which COVID-19 triggers such a unique and lifethreatening clotting disorder are not understood,” said Professor O’Donnell. “This research programme will use state-of-theart testing in order to answer this key question which is puzzling doctors and scientists around the world. “By understanding why these micro-clots are being formed within the lungs, the team aims to identify subsets of Irish patients who would likely benefit from blood thinning medication, as well as specific anti-inflammatory treatments. The study will also investigate whether clotting biomarkers may be useful in order to better define prognosis for COVID-19 patients and thereby prioritise ICU resources, with the ultimate goal of saving lives.”


Pain Relief for the Family* Feeling better already

Easofen for Children Strawberry 100 mg/5 ml Oral Suspension and Easofen for Children Six Plus Strawberry 200 mg/5 ml Oral Suspension. Contains maltitol liquid & sodium. Sugar free and colour free. *Easofen for Children Strawberry is for infants from 3+ months and should only be given to infants aged 3-6 months who weigh more than 5 kg. Easofen 200 mg Film-coated Tablets and Easofen Max Strength 400 mg Film-coated Tablets are for adults and adolescents (over the age of 12 years). Contains ibuprofen. Retail sale through pharmacies only. A copy of the summary of product characteristics is available upon request. PA 126/60/1-4 PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: December 2019. 2019/ADV/EAS/140H


16

Report

Pharmacy Landscape of Medicine Shortages during COVID-19 Before the outbreak of Covid-19, pharmacists and doctors reported that the problem of medicine shortages in Ireland was worsening. Now that SARS CoV-2 is here to stay (at least until a vaccine is found), will medicine shortages deteriorate further?

Niamh Cahill investigates

The problem of medicine shortages in Ireland is worsening. According to the Irish Pharmacy Union (IPU), pharmacists are spending up to seven hours a week trying to resolve shortfalls for patients.

of essential drugs are becoming increasingly frequent globally, burdening health systems with additional costs and posing risks to the health of patients who fail to receive the medicines they need.”

Separately, the Health Products Regulatory Authority (HPRA) highlights out of stock human medicines and documents when supply concerns have been resolved.

Ireland is not unique in this regard. According to the HSE, medicine shortages are “happening more often worldwide”.

They added: “Medicines shortages pose risks for patient health as a result of non-treatment, under-treatment and possible medication errors from attempts to substitute missing medicines.”

The Authority is responsible for coordinating the management of shortages of medicines on the Irish market and works with manufacturers, wholesale distributors, marketing authorisation holders, healthcare professionals, the HSE, patients and representative groups to respond to potential drug shortages and reduce their impact on patients.

A recent European report added weight to the Irish experience, with 95 per cent of hospital pharmacists in 2019 reporting that medicines shortages are a “current problem”. In 2016 the World Health Organisation reported: “Shortages

The IPU publishes a list of medicine shortages in Ireland every month. The April list details over 300 products usually available via the GMS where supply issues have arisen.

In 2018, it launched the “Medicine Shortages Framework as part of these efforts. The framework states: “Medicine shortages are recognised as a global problem by the World Health Organisation. Whilst medicine shortages have been a global issue for some time, they have increasingly affected Ireland and other European countries with significant impact on patient care and total healthcare costs”. Both the IPU and HPRA medicine shortage notices illustrate the ongoing challenges faced here. Unexpected increases in demand, manufacturing delays, product recalls and quality issues are some of the factors that result in supply chain issues. When a drug is unavailable, pharmacists are forced to seek an alternative drug for the patient, or in some cases, to provide a product not licensed for a patient’s particular condition, but which has shown to be effective. On occasion, however, there is no substitute available. According to results from the Pharmaceutical Group of the European Union (PGEU) Medicine Shortages Survey 2019, the time pharmacy staff spends dealing with shortages has jumped from 5,6 hours per week (2018) to 6,6 hours per week on average. Dr Nuala O'Connor, ICGP GP Lead HSE Antimicrobial Resistance and Infection Control Team

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17 Responding to the survey, released in February, Darragh O’Loughlin, General Secretary of the IPU, said the results shows the problem is getting worse. “In Ireland, we have experienced significant shortages of medicines in the last year and the situation continues to get worse. Patients can sometimes wait for weeks to get a new supply of a common drug. Not only is this putting their health at risk but it is causing undue stress, fear and anxiety for patients. Instead of directing their efforts and professional expertise towards the needs of patients, pharmacists are spending nearly seven hours a week resolving medicines shortages and firefighting on behalf of our patients.” Shortages On 20 March the HSE wrote to all GPs, community pharmacists and community nursing units advising of “critically low stock levels” of co-amoxiclav 625mg tablets. “In the context of preparedness work for the COVID-19 National Public Health Emergency we have identified that stocks of co-amoxiclav 625mg tablets are critically low,” Prof Martin Cormican, HSE National Clinical Lead for HCAI/AMR (Healthcare Associated Infections/ Antimicrobial Resistance) and Dr Nuala O’Connor, ICGP GP Lead HSE Antimicrobial Resistance and Infection Control Team, advised. The letter went on to state the specific indications the drug should be reserved for and suggested alternative medications to help “protect patients from avoidable antibiotic related side-effects and to make sure that co-amoxiclav remains available for those who need it”. By mid-April, sufficient supplies of the product had resumed. A spokesperson for the HPRA said: “It is expected that sufficient stocks of co-amoxiclav medicines will continue to be available to enable patients to be treated in line with antimicrobial prescribing guidelines”. Separately, frusemide/amilorise has been unavailable in Ireland recently. According to the IPU, “it will be back in stock shortly”. A HPRA spokesperson said: “In relation to the combination of furosemide and amiloride, there are no supply issues in relation to Frumil 40mg / 5mg Tablets which are available to order in the normal manner. There has been a temporary shortage of Frumil Low Strength 20mg / 2.5mg Tablets (which was not related

Darragh O'Loughlin, General Secretary, IPU

to COVID-19) but supply of that strength is expected to resume shortly.” Covid-19 The outbreak has generated concern among countries about the future availability of medicines and agencies globally are stepping up efforts to mitigate the risks posed by the pandemic. There have been warnings in the US that the coronavirus outbreak will lead to even greater drug shortages there, especially antibiotics. According to the European Medicines Agency (EMA), EU authorities recently agreed measures to support the availability of medicines during the pandemic. In a statement, the agency said some countries in the EU had already begun to see shortages of some medications used for patients with the virus, or were anticipating shortages soon. “These include medicines used in intensive care units such as certain anaesthetics, antibiotics and muscle relaxants as well as medicines used off-label for COVID-19. EU authorities are therefore putting in place additional measures to mitigate the impact of the pandemic on the supply chain of medicines in a coordinated manner. “The number of shortages of medicines has increased in the past few years and the issue is aggravated in this pandemic by many different factors, e.g. lockdown in factories due to quarantine, logistical issues caused by border closures, export bans, lockdowns in third countries [countries outside the EU and EEA] supplying medicines to the EU, increased demand due to the treatment of COVID-19 patients, stockpiling in certain hospitals, but also individual stockpiling by citizens as well as at Member State level. To avoid shortages due to stockpiling, some member states have imposed restrictions on the number of packs that can be prescribed to patients or purchased by citizens.” Because of this, the EMA is establishing an industry single point of contact system to help fast track the communication of medicine shortages. An EU Executive Steering Group on Shortages of Medicines Caused by Major Events has also been set up.

The system will allow pharmaceutical companies to report directly to the EMA anticipated shortages or current shortages of critical medicines required for patients with COVID-19. Furthermore, the EMA advised “mitigation measures are currently under consideration, such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a new manufacturing line or site. Discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially at risk of supply shortages”. The EU Executive Steering Group is considering areas where regulatory rules could be applied with “greater flexibility” during the pandemic to secure supply. In Ireland, authorities here have pointed out that to date there is no threat to the supply of medicines due to the outbreak and that measures are being put in place in the event shortages arise. The HPRA is a member of the National Public Health Emergency Team (NPHET), which is coordinating the management of, and response to Covid-19 (SARSCoV-2) in Ireland. “There is no evidence to suggest that Ireland is likely to face general medicines supply issues, now or in the near future, as a result of any potential delays in the supply chain caused by COVID-19 related issues,” according to a HPRA spokesperson. “Ireland is unlikely to face general medicine supply issues, and is well

placed to deal with these as they arise. However, this is very much based on normal use of medicines.” The IPU has said there has been no direct impact on general medicines availability as a result of Covid-19, but, like the HPRA, cautioned the public against stockpiling medicines. “Throughout the ongoing Covid-19 situation, the IPU has issued several calls urging the public not to stockpile medicines. Covid-19 has not caused any supply shortages and there are additional stocks of medicines routinely built into the medicine supply chain; stockpiling is completely unnecessary and, in fact, could itself hamper the availability of medicines for other patients.” The Department of Health said medicines shortages inevitably arise from time to time and are “a feature of health systems around the world”. Authorities remain vigilant to supply issues and Ireland will “continue to work with authorities at a European and International level to closely monitor the situation and ensure that all appropriate steps are taken to facilitate continuity of care and treatment”, a spokesperson confirmed. “Work is also ongoing to ensure that there are additional supplies of medicines used in the treatment and care of Covid-19 patients. “The potential future shortage of any specific medicine will be managed through the existing Medicine Shortages Framework to prevent the shortage from occurring where possible or, where it does occur, to manage the impact in terms of identifying alternative treatments.”

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18

Report Tomas Conefrey, Pharmacist

"Even before the current pandemic, we consistently heard from pharmacists that the problem of medicine shortages was worsening" Hydroxychloroquine On 30 March Professor Michael Barry, National Clinical Lead, HSE Medicines Management Programme wrote to pharmacy contractors regarding the “conservation” of the drug Hydroxychloroquine. The medication is used for the treatment of rheumatoid and lupus conditions, but has been shown to have “some antiviral activity” against Covid-19. Because of efforts to preserve stock of the medication for hospital patients with the virus, Mr Barry asked prescribers to consider alternatives when prescribing the drug for patients in the community with rheumatoid and lupus conditions. “Hydroxychloroquine has an important role in the on-going management of rheumatoid and lupus conditions of many individuals. Stocks of this medicine are being managed to ensure these individuals will continue to have access to their regular medication in the normal manner. This management is premised on the recommendations of the national guideline that hydroxychloroquine will only be prescribed for COVID-19 positive in-patients by a hospital clinician on a hospital prescription only.

“I would ask you in this COVID-19 Public Health Emergency that you would carefully consider alternative therapies before initiating new patients on long-term hydroxychloroquine for rheumatoid and lupus conditions to support continuity of supply, where such alternatives are available,” he wrote. On 14 April, further guidance was issued by the HSE to GPs and pharmacists regarding the antibiotic azithromycin. It advised that prescriptions for azithromycin should not be offered in the community for the management of patients with COVID-19 in the home. Ireland According to Tomas Conefrey, Community Pharmacist, medicine shortages are a “big problem in Ireland.” However, following the outbreak of Covid-19 here, in his view they have alleviated somewhat since the pandemic. “Since the Covid-19 situation it has got a bit better in my experience, strangely enough.” The IPU is gravely concerned about the increase in medicine shortages here in recent years, according to its spokesperson.

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“Even before the current pandemic, we consistently heard from pharmacists that the problem of medicine shortages was worsening. “Pharmacists will always make every effort to ensure that their patients receive the medicines they need, including sourcing medicines from abroad when not available in Ireland. Nevertheless, pharmacists report that the amount of time they spend on trying to resolve shortages has increased hugely, amounting to several hours per day, and that, despite their efforts, it frequently impacts on their patients. “Obviously, it can be very distressing for patients when supply problems arise, but it is important to know that Irish community pharmacists are doing all they can to support patients directly in their own communities.” Dublin GP and former president of the Irish Medical Organisation (IMO) Dr Ray Walley is increasingly concerned by the growth in the number of medicines in short supply here. He believes more should be done to raise awareness of and tackle the issue. He also maintains that shortages are a serious threat to patient safety. The current frusemide/amilorise has impacted “a significant number of patients”, he said, and has, worryingly, not yet been resolved. Dr Walley is First Vice President of the Standing Committee of European Doctors. On 3 April 2020, the CPME Executive Committee adopted the “CPME Policy on Medicine Shortages”. The policy states that “medicine shortages are a growing public health threat with a serious impact on health care systems and public health. They can severely limit doctors’ ability to provide appropriate treatment. Medicine shortages have an unquestionable impact on public health”. It outlines several ways in which shortages can be addressed at EU level, including improved communication, identifying the root causes, strengthened cooperation, increasing diversification of supply sources and reducing Europe’s reliance on external manufacturing. It claims that “the current overreliance on manufacturing sites located in third and remote countries for the production of active pharmaceutical ingredients

and medicines constitutes a real threat to the secure and stable supply in the EU”. “Currently, the majority of Active Pharmaceutical Ingredients (API) and medicines are produced outside of Europe in limited number of manufacturing sites. Distant location of factories makes it more difficult to inspect them and results in longer, less transparent and fragile supply chains . Unforeseen disruptions or quality and production problems have far-reaching consequences.” The EU should explore “regulatory measures or financial incentives to shift the production of essential medicines back to Europe,” the policy adds. The HPRA medicine shortage list, updated on 7 April, shows, to give just one example, that manufacturing delays have led to a deficit of a number of products with the active ingredient fentanyl, an opioid used in the treatment of severe pain. The shortage was notified on 22 January this year and an expected product return date is still awaited. In another example, the HPRA website states that “HRT shortages have impacted multiple countries over the past year and are not restricted to Ireland. While there are shortages of some specific brands, alternatives are available to meet patient need. The suppliers have stated that the causes of the shortages relate to both active substance availability and manufacturing delays”. The examples clearly illustrate that supply disruptions are having a direct impact on the health of Irish patients. But could Covid-19 turn the tide on medicine shortages? The pandemic has succeeded in bringing the issue of medicine shortages to the fore, both here and internationally. In light of the grave threat posed to public health, the critical importance of adequate medicine stock is now foremost in the minds of governments as they seek to protect their citizens. As efforts continue to ensure critical medications needed in the response to Covid-19 are available, there is hope, therefore, the crisis will mobilise authorities to finally do more to dramatically reduce ongoing shortages.


Perspectives

19

Community Pharmacy & Covid 19 Steve Philips is a Pharmacist working at CarePlus Pharmacy in Kilcock, County Kildare. Here, he gives us an overview of how Pharmacy is stepping up to the Covid platform. “Your community Pharmacist has one thing in common with the rest of the country these days - we can hardly believe the world we’ve had to adapt to and figure out how to do business in over the past couple of months. Over the course of a couple of days in early March, the business changed drastically. How we do our jobs, how we help the customers we know and appreciate so much, even how we look in the shop has been turned upside down. Like most people, we found very little we could describe as ‘normal’ in what we were told had to be the ‘new normal’. Every Pharmacy in the country has had to get to grips with HSE guidelines and decide how to best protect patients and staff while remaining operational, if not always fully physically ‘open’. Some have elected to provide a service from the front of the shop, taking prescriptions and over the counter medication requests from customers at the door. Our team at CarePlus Pharmacy Kilcock is lucky in that our shop layout has allowed us to implement a one-way system. We’ve marked minimum safe distances clearly on the floor, using footprint stickers to help avoid confusion. We’ve maximised ventilation by opening all our windows and thankfully the mostly fine weather means we can keep the doors open too. It’s impossible to miss the many sanitising points around our store, where customers and staff can regularly “sanitise to save lives”. We’ve had to become accustomed to wearing disposable aprons and surgical masks as an added safeguard for the health and welfare of our customers. Truth be told, we had an honest discussion among the team at the start of the restrictions, as to whether our doors should remain open. We have a young, fit and healthy team but everyone has extended family and loved ones who may be that extra bit vulnerable. That’s part of the reason we decided that if we were going to stay open, we would ensure we did it right and take all necessary precautions around the likes of PPE to minimise the risk to everyone from the start. Thankfully, we’ve all managed to stay well so far.

"Truth be told, we had an honest discussion among the team at the start of the restrictions, as to whether our doors should remain open" There were some worrying moments for the team in the early days of the health alert, when some people obviously hadn’t heard the warnings and dropped in to consult us on symptoms that were a cause for concern. Considering we did have the full PPE policy, I generally managed the situation by encouraging them outside for a chat and to offer advice at a safe distance. At the end of the day, they were still customers coming to us looking for help, but it’s a relief that this scenario arises a lot less frequently these days. We’ve spent a lot of time helping our customers adapt to the new way of accessing their medicines. Our social media accounts have been really useful to raise awareness of how patients can order their medication over the phone, and the CarePlus App has proved really helpful. One of its best features for us is that it notifies the patient when their items are ready for collection, which cuts down the time they need to spend in the Pharmacy. It goes against the grain for a community Pharmacist though, to be encouraging people to spend less time on the premises when we know a lot of them appreciate the point of contact and many vulnerable people we know could benefit from a chat and a few words of comfort. We’re focusing, like most people, on taking things one day at a time and keeping an eye on the future when at least some of these restrictions can be safely lifted. In the meantime, one of the positives we’ve seen is the cooperation on display in the local community, among voluntary groups, the Gardaî, sports clubs and individuals. In uncertain times, it’s a real privilege to see so many small acts of kindness. Some lucky Pharmacists may even have had the odd apple tart dropped in to them (thank you Mrs. Dooley). Perhaps, as a result of all that is going on,

Steve Philips, Pharmacist, CarePlus Pharmacy, Kilcock, County Kildare

the “community” in “community Pharmacy” has never felt more relevant or more important than it does right now. A couple of people have asked me if I get nervous, going to work when there’s so much concern around public health. The way I see it, we’re well-placed to take the necessary precautions that protect us and our customers, but also allow us to get on with what is still a very important role. It’s a comfort to know we at CarePlus Pharmacy Kilcock

took a comprehensive approach to PPE from the start of all this and we do appreciate the regular emails from the HSE, the IPU and PSI, and even the occasional shout-out from Minister Harris! In our working environment, we can largely control our situation and we’re taking all the necessary steps to protect staff and customers. Our colleagues in clinical settings are facing greater risks and deserve all the praise they can get for being right on the frontline, battling Covid-19.”

"It goes against the grain for a community Pharmacist though, to be encouraging people to spend less time on the premises when we know a lot of them appreciate the point of contact any many vulnerable people we know could benefit from a chat and a few words of comfort” PHARMACYNEWSIRELAND.COM


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To discuss your beauty event, get in touch with your Solgar® Territory Account Manager or call 0044 1442 821 419 or email enquiries4@solgar.com *Source: Euromonitor, 2019. **Skin tested with the Multi Skin Test Center MC 1000. Food supplements should not be used instead of a varied balanced diet and a healthy lifestyle. Solgar® is a registered trademark.


Reflecting on Pain in Children

I

n order to be able to effectively manage pain in children, it is important that community pharmacists and their teams do not just simply reach for OTC analgesics. Customers will benefit hugely from any self-care advice on coping strategies also.

Studies have demonstrated that if pain is not treated quickly and effectively in children, it can cause long-term physical and psychological sequelae. Therefore, it is important for all pharmacists to understand the importance of effective pain control in children. Pain is defined by the International Association for the Study of Pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Acute pain is one of the most common adverse stimuli experienced by children, occurring as a result of injury, illness and medical procedures. Long-term

consequences may include anticipatory anxiety during future procedures, a lowering of the pain threshold and sensitisation to future pain, reduced effectiveness of analgesics and increased analgesic requirements subsequently. Hence, it is essential for all healthcare providers to understand the importance of effectively managing a child's pain quickly to minimise potential longterm consequences. Headache Pain There is a need for more effective consultations about childrenâ&#x20AC;&#x2122;s headache in community pharmacy, it has been suggested.

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Headaches in children are prevalent, but their impact can be under-recognised by parents and healthcare professionals. While it is estimated that about 60% of children and adolescents have experienced headache and 7% of children have had migraine, 28% of pharmacists said they had never spoken to parents about headaches in children in research conducted by the Royal Pharmaceutical Society. Asking the correct questions is key in managing childhood headaches and identifying potential red flags. Be aware that self-selection straight from the shelf can limit the opportunity for interaction.

When presented with a childâ&#x20AC;&#x2122;s symptoms in a scenario, community pharmacists were more likely to consider trauma, injury, infection and stress than headache as the source of pain, research has shown, suggesting it is under recognised. When surveyed, parents said headaches can have a large impact on their childâ&#x20AC;&#x2122;s life, altering their mood (54%) and reducing their confidence (15%), as well as disrupting their school work (38%), activities and trips (23%) and their relationships with friends (14%). There are lifestyle measures you can suggest to parents, but it is important to recommend treating


Reminder of Precautions to avoid Photosensitivity Reactions with Fastum Gel (ketoprofen gel) A. Menarini Pharmaceuticals Ireland Ltd. wish to remind healthcare professionals of the necessary precautions to avoid the risk of photosensitivity reactions with Fastum Gel. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) undertook a safety review of topical ketoprofencontaining medicines in 2010 and recommended that doctors should strictly follow the contraindications when prescribing topical ketoprofen. CHMP also recommended that doctors and pharmacists should inform patients on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions. A series of risk minimisation measures for Fastum Gel was agreed with the Health Products Regulatory Authority. The Summary of Product Characteristics and the Patient Information Leaflet were updated accordingly and may be found on www.medicines.ie and www.hpra.ie. Patients should be reminded to wash their hands thoroughly after application of the product and to protect treated areas from sunlight by wearing clothing. They should avoid exposing the treated areas to sunlight, even if cloudy, or UVA from sunbeds or solarium during use and for 2 weeks after discontinuation. In addition they should be advised to avoid using Fastum Gel under occlusive bandages and to discontinue Fastum Gel immediately and contact their doctor should any skin reaction develop, including cutaneous reactions after co-application of octocrylene-containing products. A copy of the patient educational leaflet is available from A. Menarini on 01 284 6744 or 1800 283045 or is available at www.hpra.ie A. Menarini would like to remind healthcare professionals that any suspected adverse reactions associated with the use of Fastum Gel should be reported to the Health Products Regulatory Authority at www.hpra.ie or by calling 01 676 4971. Adverse reactions can also be reported to A. Menarini’s Pharmacovigilance Department on 01 284 6744.


Key Questions to Ask: Age of child? • Have you noticed a tooth erupting? • Can you feel this with your finger? • Is the child eating and taking in fluids? • Is the child able to sleep at night? • Does the child have a fever? • Has the child been given pain relief? Teething begins around age 6 months. Variations may be between 3 months and 12 months of age. Adult teeth begin to erupt around the age of 6 years. Children can experience pain in the mouth during teething, this may affect sleeping and eating. It is important the child is adequately hydrated. Liquid paracetamol or ibuprofen to relieve symptoms of pain relief and pyrexia. Pureed food, cool liquids and teething aids can be helpful. Pharmacists should reassure parents/guardians that symptoms related to teething are self-limiting.

patients with an age-appropriate analgesic and to take the highest recommended dose when headaches occur. In addition to offering analgesics, the severity and frequency of headache may be reduced by changes in lifestyle and diet, such as maintaining hydration, regular meals, exercise and sleep, limiting screen time, and avoiding caffeine and sugary drinks, it is suggested. A headache diary can also be useful to help monitor progress. Oral Pain Teething is one of the most common causes of pain in children. Baby teeth erupt continually from the age of 6 months to 3 years. Children then lose their baby teeth as they are forced out by the adult set between 6 and 12 years. It is important to reassure parents that teething is a natural process and not something to be overly worried about. Colic Colic usually presents as prolonged bouts of crying in an otherwise healthy baby. Colic tends to begin from two weeks and lasts until around four months of age.

Symptoms can include crying, drawing knees up, clenching fists or arching the back. The baby’s face is typically red and flushed, and crying often occurs in the evening. Colic is essentially harmless, albeit very stressful for all concerned. Some products can be offered to aid digestion. Advise parents on the dietary measures they can try (e.g. breastfeeding mothers cutting down on caffeine or spicy food, or omitting cows’ milk in case of any protein allergy). Recommend a GP if a one-week trial of an OTC treatment has little effect, or the crying is accompanied by diarrhoea, constipation, vomiting, a fever or any other symptom of illness. Fever in Children Fever in children can present as a temperature above 37.50C; looking tired or pale, suffering a headache or becoming irritable. Liquid paracetamol or ibuprofen formulations are recommended. Advise parents to keep fluid levels up and monitor for dehydration. Rooms should be well ventilated and clothing lighter to reduce

heat. Night-time checks (every four hours) are recommended. With viral infections, it can take up to five days for a child’s immune system to fight off the infection. Recommend a GP or emergency contact if a baby under six months old is showing a temperature of 37.50C or higher, as they cope less well with infections. Also, any child with a non-blanching rash, neck stiffness, difficulty breathing and convulsions. Tonsillitis Tonsilitis is inflammation of the tonsils, caused by a viral (and occasionally, bacterial) infection. Symptoms can include a sore throat, difficulty swallowing, hoarse or no voice, temperature of 38oC or higher, coughing, headache, feeling sick, earache, feeling tired. Antibiotics may need to be prescribed by a GP. Advise parents to ensure their child drinks plenty of fluids and rests. Viral tonsillitis spreads easily, so good hygiene should also be adopted. Recommend a GP if symptoms persist for more than four days or continue to occur.

OTC Therapy Choosing an OTC pain reliever can be a challenging task for a parent. A myriad of products exist; drops, suspensions, tablets, and chewable tablets. Complicating the situation further, the products are marketed to a range of patient populations: infants, children, and juniors. Finally, the parent of a child in pain is likely to be concerned, preoccupied, and in a hurry to help the hurt go away. The pharmacist's intervention can help simplify product selection and ensure that the child will receive pain relief that is both safe and effective. As mothers are key pharmacy customers and adolescents are increasingly using pharmacies to access services, the sector is well placed to improve child health outcomes. One idea to further engage with this demograohic is to consider a visit to local schools to deliver public health messages to pupils. It is also vital that pharmacies create an accessible, non-judgemental environment where youngsters can ask questions in confidence.

Nappy rash What is it? Irritation caused by a baby’s close contact with urine and faeces while wearing nappies. Symptoms: Red spots or blotches that can become sore, uncomfortable and infected in the worst cases Treatments: Can be managed with a simple skincare routine e.g. barrier creams to prevent problems occuring in the first place or medicated creams for clearing up any symptoms and offering relief. Advise parents to change nappies more often. There is a chance of a secondary fungal/ bacterial infection, which would need antibiotic treatment.

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News Beating Breathlessness On World Asthma Day (May 5th), the Asthma Society of Ireland launched their new Sláintecarefunded, Beating Breathlessness WhatsApp messaging support service, which is available to patients with asthma and COPD, and their family and carers. Over 380,000 people in Ireland currently have asthma and 890,000 people will have it at some stage in their lifetime. The Asthma Society’s new Beating Breathless WhatsApp messaging service allows patients to message a respiratory specialist nurse about all aspects of their asthma management. Users can simply save the WhatsApp nurse support service number 086 0590132 to their phones, send their message or support query and one of the Asthma Society’s respiratory specialist nurses will respond as soon as possible. A recent survey, conducted in April 2020 amongst 2,462 patients living with asthma and COPD in Ireland, asked patients about their concerns amid the Covid-19 pandemic and found that: • 9 out of 10 (92%) people with a long-term respiratory illness surveyed are very concerned or concerned about becoming infected with the coronavirus due to asthma or COPD. • 4 out of 10 (41%) feel that there is not enough information readily available on coronavirus and its effect on people with respiratory illnesses. • In terms of access to medications, 3 in 10 (34%) people are concerned over high demand, but not supply. • 1 in 5 (22%) people stated that they were not confident in their medication use at this time and 3 out of 10 (31%) of people with asthma/COPD have avoided support or healthcare services because they were concerned about the health impact of coronavirus. The final finding is of particular concern to the Asthma Society as ignoring worsening conditions for someone with asthma/COPD without medical advice could lead to an unnecessary asthma exacerbation or even death (in extreme circumstances).

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Boots launch Online Prescription Ordering In the face of COVID-19, the priority for Boots Ireland continues to be supplying all patients with the prescriptions, advice and medicines that they need. Michelle O'Hara, Supervising Pharmacist and James Walsh, Support Pharmacist, Boots Pharmacy Dawson Street

As the pharmacy chain is seeing an increased demand for services, they want to ensure all patients get their medication in a timely manner in line with government advice regarding minimising the spread of the virus. The Boots Prescription Ordering Service enables patients to preorder their prescriptions through the Boots app before going in to their chosen Boots to collect their medication. This helps to reduce the wait time in stores, so that patients can pick up their prescriptions as quickly as possible, avoiding long queues and to further enable social distancing. Caoimhe McAuley, Director of

Pharmacy at Boots Ireland, “We are constantly striving to offer our patients the best quality service. In light of the current circumstances and in line with government advice, giving our patients the ability to pre-order their prescriptions will ensure they spend less time queuing for their medication, which will further enable social distancing and help us protect our patients and colleagues.”

The Boots Prescription Ordering service is a feature of the Boots app that allows customers to digitally transmit their prescriptions ahead of visiting their chosen pharmacy. Repeat prescription requests can also be sent and managed via the service. Once the order is placed through the app, Boots will let cusomers know when they’ve received the order and when the prescription is ready to collect.

New Research on Dry Eye Syndrome Irish scientists have discovered a potential new treatment for a disease that causes severe dry eyes and dry mouth. Sjögren's Syndrome causes the patient’s white blood cells to attack the body’s tear and saliva glands, causing severe dry eyes and mouth. The dry and irritated eyes significantly impact their vision, day-to-day activities and quality of life. The researchers compared samples from the eyes of patients with the disease to samples from healthy patients. They found that those with the disease had abnormal levels of a certain molecule that controls eye inflammation. The molecule, microRNA-744, works like a switch, turning the production of cells on and off. The researchers found that high levels of this molecule caused uncontrolled amounts of inflammation from cells that

destroy the glands and damage the surface of the eye. In a laboratory setting, the researchers were able to reduce this molecule, which in turn reduced the levels of inflammation. “This is a first step toward a potential new treatment, and much more pre-clinical testing is needed before we can develop it into something that is ready for patients. However, our research provides the opportunity to possibly treat the root cause of the disease rather than just the symptoms,” said Dr Joan Ní Gabhann-Dromgoole, the study’s co-author and lecturer at RCSI’s School of Pharmacy and Biomolecular Sciences. The researchers also found different levels of other microRNAs in patient cells compared to

healthy controls. This could be used to help diagnose patients with Sjögren's Syndrome, for which there is currently no test. The disease is most common between the ages of 40 and 60, with women nine times more likely to suffer from it than men. It is estimated to affect three to four percent of adults in Ireland. The research was supported by the Health Research Board and the Royal Victoria Eye and Ear Hospital Research Foundation through the Medical Research Charities Group. The study was led by researchers at RCSI University of Medicine and Health Sciences, The work was carried out in collaboration with the Royal Victoria Eye and Ear Hospital and the Cedars-Sinai Medical Centre.

PHARMACYNEWSIRELAND.COM


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COVID Thoughts

A Pharmacy Owners thoughts on COVID Dr Kate McClelland, community pharmacy owner of Maghaberry Pharmacy in Belfast, returned home from Australia on one of the last flights to leave and went straight into quarantine. Here, she gives readers an overview of her self-isolation thoughts on the coronavirus and the future of community pharmacy. Dr Kate McClelland, Maghaberry Pharmacy

Suddenly all the aseptic techniques we learnt as students have had to be dragged from the depths of our grey matter and put into practise, but how many members of the public know why hand washing is so important? Why wiping not just the door handle but every item of shopping coming into the house matters?

I was in Australia when COVID reached Ireland, a visit with family that was two-years in the making. As the day grew nearer I did think about cancelling; Coronavirus was starting to make an impact in China, but having not seen my family for years and without anyone knowing the real outcome, I went. I was booked to fly back through Dubai to Dublin and in theory to get a bus back to Belfast. The Australians were not happy I left the safety of their country to the chaos, as they saw it, of Northern Ireland. I got one of the last flights out of Australia and home safe – but each airport told the story of flights cancelled and there was no relaxation until I was home. My Accountant was very pleased I’d returned to, as he thought,

control expenditure. He knew this pandemic was going to cost. So now I’m in isolation, waiting for the call that key team members are ill and I will take over – that was the team decision – keep me out of COVID reach until absolutely needed. Even with all the protection they have bought and new ways of working they have put in place, PPE they could get, they’re realists, valuing they have one team member who might not go down quite as soon. How long can front line pharmacy services keep going? How long is a piece of string? How many pharmacies will have to close as staff succumb to a particularly clever, debilitating virus? No one knows, but I do know that as many as can do, will stay open for as long as they safely can.

PHARMACYNEWSIRELAND.COM

Suddenly all the aseptic techniques we learnt as students have had to be dragged from the depths of our grey matter and put into practise, but how many members of the public know why hand washing is so important? Why wiping not just the door handle but every item of shopping coming into the house matters? We were taught to respect the risk posed by bacteria, viruses and fungi, but the general population, the man/woman in the street, what do they know? Do they understand? And with all the conspiracy stories and nonsense flying through cyber space – what will they listen to? Hopefully a community pharmacist who has had the sense and time to read the daily updates and alter practice accordingly. Will they see the government interfering in their lives as usual and not to be believed anyway isn’t that what the internet says? Many people have lost their jobs, or are not working, can’t access credit, stuck in the house with or

without relatives, nothing to focus on but worrying death rates and emergency medical facilities being created in tents and warehouses. Already, as anticipated, domestic problems are rearing their ugly head. To many it must seem like the end of the world, but you can’t not watch the news because you need to know what’s happening outside your front door. The good news is the environment is starting to benefit, you can listen to bird song on your daily walk with reduced traffic noise, when did you last see or hear a plane in the sky, the CO2 emissions must be well down and we’re all getting some exercise! People are finding they have neighbours, across the street, next door, new relationships are being formed and hopefully will continue long after this virus has passed. We have stable government, health services, wind and water tight homes, sewage systems that work, and bins that are emptied. You could argue we needed this virus to appreciate what we have and Real Needs over Vain Wants. Spare a thought for the others if you can – COVID has/will spread round the whole world. Many areas of the world were struggling before COVID. How will they cope? How will they recover? So, sitting in isolation what do I fear? Running out of toilet paper? Nah there’s enough now they’ve stopped multiple purchases. COVID? No. Not that I would welcome catching it but it is not a fear for me. Mental instability? Yeah but I’ve got some control over that. What I fear is the unknown world after this, all the ‘you should have done, you shouldn’t have done’ Will we be able to get past the blame culture endemic in our societies or will this end with an explosion of intense scrutiny, anger, rage and resentment? What will that feel like?


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Beconase Hayfever nasal spray 50 micrograms per spray contains beclometasone dipropionate. For the prevention and relief of symptoms of Hayfever and other seasonal allergic conditions. Adults aged 18 and over: 2 sprays into each nostril twice a day. Max 8 applications per day (400 mcg). Seek medical advice if symptoms do not improve after 2 weeks. Do not use continuously for longer than 3 months without consulting a doctor. Do not give to persons under 18 years. Pregnant and breastfeeding mothers should not use without consulting a healthcare professional. Caution: Recent nasal injury or surgery. Side effects: Rare cases of hypersensitivity reactions. Unpleasant taste/smell, dryness/irritation of the nose and throat, raised intra-ocular pressure, nasal septal perforation. PA 1186/8/1. P. MAH: Chefaro Ireland Limited, The Sharp Building, Hogan Place, Dublin 2, Ireland. http:// www.medicines.ie/medicine/7169/SPC/Beconase+Hayfever/ SPC: http://www.medicines.ie/medicine/7169/SPC/Beconase+Hayfever/. Becodefence is a medical device. Always read the leaflet. IRE BEC 2020 04


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CPD: VITAMIN D

Continuing Professional Development

CPD

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.

AUTHORS: Dr Eamon Laird & Professor Rose Anne Kenny The Irish Longitudinal Study on Ageing On behalf of the TILDA team The Irish Longitudinal Study on Ageing, Trinity College Dublin, Dublin 2 Tel: +353 1 896 2509 Email: tilda@tcd.ie Website: www.tilda.ie ISBN: 978-1-907894-30-5 https:// www.doi.org/10.38018/ TildaRe.2020-05

Vitamin D Deficiency in Ireland - Implications for COVID-19 In this report, we aim to describe the importance of vitamin D for immune function, the prevalence of vitamin D deficiency and vitamin D supplement use in Ireland by age group, gender, geographic location and by obesity and lung disease (particularly vulnerable to COVID-19), describe those most at risk of deficiency and the best sources of vitamin D and recommendations to improve status. By compiling this report, we hope the information given can help in the mitigation of the negative health consequences of COVID-19. Frailty is a dynamic process that changes over time and can be viewed on a continuum. An older person can transition in either direction between the different states of frailty, namely robustness, pre-frailty (an intermediate state) and frailty(9). Robust older people may have some health problems, but in general these problems are being well managed. Older people with pre-frailty are at an increased risk of adverse outcomes but are coping. Individuals living with frailty generally require some support for instrumental and/or basic activities of daily living, have increased susceptibility to infection, take longer to recover from infections and are less likely to recover to previous levels of functional independence. For older adults living with frailty, exposure to a stressor such as infection significantly increases the risk of disability, hospital admission, longer in-patient length of stay, transition to long-term care and death(10). It is highly likely that individuals living with frailty who contract COVID-19 are at greatest risk for admission to hospital, admission to critical and intensive care units and death. Identifying people living with frailty provides an opportunity to prevent this at-risk group from contracting COVID-19 in the community and proactively to develop healthcare service planning and delivery for our medically vulnerable population aged 70+ years(11). 1.1 Vitamin D and immune function Vitamin D is essential for older adults to help maintain bone and muscle health, plays a key role in the prevention and the treatment of falls and fractures and helps the absorption of calcium from the gut(2). Recent research has also highlighted that it may have an important function within the

immune system(3). With increased age, there is a shift in the immune response to a more pro-inflammatory state which may lead to chronic low level inflammation and a slow accumulation of damage, with subsequent progression to chronic disease. This age related pro-inflammatory state is referred to as ‘inflamm-aging’(4). This can be particularly important in periods of metabolic stress such as infection - the body is already pre-set to a higher level of inflammation and the necessary immune response to the infection may be impaired. Experiments and research has shown that vitamin D can alter the immune system response through its influence on the production and manufacturing of immune molecules known as cytokines(5). Vitamin D has been shown to help signal the increased production of ant-inflammatory molecules and decrease the production of pro-inflammatory molecules(6,7). This switch in immune response in theory may have some potential benefit in cases of ‘cytokine storm’ – a massive release of proinflammation (which has been observed in those infected with COVID(8)) which can cause acute respiratory distress syndrome(9). Importantly, in a large cross-sectional clinical trial (n = 18,883) the risk of respiratory infection increased with lower blood vitamin D levels and the effect was even stronger in those with underlying lung conditions(10). Many casecontrol studies have also reported associations between low vitamin D and increased risk of infection(11) while in a trial supplementing patients at risk of respiratory infection with 1,000 International units (IU) of vitamin D a day for a year, supplement use reduced both symptoms and antibiotic use(12). Recently, a large meta-analysis (data analysis of a large collection of previous studies) of 10,933 people from 25 trials conducted in 15 countries investigated whether taking a vitamin D supplement helped to prevent colds, flu and chest infections (acute respiratory infections ARIs)(13). Vitamin D had a significant protective effect when it was given daily or weekly to people with lowest vitamin D levels: the risk of having at least one ARI was reduced from 60% to 32% in these people. Overall, vitamin D supplements reduced the risk of having at least one ARI. The study authors concluded that taking a vitamin D supplement was safe

Dr Eamon Laird

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Professor Rose Anne Kenny

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. Evaluation - How will you put your learning into practice? Have I identified further learning needs? 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.

and can help protect against ARIs, particularly if baseline levels are low. In 2019, a newer analysis using 21,000 participants from across eight studies showed that those with a low blood vitamin D level had a 64% increased risk of communityacquired pneumonia(14). Therefore, maintaining a sufficient vitamin D status in the adults is beneficial in prevention of ARI and may therefore be of benefit in the COVID-19 pandemic. Vitamin D Status of Older Adults in Ireland in Winter During the winter period, 21.3% (244,209) of adults aged >55 years were vitamin D deficient. The highest rates of deficiency were observed for those aged 80-84 years (29.6%; 23,987) and those aged >85 years (46.6%; 31,480). For those aged >70 years, the deficiency rates were 27.1% (115,536). Across all ages, deficiency rates were similar for both men and women


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CPD: VITAMIN D

KEY MES 1. Why is Vitamin D important? • Vitamin D is essential for bone and muscle health • Vitamin D may help prevent respiratory infections in those who have low vitamin D levels • Vitamin D is seasonal and cannot be made during the winter-time while the amount in summer time is subject to sunshine, weather and other factors 2. What are the rates of deficiency in older adults in Ireland*1? • 47% of all adults aged >85 are deficient in winter (31,480) • 27% of the over 70s who are ‘cocooning’ are likely to be deficient (115,536) • 1 in 8 (13%) adults over 55 are deficient (149,049) all year 3. Who is at risk of Vitamin D deficiency in Ireland? • People who are housebound/confined, little sun exposure and/or eat inadequate amounts of fortified foods • People who don’t take vitamin D supplements - currently over 91% of older adults 55+ do not take a supplement during the winter (1,038,752). Only 4% of men and 15% of women take a supplement

though with men tending to have slightly higher deficiency rates overall. Similar high rates of deficiency were observed when examined by province of residence. Again, those aged >85 years had the highest rates of deficiency regardless of province. However, those aged 85+ in the Connacht & Ulster area had the highest deficiency rate (59.5%; 8,738). For those aged >70 years, the Munster region had the highest deficiency rate

(31.8%; 39,410) vs the Leinster region (21.4%; 46,231). Overall, Leinster had the lowest rate of deficiency (17.6%; 103,615) compared to those residing in either Munster (25.3%; 83,615) or Connacht & Ulster (24.5%; 55,690). In winter, only 9.4% (107,773) of those aged 55+ and 11.5% (49,028) of those aged 70+ reported taking a vitamin D supplement. A much higher proportion of women (14.6%; 87,181) compared to men (3.8%; 20,877) took a

supplement. This sex difference was consistent when examined by age as for instance, in those aged 85+ only 5.6% (1,291) of men vs 17.7% (7,875) of women reported taking a supplement. Vitamin D Status of Older Adults in Ireland in Summer During the summer period (optimum period for making vitamin D from sunlight), 8.4% (96,308) of adults aged >55 years were vitamin


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SSAGES

Figure 6. Vitamin D deficiency in older adults in Ireland with obesity by age (winter) Figure 6.Vitamin VitaminDDdeficiency deficiency in in older older adults age (winter) adultsininIreland Irelandwith withobesity obesitybyby age (winter)

• People who are obese, physically inactive, have asthma or chronic lung disease 4. Where is Vitamin D found • Vitamin D is made in the skin from 10-15 minutes 7.Vitamin VitaminDDdeficiency deficiency in in older older adults age (summer) per day of sun exposureFigure adultsininIreland Irelandwith withobesity obesitybyby age (summer) Figure 7. Vitamin D deficiency in older adults in Ireland with obesity by age (summer) in Ireland only made from late March to late September • Vitamin D is available in oily fish (salmon, mackerel etc.), eggs, liver, fortified foods such as cereals and dairy products 5. How much Vitamin D should be taken to prevent deficiency? • 10 ug (400 IU) is the Figure 7. Vitamin D deficiency in older adults in Ireland with lung conditions (winter) by age VitaminDDdeficiency deficiency in older adults (winter) byby age adults ininIreland Irelandwith withlung lungconditions conditions (winter) age minimum recommendedFigure 7.Vitamin daily during the winter time • Between 15 -20 ug (800-1,000 IU/day) recommended for most at risk groups *1 For further information see: Laird E, O’Halloran AM, Carey D, Healy M, O’Connor D, Moore P, Shannon T, Molloy AM, Kenny RA. The prevalence of vitamin D deficiency and the determinants of 25 (OH) D concentration in older Figure 7.Vitamin VitaminDDdeficiency deficiency in older adults (summer) byby ageage adults ininIreland Irelandwith withlung lungconditions conditions (summer) Irish adults: Data from The Figure 7. Vitamin D deficiency in older adults in Ireland with lung conditions (summer) by age Irish Longitudinal Study on Ageing (TILDA). The Journals of Gerontology: Series A. 2018 73(4):519525. https://academic.oup. com/biomedgerontology/ article/73/4/519/4103040

2020 D deficient while for those aged 70+, the rate of deficiency was 12.1% (51,586). The highest rates of deficiency were observed for those aged 85+ years (30.7%; 20,739). Similar age defined rates were observed for both men and women though with women having slightly higher deficiency rates overall. Similar rates of deficiency were observed when examined by province of residence. Again, those aged >85 years had the highest rates of

deficiency regardless of province. However, those aged 85+ in the Connacht & Ulster area had the highest deficiency rate (48.3%; 7,093) followed by Munster area (41.1%; 7,826) and then Leinster (20.7%; 7,002). Overall, Leinster again had the lowest rate of deficiency (6.8%; 40,033) compared to those residing in either Munster (9.5%; 31,397) or Connacht & Ulster (10.0%; 22,731). For those aged 70+, those residing in Munster had a deficiency rate of 15.9% (19,705) vs 10.3% (22,252) in Leinster.

In summer, 10.3% (118,092) of those aged 55+ reported taking a vitamin D supplement. Again, a much higher proportion of women (14.6%; 87,181) compared to men (5.5%; 30,217) took a supplement. For those aged 70+, only 14.2% (60,539) took a vitamin D supplement. Risk factors for deficiency The largest negative predictors included smoking, geographic location (living in the


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CPD: VITAMIN D

North and West compared to the East of the country), winter season, physically inactivity, and older age. The largest positive predictor of vitamin D was vitamin D supplement use followed by being female.

D supplement policy and educating the public and medical practitioners on the importance of vitamin D. This vitamin D success story demonstrates what could be achieved in Ireland.

Vitamin D status by obesity and respiratory lung conditions

Here we outline the main sources of vitamin D and what are the intake recommendations.

Overall, obese older adults had much higher rates of vitamin D deficiency both in winter and summer (Figures 6-7). During winter, rates of vitamin D deficiency in the obese were 27.3% for those aged 55+ and 35.3% for those aged 70+ compared to 20.8% and 27.0% respectively for those not obese. Similar trends were also observed during summer.

Vitamin D sources

In those reporting chronic lung disease (such as chronic bronchitis or emphysema), the prevalence of vitamin D deficiency was significantly higher than those not reporting disease across the age groups both in winter and summer. For instance in those aged >55 years, the prevalence in winter of deficiency was 33.8% in those with lung conditions vs 22.7% with no conditions. Similar trends were observed in 70+ age group where rates were 32 vs 29.9% in winter and 16.9 vs 12.3% in summer.

There are three main sources of vitamin D – sunlight, food and supplements. Due to Ireland’s far latitude geographic location, vitamin D synthesis by sunlight is only during the months of late March to late September. This is 10-15 minutes exposure to sunlight (before application with sun-protection at a time period between 12-4 pm). However, even during the summer, the amount of vitamin D that can be made is affected by cloud cover, use of skin creams, clothing, obesity and age(18). Foods rich in this micronutrient include oily fish (tinned or fresh salmon, mackerel etc.), egg yolks, liver and vitamin D fortified foods such as cereals and dairy products. Regular consumption of vitamin D rich foods is recommended to help prevent deficiency, particularly in the winter months and those not exposed to sunshine in the summer time.

Discussion

Vitamin D Intake recommendations

This report demonstrates that of those aged 55+ years in Rep. of Ireland, 1 in 5 are vitamin D deficient during the winter and 1 in 12 during the summer. Of particular concern is that nearly 30% of those aged 70+ and 47% of those aged 85+ are deficient in vitamin D. These are the age groups who are considered to be ‘extremely medically vulnerable’ to the adverse health outcomes of COVID-19 and have been advised to participate in ‘cocooning’ during the COVID-19 public health emergency. Of extra concern is the fact that only 10.5% of those aged 70+ actually report taking a vitamin D supplement – because of ‘cocooning’ many may now lack the opportunity for sun exposure and given the low use of supplements, many of this vulnerable group could be at very high risk of deficiency. This of key importance given the usefulness of vitamin D for immune function particularly at this time.

During the winter-period at least 10 ug/day (400 IU) from the diet is required (due to the lack of sunlight for vitamin D synthesis). Recent data has shown that the average intakes from diet are significantly below this level and therefore a 10 ug (400 IU) vitamin D supplement maybe be required during the winter. For those who are housebound (due to illness or quarantine for an extended period) an upper supplement of 15-20 ug/day (600800 IU) maybe required due to the lack of sunshine exposure. In persons over 70 years, 20-25 ug/day (800-100IU) is recommended.

Of particular concern we have observed very high levels of vitamin D deficiency in those who are obese and those with pre-existing lung conditions both of which have been observed to make individuals particularly vulnerable to COVID-19 and complications from the virus(15,16). Ireland does not have any formal vitamin D food policy – we practice a voluntary but not mandatory food fortification policy where food manufacturers can decide to fortify (or not) their food products with vitamin D. The vitamin D status of those in Ireland is lower than either the United States or Canada who have systematic (mass) vitamin D food fortification. However, vitamin D deficiency is not inevitable in older adults in Ireland and the ability to have sufficient vitamin D status year round is an achievable goal that many countries meet. For example, another European country - Finland (which is at a much higher latitude and therefore receives less sunshine than Ireland) has virtually eliminated vitamin D deficiency in its population with rates <1%(17). This is due in part to a successful food fortification and vitamin

Conclusion Our people aged 70 and over are the fabric of our society(19) and we must use all available tools to facilitate the reduction and transmission of COVD-19. Vitamin D is a potent immune modifying micronutrient and if vitamin D status is sufficient, it could benefit vulnerable adults in particular those 70+ years and older who are ‘cocooning’ during the COVID-19 outbreak. References on Request

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Self-Appraisal WHAT I intend to learn and why When I completed the PSI Pharmacy Assessment System, two of the ‘areas for improvement’ identified from the ‘Management and Supervision’ section and the ‘Sale and Supply of Non-Prescription Medicines’ Section related to providing evidence that all staff are trained and competent in their role. I realised that I have no formal method of standardising or demonstrating staff training and I want to address this.

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Personal Plan HOW I intend to learn it I plan to research training options available in Ireland. I plan to ask my staff to bring in their course completion certificates. I plan to speak to staff at performance appraisal to explore their learning needs.

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Action What I actually did I reviewed IPU OTC off-site training and distance learning. I read OTC related articles in pharmacy magazines such as IPN. I spoke to my staff about their qualifications and training needs. I contacted www.4FrontPharmacy.ie for a demo of their online Pharmacy Training Programme.

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Document What I have learned specifically Three key realisations • Training staff to manage OTC sales of medicines is a core part of the Medicines Supply Chain. • The true cost of off-site training, taking into account the training fee, travel expenses, overnight and food expenses, pharmacy cover, day’s wages for person attending the training. • The value of online team training extending beyond the expertise, to include leveraging and implementing whole team learning with marketing and sales activities, for the sake of patient care.

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Evaluate ONE example of how I put my learning into practice • By using an online programme designed by pharmacists for pharmacy teams, at the tip of a button, I can demonstrate my team’s up-to-date training and meet PSI training guidelines. • I can now concentrate on leveraging the expanded team skill base to extend my pharmacist service offering. • My time is now used for higher value activities that ONLY a pharmacist can do, and I am confident that OTC sales conducted by my staff, will be referred appropriately.


News INFANT creates Family Hub The Irish Centre for Maternal and Child Health Research (INFANT) at UCC has created a dedicated Hub. This has been created specifically for families, researchers and healthcare professionals in order that they can find factual, up-to-date, and accessible information. This information will relate to COVID-19 during pregnancy, birth, and early childhood. The INFANT Research Centre’s COVID-19 Hub is designed to be a one-stop shop that brings all the latest public advice, science and clinical guidelines on COVID-19 during pregnancy, birth, newborns, and early childhood together on a singular platform. Researchers can visit the Hub to find the latest in scientific literature and reports pertinent to COVID-19 and maternal, newborn, and child health, while parents will find resources and advice to address their queries and concerns.

Supporting Pharmacy at the Frontline As the Covid-19 pandemic told hold, one local company made a detemined decision to stand shoulder to shoulder with pharmacists and frontline colleagues. Paul Hatton, National Field Sales Controller with Perrigo Ireland told Irish Pharmacy News, “It’s been a crazy few weeks here in Ireland with things kicking off on March 7/8th. Both Wholesalers put Transfer Order’s on hold and put a significant number of OTC SKU’s on allocation in order to prioritise Rx demand – they were, and still are, under serious pressure to manage demand and supply but doing a great job considering the current challenges. “After our Taoiseach announced, on March 12th, that the school’s and public facilities were to close we, as a business, decided to withdraw our Field Sales Team from Trade – we weren’t the only ones, it was pretty much across all Suppliers. “We’ve no idea how long this crisis will last but we’re pulling

Paul Hatton, National Field Sales Controller, Perrigo Ireland together to face into this period of unrest standing shoulder to shoulder, and doing our utmost to support our customers. As a Sales Team we have felt quite helpless but through adversity comes great spirit and a determination to support our customers! “Our Field Sales Team made a decision to reach out to their local Pharmacies and offer their services to support Medicine Deliveries to those patients that were unable to make the journey to collect their prescriptions due to the need for cocooning. Our offer to help was very well received across the Country and between us, as a team, we’re supporting this initiative. “It’s a privilege to be able to help in some way during this global time of need. In the background of all of this the Perrigo Field Team are adapting to life “working from home” and we’ve re-engaged with our customers to facilitate Transfer Order’s with both Wholesalers now processing orders daily. Let’s keep washing our hands, coughing into our arms, practicing social distance and sanitising regularly.”

INFANT Director Prof Geraldine Boylan said the Hub has been implemented to address some of the anxieties and concerns prompted by the pandemic. “COVID-19 has impacted everyone’s lives and INFANT, as a Maternal and Child Health Research Centre, is particularly conscious of the impact of this crisis on our many colleagues working in the front line in Cork University Maternity Hospital and Cork University Hospital, and the many mums that are pregnant and giving birth during this uncertain time. “We are also keenly aware of the anxiety and stress that families and children are feeling especially those that have supported our studies in the past. “We will also use the hub to keep the public updated about what we are doing here at INFANT, specifically in COVID-19 research such as innovations like the virtual visitation app that we developed for babies in the NICU.” Anyone interested in assisting or collaborating with the Hub, or who needs additional information, should contact infantcovidresponse@ucc.ie The Hub can be visited at https://www.infantcentre.ie/ research/covid-19-hub

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*Please note that all Pharmacy SOP’s are complied with for the delivery of medicines in the community

Ollie Higgins, Pharmacy Business Manager, Perrigo Ireland

New Hi-Tech Medicine Accord Healthcare is delighted to announce the launch of another Hi-Tech medicine to their extensive range of Hi Tech medicines, Cinacalcet Accord 30 mg, 60 mg and 90 mg film-coated tablets in pack size of 28. This medicine is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Accord may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. It is also indicated for the reduction of

hypercalcaemia in adult patients with parathyroid carcinoma or primary HPT for whom parathyroidectomy would be indicated based on serum calcium levels, but is not clinically appropriate or is contraindicated. Please refer to the Summary of Product Characteristics (SPC) for

further information. The SPC will be available from the launch date at www.hpra.ie and for Healthcare Professionals at www.accord-healthcare.ie. For further information please contact Accord in Cork on 021-461 9040 or visit www.accord-healthcare.ie

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Report

Pharmacy Face Masks for Seoul Survival? Peter Conry, Community Pharmacist in Gorey looks at the issue of the use of face masks within pharmacy and reflects on past experience and global research as to their best practice. Peter and staff at LloydsPharmacy Gorey

in the U.S. and Europe, in my opinion, is that people aren’t wearing masks. This virus is transmitted by droplets and close contact. Droplets play a very important role….Many people have asymptomatic or presymptomatic infections” Outdoors, sunlight can evaporate droplets and reduce their flight time. The greater risk is in enclosed spaces - whether a cruise ship stateroom, or the confines of a shop. Closed doors reduce air exchange further.

Masks and More On April 22nd, the PSI shared guidance from the HPSC (Health Protection Surveillance Centre) advising healthcare workers to wear masks if they are likely to be within 2 metres of a patient, regardless of their COVID-19 status. In winters long past, when I commuted in Seoul and especially Beijing, masks were already a common sight. In a megacity, face is necessarily close to face. I marvelled at the unselfconsciousness of it, even as I figured it’d never catch on at home. But now we’re all Beijingers or Seoulites. I was in Beijing during the 2003 SARS outbreak. Neighbours died. So I’ve been watching how Asia, forewarned, has handled SARS-CoV-2. For example, what’s the optimal mask etiquette and how does it mesh with other containment strategies? And how do you recycle masks if supply is scarce?

South Korea has registered less COVID-19 cases and fatalities than Ireland. How did they manage this despite a ten-fold larger population, much greater population density and an older age pyramid?

displaying live stocks by location. If your birth year ends in 1 or 6 you can buy on a Monday. And so on until Friday when birth years 5 and 0 attend. For the unwell or elderly, purchasing can be delegated. In Korea, elderly means 80+.

Seoul Survival

My mother-in-law is in that category. She’s been through the Korean War and the perilous trek South. She is being careful but still buys vegetables in her local organic farm shop. She was pleasantly surprised when 3 extra masks arrived in the post just ahead of her birthday in April - a gift from the local District Council. One made all the sweeter by not being available to youngsters under 80.

Sanghee Park is a pharmacist who studied and qualified in Dublin. Recently, he’s been doing gruelling evening locums in Seoul. Dispensing, he says, now takes a back seat to his other task - selling facemasks. His customers are required to wear them, even if some don’t. Early in the outbreak, the government brought in rationing and price controls and chose pharmacies as the designated retail channel - so that masks would come with professional advice. Each resident had the right to purchase two KF94 masks (equivalent to N95 or FFP2) per week. As I write, this allocation has just increased to three. Social media apps help manage the process including

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Infection was the first and most researched topic of the past century. People recalled and feared pandemics like the Spanish flu and, later, TB. The very first copyrighted movie, in 1894, immortalized “Fred Ott’s sneeze”. In the 1930s, MIT used high-speed photography to analyse flight patterns and droplet distribution from coughs and sneezes. Other studies determined that speaking loudly or singing adds distance to exhaled droplets, as do the letters P, T, S and F. Some of these letters have received extra exposure in our dispensary recently (Quick shout out to Grace at this point). More recent MIT research, from 2014, showed that tiny droplet nuclei (dried out droplets) from a sneeze can travel further than I’d kick a football.

With 2-3 masks weekly, there is a need to ration and recycle. And that, when I get to it later, is the topic of this article. First, I’ll recap some more reasons why.

Masks aren’t a perfect barrier, but they offer us a tangible means to reduce the risk to ourselves and those around us. Asia adopted them from the start, but authorities in Ireland, most of the EU and even the WHO cast doubt on their usefulness until recently. I can empathize with the desire to reserve them for frontline staff. And I can empathize with concerns that people wearing masks might take greater risks or mightn’t wear them correctly. I’ve even seen a few DIY mask fails - like the solitary bra cup dangling like bunting from one customer’s ears.

The Director of China’s CDC, Dr. George GAO Fu – a veteran of WHO Ebola missions in Sierra Leone -has said: “The big mistake

It was, let’s say, brave to ignore the successful experience of Korea, China and Taiwan and embark on a separate course based on very


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"The local drug dealers have been wearing PPE for over a month. Pharmacies are playing catch-up. Thanks to the lockdown, we’ve probably got away with it. But we need to be ready for the potential second wave. So how can you stretch a limited supply of masks?"

little. As to incorrect use, most of Asia copped on to correct mask use pretty quickly. Two barriers are better than one. If a masked COVID carrier meets a masked vulnerable individual, there are two sets of physical and electrostatic barriers impeding the transmission of infectious droplets. Masks won’t block escape of all particles emitted via a cough, but they’ll catch a lot. And the experience from Wuhan suggests that total viral load is important in determining the severity of an infection. Which is why frontline staff were more vulnerable. In late April, Korea shared that 3% of “cured” cases (following two successive negative PCR swab tests) subsequently re-developed symptoms and tested positive. Attempts to culture virus from the samples drew a blank so the lab results were probably a result of viral debris. And re-activation of symptoms was most likely due to the common cold or hay fever. There isn’t currently any suggestion that COVID can persist like herpes. It seems that, like SARS-1, when SARS-CoV-2 is gone, it’s definitely gone. But we’re a long way from finished yet! Korea’s success isn’t all down to mask-compliance. They also

Sanghee Park MPSI selling masks in his pharmacy in Seoul

have rigorous and labour-intensive contact tracing that allows them to quickly hunt down new cases. As we’re planning to get there in Ireland, it’s worth looking at how it works in Korea. If your sample tests COVIDpositive, detailed timeline reports are posted online (without patient names) by town district. Anyone can check their local website and see if they crossed paths with a diagnosed case. And the data timeline begins 2 days before initial symptoms. Apart from name and detailed address, the report is comprehensive. It includes name and gender and a daily diary of your exact movements, when and where you boarded and exited the subway, which exit you used, which shops, cafes, restaurants and apartment blocks you visited on your way home. After a fortnight, café and restaurant names are excised. They’ll already have been visited and decontaminated by the “Ghostbuster” disinfection squad as soon as the diagnosis was confirmed. They retrace your timeline in their hazmat suits, spraying and disinfecting as they go. Another critical feature is availability of walk-in testing without the need to bother your GP. The figures show that most tests are still by appointment – they arise when tracking all contacts of confirmed cases. Your local test centre will send a car if needed. You’re in and out in 7 minutes. From outside, it looks like a row of phone booths. Before entering, you complete forms and are given your sampling kit. Inside, you face the lab window and pick up the phone. The nurse tester on the other side is further protected from contamination by the negative air pressure in your booth. He or she checks your reasons for testing. They then collect the nasal and buccal samples using arm-length vinyl gloves built into the window. When you leave, a hazmat Ghostbuster enters, checks your sample is sealed in the bag, and decontaminates the booth. You’ll be phoned by the following morning. If COVID-positive, the contact chase begins, as does your quarantine. If inconclusive, testing is repeated. Korea has done well and the grateful population returned the sitting government by a landslide

on April 15th. Like China and Taiwan, they had the advantage of recent experience of SARS, COVID-19’s less infectious but more lethal cousin, and a vibrant diagnostics development industry. The Korean government closed the likes of schools, gyms and churches early but left most businesses open. Pubs and clubs were ultimately shut down due to rule breaches. Ironically, the high population density aided social distancing. It’s so easy to order online that people are accustomed to having a cup of coffee delivered, by scooter-courier, in minutes. Social distancing didn’t even need a lockdown! But it hasn’t all been plain sailing. They’ve had disruptive elements. Like the fringe Christian sect in the city of Daegu who were so secretive they wouldn’t share contact information with the authorities. This group fuelled Korea’s initial case surge and still accounts for close to half of all cases. And success itself brings risks. The long May bank holiday came after a sequence of days when no new local cases were recorded. Emboldened, the 19-29 age group hit town in style. On May 6th, the government announced a new surge and urged those who had been in parts of Itaewon, the pub and nightlife area, to attend testing. 35,000 tests were carried out and 140 new cases identified. Contact tracing for latenight clubs, bars and restaurants is complicated. One student, from the satellite city of Incheon, had no symptoms (like many of his peers) after his nights in Seoul so initially didn’t get tested. When he did, like many of his peers, he failed to list his nixers tutoring secondary school students in his timeline profile. But he still infected them, and their parents and their other tutor. In all, his long weekend has led to 14 direct infections and to 1,700 people being quarantined.

But back to Ireland. The local drug dealers have been wearing PPE for over a month. Pharmacies are playing catch-up. Thanks to the lockdown, we’ve probably got away with it. But we need to be ready for the potential second wave. So how can you stretch a limited supply of masks? Re-cycling your masks There are encouraging signs that N95 or FFP2 masks are becoming more available. So, let’s start with the small print: PPE wasn’t meant to be recycled. If you’ve adequate supply, discard rather than recycle. But we need to avoid a situation like Italy, where frontline staff used PPE until they were gone and then still continued to care for the sick. Here are the leading methods. 1. Milton Solution/Sodium Hypochorite Method: This was tried out some years ago in the US by 2 physics lecturers using N95 masks. They used a simple nebulizer, added a fluorescent dye then wore two masks and inhaled. The second – inner – mask – was worn so as to detect how much fluorescence penetrated the first mask. Between tests, they soaked the masks in Chlorox – or Milton Solution as we know it - diluted 1 in 10. They bathed the masks thoroughly in the bucket of diluted Milton for 10 minutes then rinsed and dried the masks. Even after 50 wash and test cycles, the fluorescent droplets didn’t get through to the second mask. So that’s method number 1. 2. Home Steamer Method: This strategy comes from Korea. The research tells us that Coronaviruses won’t survive heating at 65 degrees (so bat soup was definitely not part of the COVID-19 story!). They bring water to the boil, then add the home steamer – a gadget with holes that is placed over the pot. Place the mask inside

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27.03.2020: https://www.sciencemag.org/news/2020/03/not-wearing-masks-protect coronavirus-big-mistake-top-chinese-scientist-says 36

van Doremalen, Neeltje, Trenton Bushmaker, Dylan H. Morris, Myndi G. Holbrook, Am Time was when you’d hit the panic These masks have quality vital. Your baseline assumption and steam for 20 minutes. Gamble, Brandi TaminlikeetN95al.or FFP2 2020. "Aerosol And Surface Sta button when someone entered a or must be that you orand your Azaibi certification Afterwards, remove the lid N. Williamson, pharmacy in a mask. Now, it’s the colleagues are infected. Wear the FFP3. What do they mean? N95 and allow to cool. As some caring thing to do – for you, best youSARS-Cov-1". can get. water droplets can become means that it blocks at least 95% Of Cov-2 As Compared With New England Journal Medicine. your colleagues and customers. superheated and damage the of small particles (0.3 micron). For The right mask for the job Stay safe! mask when dropping from the FFP2, an EU designation (Filtering doi:10.1056/nejmc2004973. lid, they advise putting a muslin FacePiece), the corresponding If your mask has a filter – usually or microfibre cloth on top of your mask to protect it. Their research suggested gradual loss of filtering capacity but they say that it’s fine for 5 re-uses.

visible as a circular or square valve or disk – this will allow you to exhale more freely, but remember that the exhaled air isn’t filtered. These masks were designed for use when exposed to fumes or dust, they’re not a good choice for when you’re sharing a workspace with colleagues. But they would be handy if dealing with a confirmed COVID case.

figure is 94%. FFP2 also has a certified maximum inward leakage limit of 8%. FFP3 would filter out 99% of particles and have a maximum leakage of 2%. Common builder’s masks would be FFP1 blocking 88% but with potential inward leakage of up to 22%.

Surgical masks have decent filtration in both directions but tend not to fit tightly enough. You may recall early TV images from Wuhan showing the public and healthcare workers wearing a second lycra or flexible mask outside their surgical mask. This was purely to make the surgical mask fit more tightly to the skin. A study in April in the US confirmed that this improves protection, though they used rings from stockings or tights to hold the mask in place.

handle COVID-19 like a hazardous chemical used in the workplace. They emphasize that protective clothing should cover as much as much of a colleague’s skin and clothes as possible. They advise use of lockers to avoid street clothes coming in contact with work clothes. Lacking lockers, we’re using large fabric or paper bags. In the morning, you place street clothes/coats in the bag and at closing you use the same bag to transport white coat, cotton gloves and mask home for disinfection or washing.

References:

27.03.2020: https://www.

sciencemag.org/news/2020/03/ Wang, C. et al. Preprint at MedRxiv https://doi.org/10.1101/2020.03.03.20030593 (20 not-wearing-masks-protectagainst-coronavirus-big-mistaketop-chinese-scientist-says van Doremalen, Neeltje, Trenton Bushmaker, Dylan H. Morris, Myndi G. Holbrook, Amandine Gamble, Brandi N. Williamson, and Azaibi Tamin et al. 2020. "Aerosol And Surface Stability Of SARS-Cov-2 As Compared With SARS-Cov-1". New England Journal Of Medicine. doi:10.1056/nejmc2004973.

3. Dry Heat Sterilization: Rabenau, H. F., J. Cinatl, B. Morgenstern, G. Bauer, W. Preiser, and H. W. Doerr. 2004. This is the method officially recommended by the German Inactivation SARS Coronavirus". Medical Microbiology And Immunology 194 (1-2): and Austrian HealthOf Ministries. A few final points. Germany issued You preheat a household oven updated SOPs on COVID-19 on to 65-70 degrees Celsius. April 8th. Their approach is to doi:10.1007/s00430-004-0219-0. Then place your mask on the oven rack and keep at this temperature for 30 minutes.

Bundesapothekerkammer 08/04/2020: Taetigkeiten in der Apotheke waehrend einer In Germany and Austria – and an Wang, C. et al. Preprint increasing array of countries, the at MedRxiv https://doi. Pandemie in the Pharmacy during a COVID-19 Pandemic). E-mail Peter for t public are required(Activities to wear masks org/10.1101/2020.03.03.20030593 – either surgical or homemade. (2020). And, if interested, the protocol for summary sterilization is to machine-wash using washing powder at 60 degrees C. In Gorey, local groups have been turning out home-sewn masks for carers. The European Centres for Disease Control have shared a suggested standard (AFNOR) for homemade masks (afnor.org). Frequent (daily) machine washing is also suitable for uniforms, cotton gloves or white coats. A final word about protection in the pharmacy. It’s not generally practical to maintain a distance of 2 metres, so PPE is

The best masks to wear (and the hardest to get) are so-called respirators, generally cone- or duck-bill shaped. They tend to have a better face-fit and firmer metal strip at the top (to bend over the nose). If your glasses fog, the seal isn’t tight. You can use a paper clip to join the elastics at the back if it’s loose, or tie extra elastic to help reduce leaks.

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The SOPs also emphasize the usual ways of handling, donning and doffing PPE and advise that canteen areas are an area of particular concern as there will be less PPE. Frequent air exchange, surface disinfection and distancing are vital in these mask-free areas. And don’t forget the toilet facilities.

Rabenau, H. F., J. Cinatl, B. Morgenstern, G. Bauer, W. Preiser, and H. W. Doerr. 2004. "Stability And Inactivation Of SARS Coronavirus". Medical Microbiology And Immunology 194 (1-2): 1-6. doi:10.1007/s00430004-0219-0. Bundesapothekerkammer 08/04/2020: Taetigkeiten in der Apotheke waehrend einer COVID-19 Pandemie (Activities in the Pharmacy during a COVID-19 Pandemic). E-mail Peter for translated summary.


Feature

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Effective Oral Care in Pharmacy Oral disease impacts on the vast majority of the population and despite advances in preventive dentistry the prevalence of dental decay and gum disease remains high. At the frontline of healthcare, pharmacists and pharmacies have a substantial role to play in improving oral health. Pharmacists in the heart of any community are an ideal source of information and teams should be educated and knowledgeable in being able to provide consumers with advice about caring for their oral health, by recommending which products may be more effective for their needs. Many people visiting a pharmacy are looking for pain relief and medication to rid themselves of toothache, mouth ulcers and other areas of discomfort in the mouth and jaw. Oral Health in Ireland Oral disease is one of the most common diseases in contemporary society. In spite of considerable advances in preventive dentistry, the vast majority of the population will have experienced both dental decay and gum disease by their early twenties. Advances in the prevention and treatment of oral diseases mean that most children born in this century will keep their teeth into old age, and the condition of these teeth will depend on how well they are looked after over a lifetime. The vital role our oral health plays in our daily lives, in terms of eating, speaking, smiling and socialising, is often overlooked but it is impossible to separate oral health from general health; behaviours that cause general disease are also implicated in oral disease. High sugar intake, for example, is linked to obesity, heart disease, diabetes and dental decay. Smoking is linked to cardiovascular disease, respiratory disease, gum disease and cancer, including oral cancer. In addition to sharing common risk factors, poor oral health appears to impact on general health. Research has shown a link between gum disease and heart disease; a link between gum disease in pregnancy and adverse

pregnancy outcomes has also been reported, although further research is required to explain this association. Patients are in need of more than just toothpaste, however, and improving oral hygiene is paramount and can prevent many illnesses from emerging. In addition to what you recommend, it is good to also provide trips on general oral hygiene. These tips include: â&#x20AC;˘ regularly (twice daily) brushing teeth and gums using a fluoride toothpaste â&#x20AC;˘ flossing between teeth using dental floss, dental tape, or interdental brushes â&#x20AC;˘ keeping the tongue clean (Gently brush the tongue a couple of times to remove bacteria and freshen breath when brushing teeth) In addition to those seeking good oral health, there will be patients who have already developed illnesses related to poor oral hygiene. The most common are Gingivitis and Halitosis.

Gingivitis Gingivitis is a form of periodontal disease. Periodontal disease is the inflammation and infection that destroys the tissues, such as the gums, ligaments and the tooth sockets, which support the teeth. This is caused by a build-up of plaque over periods of time and is caused by poor dental hygiene, undiagnosed diabetes or a poor diet. The disease can often remain silent for many years and will only present itself when the gums become swollen or bleed. Gum disease can result in teeth loss. Patients who smoke or suffer from diabetes are at a higher risk of developing the disease. If a patient presents with symptoms of gingivitis, they should have their teeth professionally cleaned and they should also be advised to practice good oral hygiene. In order to prevent a build-up of plaque, toothbrushes or water irrigation devices can be advised, along with anti-bacterial mouthwashes and anti-plaque or

anti-tartar toothpastes. Soft bristle brushes should be used and the recommended time for cleaning the teeth is two minutes. Halitosis Halitosis or bad breath can be caused by excessive amounts of volatile sulphur compounds (VSCs) being produced by bacteria in the mouth. This can be influenced by any number of factors, such as eating, drinking, oral hygiene, sleeping and the effect that these activities have on saliva flow. Mouthwashes will reduce halitosis, due to the anti-microbial influences of the products. Routines and Products There is more to oral hygiene than a toothbrush and some toothpaste. Pharmacy teams need to be able to advise on brushing technique, as well as the types of product available to manage specific oral health problems, such as acid erosion, staining and gum disease In fact, poor gum health has been linked with systemic disorders

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Feature • A focus on vulnerable groups with the development of appropriate oral health interventions and clinical care pathways • A full review of education and training to ensure that the skill levels of the profession are commensurate with today’s requirements • Oral health promotion programmes for the entire population • The maintenance of the programme of water fluoridation There are three key reasons why a new national oral health policy is needed: • Improvements in health, including oral health status, in the general population at all ages have altered the type of healthcare and oral (dental) healthcare required.

such as diabetes and heart conditions, so pharmacy teams should be aware of the link and the need to remind customers to have regular dental check-ups. Reinforcing the message about twice-daily brushing remains the most important priority and is one of the most effective ways of preventing dental decay. Lifestyle Good oral hygiene is the cornerstone of dental health, but there are other lifestyle factors that also have an effect, such as diet, smoking, smokeless tobacco and alcohol. Most people don’t realise that their diet can have a significant impact on their oral health. Crash dieting, fasting and lowcarbohydrate diets can have nasty side-effects on breath due to acetone caused by ketosis, or an excess of protein in the diet producing volatile sulphur compounds in the breath. Certain types of food can also feed the bacteria in the mouth that cause bad breath. Hard sweets are a major culprit. Similarly, ice lollies are known to stain the teeth because of the amount of sugar they contain. Smoking is, unsurprisingly, another no-no for healthy mouths as it quickly dries out the mouth and introduces nicotine and tar.

For customers who do smoke but want to mask bad breath, an alcohol-free mouthwash should be advised to kill bacteria. Alcohol is also a drying agent and will reduce saliva flow, in turn creating a perfect breeding ground for bacteria.

but they are usually harmless. Most mouth ulcers will clear up on their own within a week or two, but a GP or dentist should be consulted if the ulcer gets worse, lasts for longer than three weeks, or if the patient develops ulcers on a regular basis.

Cold Sores

Smile agus Sláinte

Cold sores are caused by the herpes simplex virus. The first symptom is usually a burning or stinging pain on the lips or around the mouth, followed by pink bumps and small blisters that dry and crust over. Cold sores usually clear up by themselves within seven to 10 days without treatment, but a cool wet compress may help to soothe the irritation, as will applying a moisturising cream, such as petroleum jelly. Washing the area gently with a salt bath or wash can also help. OTC antiviral creams can ease symptoms and speed up healing time, but to be effective they need to be applied as soon as the first signs of a cold sore appear.

Under the Smile agus Sláinte Policy, all children up to 16 years will receive eight oral healthcare packages including examinations, assessments, advice, prevention interventions, emergency care and referral as appropriate. Oral healthcare packages will also be provided for medical card holders over 16 years. The packages will be provided in a primary care setting by oral healthcare practitioners contracted by the HSE.

Mouth Ulcers Mouth ulcers affect up to 20% of the population, particularly women and young people. They are usually white, red, yellow or grey in colour and inflamed around the edge. Mouth ulcers can be uncomfortable, especially when sufferers are eating, drinking or brushing their teeth,

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There will be a particular focus on improved oral health services for all vulnerable groups, including people in nursing and residential homes. Smile agus Sláinte will ensure that the local dentist will be the first point of contact for these groups with the HSE community oral healthcare services providing additional high-support care as required. The key actions contained in the Policy include: • Provision of preventative oral health packages for children and eligible adults

• Changing demographics and oral health challenges confronting vulnerable groups have resulted in inequalities in oral health status and in access to oral healthcare. • New technology, knowledge and philosophies in dental care have changed service delivery and now enable the delivery of complex care in primary oral healthcare settings. The decline in dental decay in Ireland has been mainly attributed to a number of factors, including the widespread use of fluoridated toothpaste since the 1980s and the protective presence of fluoride in public water supplies in Ireland since the 1960s. The decline in tooth loss and increasing maintenance of teeth has been attributed to changes in treatment philosophies, emphasising prevention as well as stabilising and reversing early dental decay. Minimal intervention techniques are increasingly used, supported by improved technology. It is proposed that there will be a phased implementation of Smile agus Sláinte over the period 2019-2026. The ESRI has estimated that the oral healthcare packages approach contained in the Policy would cost approximately ¤80 million.


S

IN A T CON C* CP

*CPC â&#x20AC;&#x201C; Cetylpyridinium Chloride 0.05%

Pamex Limited, 14 Moneen Business Park, Castlebar, Co. Mayo, Ireland. Tel: +353 94 9024000 Fax: +353 94 9022824 Email: info@pamex.ie


Topic Team Training – Cough A community pharmacy environment that fosters teamwork ensured high levels of consumer satisfaction. This series of articles is designed for you to use as guide to assist your team in focusing on meeting ongoing CPD targets and to identify any training needs in order to keep the knowledge and skills of you and your team up to date.

A cough is the body's response to irritation in the airways - this could be due to external irritants or conditions, such as asthma, causing a change in the airways. The most common cause of a cough is an acute upper respiratory tract infection, and these are most commonly caused by viruses such as the rhinovirus. Respiratory tract infections are most common from September to March. Although most coughs clear up within three weeks on their own,

they can be very bothersome for customers who may be looking for your advice on symptom relief.

Non-Productive: Not producing mucus/phlegm, described as dry/tickly

As many are caused by viruses, antibiotics from their GP would not help, and having green phlegm is not a sign that antibiotics are needed.

A dry cough is caused by inflamed airways due to a viral infection

There are two main types of cough. Productive: Producing mucus/ phlegm and may be described as chesty, wet or having a feeling of mucus on the chest;

Consider:  Do I/my staff know that OTC cough medicines are not suitable for children under the age of six years?  Do I/my team know that requests for OTC cough medicines for all children up to the age of 12 years should be referred to the pharmacist?  Am I aware of the evidence base for the use of antibiotics in different types of cough in children?  Can I explain to my assistants the difference between acute, subacute and chronic cough?

40 | PHARMACYNEWSIRELAND.COM

Key Points: Check your pharmacy team are aware and understand the following key points:  The importance of referring all requests for cough medicines for children under 12 years to the pharmacist  The difference between and causes of an acute and a chronic cough  The common causes of cough  The infectious causes of cough (e.g. common cold/flu, bronchiolitis, croup, whooping cough, tuberculosis)  When to refer

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 medical conditions that may affect any treatment or product you recommend.

Actions:  Update my knowledge of cough and its management  Reassess my and my staff’s interventions regarding cough  Train my pharmacy assistants to ensure that they can meet the points in this training checklist and consider this training exercise for inclusion in my CPD record


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


42

Gut Health

Training your Pharmacy in Gut Health Digestive health is in the top 5 over-the-counter (OTC) categories and spans ailments across both the upper and lower gastrointestinal tract. So digestive health pharmacy training is a priority. Customers value a dedicated consultation away from the shop floor where they can discuss their concerns and needs more openly. Advice for digestive health can form part of the travel clinic (e.g. around holiday diarrhoea, travel sickness, waterborne infections) or as a stand-alone service.

Indigestion (also called dyspepsia) occurs when stomach acids start to irritate the lining of the digestive tract. It usually occurs soon after eating or drinking.

There has been a lot of press about severe and sometimes fatal cases of food allergies. Understanding these means you can help advise customers on reducing the risks, what symptoms to look for and why it is important to seek help immediately. For those who have a known food allergy then reminding them to always carry their emergency adrenaline auto-injector is important.

There are a number of things that can worsen symptoms or make a customer more likely to suffer, including:

Digestive health covers a multitude of gastrointestinal (GI) problem. These can be upper GI problems affecting the stomach and oesophagus (food pipe), such as indigestion, heartburn, nausea and vomiting. Or they can be lower GI problems affecting the bowels (intestine and colon) and rectum (back passage), such as diarrhoea, constipation and haemorrhoids. Add to that the ‘holiday health’ conditions of travel sickness and traveller’s diarrhoea and you can see why GI problems are commonplace in the pharmacy. While many GI problems can be managed with OTC treatments and lifestyle changes, they can persist. They may also be a sign of more serious conditions such as bowel cancer. So, you have an important role to play in spotting when this might be the case and referring these customers for medical help. Indigestion Customers with indigestion may complain of many different symptoms as it is often a bit of a catch-all for anything that is not going quite right with the upper part of the GI tract. It is therefore important to get a full picture of the symptoms so you know what you are dealing with.

Indigestion refers to symptoms that affect the stomach and the oesophagus (the gullet). Causes

• High alcohol intake • Eating heavy or spicy meals • Being overweight • Smoking • Taking certain medicines such as non-steroidal antiinflammatory drugs (NSAID e.g. ibuprofen) • Certain medical conditions e.g. stomach ulcers, hiatus hernia, stomach cancer Patients who suffer from indigestion regularly should be given lifestyle advice on the above and be referred to the pharmacist. NOTE: Patients who are on prescribed NSAIDs are also being targeted by pharmacists for a medication review to make sure there are no long term problems associated with their use. Check with your pharmacist if they want you to get involved in identifying and referring on these customers. Heartburn Heartburn (also called acid reflux) is a specific type of indigestion that develops when the acid contents of the stomach flow back up the oesophagus. People who say they have indigestion may also have heartburn so you should check the symptoms so the correct product can be recommended. Symptoms • Burning sensation behind the chest bone and back of the throat

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• Bitter taste in the mouth • Regurgitation of stomach acid The pain can be so bad that sufferers think they are having a heart attack. Heartburn develops when the acid contents of the stomach flow back up the oesophagus. There is a muscle, called a sphincter, which sits at the top of the stomach and acts as a lid to keep stomach acids in place. Sometimes this sphincter gets a bit weak or gets put under too much pressure, allowing acid to flow back up into the oesophagus. Triggers for heartburn include: • Alcohol • Smoking • Caffeine drinks • Citrus fruits • Fatty and/or spicy foods

If heartburn is particularly troublesome the following may be recommended: Alginates Alginates form a raft at the top of the stomach stopping acids from flowing upwards into the oesophagus and causing heartburn. They are fast-acting and usually taken after meals and before bedtime. They are combined with an antacid. Proton pump inhibitors Proton pump inhibitors (PPIs) block stomach acid production. They usually take 2 to 4 days for the full effect to be felt. They are taken as a short course of 2-4 weeks (refer to individual products for details) and should be discontinued as soon as symptoms are relieved. Patients should be referred to the doctor if symptom relief is not achieved within two weeks.

• Wearing tight clothes

Note: PPIs must not be taken by people on warfarin or by those already taking H2 antagonists. PPIs can also interact with other medicines so always check with the customer if they are taking anything else.

INDIGESTION TREATMENTS

When to refer

Antacids

There may be other occasions when it is necessary to refer a customer to the pharmacist but here are a few examples when it will be necessary:

• Large portions of food • Being overweight • Being pregnant

Antacids work by neutralising excess acid produced by the stomach. They act quickly but the effects don’t last long so this means repeat doses may be required. Many products contain a combination of the following: aluminium and magnesium salts and sodium bicarbonate. Constipation (caused by aluminium salts) and diarrhoea (caused by magnesium salts) are possible side effects, so check the packaging ingredients and alert customers to stop taking them if they experience any of these. Simeticone can be found in combination products with an antacid or on its own. Bismuth coats the lining of the stomach and prevents irritation.

• Anyone asking for large amounts of indigestion remedies • Over 45 years of age and experiencing indigestion or heartburn for the first time • Over 55 years of age and having recurring indigestion • Unexplained weight loss • Difficulty in swallowing • Pain in the centre of the chest • If the pain is also felt in the neck, shoulder and down the left arm (may indicate a heart problem) • Pregnant woman with heartburn


43 • If there is no relief from heartburn after taking a proton pump inhibitor for two weeks • Persistent vomiting • Iron deficiency (anaemic) • Blood in vomit or stools • If a person is taking other medication e.g. warfarin cannot be taken with PPIs Constipation If you ask someone what their normal bowel habit is, you’ll find the answer varies widely. The important thing to recognise is that there is no definite rule for what is ‘normal’. The symptoms can occur over a short period of time, or it can be a chronic condition and can include: • Having to go to the toilet less than usual • Going to the toilet as often but having small, hard stools (or straining to pass a stool) • Stomach ache or cramps • Feeling bloated or nauseous • Loss of appetite

The main types of laxatives available are listed below. A bulkforming laxative might be the first choice but they can take time to work and if the person is looking for quicker relief then an alternative laxative might be recommended. This should form part of WWHAM. Bulk-forming laxatives These contain natural fibre and work by bulking out the stools to help the intestine (small bowel) move the stools faster. They also retain more water in the stool, making them softer and easier to pass. They can take a few days to work and users should be advised to drink plenty of water. Osmotic laxatives These retain water in the bowel, helping to soften stools. They can take up to three days to take effect and examples include lactulose and magnesium sulphate. Lactulose is unsuitable for people with lactose intolerance. Stool softeners These work by softening stools and making them easier to pass. Docusate sodium is a stool softener.

Stimulant laxatives These promote the movement of stools through the bowel so less water is absorbed and stools become softer and easier to pass. They act quickly (6-12 hours if taken as a tablet, even less if a suppository is used). The dose should be taken at night time, and they should be used short-term only for occasional constipation, otherwise, the bowel can become ‘lazy’, not working correctly without a stimulant. They can cause cramping. When to refer There may be other occasions when it is necessary to refer a customer to the pharmacist but here are a few examples when it will be necessary: • If there is any major change in bowel habits, especially in the middle-aged or elderly customer (could indicate a more serious problem such as bowel cancer) • If there is blood or mucus in the stools • Unexplained weight loss • Loss of appetite

than a week, despite lifestyle changes and short-term laxative use • Severe pain when trying to pass stools • When large amounts/regular purchases of laxatives are requested • If the customer is a child • If the customer is on other medication IBS Abdominal pain and cramping is a relatively common complaint. One condition which could be the cause is irritable bowel syndrome (IBS), which needs to be diagnosed by a doctor. It is a long-term condition that affects up to 20% of people at some time in their life and is more common in women. There is no known cause for IBS, though in some people it started after a period of stress or a GI infection. Once people have IBS, recurrent bouts may be brought on by different triggers e.g. stress or certain foods.

• If constipation persists for more

Causes It can be difficult to identify the exact cause of constipation, but some common causes include: • Lack of fibre in the diet • Not drinking enough fluids • Lack of exercise • Medicines that cause constipation as a side effect e.g. codeine-containing pain relievers, aluminiumcontaining antacids • Pregnancy (due to increased pressure in the abdomen and hormone changes) • Ignoring the urge to pass a stool • Change in routine/lifestyle (e.g. going on holiday) • Anxiety • Old age • Cancer Constipation Treatments If lifestyle and dietary measures alone haven’t helped to relieve constipation, a laxative can also be used. These are available as tablets, capsules, liquids, granules, and suppositories (inserted into the rectum [back passage]). Many of these should not be used in children.

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Let's Talk Sexual Health

I

n recent years, sexually transmitted infections have increased in Ireland. Sexual health has been defined as a state of physical, mental and social well-being in relation to sexuality. It pertains to all those that have been or are currently sexually active.

Some might ask, why should sexual health issues be highlighted? In a recent study by HIV Ireland it was found that sexually transmitted infections (STIs) were on the rise. Over 13,000 people in Ireland have been recorded as having an STI. Chlamydia, a bacterial infection affecting both men and women, is currently the most common STI seen by the HSE today. Other common STIs include gonorrhoea, syphilis and HIV. These infections can have damaging effects on an individual if not treated correctly. Having identified an STI, preventative methods should be implemented to help stop the spread.

(May) by the Irish Pharmacy Union (IPU) shows that there has been a 10% decrease in prescriptions for the pill dispensed compared to the same period last year. HMR Ireland worked with 73% of Irish pharmacies in collecting this information, which showed a significant drop off in both the oral contraception that is taken by women on an ongoing basis (the pill), and the Emergency Hormonal Contraception, also known as the ‘morning after pill’. Community pharmacist and IPU Executive Committee member Caitriona O’Riordan said there are two important messages for Irish women:

Drop in Contraception Scripts

• Under new regulations brought in because of the ongoing health crisis, pharmacists can now increase the maximum period of validity of a prescription from 6 months to 9 months, so you don’t have to get a new prescription for your oral contraception; and

There has been a significant drop in the number of prescriptions being dispensed for oral contraception (the pill) since the start of the COVID-19 crisis. Information revealed last month

• You can get your Emergency Hormonal Contraception from the pharmacy without a prescription. We encourage women to phone the pharmacy first so the EHC consultation

Another topic relating to sexual health is that of contraception. Contraception is vital for both men and women in Ireland. Contraceptives prevent unplanned pregnancies and inhibit the spread of STIs.

44 | PHARMACYNEWSIRELAND.COM

can be carried out over the phone in advance of coming to the pharmacy to collect the medicine. Ms O’Riordan said, “There could be a number of reasons why fewer women are currently accessing the pill. Some may be wary of moving around and visiting a pharmacy, while others may have already finished their six-month prescription and don’t realise that pharmacists can currently extend this. We want to reassure everyone that pharmacies are open and operating as normal; they have also put in place stringent physical distancing measures to ensure there is no risk to patients.” Ms O’Riordan concluded, “Pharmacists have previously called for the pill to be made available in pharmacies without prescription. The drop in use that we are seeing at the moment further emphasises the importance of improving access to contraception. This is about giving choice to women, and pharmacists are happy to offer that choice currently; we hope it can be enhanced in future.” Value of Pharmacy Community pharmacy has, for

many years, been involved in providing support for sexual health. Pharmacists sell products ranging from condoms, lubricants, emergency hormonal contraception (EHC), sanitary goods, pregnancy and ovulation tests, herbal supplements for the menopause, treatments for cystitis and thrush. Pharmacy is locally commissioned to provide condoms, sexually transmitted infection (STI) screening and treatment, pre-conception support, pregnancy testing, EHC and oral contraception. This range of products and services is not available from any other single provider and so community pharmacy is well-placed to position itself as a one-stop shop for sexual health. However, if community pharmacy is to be seen as a sexual health clinic, there are some important questions to ask including: • How could community pharmacy effectively position itself as a place where the public can get support for most of their sexual health needs? • What would influence an individual to access sexual health services from a pharmacy?


• What are the benefits to the community pharmacy of developing a sexual health clinic offer? • What development would the pharmacist and team require to offer a more complete sexual health service? • How could pharmacy position its products and services as a comprehensive sexual health offer? The World Health Organisation (WHO) defines sexual health as a state of physical, emotional, mental and social wellbeing in relation to sexuality; it is not just the absence of disease, dysfunction or infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence. For sexual health to be attained and maintained, the sexual rights of all persons must be respected, protected and fulfilled. These are important principles for all involved in the provision of sexual healthcare. Most adults are sexually active and good sexual health matters to individuals and communities. Having good sexual health is linked to our mental and physical wellbeing, and vice versa. Health Needs Sexual health needs vary according to factors such as age, gender, sexuality and ethnicity. However, there are certain core needs for all, including easily accessing services where confidentiality can be assured and individuals feel that they will be treated with respect and will not be judged. Additionally, people want evidence-based information and advice so that they can make informed responsible decisions and receive high quality services, treatment and interventions. The consequences of poor sexual health are significant and, like many issues, are worse in areas of deprivation where health inequalities are higher. These include unintended pregnancies and abortions, the psychological consequences of sexual coercion and abuse, poor educational, social and economic opportunities for teenage mothers, young fathers and their children, HIV, cervical and other genital cancers, hepatitis, chronic liver disease and liver cancer, recurrent genital herpes and pelvic inflammatory disease, which can cause ectopic pregnancies and infertility. Setting up a sexual health clinic Planning effectively for service provision significantly increases success and setting up a sexual health clinic is no exception, even if several aspects are already being delivered.

The areas to concentrate on are: • Research to evaluate gaps in local provision and the local demographics to ensure there is a market. Include discussions with customers, perhaps in a small focus group, to best understand their needs and how they would like to receive information about your services • Look at what is currently offered and how this could be better packaged as a sexual health service offer. Then identify, based on the research, what other products and services might be added • Gain early insight and engagement from the team to get their views and overcome any concerns or issues they might have with being involved in supporting the service. The more they are included in the development of the complete service, the more likely they will be to promote it when it is available • Identify suppliers for products such as STI testing – some will be offered by the pharmacy, while others will be brought as self-testing kits by the patient to perform at home • Consider the pharmacy environment and the customer experience from before they walk in to after the service has been delivered • Many pharmacists find promoting any service their biggest challenge, so seek professional advice or plan from the start how the service will be promoted. Involving the whole team Everyone can get involved in developing a pharmacy sexual health clinic from the planning and design through to supporting customers and delivering services. Whoever is included in shaping the service, it’s critical that the customer’s experience is at the centre. Those using the services will want to feel that they are not being judged, that they are receiving quality advice and support that puts their needs first and that their information will be dealt with confidentially and with sensitivity. Training for all should include communication skills on managing sensitive conversations. An efficient service will use the skills of the whole team including counter assistants, pharmacy technicians and the pharmacist. Ideally, the pharmacist will only deliver aspects of the service that only they can do such as vaccination , using others to support the paperwork, testing, health promotion and uncomplicated retail sales within their competence.

Letter to Pharmacists Following an EU review of sodium valproate-containing medicines, updates to the product information for the Epilim range of products were approved by the HPRA regarding the requirements for a pregnancy prevention plan. These updates included changes to the package leaflets, the inclusion of a pregnancy warning symbol on the blister packs, and a pregnancy warning symbol and an updated text warning on the outer cartons. The HPRA is aware that there are some legacy batches of Epilim products remaining on the Irish market which, although released in compliance with the relevant marketing authorisations at the time, do not contain the updates required after the 2018 review. Some of these batches have expiry dates into late 2020 and early 2021. The HPRA wishes to highlight the existence of these batches to pharmacists. This is so that pharmacists may take measures to ensure that any woman/girl of childbearing potential who is being dispensed Epilim receives the most up-to-date information about their medicine, specifically in relation to pregnancy prevention. • If you are dispensing any of the above listed Epilim products, please check if the batch number on the pack you have is listed above. • If it is listed above, please ensure that your patient receives a copy of the latest package leaflet for that Epilim product at the time of dispensing – the most up-to-date package leaflet is available on the HPRA website (www.hpra.ie) in the Find a Medicine section. It can be printed and given to the patient. • There are pharmacy warning stickers available from Sanofi (the Marketing Authorisation Holder for Epilim) which were provided for situations where broken bulk dispensing cannot be avoided. These stickers contain the pregnancy warning symbol and could be utilised at the time of dispensing for those batches that do not display the pregnancy warning symbol on the outer pack. We understand that they were distributed to pharmacies by Sanofi in May 2018 and February 2020. They may be ordered from Sanofi by contacting Sanofi Medical Information on Tel: (01) 403 5600 or e-mail: IEMedinfo@sanofi.com. The pharmacy warning stickers are also available to print from the HPRA website, at <http://www.hpra. ie/homepage/medicines/special- topics/valproate(epilim)/educationalmaterials-toolkit>. • An Epilim patient card is also available from Sanofi – it also was distributed to pharmacies in May. • 2018 and February 2020. It may also be printed from the above HPRA website location. These cards should be given to all women/girls of childbearing potential who are being dispensed Epilim. • There are various other risk mitigation measure materials available on the HPRA website, as the same location as above.

PHARMACYNEWSIRELAND.COM | 45


46

Sleep Feature

Super Foods as Sleep Aids If customers are reporting that they are struggling to fall asleep or stay asleep at night, they are not alone. Lucy Wolfe CGSC, MAPSC, H.Dip RM, runs a private sleep consulting practice where she provides knowledge, expertise and valuable support to people across the country. She is a regular guest on television and radio, writing for many magazines and online media sources.

supervising a wide variety of biological maintenance jobs and ensuring that everyone can function at a high level by day and live a long and healthy life. So many force factors affect sleep patterns, including those that are psychological, physiological and environmental. Here, we focus on how everything consumers eat and drink can affect and aid a restful sleep and how pharmacists as pivotal healthcare professionals within the community. Getting adequate sleep each night is a vital component to maintaining a healthy lifestyle, and according to research, many Irish consumers are falling short of receiving the recommended amounts of rest. Being chronically sleep deprived can increase risk of developing chronic disease states, such as diabetes, depression, cardiovascular disease, and others. Sleep deprivation can also impact neuropsylogical disorders including acute manafestations, such as increased nightmares. It is important for consumers to utilise assistance in managing their sleep disorders to ensure they are getting the proper rest they need. Pharmacists can play an important role in championing optimal sleep health. Sleep disorders have many aggravating factors that can be identified by a pharmacist, such as lifestyle habits and certain medication regimens. There is an abundance of medications that can negatively impact the body’s sleep cycle. Pharmacists are experts at identifying such medications and can help guide their patients in the right direction if their medications are the culprit of the problem. Sleep is necessary to ensure that you are optimally functioning. While sleeping the brain and body is repairing and restoring,

Anti-sleep foods include: Sugar, processed, high-sugar foods and refined carbohydrates. These raise the blood sugar levels and can cause a surge of energy that disturbs sleep, so it is best to avoid these food types in order to enhance sleep. SLEEP SUPER FOODS The banana The non-medical equivalent to a sleeping pill; containing the sleep hormone melatonin and relaxing chemical serotonin and also magnesium, that helps to relax the muscles. Dairy products Milk, cottage cheese, yoghurt and cheese are all good sources of tryptophan that helps to make serotonin; which makes us feel sleepy. Also, dairy contains calcium which helps the body to process the tryptophan and produce a second sleep inducing neurotransmitter; melatonin. Oatmeal Oats are a rich source of melatonin and are filling too. Honey A spoon of honey in milk is an age-old remedy for insomnia. Too much sugar is stimulating, but a little glucose signals to the brain to turn off orexin, which is a neurotransmitter linked to alertness.

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Whole-wheat bread A slice of brown bread toast with a drink of milk and honey is delicious, but also useful. This will release insulin which enables the tryptophan (makes us sleepy), to get to the brain, where it is converted to serotonin, the sleepinducing hormone, which in turn lets the body know it is sleep time. Seeds & Almonds

• Be careful of caffeine intake towards the end of the shift remember it takes 6-8 hours to clear from system • If coming from a night shift; go straight home • Be mindful of technology use 1-2 hours before sleep time • Wear sunglasses to offset the morning light stimulating the waking part of brain

Some seeds-flaxseed, jujube seeds and chia seeds can have a calming and sedative effect. Another sleepinducing food- they can be found ground or whole. They contain both tryptophan and also magnesium that helps to relax muscles.

• Ensure that the temperature in bedroom is cool by day

The potato

Further Natural Solutions to Enhance Sleep:

A small baked potato won't send the GI tract into overload; it will clear away acids that can inhibit the sleepy friend tryptophan in order to make way for restful sleep. Turkey Probably the best source of tryptophan. Put a slice of turkey on some wholegrain bread and the result is one of the best sleepenhancing foods that can be used. Some Shift Work Suggestions: • Try to eat regularly despite the shift

• Black out blinds | eye masks | white noise • Sleep in 2 parts to reach sleep quota

• Magnesium spray • Epsom salt baths • Iron supplements • Essential Oils: chamomile, lavender , camphor, vetiver, chamomile - diffuser, candles, body lotion, bed and body spray • Chamomile/Lavender Tea • Salt therapy Air Purifier-good for sinus, snoring, asthma etc.


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