issue 7 volume 10 • july/august 2008
The independent monthly for Irish Pharmacists
Olympic dreams: what’s the dope? diarmuid coughlan
Dark side of the internet june shannon
Sole traders – the case for incorporation shane mcloughlin
Lip Gloss Julian Judge
The doctor will see you now fintan moore
Quiet revolution in hospital pharmacy – Elaine Conyard, President HPAI
The only Effervescent drink with the power of 20 sun ripened oranges and Glucose in every tablet Talk to your local Pharmacist today and ask how RUBEX can help to defend your immune system from colds and ﬂu Rubex is used for the prophylaxis and treatment of ascorbic acid deﬁciency.
news news New EHPM appointment Alan Ruth, chief executive officer of the Irish Health Trade Association (IHTA), has been appointed vice president of the European Federation of Associations of Health Product Manufacturers (EHPM). EHPM represents specialist health product manufacturers in Europe, working towards developing an appropriate regulatory framework throughout the EU for its members’ products. Established in 1975, it represents approximately 2,000 health-product manufacturers in 21 European countries. “As vice president of EHPM, I look forward to working towards an appropriate regulatory framework in Ireland and throughout the EU for the marketing of specialist health
products including food supplements, traditional herbal medicinal products and homoeopathic medicines,” said Ruth. “Currently, the key challenge is to ensure that consumer choice is protected by ensuring the continued availability of the safe higher strength vitamin and mineral supplements which have been available in Ireland and other countries for over four decades. “As CEO of the IHTA, I will continue to work in harmony with the Irish Medicines Board, the Food Safety Authority of Ireland and the Department of Health and Children to facilitate the implementation of appropriate and proportionate regulation within our industry sector. As a result, healthcare professionals
and consumers alike will be able to have even greater confidence in the quality, safety and benefits of the specialist health products available on the Irish market. The fact that the chief executives of both the IMB and the FSAI were the keynote speakers at the IHTA’s recent AGM augurs well for a good working relationship with their respective organisations.” The IHTA represents the interests of manufacturers, importers, and distributors of specialist health products in Ireland. Its members supply health food stores and pharmacies with vitamin and mineral supplements, herbal medicines, homeopathic medicines, natural body care products and health foods. The principal aim of the IHTA is to promote
the wellness of all people in Ireland and to ensure they have the freedom to continue to access natural health products and traditional medicines that are safe, beneficial and of high quality.
First aid campaign launched as 40 per cent of accidents happen during the summer The annual ‘Be First Aid Prepared Accidents Happen’ campaign was launched recently by first aid antiseptic, TCP in conjunction with the Order of Malta, which also called for mandatory first aid training, saying it should be implemented in transition year at secondary school. The campaign aims to encourage families to get ready for accidents that may occur in and around the home and garden during the summer statistically the time of year when most accidents will happen. A TCP Tip Sheet containing handy tips on how to help protect your family from accidents this summer can be downloaded from www. orderofmalta.ie. Research carried out by TCP shows that 50 per cent of Irish people have not participated in a first aid course. According to Winnie Maye, national director, Order of Malta Ambulance Corps, the fact that half of Ireland¹s population hasn¹t been trained in first aid is of great concern. “A basic knowledge of first aid is essential and provides valuable skills, which may some day lessen the pain and trauma of someone you care about and may even help in saving someone¹s life,” she said. Pictured at the ‘Be First Aid Prepared Accidents Happen’ campaign launch are Vivienne Connolly and her four-year-old son, Ben.
Issue 7 Vol 10 July/August 2008
The independent monthly for Irish Pharmacists
A summer of hope Pharmacists all over the country will surely welcome the opinion of the European Commission that under EU Competition Law, the Irish State can negotiate pharmacists’ fees with their representative body, the Irish Pharmacy Union. According to Liz Hoctor, president of the IPU, the HSE has been hiding behind competition law in its refusal to negotiate with representative bodies
issue 7 volume 10 • july/august 2008
3 NEWS New EHPM appointment 6 NEWS IPU welcomes European Commission decision
such as the Irish Pharmacy Union and to force through changes without negotiation. The IPU is now calling on the HSE to reverse its decision to cut payments to pharmacists and to enter into negotiations with it on a new
18 THE COALFACE David Jordan wonders about a new job
pharmacy contract. So perhaps as we go further into a rainy summer, there is hope that the current situation between pharmacists and the HSE can be finally resolved. This month’s issue of Irish Pharmacist covers July and August
20 THE LAW Retaining data?
so who knows, by the time September comes, there may be a result to report. Highlights for the July/August edition include an interview with president of the Hospital Pharmacist Association Ireland (HPAI), Elaine Conyard, who, in
22 INTERVIEW Talking to HPAI’s president
her second year at the helm, hopes that the government and health service management make a real commitment to the development of hospital pharmacy in Ireland. We also look at the rise of illegal online pharmacies, which proves once again that there is a dark side to the internet. As the Olympics get closer, research pharmacist Diarmuid Coughlan looks at the use of drugs in sport, while David Jordan ponders a career move. Our law expert talks about data retention, as Fintan Moore discusses the roll-out of
26 e-PHARMACY Dark side of the world wide web 29 FINANCE All about sole traders
the primary care strategy. And that’s just some of what’s in this issue of Irish Pharmacist. We hope you all have a pleasant summer, assuming the weather
30 SHORT STORY
will improve, and we’ll be back again with a September issue when it’s all over.
GreenCross Publishing is a recently established publishing house which
32 DRUGS IN SPORT A growing problem?
is jointly owned by Graham Cooke and Maura Henderson. Between them Graham and Maura have over 25 years experience working in healthcare
publishing. Their stated aim is to publish titles which are incisive, vibrant and pertinent to their readership.
Irish Pharmacist is published by GreenCross Publishing, Lr Ground Floor, 5 Harrington Street, Dublin 8. Tel: 01 478 9770. Fax: 01 478 9764. www.greencrosspublishing.ie
40 OUTSIDE EDGE Primary care strategy purposes without the prior written permission of the publishers.
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Editor: Karina Corbett Publisher: Graham Cooke PARNTER: Maura Henderson Consulting Editor: Stephen Meyler Reporter: June Shannon Contributors: Diarmuid Coughlan, David Jordan, Julian Judge, Fintan Moore, Cormac O’Neill, Shane McLoughlin
Design: Carl McDonnell Cartoonist/Illustrator: John Corrigan Photography: Audrey Hanley Printers: Bairds Letters to the Editor: [email protected]
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The solution to stomach problems has never looked better.
Motilium is still as effective as ever against fullness, bloating and nausea but it’s now available in a new-look pack. Motilium is the No.1* brand for stomach remedies in Ireland and it’s the main over the counter product on the market for treating dysmotility, the indigestion which results from the stomach’s natural rhythm slowing down. So next time a customer asks for a treatment to relieve their stomach discomfort, reach for Motilium.
Tradename: Motilium 10mg film-coated Tablets. Qualitative & quantitative composition: One film-coated tablets domperidone 10 mg. Pharmaceutical form: Film-coated tablets. White to faintly cream-coloured, circular biconvex tablets. Therapeutic Indications: For the post-prandial symptoms of fullness, nausea, epigastric bloating and belching that is occasionally accompanied by epigastric discomfort and heartburn. Posology and Method of Administration: Adults and children 16 years of age and older: Up to 10mg three times daily and at night. Maximum duration of course of treatment 2 weeks. Use in children under 16 years of age: Not recommended. Contraindications: Known hypersensitivity to demperidone or any of the excipients. Prolaction-releasing pituitary tumour (prolactinoma).When stimulation of the gastric motility could be harmful: gastrointestinal haemorrhage, mechanical obstruction or perforation. Hepatic and renal impairment. Special Warnings and Precautions for Use: Motilium Tablets should only be taken according to the above posology (See 4.2). Patients who find they have symptoms persist, and are having to take domperidone continuously for more than 2 weeks should be referred to their GP. These tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosemia or glucose/galactose malabsorption. A slight increase of QT interval (mean less than 10msec) was reported in a drug-drug interaction study with oral ketoconazole. Even if the significance of this study is not clear, alternative therapeutic options should be considered if antifungal treatment is required. Interactions with other Medicaments and other forms of Interaction: The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. In vivo interaction studies with ketoconazole revealed a marked inhibition of domperidone’s CYP3A4 mediated first pass metabolism by ketoconazole. A pharmacokinetic study has demonstrated that the AUC and the peak plasma concentration of domperidone is increased by a factor of 3 when oral ketoconazole is administered concomitantly (at a steady state). A slight QT-prolonging effect (mean less than 10msec) of this combination was detected, which was greater than the one seen with ketoconazole alone. A QT-prolonging effect could not be detected when domperidone was given alone in patients with no co-morbidity, even at high oral doses (up to 160mg/day). The results of this interaction study should be taken into account when prescribing domperidone concomitantly with strong CYP3A4 inhibitors: For example, ketoconazole, ritinovar and erythromycin. Pregnancy and Lactation: There is limited post-marketing data on the use of domperidone in pregnant women. Therefore, Motilium Tablets should only be used during pregnancy when justified by the anticipated therapeutic benefit. Studies have shown that domperidone enters breast milk. It is not known whether this is harmful to the newborn. Therefore, breast feeding is not recommended for mothers who are taking Motilium. Marketing Authorisation Holder: McNeil Limited, Saunderton, High Wycombe, Buckinghamshire, HP14 4HJ UK. Marketing Authorisation Holder: PA 755/8/1.Further information available upon request from McNeil healthcare (Ireland) Ltd. Tel: 01-4665200 * IMS Health MAT Nov 2007 by Value.
news news IPU waiting for Body for Pharmacy Contract Pricing report By June Shannon THE IPU is eagerly awaiting the publication of the report by the Body for Pharmacy Contract Pricing, a copy of which was submitted to the Minister for Health Mary Harney recently. Chaired by Sean Dorgan, former chief exceutive of the IDA, the body was established by the Minister on February 18th in an effort to resolve the current rift between the IPU and
the HSE following the latter’s decision to cut wholesale prices of medicines. A spokesperson for the IPU told Irish Pharmacist that it had not yet seen the report and had no indication from the Department as to a date for its publication. According to the Department, ‘the Body’s report has now been received by the Minister and she is considering the report prior to submitting it to the Government’. At the time of going to press it
was unclear whether this would be achieved before the Dail breaks for summer at the end of July. The IPU has said that many of its members now face genuine financial difficulties as a result of being in receipt of reduced payments for three months. Meanwhile the court mediation process between the HSE and the IPU, recommended by Justice Peter Kelly broke down last month. The IPU, which is bound by a confidentiality
IPU welcomes European Commission opinion The Irish Pharmacy Union (IPU has welcomed the opinion of Neelie Kroes, European Commissioner for Competition, that under EU Competition Law, the Irish State can negotiate pharmacists’ fees with their representative body, the Irish Pharmacy Union. The Commissioner was responding to a question raised by Marian Harkin, MEP in the European Parliament. “The European Commission opinion, which vindicates the rights of pharmacists to be represented by their Union on all issues, is to be welcomed,” said Liz Hoctor, president of the IPU. “It has major implications not just for pharmacists, but also for GPs, dentists and optometrists. The HSE has been hiding behind competition law in its refusal to negotiate with representative bodies such as the Irish Pharmacy Union and to force through changes without negotiation. The HSE adopted a ‘take it or leave it’ approach with pharmacists and in doing so is clearly abusing its dominant position as the largest purchaser of medicines in Ireland. The Union always believed that negotiating fees
with the HSE was not a breach of competition law.” The Commission stated, in its opinion that, ‘the fixation of fees for pharmacy services would only be problematic from the point of view of EC competition law if it was not the Irish State which had the final word in fixing the price…’. “I am now calling on the HSE to reverse its decision to cut payments to pharmacists..and to enter into negotiations with the Union on a new pharmacy contract,” added Hoctor. In January 2007, the HSE wrote to individual pharmacists informing them that it would no longer negotiate their fees for the provision of medicines on the Medical Card Scheme and the Drugs Payment Scheme with the Irish Pharmacy Union. The HSE claimed that this would be in breach of the Competition Act. This claim by the HSE caused major anxiety among pharmacists who believed it was a challenge to their right of representation by their Union. This was further compounded in September 2007, when the HSE announced that it was cutting payments to pharmacists on the Community Drugs Schemes.
Boots plans Irish operations’ expansion Alliance Boots is planning significant additions to its chain of pharmacies in Ireland, following its ten per cent rise in sales here during the last financial year to £184m (€231.2m). The company, which operates almost 50 stores in the Republic, said like-forlike sales in the year to the end of March rose ten per cent, while total sales were up 18.7 per cent. Irish operations had been one of the best performers in the group, it added and its cosmetics and fragrances sub-category within Ireland had performed particularly well in terms of sales and margins. Boots has already said it wants to add a further 40 stores here within five years, however a spokesperson has now predicted the number could be more than that, and further expansion would be achieved through avenues including organic growth and acquisitions. The company recently completed its first acquisition here in several years when it bought a Waterford pharmacy.
Issue 7 Vol 10 July/August 2008
agreement from commenting on the reasons for the breakdown, said it was disappointed at the outcome of the talks, which were suspended indefinitely. It is now proceeding with a number of cases through the courts, it added. The HSE also expressed its disappointment that the mediation process had been adjourned. The first court case taken by Paddy Hickey against the HSE was due to be heard on the July 22nd.
Irish briefs Evidence is building that the cold sore virus may be linked to Alzheimer’s disease, according to an expert. In lab tests, Manchester University found brains infected with the herpes simplex virus, HSV-1, saw a rise in a protein linked to Alzheimer’s. Scientists believe the discovery could pave the way for a vaccine that may help prevent the brain disorder, New Scientist magazine reported. Such a breakthrough is a long way off, however. “We need to carry out much more work into this, but the problem is people are quite sceptical of a viral link,” said Dr Ruth Itzhaki, of Manchester University Researchers discovered infected cultures of human brain cells with the virus and found a ‘dramatic’ increase in levels of the beta amyloid protein - the building blocks of deposits, or plaques, which form in the brains of people with Alzheimer’s. A similar increase was seen in the brains of mice infected with HSV-1. Travel fatigue affects many people, but there are ways to minimise the effects, according Dr Giles Warrington, a sports and exercise physiologist and lecturer in the school of Health and Human Performance at DCU. Travel is associated with a number of negative symptoms, collectively termed ‘travel fatigue’. These negative effects are associated with a disruption to normal routine and the stresses associated with travel. With appropriate planning and effective coping strategies, symptoms will disappear within one or two days. Travel - in particular long-haul - can be extremely stressful and tiring. Effective preparation is the key to making sure that the disruption of travel is minimal and that the transition to local time of destination is as smooth as possible - this requires planning and preparation. More than 50 per cent of men over 40 suffer from erectile dysfunction, yet less than one third of men affected seek treatment from their doctor. As part of Men’s Health Week in June, men were encouraged to seek help from their GP or pharmacist, because erectile dysfunction (ED) can be treated. “The majority of ED cases, about 70 per cent, are symptomatic of broader health concerns such as depression, diabetes, cardiovascular disease or even neurological disease,” said Dr Stephen Murphy, chairman of the Sexual Dysfunction Information Bureau (SDIB), adding that only 25 per cent of ED cases are psychological. “Erectile dysfunction can be successfully treated, so we would urge sufferers to speak to their doctor or pick up a booklet in their local GP or pharmacy.”
news news Pharmacists warn of dangers of buying drugs online The Irish Pharmacy Union (IPU) has warned of the dangers of buying medicines over the internet. The warning follows a move by a company, Dr Thom, to supply the contraceptive pill and the morning after pill over the internet to women in Ireland and the UK. The IPU emphasised the importance of faceto-face contact with a pharmacist when receiving medication and called for the morning after pill to be made available directly from the pharmacist to ensure women had timely access to emergency
contraception. “When a patient buys medicines from the internet they have no faceto-face consultation with a doctor or pharmacist,” said IPU president Liz Hoctor. “This would have serious patient safety implications. It is vital that patients have the opportunity to speak to a community pharmacist when receiving their medication. A pharmacist, as a healthcare professional, can advise a patient on the appropriate use of a medication and checks whether a medication is safe for a patient to take. Before
dispensing a medication to a patient, the pharmacist checks for possible drug interactions; incorrect drug dosage and clinical abuse. Patients buying medicines from the internet also have no way of knowing whether the medicines are counterfeit or genuine. It is also illegal to buy medicines on the internet in Ireland.” Meanwhile, Irish women can experience problems in accessing the morning after pill (Emergency Hormonal Contraception), Hoctor continued, and she called on the
Government to enable pharmacists to provide it to patients without a prescription. “This would only be done with appropriate counselling and within agreed protocols,” she said. “Emergency Hormonal Contraception should never be the only form of contraception used. Appropriate protocols on how and when it can be supplied are essential. On dispensing the morning after pill, the pharmacist would also refer the patient to the GP, where appropriate, for a consultation on their contraceptive options.”
Digestive problems should not be ignored While 80 per cent of Irish women experience digestive discomfort at some stage, less than one third seek help for the condition, according to a recent survey. Over 650 women aged over 25 took part in the study, which was carried out as part of World Digestive Health Day (May 29th). And it was found that digestive discomfort was having a serious impact on the general wellbeing and mood of those affected. According to Prof Eamonn Quigley, president of the World Gastroenterology Organisation (WGO) and consultant
gastroenterologist at Cork University Hospital, digestive disorders should not be ignored. “They affect a significant percentage of the population and can lead to serious conditions such as colon cancer”, he said. “In Europe, 10-15 per cent of the population suffers from IBS (irritable bowel syndrome) and 5-10 percent suffer with gastro-oesophageal reflux. Even so-called minor digestive complaints impair a person’s quality of life and are responsible for loss of time from work and school. But most of these digestive complaints are preventable.”
Dublin nutritionist, Paula Mee, said digestive health was an excellent indicator of our overall health. “Discomfort isn’t just something women get from time to time and it really isn’t something that should be ignored. If you do experience it, first check your diet – eat lots of fruit and vegetables, wholegrains and try a probiotic yogurt that has scientifically proven benefits”, she said. People should try to eat more slowly, make sure to drink plenty of fluids and try to do regular exercise,” she added.
The survey, which was carried out by Danone, found that women who reported the worst digestive discomfort consumed too many fried or fatty foods. Almost one in five women reported eating fried/fatty foods two to three times a week, with this figure highest in the Connacht/ Ulster region of the country (32 per cent). It also discovered that 17 per cent of younger working women indicated that they skipped breakfast – the most important meal for jumpstarting the day’s digestive process. This group also tended to snack more as a result, particularly in the Dublin region.
Issue 7 Vol 10 July/August 2008
news news Golf outing in Portumna
The Lady Pharmacist Golf Society enjoyed the first of three golf outings in Portumna on May 24th. Pictured (l-r) is first prize winner Marie Donnellan (right) with Lady Captain Jean Brogan and Niamh Coffey from Uniphar, which sponsored the event; second prize winner Toni Mulholland with Jean Brogan and Niamh Coffey and third prize winner Doreen O’Donoghue with Jean Brogan and Niamh Coffey. The next two outings will take place on July 26th at Curragh Golf Club and on August 23rd at Adare Manor Golf Club. The society welcomes new members - for further information or bookings phone Ann O’Driscoll (competition secretary) on 087 7678345 or Mairin Holohan on 087 6677391.
Issue 7 Vol 10 July/August 2008
news news Ennis pharmacy wins Berocca Pharmacy Window Display competition Mary Jo Duffy of Duffy’s Pharmacy in Ennis, Co. Clare has been announced as the winner of the National Berocca Pharmacy Window Display competition, sponsored by Berocca multivitamin from Bayer Healthcare. Pharmacies around the country were given a range of Berocca display materials and were asked to use their design skills to create a window display themed for St Patrick’s Day. The competition ran nationwide for the month of March and involved over 150 pharmacies. Mary Jo’s window display was judged to be the most creative and professionally presented. “The winning display was an example of excellent window merchandising and the use of additional themed materials added extra flair while the green, white and gold colour scheme was executed perfectly,” said Marion Rogan of Bayer Healthcare. “Overall Mary Jo has succeeded in setting a high standard of professional display.” In addition to the acclaim for her winning display, Mary Jo won a weekend trip for two to a European city of her choice. Two runner-up prizes were awarded to Marron’s Pharmacy in Clane, Co Kildare and Sean Meade’s Pharmacy in Carrick on Suir, Co. Tipperary. Pictured are Mary Jo Duffy and Michael Clarke of Bayer Healthcare.
Issue 7 Vol 10 July/August 2008
news news All you need to know about the link between allergies and asthma A new patient information website has been launched by Merck Sharp & Dohme Ireland (Human Health) Ltd for people living with asthma or an allergy, or both - www. allergyandasthma.ie is an on-line resource where people can learn about the link between allergies and asthma, the main symptoms and triggers associated with both conditions. They can also take a two minute self-assessment test. In Ireland 470,000 have asthma and it has been shown that up to 80 per cent of those with asthma also have symptoms of allergic rhinitis. The new site provides information on the close link between asthma and allergic rhinitis. “This new website provides information on asthma and allergies and the link between them in a simple and digestible format for patients or indeed a family member of a person with asthma,” said Wexford GP Dr Reggie Spelman. “It is an excellent resource for
anyone with asthma who may not be aware that both conditions are connected. The online ‘Self-test’ is a simple, effective tool that can be used to see if a seasonal allergy may be affecting someone’s asthma and help them discuss this with their doctor.” The site features information on how both asthma and allergic rhinitis are connected, typical symptoms of both, and practical advice on ways to help reduce the impact of the triggers shared by both conditions. In addition, it provides ‘Fast facts’ on asthma and allergies and an interactive ‘Asthma Race’ where visitors can have some fun too by testing their knowledge of allergies and asthma while using their on-line gaming skills. The launch of www.allergyandasthma.ie, will be supported by a series of adverts in the health supplement of The Irish Times and a national radio campaign. The site is a fun and informative way for people with asthma to navigate and is a free service available to all.
Nurofen supporting pain education in pharmacy
Working together towards a tobacco free society The ‘Working together towards a tobacco free society’ tobacco control conference took place recently at the Mansion House in Dublin. The event was organised by Pfizer Healthcare Ireland, in association with the Health Service Executive, the Irish Cancer Society, the Irish Heart Foundation, ASH Ireland, the Irish Thoracic Society, the Research Institute for a Tobacco Free Society and the Environmental Health Officers’ Association. Pictured (l-r) are Professor Luke Clancy, director general, RIFTS, Brenda Dooley, customer director, Health Service Relations, Pfizer Healthcare Ireland, Dr Emer Shelley, population health directorate, HSE and Dr Fenton Howell, director of Public Health, HSE.
Over 450 pharmacists and pharmacy assistants attended several educational meetings, which were held nationwide to celebrate the 25th anniversary of Nurofen. The theme of the evening was ‘Spotlight on Pain with a focus on Nurofen’ and the key focus was to educate pharmacy staff on the analgesics category whilst also providing responsible pain management and advice to customers on the various types of analgesics available over the counter. Specifically, the meeting addressed two key areas; general pain management - understanding pain with a focus on key pain including headache and migraine, back, joint and muscle pain, dental, cold and flu, and pain in children, and communication skills training – key tips on how to build relationships with customers in pharmacy. Pictured are speakers Declan Kerins, pharmacist and Mark Mortell, communications specialist, with Jennifer Shannon, senior product manager, Nurofen.
Issue 7 Vol 10 July/August 2008
Recommend Imodium to your customers for holidays to send diarrhoea packing. Diarrhoea is the last thing anyone needs when they’re on holidays but quite often, that’s exactly when it strikes. The good news for your customers is that they don’t have to put up with it and there’s no need to let it spoil their break. Imodium Plus is the leading over the counter medicine on the market formulated specifically to treat diarrhoea. Imodium Plus not only treats diarrhoea, it also helps relieve wind, cramps and bloating. It’s also available in chewable tablet format for when you’re on the move or there’s Imodium Instants when no water is available. So your customers can rest assured that if the dreaded diarrhoea strikes while they’re on holiday, they can send it packing.
One solution - 3 convenient ways to take it. TRADENAME: Imodium Plus 2mg/125mg Tablets and Imodium Plus Chewable Tablets and Imodium Instants 2mg Tablets. Qualitative and Quantitative Composition: Imodium Plus: Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg polydimethylsiloxane. Imodium Instants: Loperamide ydrochloride 2 mg per tablet. For excipients see section 6.1. Pharmaceutical form: Imodium Plus 2mg/125mg Tablet: Tablet, White, capsule-shaped tablet and Imodium Plus Chewable: White, round, flat-faced tablet with a vanilla-mint odour. Imodium Instants: Orodispersible tablet White to off-white, circular, freeze-dried tablets. Therapeutic indications: Imodium Plus are indicated for the symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years when acute diarrhoea is associated with gas-related abdominal discomfort including bloating, cramping or flatulence. Imodium Instants: As an adjunct in the management of diarrhoea together with fluid and electrolyte replacement. Posology and method of administration: Adults over 18 years: Imodium Plus: Take/Chew two tablets initially, followed by one tablet after every loose stool. Not more than 4 tablets should be taken in a day, limited to no more than 2 days. Adolescents between 12 and 18 years: Take/Chew one tablet initially, followed by one tablet after every loose stool. Not more than 4 tablets should be taken in a day, limited to no more than 2 days. Use in children: Imodium Plus and Imodium Plus Chewable should not be used in children under 12 years. Use in the elderly: No dosage adjustments are required for the elderly. Use in renal impairment: No dosage adjustment is necessary in renal impairment.Hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodium Plus should be used with caution in such patients because of reduced first pass metabolism. Imodium Instants: Adults and children over 12 years only:The usual dose is 2 tablets initially, followed by 1 tablet after each further episode of diarrhoea up to a maximum of 5 in 24 hours. Elderly: No dose adjustment is required for the elderly. Method of administration: Oral. Contraindications: Imodium should not be used in: Children less than 12 years of age. Patients with a known hypersensitivity (allergy) to any component of the product. Acute dysentery, which is characterised by blood in stool and high fever. Acute ulcerative colitis. Pseudomembranous colitis associated with broad spectrum antibiotics.Patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter.In general, Imodium should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. It must be discontinued promptly if constipation, subileus and/or abdominal distension develop. In addition Imodium Plus Chewable should also not be used in: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, because the product contains sorbitol and sucrose. In addition Imodium Instants: Patients with AIDS treated with Imodium Instants for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. Antimotility agents such as loperamide may precipitate ileus and toxic megacolon in patients with ulcerative colitis, and should be avoided in severe acute attacks. It may be used cautiously in mild or less severe attacks as an adjunct to other measures, but should be discontinued promptly should abdominal distension or other untoward symptoms occur.The stated dose should not be exceeded. In addition to taking Imodium, patients should be advised to drink plenty of fluids such as water, clear soup and squash. Patients should be advised to consult their doctor if diarrhea persistes for more than 24 hours. Special warnings and precautions for use: In patients with (severe) diarrhoea, fluid and electrolyte depletion may occur. It is important that attention is paid to appropriate fluid and electrolyte replacement. If clinical improvement is not observed within 48 hours, the administration of Imodium must be discontinued. Patients should be advised to consult their physician.Patients with AIDS treated with Imodium Plus for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been very rare reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. Although no pharmacokinetic data are available in patients with hepatic insufficiency, Imodium should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. Imodium Plus should be used under medical supervision in patients with severe hepatic dysfunction. Since treatment of diarrhoea with loperamide and simeticone is symptomatic, diarrhoea should be treated causally whenever such treatment is available. Interaction with other medicinal products and other forms of interaction. Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is given at recommended dosages (2 mg, up to 8 mg maximum daily dose), is unknown. Pregnancy and lactation There are no indications that loperamide or simeticone possesses teratogenic or embryotoxic properties in animal studies. As there is no experience of the use of Imodium during pregnancy it should not be administered if not clinically justified.Small amounts of loperamide may appear in human breast milk. Therefore Imodium is not recommended during breast-feeding. Adverse Effects Imodium Plus: Clinical trial data (common events only, reported for loperamide with simethicone).Gastrointestinal system disorders: Nausea. Special senses: Taste perversion.Post-marketing experience (reported with loperamide with simethicone, or loperamide alone). Skin and appendages: Very rare: skin rashes, pruritus and urticaria. Very rare (for loperamide): angioedema. Body as a whole, general: Very rare (for loperamide): allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions. Gastrointestinal system disorders: Very rare: abdominal pain, nausea, constipation, flatulence, vomiting, and dyspepsia. Very rare (for loperamide): abdominal distension, ileus and megacolon including toxic megacolon (See warnings and special precautions for use).Genitourinary: Very rare (for loperamide): urinary retention. Central and Peripheral Nervous System: Very rare (for loperamide): dizziness. Special senses: Very rare: taste perversion. Psychiatric: Very rare: drowsiness. Imodium Instants: In clinical trials, constipation and dizziness have been reported with greater frequency in loperamide hydrochloride treated patients than placebo treated patients. The following adverse events have also been reported with use of loperamide hydrochloride: Skin and Appendages Very rare: rash, urticaria and pruritus. Isolated occurrences of angioedema, and bullous eruptions including Stevens-Johnson Syndrome, erythema multiforme, and toxic epidermal necrolysis. Body as a whole, general Very rare: isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions. Gastrointestinal System Disorders Very rare: abdominal pain, ileus, abdominal distension, nausea, constipation, vomiting, megacolon including toxic megacolon, flatulence, and dyspepsia. Genitourinary Very rare: isolated reports of urinary retention. Psychiatric Very rare: drowsiness Central and Peripheral Nervous System Very rare: dizziness. A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrhoeal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects. Marketing Authorisation Holder: Imodium Plus: McNeil Ltd,Saunderton,High Wycombe,Buckinghamshire,HP14 4HJ. Imodium Instants: Marketing Authorisation Holder JanssenCilag Limited,Saunderton, High Wycombe,Buckinghamshire,HP14 4HJ UK. Marketing Authorisation Number: Imodium Plus Tablets:PA755/3/2. Imodium Plus Chewable Tablets: PA755/3/1. Imodium Instants: PA 755/43/3 Further information available upon request from Johnson & Johnson (Ireland) Ltd. Tel: 01-4665200.
Imodium Irish Pharmacist.indd 1
news news Pharmacists issue tips for a healthy summer holiday Pharmacists have issued some practical tips to help families have a more enjoyable holiday abroad. Sunburn, stomach upsets, dehydration, hay fever, insect bites and even a summer cold can hit holidaymakers from time to time but a little forward planning and a few precautionary steps can help to avoid some of the upsets that might interrupt a happy holiday. “We are inviting people to ask their local pharmacist for advice on how to keep well on holiday before travelling abroad,” said pharmacist Rory O’Donnell said. “It is important to be aware of some simple steps that can be taken before heading on holiday. Preparation is key so we advise people to take some simple precautions to ensure a great holiday is had by all.” Pharmacists’ tips for keeping well on
holiday include: • Be Medication Smart. • Travelling on planes, boats, cars – sinus problems and discomfort in the ears can be caused by flying. Taking a decongestant can reduce or avoid this. • Be Jab Smart - check if you need any vaccinations before you travel to your destination. Don’t leave it until the last minute to get them as people can experience tiredness or flu-like symptoms for a few days after receiving certain injections. • Be Liquid Smart - drink plenty of fluids while abroad as dehydration can occur very quickly in the sun. • Be Sun Smart - stay out of the sun between 12pm and 3pm. Wear a hat, sunglasses
and a t-shirt as well as sun-cream of factor 20 or higher. Children should be covered in a complete sun block and be kept in the shade to sleep or play. People’s skin types vary so seek advice from your local pharmacist about the best sunscreen to use. • Be Food Smart – If you are prone to an upset stomach, do not eat unwashed fruit or salads. Make sure that food is thoroughly cooked and is hot. • Be Insect Smart - bites and stings can be very common on holidays. Most only cause local reactions, however some people can suffer severe reactions, which need to be treated immediately by a doctor or A&E department. • Hay Fever - simple steps such as keeping doors and windows closed in mid-morning and early evening when pollen levels peak can help reduce hay fever.
Topaz chooses Meningitis Trust The Meningitis Trust has expressed delight at being chosen by Topaz as its Retail Charity Partner of the Year for 2008/2009. Partnering with Topaz, Ireland’s largest fuel and convenience retailer, will allow the Trust to have a collection point in virtually every county in Ireland. Carole Nealon, general manager of the Meningitis Trust underlined the importance of being selected as the Topaz Retail Charity Partner for 2008/2009. “This will really help the Meningitis Trust to raise the vital funds necessary to inform people of the serious threat Meningitis poses to health. The Topaz initiative is fantastic as we receive no statutory funding for our services.” “Meningitis kills more under fives in Ireland than any other infectious disease. However, it can also affect people of all ages and from all walks of life.” This is the first major charity partnership for Topaz, which acquired the Irish retail and commercial fuels businesses of Shell and Statoil in 2005 and 2006 respectively. The Meningitis Trust provides support through counselling, home visits and a nationwide 24 hour nurse-led helpline, tel: 1800 523 196.
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Protect early for future sales W E N
* Image adjusted to illustrate clinical situation
n o i t c e t o r p Daily id erosion c a t s n i aga . n e r d l i h c r o f
news news Fleishman-Hillard and Sanofi Pasteur MSD win international SABRE Award Fleishman-Hillard and sanofi pasteur MSD beat stiff competition to win the top award in the pharmaceutical category at the 2008 Pan-European SABRE (Superior Achievement in Branding and Reputation) Awards in Venice. The prize was awarded for the ‘Tell Her’ campaign, a cervical cancer awareness programme carried out by Fleishman-Hillard’s health team on behalf of sanofi pasteur MSD. The campaign was the only entry from the Republic of Ireland to win an award at the prestigious ceremony. The ‘Tell Her’ project has achieved much recognition internationally, having received a Golden World Award for Excellence in PR from IPRA, the International Public Relations Association, recently. The SABRE Awards featured 1,450 entries from 28 countries around the EMEA region whilst the IPRA winners were selected from 404 entries from 52 countries worldwide, further highlighting the significance of these awards. Pictured receiving the award were (l-r) are Amy Pilgrim, client director, Fleishman-Hillard and Paul Fogarty, senior product manager, sanofi pasteur MSD.
Half of elderly are on wrong drugs
HSE, safefood and Health Promotion Agency, NI called for reality check on obesity The Health Service Executive and safefood, in collaboration with the Health Promotion Agency, Northern Ireland, have launched a major campaign aimed at tackling the serious problem of obesity across the island of Ireland. The campaign, launched by Minister Mary Wallace, TD, Minister for Health Promotion and Food Safety, has been informed by new research into children’s eating habits and physical activity levels, which also looked at parents’ attitudes towards eating and physical activity. Entitled Little Steps Go A Long Way, the campaign is a major awareness initiative involving TV, radio advertising and digital activity designed to empower people by showing that small changes to physical activity and food habits will have a big impact on health and on the levels of people who are either overweight, or obese. The problem of obesity is at epidemic proportions among adults and children across the island of Ireland and looks set to continue growing at a rate of one per cent every year. In 2005, it was estimated that about 2,000 premature deaths in the Republic of Ireland
were attributed to obesity and that these deaths could be costing the State as much as €4 billion a year. “The report of the obesity taskforce identified childhood obesity as a key threat to the future health of people on the island of Ireland,” said Minister Wallace. “It called for real practical engagement by all sectors with this issue. This initiative represents true cooperation and avoidance of duplication of effort by the key agencies charged with promoting health, healthy diets, physical activity and lifestyles. I welcome this campaign, which through concerted action aims to tackle this important issue.” An information booklet, ‘Little Steps Go a Long Way’ is also available by calling 1850 24 1850. Further information is available at www.littlesteps.eu. Pictured at the launch campaign are (l-r) Aveen Bannon, consultant nutritionist, Dublin Nutrition Centre, Halog Mellet, president, Irish Nutrition and Dietetic Institute and Margot Brennan, Nutritionist, Irish Nutrition and Dietetic Institute.
Large numbers of elderly patients may be on medicines they do not need and may be taking the wrong dose of medicine for their medical condition, according to a recent study that was presented to the Irish College of General Practitioners. Dr Elaine Walsh, a Cork GP, revealed that an examination of one doctor’s practice in the south east showed that, following a medicines review, as many as 54 per cent of older patients were on inappropriate medications. The consequences of being on too many tablets can be serious for elderly people, said Dr Walsh, as they can end up feeling unwell or be at a greater chance of being admitted to hospital if they are taking several, or needless, medicines. The ten-minute review of each of the patients led to a reduction in the average number of medications they were taking. Doctors even decided to stop medication in as many as 70 per cent of the cases. The study should act as a signal to other GPs to do a medication review with their elderly patients, she added. The advice to patients is to never stop taking any medication before consulting with the GP first but if they feel it would be worth approaching the doctor for a review, they should prepare in advance. Medicine doesn’t just mean tablets - it includes any vitamins, herbal products or other supplements from the pharmacy, health shop or supermarket. Also, the doctor should be told about any over the counter medicines the patient is using, such as painkillers or cough syrup, liquid medicines or tonics, lotions, creams and ointments, inhalers or other devices.
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Pharmacists Call For Consistent Approach To ‘Top-Up’ Payments The Royal Pharmaceutical Society of Great Britain (RPSGB) last month called for consistency and fairness to be overriding factors in response to the announcement made by Alan Johnson, Secretary of State for Health, of a Government review in to the current policy on ‘top-up’ payments for NHS treatment. “The Government has encouraged the development of multiple access routes to medicines, for instance by de-regulating some medicines so that they can be purchased in pharmacies, while remaining accessible via GPs on prescription as well,” said Paul Bennett, chair
of RPSGB’s English Pharmacy Board. “Some patients are able and willing to pay to get quicker access to a medicine and make trade-offs between cost and time. No one has suggested that those who pay for medicines in this way should be ineligible for prescription medicines. Many patients also choose to pay for private diagnostic tests that do not impact on their right to receive treatment through the NHS…The review needs to consider government policy on other situations in which patients mix private and publicly-funded care, otherwise there will be major inconsistencies.”
Managing blood pressure via the internet Pharmacists delivering care over the internet to patients with hypertension in the community can help to significantly control blood pressure (BP), thereby aiding to decrease mortality and disability from cardiovascular disease, a new study has shown. The Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model and care was delivered over a secure patient website from June 2005 to December 2007. Participants were randomly assigned to usual care, home BP monitoring and secure patient website training only, or home BP monitoring and secure patient website training plus pharmacist care management delivered through web communications. Of the 778 patients, 730 or 94 per cent completed the one-year followup visit. The results of the study
revealed that patients assigned to the home BP monitoring and web training only, had a non-significant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care. Adding web-based pharmacist care to home BP monitoring and web training ‘significantly increased’ the percentage of patients with controlled BP compared with usual care and home BP monitoring and web training only. The results also revealed that systolic BP was decreased stepwise from usual care to home BP monitoring and web training only to home BP monitoring and web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and web training only groups.
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For further information please contact: Bayer Consumer Care, The Atrium, Blackthorn Road, Sandyford Industrial Estate, Dublin 18. Telephone: 00 353 (0)1 2999313.
what will i do when? While he waits to see how things pan out with the HSE, David Jordan contemplates alternative careers.
have been thinking of alternative careers that I might follow if the world of community pharmacy goes belly up. This is all part of what I call prudent planning. Another name would be panic planning. As I said in an earlier article, my needs are few and simple. Enough to feed and clothe my family and myself, mortgages paid off and a little put by for retirement. The first stages of my planning seemed to be reasonable and logical. But as with all plans there is always a flaw or two. The first and most obvious option is to do what I’m doing now, only for somebody else. I admit that it would be a big wrench for me to go from 60 hours per week to 40 or 45. I’m sure that I will get over the initial boredom of having time for family and a life. One of the flaws in this plan is that current salary levels are unlikely to be maintained. However, this is countered by the fact that I am damn good at what I do so I am head and shoulders above my competitors in this field. A variation on this plan would be to take up full time locum work. This might not be stable or plentiful enough to meet my needs. And this coupled with the downward pressure
My thoughts then developed further as I considered a return to retail, plain and simple. I started my working life in Superquinn and one way or another I have been involved with retail for over 30 years.
on locum rates made this variation less preferable. My next option was still pharmacy related. Make more use of my excellent B.Sc.(Pharm) from TCD and start a new career in the pharmaceutical industry. The flaw in this plan is that I would need to get some experience before I reach Qualified Person status. But at least my degree leaves the option of QP status open. This may not be available to all of the pharmacy degrees currently on offer. A slightly more significant drawback in this plan is that the knowledge earned getting my degree may be slightly past its best by date. This was brought home to me following a conversation I had with my pre-reg. Over tea and bickies we were discussing various aspects of pharmaceutical chemistry and pharmacognosy, as you would. It quickly became apparent that large portions of the current course had not been discovered when I was in college. All of a sudden I was beginning to feel old. My thoughts then developed further as I considered a return to retail, plain and simple. I started my working life in Superquinn and one way or another I have been involved with retail for over 30 years I have loads of experience there and also there is no need for a locum whenever I wanted a day off or heaven forbid a holiday. One of the newer German retailers
dav i d j o r da n
in the Irish market recently advertised for managers. The salary on offer was more than I am currently taking from the business for myself. I looked for the flaws or pitfalls in this plan and to be honest they are few and far between. I almost find myself filling out my application form straight away. I then decided that it was time to think outside of the box. What other skills do I have that I can use to turn a bob or two? This is an interesting exercise to do at any time regardless of the current HSE terror tactics. One that I hadn’t thought too much about would be my skills in project management. Over the last 15 years I have been involved in eight pharmacy fit-outs. Add to this overseeing the build, fitting out and decorating of two new houses and the building of a new kitchen and extension. Up to this I would not have considered this to be a skill. It was just something I had to do. However when I finish writing this article I’m going to do some research on the going rate for project management. Another method is to look at your hobbies and see if you can turn these into money makers. This can be a risky move as it involves turning a relaxing hobby into a potentially stressful salary earning career. Shakespeare put it well in Henry IV Part I (Intermediate Cert 1976): “If all the year were sporting holidays, then to sport would be as tedious as to work.” So what are my hobbies? The first would be motor biking. The only obvious career here is to become a motorcycle courier. My current bike a CB500 is a suitable choice for a courier. I already have all the wet and dry weather gear. I have a good knowledge of Dublin and the hinterland having lived here for over 40 years. The downside is the dangers involved in motorbiking in Dublin. As long as you are faster than the cars, buses and lorries that are trying to hit you you should be OK. At least there is nobody coming after you with guns, knives, blood filled syringes etc. On second thoughts it might be a safer career choice. Or I could do what I’m doing now, writng articles for publication. Maura, is there any jobs going there in GreenCross Publishing? I’m very versatile, I can write on any subject and make it sound convincing. Indeed with the worldwide webby thing you can research any subject and become an expert overnight. My other main hobby is internet poker. In terms of money this is the wild card. If I was to play successfully five nights a week (and it would be a night time job) and make say e200 a night, that’s e1,000 per week or say e50,000 per year. As this is tax-free it is the equivalent of about a e75,000 salary. Not a bad living. No locums needed, most of the day free, work from home, what more could you want? Yes you are taking a bit of a gamble but I reckon that is no bigger a gamble than having to sue the HSE in the High Court. And at least with internet poker the rewards are instant, no waiting for the Supreme Court in two to three years time. So as you are reading this I am most likely enjoying our first decent family holiday in three years. My holiday reading is four books on poker theory and styles of playing. So depending on how things go with the HSE if you want to keep reading my articles you might have to switch to Poker Monthly. If you are a potential employer in any of the above categories please consider this to be a CV. IP (Editor’s note: Thanks for your application Mr Jordan - your CV has been forwarded to HR!)
Issue 7 Vol 10 July/August 2008
Save your skin with AfterBURN a new chapter in suncare Set to be the latest medicine cabinet and holiday essential, AfterBURN Sunburn Rescue Gel is a revolutionary new product specifically developed and clinically proven to treat and repair sun damaged skin, unlike traditional ‘aftersun’ products that simply moisturise. AfterBURN Sunburn Rescue Gel is a unique dermatological gel with an osmotic action that draws water from deep in the skin (the dermis) to the surface (the epidermis) helping to rehydrate and treat sun damaged skin. The product has
Issue 5 Vol 10 May 2008
undergone clinical trials highlighting its efficacy which have shown it helps to: * Aid the skin healing process, helping to reduce the chances of premature skin aging * Reduce redness of the skin * Cool irritation and ease discomfort 9 out of 10 people have been caught out and experienced painful sunburn by overexposure to UV rays – not surprising when 40% of us still use below the recommended minimum sun protection factor and 43% only use sun protection cream when on holiday overseas. Sunburn can lead to skin becoming red, tender and painful, with symptoms being at their worst between 6 and 48 hours after exposure to the sun. Dr John Ashworth, Consultant Dermatologist says: “Sunburn is effectively a radiation burn. Prolonged sun exposure causes skin to overheat and become red and painful. If skin is burnt then people should be sun safe by staying
out of the sun and using a hydrating treatment like AfterBURN to soothe the area and to help repair the skin – conventional aftersun may not be effective and is simply not enough. Remember, you do not need to be overseas on holiday to get sunburnt and you should never ignore serious sunburn.” AfterBURN Sunburn Rescue Gel is an odourless, non sticky and non-staining dermatological gel that is rapidly absorbed and acts quickly on the skin.
Issue 7 Vol 10 July/August 2008
Data retention directive co r m ac o’n ei l l
The new laws regarding data retention might be more about protecting the weak than an invasion of privacy.
he Data Retention Directive will extend obligations with regard to data retention, to include data retention of internet activity. Previously data retention legislation did not create obligations to include such massive quantities of data. Once the Directive has been fully implemented it will result in a record being kept of all electronic communications for a period of two years. Therefore every phone call, e-mail and fax sent by pharmacists and their staff will be recorded. Enormous amounts of data will have to be recorded and stored. Perhaps the Directive has come at this time because only in the recent past has the technology required to store and retrieve such volumes of data in a timely and cost effective manner become available. Internet service providers (ISPs) are the organisations that will be made responsible by the Directive for the actual storage of the data. The clients of the ISPs don’t have to invest in the necessary software or hardware to perform the required task instead, it is the phone
companies who will do the actual data storage of their clients’ internet activities, in order to meet with the requirements of the new Directive. Many pharmacists will have heard about the Directive or read about it over the past year but may not have had reason to consider the Directive in much detail. Often busy people working in the pharmacy industry with responsibility for this area of an organisation’s business will be confined to planning, controlling and recording the work of their departments. Owing to the fact that the ISPs are obliged to make the necessary investments in terms of cash, management time and design amongst other factors, many pharmacists and managers in Ireland have not have been able to justify spending much time or attention on the implications of the Directive. The Directive raises many issues of strategic importance for every Irish and European company. UNDERSTANDING THE ISSUES First of all, it’s necessary to understand exactly what type of data is being stored and what is not being stored. The Data
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Retention Directive will require European telecoms companies to retain electronic communications data such as phone calls, e-mails, text messages, internet chat messages and internet connection data along with the time users logged on and off the internet. Internet protocol address data, which identifies individual users or computers on the internet, will also be retained, along with who initiated the communication and who received it. The time and date of the communication will also be recorded along with the size of the message. What is not being stored are the contents of these communications. Perhaps of some comfort to those people opposed to the Directive on the grounds that they are concerned that it maybe used to violate privacy rights, it is data that is to be retained and not ‘information’. ‘Information’ in this context is intended to mean processed data. Therefore, the firms whose duty it is to store the data must not use it in anyway whatsoever. Indeed the ISPs are prohibited from accessing the data for any purpose other than to facilitate the investigation of serious crime and even then it must be done under strict procedures determined by the national authority of each member state. At this time a warrant is not required in Ireland for those involved with the investigation of serious crime to gain access to the retained data. Perhaps in the future it may emerge as a further control and protection of the citizen’s privacy rights that a properly executed warrant is obtained before retained data can be accessed. Serious crime might include child trafficking, drugs smuggling and illegal arms trading by use of the internet. The single greatest protection of the individual’s privacy rights contained in the Directive is that it requires national governments to take the necessary measures to ensure that any intentional access to, or transfer of retained data contrary to national law, is punishable by criminal penalties that are effective and dissuasive. Further the data can only be held for a period of up to two years and then it must be destroyed. PROTECTING THE WEAK I have always thought that the law should protect the weakest people in
our society first. This sounds like a straightforward opinion and perhaps an opinion not too many people would argue against. I believe that if the law fails to protect the weak, or worse still, it protects the strong at the expense of the weak, then the law is failing. In law, as in life, simple straightforward ideas such as this one sometimes become lost in the complexity of debate. The Data Retention Directive has been introduced so that sufficient data would be available to those investigating serious crime. The victims of these serious crimes are often the weakest members of our society, such as children. Those arguing against the Directive are often very large, wealthy and powerful companies such as the telecoms companies themselves, who are burdened with having to retain the data. Without data retention we will fail our weakest members of society at the time they need us most. However without the Directive telecoms companies operating in Europe would be able to reduce their expenses and thus increase their profits as the capital investment in software, hardware, salaries, training and maintenance would not have to be made. I do not believe that the requirements of the Data Retention Directive are disproportionate to the objectives it attempts to achieve, and considering the controls that have been put in place I believe we can as a nation continue to use our telecommunications systems with this new Directive in operation with our privacy rights intact and respected. We have reached a point in the development of our law enforcement, jurisprudence and technological development where information technology can be used successfully to fight crime to the same extent that technology has to date facilitated the commission of crime by individuals intent on doing so. Cormac O’Neill is a barrister practising on the Dublin and South Western circuits, and a chartered management accountant with considerable experience in industry and banking. He lectures at the Institute of Technology in Tralee and be contacted on 087 6571124.
Issue 7 Vol 10 July/August 2008
looking to the future
As she heads into her second year as president of the Hospital Pharmacist Association Ireland (HPAI), Elaine Conyard hopes that the government and health service management make a real commitment to the development of the hospital pharmacy sector here. june shannon
ospital pharmacy in Ireland has been largely ignored by government and health service management alike over the past number of years. While the recent media spotlight has been on their colleagues in the community, dedicated individuals and hospital pharmacy departments have been quietly revolutionising the service by specialising in areas such as palliative care and antimicrobial pharmacy, radically improving services for patients. Despite the increased specialisation of the profession, it has been over 30 years since the hospital pharmacy sector has been reviewed. Standards for only ten per cent of hospital pharmacy practice were dealt with in the Pharmacy Act 2007 and hospital pharmacy posts remain unfilled with the current HSE restrictions. Elaine Conyard, president of the Hospital Pharmacist Association Ireland (HPAI), and chief pharmacist at Our Lady of Lourdes Hospital in Drogheda, is concerned with the effect these factors will have on patient care. The Dundalk-born pharmacist is facing into the second year of her presidency and lists the successful completion of the career structure negotiations with the Department of Health, the HSE and the HSE Employers Agency (HSE EA) as one of her main objectives for the year ahead. BACKGROUND TO NEGOTIATIONS According to Conyard these negotiations have been ongoing since 2002 and were ‘quite active’ between 2002 and 2004. However, the dissolution of the health boards and the advent of the HSE frustratingly brought things to a standstill from 2004 until just last year when IMPACT – the union which represents hospital pharmacists – together with the HPAI re-entered negotiations with health service management. “We recommenced negotiations in 2007 and had our first meeting in May that year,” Conyard explained to Irish Pharmacist. “Subsequent to that we had a number of meetings between September 2007 and January 2008. “Our last career structure was set out in 1978, 30 years ago. As I am sure you can imagine medicine and pharmacy have changed radically in the last 30 years. During this time we have developed from being a purely dispensary based service into a service with seven strands: dispensary, medicines information, pharmacy procurement, clinical pharmacy, aseptic/oncology manufacture, education/training and risk management/quality assurance. “The development of services to meet the needs of patients today has been down to the
We recognise that there is a need for regular, highquality continuing professional development for all grades of staff regardless of what section of the profession they are working in 22
dedication of our own chief pharmacists and their teams. The absence of strategic development of hospital pharmacy services at national level has been a challenge for us. We now need agreement on a career structure that recognises the service developments that have taken place and the significant changes in the roles and responsibilities of hospital pharmacists since 1978. The structure will need to reflect contemporary health service needs and anticipates organisation and practice advances.” The increasing specialisation of hospital pharmacy is evident from the number of specialist pharmacists currently working in hospitals throughout Ireland. These include antimicrobial pharmacists, renal pharmacists, intensive care pharmacists, heart and lung transplant pharmacists, medicine information, medication safety and aseptic manufacturing specialists and palliative care pharmacists, to name but a few. “Negotiations have been quite protracted. It was disappointing for us that we had such a gap between 2004 and 2007 because we feel we could have had constructive negotiations during that time…but now we are back in negotiations and are awaiting the management side to confirm a meeting date within the next few of weeks. We had some very positive discussions with the HSE and the HSE EA between September and January. The development in services, the contribution that hospital pharmacists can make to progress the HSE Transformation priorities and ultimately improve patient care were discussed.”
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“To be in career structure negotiations for six years I would consider as being unprecedented,” continued Conyard. “Our members have been extremely patient during this time, however, it was very evident at our AGM in April that they are becoming increasingly frustrated with the lack of progress in bringing the negotiations to a satisfactory conclusion. It is vital that the management side remain actively engaged with the HPAI and IMPACT in the coming months and that considerable effort is made to finalise an agreement. “Ultimately all of the proposals we have put forward in the career structure negotiations will result in ensuring the highest quality of care for patients while still being cost effective for the health service.” RAISING THE PROFILE, FACING THE CHALLENGES Coupled with getting agreement on the career structure for hospital pharmacists, Elaine Conyard, together with the HPAI, is also keen to raise the profile of hospital pharmacy and to increase interaction between the association, health service management and other bodies. To this end the HPAI has made a number of recent submissions to national policy development, including submissions to the Patient Safety Commission and the Health Information and Quality Authority (HIQA). “We are constantly horizon scanning and looking at what is happening nationally with the HSE and the Department of Health to ensure that the views of hospital pharmacists are represented,” she said. Commenting on the main challenges facing hospital pharmacy, the HPAI president, who heads a team of 16 staff including seven full time technicians and 6.3 pharmacists, said that the lack of policy development in the sector by the HSE and the Department of Health and the absence of national standards continue to be a challenge. Conyard also identified the current recruitment restrictions across the HSE as a concern, particularly as newer posts such as positions for antimicrobial pharmacists, which have proved to be of huge benefit to the health service, have been affected. “I am sure they [recruitment restrictions] are having an effect right across the HSE. The restrictions have been very frustrating, especially when you are trying to improve the level and quality of service being provided to patients. Also ensuring that services are maintained to the patient when your department is short staffed due to the restrictions, is very difficult. “One of the positive developments for hospital pharmacy that has taken place in recent years was the approval of 20 antimicrobial pharmacy posts in 2006 by the HSE. With the establishment of these new posts the role of hospital pharmacists has now been recognised as a key component in the HSE strategy to reduce infection levels within healthcare facilities, alter antibiotic usage and ultimately improve patient care,” she said. Working in multidisciplinary teams with consultant microbiologists, clinical antimicrobial pharmacists can ensure that the prescribing of antibiotics is rationalised. This in turn decreases antibiotic resistance, decreases costs and the risk of the patient acquiring infections such as C. difficile, which is associated with antibiotic use. These specialists also work on IV to oral switch programmes. Timely intravenous to oral switching has been shown to significantly reduce the length of hospital stay, which in turn also reduces the risk of the patient being exposed to HAIs. “Unfortunately, despite the HSE recognition in 2006 that clinical pharmacists needed to be a key member of the infection control team, at least three of these posts are tied up in the recruitment restrictions. This is very frustrating, when you know that the benefits have been recognised but the recruitment restrictions are restricting you from implementing those benefits for the patient.” One of the three empty antimicrobial pharmacist posts is at Conyard’s own hospital in Drogheda, however she is currently ‘actively working’ with hospital management to get this position filled. SECOND PHARMACY BILL? The introduction of the new Pharmacy Act and the restructuring of the Pharmaceutical Society of Ireland (PSI) will radically change the face of pharmacy in Ireland. However the hospital pharmacy sector has largely been omitted from the new legislation much to the disappointment of the HPAI. “Hospital pharmacy isn’t actually mentioned in the Act which is something that we obviously aren’t happy about,” she explained. “We actively lobbied a number of politicians when the Bill was going through the D���������������� á��������������� il to have the omission of hospital pharmacy services from the Bill rectified. This did not happen and we were told that hospital pharmacy would be addressed in a second Pharmacy Bill. In the meantime nearly every hospital in the country will have to register as a retail pharmacy business to be able to continue to provide medication on discharge to patients and out-patient clinics. This means we will have to comply with the same standard of premises as retail pharmacy businesses in the community. Although we welcome standards that will increase the quality of service pharmacists provide to patients across
the profession, our concern is that the standards are only going to cover part of our service. Our inpatient service, which represents 90 per cent of our activity and is the most complex part of our service to provide, hasn’t been covered under the Act.” According to the HPAI president, when the Minister for Health Mary Harney was reviewing the pharmacy legislation - the first time a review was carried out in 125 years - she stated that she was going to carry out the review in two parts with, with two Pharmacy Bills. “As far as we are aware the second Pharmacy Bill hasn’t been tabled yet. We will certainly be actively requesting it to ensure that all of our services are covered under the legislation. Pharmacists’ fitness to practice is covered regardless of whether you are working in a hospital or the community, but [in relation to] the standards of service and premises, only the outpatient and discharge component of that is covered in hospital, the inpatient component is not. “We have responded to the draft regulations under Section 18 of the Pharmacy Act 2008 which relate to standards of premises and practice issued by the Department of Health in March and the draft ‘Statutory Rules for Registration of Retail Pharmacy Business’ issued by the PSI also in March. It will be interesting to see if the views of hospital pharmacists have been taken into consideration in the final draft of this legislation or if we have been left behind once again.” CONTINUING PROFESSIONAL DEVELOPMENT Continuing Professional Development (CPD) will be a vital provision of the new Pharmacy Act, something that is warmly welcomed by Conyard and the HPAI. “We recognise that there is a need for regular, high-quality continuing professional development for all grades of staff regardless of what section of the profession they are working in and fitness to practice is underpinned by pharmacists maintaining their professional development. We consider it important that whatever centre is going to provide continuing professional development that they provide it for hospital and community pharmacists. “However we do recognise that different pharmacists have different needs depending on their area of interest and their level of expertise. It is not going to be possible for one centre to provide all the CPD requirements for every single pharmacist in the country. There is a need for pharmacists to avail of educational sessions from other bodies organised locally, nationally or internationally…therefore we would consider it very important that there is a mechanism in place to accredit such courses and for them to be accepted as part of pharmacists’ CPD portfolio.” LOOKING TO THE FUTURE When it comes to the future of hospital pharmacy Elaine Conyard maintains that there is growing evidence outlining the absolute need for hospital pharmacists to be an integral part of the patient care team. “It has not only been shown to be cost effective but also to improve the quality of care and decrease the risks associated with medication use. Hospital pharmacists in the future will be more involved in the complete patient journey…not just the inpatient stay…but at the point of admission and discharge from hospital…linking in with the community pharmacists and GPs to ensure that we have an accurate medication history on admission and a seamless transfer of patients back into the community…an integrated medicines management approach.” Quoting one recently published study by researchers in Northern Ireland, Conyard stated that clinical pharmacists being resourced to undertake integrated medication management, they were able to show a decrease in the number of re-admissions, increase the length of time to re-admit and a two-day decrease in the length of stay for the patient. “These are very significant figures,” she said, “if you consider these results in the context of the HSE Transformation Programme priorities of ensuring high quality and cost effective care. The Northern Ireland study provides us with the evidence that hospital pharmacists can have a major impact on ensuring that such priorities are achieved. However in order to be able to achieve these results for patients in Irish hospitals, hospital pharmacists need the government and health service management alike to make a real commitment to the development of hospital pharmacy services and bring our career structure negotiation to a satisfactory conclusion.” If the negotiations on career structure are successfully concluded and health service management begin to finally acknowledge the many indisputable benefits of hospital pharmacy to patients and the health service as a whole, then hospital pharmacy in Ireland looks destined to soar. With dedicated and highly competent people like Elaine Conyard at the helm of the HPAI, it can do no less.
Issue 7 Vol 10 July/August 2008
out & about
Pharmaceutical Society of Ireland Benevolent Fund Golf Classic 2008 The Pharmaceutical Society of Ireland Benevolent Fund Golf Classic 2008 was held in Newlands Golf Club on June 12th. The 2008 event saw the introduction of the Benevolent Fund Cup, a perpetual trophy presented by the Irish Chemists Golf Society. The possibility of having one’s team or company name engraved on the trophy will surely add to the attraction of making the PSI Benevolent Fund Golf Classic part of every golfer’s diary. Congratulations to the CMR team - Brian Mangan, Pat Mangan and Ollie Kenny - who are the proud custodians of the trophy for the coming year. Results: • 1st : CMR (88 pts): Brian Mangan, Pat Mangan and Ollie Kenny • 2nd: CMR (80 pts): John Mc Goey, B. Plunkett and Ciaran Clarke • 3rd: UD (77pts): Ed Gibbons, Ger Nagle and Stephen O Donoghue • 4th : Murrays (76pts): Liam Murray, John Murray and Tom Mc Auliffe • 5th : Holly et al (76pts): Tom Holly, Frank Reen and Denis Murphy • NTP : Mary Dowd (90cms!): Paddy Sherry, Ciaran Clarke, Kevin Carey • LD : Ladies: Tracey Eakin; Gents: Ed Johnston All winners pictured with Cicely Roche and Peter Finnegan. A thoroughly enjoyable day was had by all and both the staff at Newlands Golf Club. Thanks to those who played on the day, sponsored teams or donated towards the running of the event. Please note that the 2009 Benevolent Fund Golf Classic is scheduled to take place on June 11th, 2009.
Issue 7 Vol 10 July/August 2008
POWER in reducing blood pressure1
Full prescribing information is available on request Cozaar® (losartan potassium), Cozaar® Comp (losartan potassium/hydrochlorothiazide) ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing. PRESENTATION ‘Cozaar’ Range ‘Cozaar’ 100 mg Film-Coated Tablets: White, teardrop-shaped tablets marked ‘960’. ‘Cozaar’ 50 mg FilmCoated Tablets: White, oval-shaped tablets with a single score line on one side and marked ‘952’ on the other. ‘Cozaar’ 12.5 mg FilmCoated Tablets: Blue, oval-shaped tablets marked ‘11’. ‘Cozaar’ Comp Range ‘Cozaar’ Comp 100 mg/ 25 mg Film-Coated Tablets: Yellow, oval, tablets marked ‘747’. ‘Cozaar’ Comp 100mg /12.5 mg Film-Coated Tablets: White, oval, tablets marked ‘745’. ‘Cozaar’ Comp 50 mg/ 12.5 mg Film-Coated Tablets: Yellow, oval, tablets marked ‘717’. USES ‘Cozaar’ and ‘Cozaar’ Comp Range, Treatment of hypertension. ‘Cozaar’ Comp is not usually appropriate for initial therapy. ‘Cozaar’ Range, Reduction in risk of cardiovascular morbidity in hypertensive patients with left ventricular hypertrophy. Treatment of heart failure when an ACE inhibitor is not considered appropriate (see SPC for details). Renal protection in Type 2 diabetic patients with Proteinuria. DOSAGE AND ADMINISTRATION ‘Cozaar’ and ‘Cozaar’ Comp Range, Concomitant therapy: ‘Cozaar’ and ‘Cozaar’ Comp may be administered with other antihypertensive agents. ‘Cozaar’ Range, Hypertension, Starting and maintenance dose - usually 50 mg once daily. Some patients require 100 mg once daily. Reduction in risk of cardiovascular morbidity in hypertensive patients with left ventricular hypertrophy. Starting dose – usually 50 mg once daily. A low dose of HCTZ may be added and/or the dose of ‘Cozaar’ may be increased to 100 mg once daily. Intravascular volume depletion: (e.g. those treated with highdose diuretics). Consider a starting dose of 25 mg once daily. Use in the elderly, in renal impairment and in dialysis patients: No initial dosage adjustment necessary. Hepatic impairment: Consider a lower dose. Heart failure, Initial dose - 12.5 mg once daily titrated at weekly intervals to the usual maintenance dose of 50 mg once daily (see SPC for details). ‘Cozaar’ is usually given with diuretics and digitalis. No initial dosage adjustment is required in renal or hepatic impairment or intravascular depletion. Renal protection in Type 2 Diabetic Patients with Proteinuria. Starting dose - usually 50 mg once daily. Dose may be increased to 100 mg once daily if necessary. ‘Cozaar’ Comp Range Initial and maintenance dose is 50/12.5 once daily. Cozaar Comp 100mg / 12.5 mg once daily may be given to those patients requiring additional blood pressure control who are receiving losartan 100mg as monotherapy or for those patients who do not respond adequately to losartan 50mg / hydrochlorothiazide 12.5mg, the usual starting dose of the fixed combination of losartan and hydrochlorothiazide. For patients who do not respond adequately, the dosage may be increased to 100mg/ 25 mg once daily, the maximum dose of the fixed combination of losartan and hydrochlorothiazide. Antihypertensive effect is usually attained within three weeks. Elderly, mild to moderate renal impairment: No initial dosage adjustment. Periodically monitor potassium, creatinine and serum uric levels in renal impairment. Severe renal impairment; patients with intravascular volume depletion; hepatic impairment; Not recommended. Use in children: Safety and efficacy have not been established. CONTRA-INDICATIONS ‘Cozaar’ and ‘Cozaar’ Comp Range, Pregnancy. Hypersensitivity to any component. ‘Cozaar’ Comp Range. As above. Hypersensitivity to other sulphonamide-derived drugs, patients with anuria. PRECAUTIONS ‘Cozaar’ and ‘Cozaar’ Comp Range, This product contains lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Precautions Specific to Losartan potassium in both ranges: Hypersensitivity: Angioedema, see Side Effects. Use during pregnancy: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing foetus. When pregnancy is detected, ‘Cozaar’ or ‘Cozaar’ Comp should be discontinued as soon as possible. Use during lactation: Discontinue breast-feeding or discontinue ‘Cozaar’ or ‘Cozaar’ Comp. Effects on renal function: Changes in renal function have been reported including renal failure in susceptible individuals; increases in blood urea and serum creatinine have been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. These changes in renal function may be reversible upon discontinuation of therapy. The use of ‘Cozaar’ and ‘Cozaar’ Comp in patients with haemodynamically significant obstructive valvular disease has not been adequately studied. Drug interactions: K+-sparing diuretics, K+ supplements or K+-containing salt substitutes may lead to increases in serum potassium. Rifampicin and fluconazole have been reported to reduce levels of active metabolite. Antihypertensive effects may be attenuated by indometacin. Non-steroidal anti-inflammatory drugs: administer with caution (particularly in the elderly) as attenuation of antihypertensive effects may occur and increased risk of worsening of renal function. Lithium: increased risk of lithium toxicity, use with caution and if combination is essential, monitor serum lithium levels. ‘Cozaar’ Range, Intravascular volume depletion: Symptomatic hypotension may occur. Correct before using ‘Cozaar’, or use a lower starting dose. Renal impairment: Electrolyte imbalances are common in patients with renal impairment and should be addressed. Heart failure: Replacement of an ACE inhibitor with ‘Cozaar’ in stable heart-failure patients has not been adequately studied nor has the concomitant use of ‘Cozaar’ with ACE inhibitors. ‘Cozaar’ Comp Range, Hepatic and renal impairment: not recommended for patients with hepatic impairment or severe renal impairment. Use in patients with cardiomyopathy has not been adequately studied. Precautions specific to Hydrochlorothiazide in the ‘Cozaar’ Comp Range Hypotension and electrolyte/fluid imbalance: As with all antihypertensive therapy, symptomatic hypotension
may occur and is more likely in the presence of fluid or electrolyte imbalance. Perform periodic determination of serum electrolytes at appropriate intervals. Metabolic and endocrine effects, Thiazide therapy may impair glucose tolerance. Dosage adjustment of antidiabetic agents, including insulin, may be required. Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium. Marked hypercalcaemia may be evidence of hidden hyperparathyroidism. Discontinue thiazides before testing for parathyroid function. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Thiazide therapy may precipitate hyperuricaemia and/or gout in certain patients. Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricaema. Other, In patients receiving thiazides, hypersensitivity reactions may occur. Exacerbation or activation of systemic lupus erythematosus has been reported. Drug interactions, Alcohol, barbiturates, or narcotics; antidiabetic drugs (oral agents and insulin); other antihypertensive drugs; colestyramine and colestipol resins; corticosteroids, ACTH; pressor amines (e.g. adrenaline); skeletal muscle relaxants, non-depolarising (e.g. tubocurarine); lithium; non-steroidal antiinflammatory drugs, tests for parathyroid function. Lithium: concomitant use not recommended due to risk of lithium toxicity. If use of ‘Cozaar’ Comp Range is essential, monitor serum lithium levels. The routine use of diuretics in otherwise healthy pregnant women is not recommended. SIDE EFFECTS ‘Cozaar’ and ‘Cozaar’ Comp Range, ‘Cozaar’ and ‘Cozaar’ Comp are generally well tolerated; the overall incidence of side effects reported with ‘Cozaar’ and ‘Cozaar’ Comp was comparable to placebo. In clinical trials in hypertension, dizziness was the only drug-related side effect occurring with an incidence greater than placebo in 1% or more of patients treated with ‘Cozaar’ or ‘Cozaar’ Comp. The following adverse reactions have been reported in post-marketing experience: Anaphylactic reactions, angioedema including swelling of the larynx and glottis causing airway obstruction (and/or swelling of the face, lips, pharynx and/or tongue) has been reported rarely in patients treated with losartan, some of whom previously experienced angioedema with other drugs including ACE inhibitors; vasculitis, including Henoch-Schoenlein, purpura, hepatitis has been reported rarely in patients treated with losartan; diarrhoea; cough, urticaria. Also, dose-related orthostatic effects, liver function abnormalities, myalgia, migraine, anaemia, rash, pruritus, elevated ALT (rarely). ‘Cozaar’ Range, In clinical trials in hypertensive patients with LVH, the most common drug-related side effects were dizziness, asthenia/fatigue and vertigo. In clinical trials in heart failure, the most common drug-related side effects were dizziness and hypotension. In a clinical trial in Type 2 diabetic patients with nephropathy the most common drug related side effects were asthenia/fatigue, dizziness, hypotension and hyperkalaemia. ‘Cozaar’ Comp Range, In clinical trials with ‘Cozaar Comp’ no adverse experiences peculiar to this combination drug have been observed. Adverse experiences were limited to those that were reported previously with losartan potassium and/or hydrochlorothiazide. The percentage of discontinuations of therapy was also comparable to placebo. Adverse experiences have usually been mild and transient in nature and have not required discontinuation of therapy. Anorexia, gastric irritation, nausea, vomiting, cramping, diarrhoea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, sialadenitis, vertigo, paraesthesiae, headache, xanthopsia, leucopenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia, purpura, photosensitivity, fever, urticaria, necrotising angiitis (vasculitis, cutaneous vasculitis), respiratory distress (including pneumonitis and pulmonary oedema), anaphylactic reactions, toxic epidermal necrolysis, hyperglycaemia, glycosuria, hyperuricaemia, electrolyte imbalance (including hyponatraemia and hypokalaemia), renal dysfunction, interstitial nephritis, renal failure, muscle spasm, weakness, restlessness, transient blurred vision. PACKAGE QUANTITIES ‘Cozaar’ Range, 50 mg and 100 mg: 28-day calendar pack. Titration pack: 21 x 12.5 mg tablets and 14 x 50 mg tablets. ‘Cozaar’ Comp Range, 50 mg/ 12.5 mg and 100 mg/ 25 mg: 28- day calendar pack. 100 mg/12.5 mg: 28- day calendar pack Marketing Authorisation numbers: PA 35/82/1 – 50 mg Tablet, PA 35/82/2 – 12.5 mg Tablet, PA 35/82/3 – 100 mg Tablet, PA 35/90/1 – 100 mg/ 25 mg Tablet, PA 35/84/1 – 50 mg/12.5 mg Tablet, PA 1286/1/1 – 100 mg/12.5 mg Tablet Marketing Authorisation holder Cozaar Range and Cozaar Comp 50mg /12.5mg and 100 mg/ 25 mg: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. Marketing Authorisation holder Cozaar Comp 100 mg/ 12.5 mg: Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18 ® denotes registered trademark of E. I. du Pont de Nemours and Company, Wilmington, Delaware, USA. © Merck Sharp & Dohme Limited 2008. Date of review: February 2008. COZAAR 100/12.5mg should not be administered as the initial dose, please see full prescribing information for dosage details. References 1. Devereux RB, de Faire U, Fyhrquist F, Harris KE, Ibsen H, Kjeldsen SE, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H, Hille DA, Dahlof B. Blood pressure reduction and antihypertensive medication use in the losartan intervention for endpoint reduction in hypertension (LIFE) study in patients with hypertension and left ventricular hypertrophy. Curr Med Res Opin 2007;23(2):259-270. Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18 Ireland. ® denotes registered trademark of Merck & Inc. Whitehouse Station NJ, USA © Merck Sharp & Dohme Ireland (Human Health) Limited. All rights reserved. Additional information available on request.
losartan + HCTZ 100/12.5
Dark side of the internet A recent report on the growth of illegal online pharmacies has revealed some disturbing results, writes June Shannon.
hile the internet has quite literally revolutionised the way we work, shop and communicate, it can also be a very dark and dangerous virtual world as revealed by the results of a new report on the growth of illegal online pharmacies, published last month by the European Alliance for Access to Safe Medicines (EAASM). Entitled The Counterfeiting Superhighway, the report revealed that over half or 62 per cent of medicines purchased online were fake or substandard, 95.6 per cent of online pharmacies researched were operating illegally, 94 per cent of websites did not have a verifiable pharmacist and more than 90 per cent of websites supplied prescription-only medicines without a prescription. The report also revealed that the fake or substandard medicines purchased online included medicines ‘indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions’. According to the EAASM report, ‘untrained, unsuspecting consumers are vulnerable to the potentially lethal outcomes of buying medicines online. In addition, ‘The Counterfeiting Superhighway reveals the scope and repercussions of this dangerous practice through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines’. The report defines a counterfeit medicine as one that is ‘deliberately and fraudulently mislabelled with respect to its identity, history and or source’. “If there is anything suspicious about a medicine or it is different from the original product in terms of presentation (colour, taste, crumbliness, shape, size, stamped logo etc) or packaging (language, medicine names, indicated dose strength, printing etc) then it may be a counterfeit product,” the report continued. It further warned that counterfeit medicines can be very dangerous as they are frequently substandard, poor copies of original products. “Due to their altered chemical composition they may contain too little or too much active ingredient as well as other, non standard chemicals.” The vast majority of counterfeit medicines tend to fall into two main categories: those which are sold in high volume and expensive medicines. The main type of drugs widely available online are so called ‘lifestyle drugs’ eg treatments for erectile dysfunction and weight loss, which consumers generally prefer to buy online to avoid what they may see as an embarrassing consultation with their doctor. According to the report it has also recently been discovered that medicines for life threatening conditions such as cancer and cardiovascular disease can also be sold online without a prescription. Due to the secretive and criminal nature of illegal counterfeit medicines it is practically impossible to calculate the exact extent of operations worldwide, however according to the report the latest intelligence available on the incursion of counterfeit medicines ‘reveals a worrying trend’. The report states that the volume of counterfeit medicines in Europe has increased dramatically in recent years. In 2005 in excess of 500,000 products were discovered - twice the figure reported for the previous year. In 2006 this figure was reported to have increased by more than five times to 2.7 million. In The Counterfeiting Superhighway, researchers examined more than 100 online pharmacies by searching for prescription only medicines based on a number of keywords entered into online search engines. These included ‘online pharmacy’ and ‘cheap medicines’. They also followed links provided by spam e-mails and accessed online medicine supermarkets to source web based pharmacies. Findings revealed that the vast majority of sites surveyed or 93.8 per cent did not have a named verifiable pharmacist to answer questions, more than 90 per cent did not request a prescription to sell prescription only drugs, and over half or 55.8 per cent offered bulk discounts or special deals on prescription only medicines. More than eight out of ten or 84.5 per cent of the pharmacies researched did not physically exist – ‘in order to comply with the law all online pharmacies must be traceable to a bricks and mortar address’, noted the report. Less than five in 100 websites were licensed by a board of pharmacies 26
or appropriate pharmacy listing, meaning that they are not bound by any professional, legal or safety regulations, and only one in five had a stamp of approval by a recognised society. However when the researchers clicked on these stamps they found that 86 per cent linked to a bogus ‘approval’ web page. The authors also found that over half or 58 per cent did not have a working telephone number. Researchers ordered more than 36 prescription only medicines, comprising two packets each of 18 medicines commonly purchased over the internet. Of the medicines ordered, all but two were delivered and ‘five of the orders arrived with a few extra, free tablets’. At no stage were the researchers asked for prescriptions and they described the process as ‘quick, simple and straightforward’. “During the multiple purchasing process few questions were asked and no advice was given.” All the medicines purchased were then analysed by a 22-member expert panel, which included security specialists, pharmacists, pharmaceutical manufacturer employees, former senior police officials and Government representatives. The group then examined the packaging and found that some of it was ‘alarmingly substandard…with more than one set of medicines merely wrapped in a used newspaper fixed with sticky tape’. Meanwhile, ‘one delivery was simply an envelope containing some loose, unidentifiable tablets inside a small transparent plastic bag’. The expert analysis of the packaging revealed that ‘the details on the packaging and tablet blister packs as well as the product themselves were frequently incorrect or suspect’. The panel also found that 50 per cent did not include a patient information leaflet and the only guidance provided by some of the packages was ‘take when needed’. The medicines were then sent for chemical analysis, the results of which were highly disturbing. “Results of the laboratory analysis alarmingly revealed that 62 per cent of the products received were counterfeit, substandard or unapproved generic medicines. This figure closely reflects the findings of the expert panel during their visual analysis of the medicines. However for the general public it would prove much harder to correctly identify the substandard or counterfeit products. Worryingly, one of the products which the expert panel deemed to be genuine on visual inspection, was found to be counterfeit upon laboratory analysis.” The report concludes by providing recommendations based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators to take action and halt this dangerous trend. The EAASM acknowledges that genuine registered online pharmacies ‘when used appropriately offer a convenient, discreet and fast delivery service for medicines and healthcare products and can provide convenient access to healthcare products for people who are perhaps elderly, disabled or who live in remote areas’. However, as this alarming report reveals, when it comes to counterfeit medicines illegal online pharmacies are quite literally dicing with death. Or as Brian Murphy, director of Commercial Affairs at the Irish Pharmaceutical Healthcare Association (IPHA) put it in a recent publication on this issue from the association entitled ‘Counterfeit Medicines – a threat to patient safety’: “The internet as a potential distribution channel for counterfeit medicines raises massive concerns for patient safety. Buying medicines online is like gambling with your life.” For more information or to read a copy of The Counterfeiting Superhighway go to www.eaasm.eu. sponsored by
Issue 7 Vol 10 July/August 2008
A spray a day helps keep allergie s away*
Flixonase Allergy Relief Nasal Spray Product Information Presentation: Aqueous nasal spray suspension containing 50 micrograms of fluticasone propionate per spray. Uses: Prophylaxis and treatment of allergic rhinitis including hayfever and that caused by other airborne allergies. Dosage and administration: Intranasal use only. Adults (including healthy elderly) and children 12 years and over: two sprays into each nostril once a day, preferably in the morning. Children under 12 years of age: treatment should not be initiatated without advice from a physican. Once control is achieved the dose should be titrated down to the lowest efffective dose of one spray in each nostril once a day (100mg per day). In some cases 2 sprays into each nostril twice daily may be required for short periods to achieve control of symptoms, after which the dose should be titrated to the lowest effective dose (see above). The maximun dose should not exceed 4 sprays into each nostril. Use twice daily if required. Do not use more than 4 sprays a day in each nostril. Prophylaxis of allergic rhinitis requires treatment before contact with allergen. Contradindications: known hypersensitivity to ingredients. Precautions: If symptoms have not improved after 7 days of continuous use, or if symptoms have improved but are not adequately controlled, consult a doctor. Not to be used for more than 6 months continuously without consulting a doctor. Consult a doctor before use in: concomitant use of other corticosteroid products, nasal / sinus infection, recent nasal injury / surgery, nasal ulceration. Concomitant use of Fluticasone Propionate and ritonavir should be avoided due to the risk of systemic corticosteroid effects, including Cushing’s Syndrome, and adrenal suppression. Interactions: Significant interactions between fluticasone propionate and potent inhibitors of the cytochrome PA450 3A4 system, e.g. ketoconazole and protease inhibitors, such as ritonavir, may occur. This may result in increased systemic exposure to fluticasone propionate. Side effects: Very rarely: glaucoma, raised intraocular pressure, cataract, nasal septal perforation, hypersensitivity reactions including anaphylaxis/anaphylactic reactions, bronchospasm, skin rash and oedema of the face or tongue. Common: headache, unpleasant taste and smell, dryness and irritation of nose and throat. Very common: epistaxis. Pregnancy and lactation: do not use except with medical advice. Legal category: Pharmacy Confined Product Authorisation Number: PA 678/95/1. PA Holder: GlaxoSmithKline Consumer Healthcare (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16. Contains fluticasone propionate. Always read the label/leaflet. Package quantity: 60 sprays. Date of printing: April 2008. Flixonase is a registered trademark of the GlaxoSmithKline group of companies. Additional information is available upon request. *Once control of symptoms has been achieved.
Europe’s Leading Contract Sales & Marketing Organisation
n i a l l o’su l l i va n
Niall O’Sullivan grew up in Limerick, where he went to Crescent College Comprehensive before attending university in England. In 1998 he returned to Ireland to purchase his first pharmacy on O’Connell Avenue, Limerick. The business currently consists of five pharmacies, three beauty salons and a photo processing lab. Niall is married to Anu and they have four children. What other career might you have chosen? Engineering, but I always wanted to be a community pharmacist.
Favourite composer/entertainer/rock group? U2.
What figure in Irish life (living or dead) do you admire and why? A fellow Limerick man, Aidan Brooks (international property developer). He undertook no formal studies after finishing his Leaving, but instead went to work for his father in a TV and video rental and sales shop. His main responsibility was TV installations and erecting aerials. He now owns most of those chimney pots.
Favourite film and book? Gone in 60 Seconds and most recent book I’ve read and enjoyed was Jack Welsh’s Winning.
What is the one thing you would suggest to improve the Irish health service? Return Professor Drumm to his field of expertise. He was well respected among his peers and highly thought of in paediatrics but the HSE needs to be lead by a candidate with more practical management abilities and experience - a Denis O’Brien type rather than Michael O’Leary.
How would you like to be remembered? Not for another 40 years! IP
What is your motto? Live and learn.
What is your earliest memory? The classic vinyl interior smell of my gran aunt’s Morris Minor (we subsequently called our first daughter after her). What is your greatest fear? That anything would happen to any member of my family (illness or physical injury). When and where were you happiest? At home with my family. What would your super power be? X-ray vision. What is the worst job you’ve done? Manually picking stones to prepare the base of a 12 acre manmade lake (summer job as a student). What is your best trait? Positive outlook. What is your most unappealing habit? Not finishing (m)any of my many projects. What trait do you most dislike in others? Sloppiness. Do you use alternative medicine? What kind? Yes, Arnica cream for bruising. Cat or dog? Cat – sly, selfish and generally less maintenance! What keeps you awake at night? Any one of my four kids. Who or what makes you laugh? Billy Connolly or good sarcasm. Who or what is the greatest love of your life? Wife and kids. How do you relax? By fixing cars or driving them. Favourite TV/radio programme? Top Gear. 28
Issue 7 Vol 10 July/August 2008
Sole traders should incorporate, according to Shane McLoughlin.
henever I meet a new client who operates as a sole trader one of the first questions I ask is: “Have you considered establishing a company?” The response is invariably: “Why would I?” The following article will help address this question. Traditionally, the rule of thumb was that a business should only be incorporated at the point when it generated more taxable profits than the owner needed to support his/her lifestyle. While this is largely true, it does not give the full picture. So why incorporate? Lower tax rates and cheaper working capital One of the major benefits of incorporation is access to the lower tax rates that apply to a company’s profits. The corporation tax rate in Ireland is currently 12.5 per cent (or 25 per cent for passive income), a significant saving when compared to the maximum tax rate of 46.5 per cent (including PRSI and levies) in the sole trader’s world. The lower tax rate is, in practical terms, only relevant when the business is generating more profit than the business owner needs to fund his/her lifestyle. While this maybe the case, another benefit arises with regard to working capital. As a sole trader, an individual is subject to income tax on his taxable profits at the individual’s marginal rate of tax. However, as most sole traders will know, it is rare that the amount of profits that an individual draws down from his/her business equates with their taxable profits as calculated for their tax return. This is because a certain amount of the profits must be retained within the business to act as working capital. As the sole trader will have paid tax on these profits at 46.5 per cent, the actual cost of e1,000 of working capital to a sole trader is e1,870. Because the tax rates that apply to a company are lower, the corresponding cost of e1,000 of working capital in a company is e1,143. So, it is more economical to build up working capital in a company than as a sole trader, allowing you to increase your investment in the business, if desired, thus enabling the business to grow and prosper. Retirement planning Sole traders only have access to personal pension plans. Tax relief on contributions to these pension plans is limited by reference to the age and earnings of the individual. The contribution levels range from 20 per cent up to a maximum of 40 per cent of relevant earnings with an earnings cap also applicable (e275,239 for 2008). A sole trader, even where he/she maximises his/her pension contributions within the allowable limits every year of his/her working life, is unlikely to ever get near the current permitted fund limit of e5,418,085. Company directors, on the other hand, have access to occupational pension
schemes where combined (employer and employee) tax-free contributions can amount to a significant multiple of an individual’s salary. Therefore, company directors are in a much better position to achieve a greater level of pension funding, even where the director only starts to fund his/her pension in the latter part of his/her working life. These retirement structures and allowances allow the company owner retain significantly more of the generated wealth than that same business operating in the sole trader environment. Indeed, this is borne out by the fact that all of the pension funds which exceeded the original e5,000,000 cap when it was first introduced in 2006 belonged to company directors. Retirement planning is just one area where profits can be extracted from a company in a more tax efficient manner than they can for a sole trader. There are more examples of this, which are beyond the scope of this article. Succession planning Generally speaking, a company will be a more attractive business prospect to either a potential purchaser in the future or to transferring ownership of the business to the children. Not only will the stamp duty cost be reduced with the company structure but the business owner may also be in a position to extract profits in a tax efficient manner before the disposal, thus reducing the overall tax cost to both the seller and the purchaser. Limited Liability The availability of limited liability, within a company, will be particularly attractive in certain industries where the risk to the sole trader of losing everything as a result of a claim against the business is substantial. The limited company structure allows you to limit your financial exposure to the amount of capital you have invested in the business. Cash extraction The process of incorporation itself, for an existing business, can be used as a tool to allow the sole trader to extract capital value from the business in a tax efficient manner as a part of the transfer of the business (for example, the company can purchase the goodwill built up over the years by the sole trader from the sole trader). This allows the business owner to avail of the tax benefits of selling the business (at 20 per cent capital gains tax rate rather than at the income tax rate) whilst retaining control of the business itself. With careful planning, this can lead to substantial benefits for the business owner. In light of the above, surely the question that sole traders should be asking their advisors is: “Why am I not incorporated?” Shane McLoughlin is an associate director of Financial Engineering Network Ltd and can be contact at [email protected]
Issue 7 Vol 10 July/August 2008
J U L I A N J U D G E, M PS I
aren pulled away the blankets, trying to find a way through the folded fat. Lying there, strapped to beds like pigs on spits, the touch of another was everything. She knew that. It gave them some little sense of feeling and humanity. Immobility led to them putting on weight, layers and layers of fresh grease. She thought it felt cheesy.
She realised she still had her ring on and turning the stone inward towards her palm she rubbed it once with her thumb. The jade-stone turned easily but was always difficult to remove. She slipped her finger into her mouth, sucked and ran her tongue around the ring. She removed it from her tongue tip and put it in her pocket. Karen went back to his body and found the catheter tube. It had twisted overnight and was pulling on his penis. She held it upright removing the blockage. The urine flowed again. Like an upturned tickled dog he smiled with relief. Jack was semi-paralysed from the waist down following a car accident a month ago and had little to no movement left in his arms. To aid recovery and give him some sense of spatial reality they had been attached to hooks on the ceiling. He was supposed to try and move his arms towards each other every ten minutes. He tried to achieve this and mainly did, unless he fell asleep. A clock was on his locker to aid him. It was a rehab clock that ‘beeped’ at set intervals. Jack told her he felt like a suspended pornographic spider caught in a web. His was the first bed in the ward and everybody looked at him when they came in. She laughed a lot at this image. His bed faced away from the window. Outside was a Cherry Blossom. It was late April and was in full bloom. Small birds chased each other round its flowers. She felt sorry for him being able to hear this and not see it. Sometimes she wanted to rearrange the ward with a middle partition and reverse all the beds, leaving them face the windows. He reminded her of a broken scarecrow, useless and surrounded by the birds. Karen was tired as she had been up with Jack most of the night. Due to his spinal injury he had poor temperature control. He had soaked his bed twice. They had stripped, fanned and given him a lot of paracetamol but he just wouldn´t stop sweating. He was getting scared, began to retch and get panicky. Doctors were called and at around 2.00am, they gave him an ice bath. Jack couldn´t be moved so the ice was brought to him. Karen was given a large basin half full of water and bags of ice. Breaking the ice into small pieces she
stirred and dissolved them. She just stirred and stirred. Years ago she had worked in an army kitchen making large pots of soup. She thought of this as she broke the ice. Towels and then sheets were soaked in the freezing water and wrapped around Jack. This process was repeated for about an hour until his temperature was brought under control. Jack was exhausted and the staff wanted him to take a sleeping tablet. He refused. “Why not. That doesn´t make sense. You´re a pharmacist. You know that,” said the doctor. “All I see right now is a black hole. If I go to sleep I´m afraid of going in there.” Unlike others who didn´t listen and just preached this doctor did. She instructed that Jack was to be stayed with until he fell asleep. Karen was given that job. She was from the Philippines and was in Ireland on a six month contract as a nurse´s aid. She stayed with Jack. He began to get jerky and nod off but then he´d wake up again. She stood behind him and rubbed his eyebrows until he nodded off. She kept rubbing for a bit to make sure he stayed asleep. She had an insane thought that she could be stuck there forever. She laughed at this. ************************ She saw that his lips were dry and wet her fingers from the drinking water that lay above his bed. Running them over his lips and pulling the lower one with a squeeze, she removed them, leaving behind the moisture. ‘Lip gloss suits you’ re-wetting her fingers and rubbing them again over his lips, this time pulling the top one. “Thanks Karen.” A sleepy smile came slowly. “You thirsty?” His tongue came out and licked the water off. “Yes, yes I am.” She took the jug and placed the straw between his lips. He drank too quickly and spilt some down his chin. He chased it with his tongue but it got away. She smiled and caught the drops with her fingers and once more wet his lips. “Lip gloss, that’s what I’ll call you.”
view from above
We are what we sell
t er ry m ag u i r e
If the pharmacy industry wishes to play a part in tackling obesity, there is a need to take a closer look at OTC slimming aids, says Terry Maguire.
nlike newsagents up North, religious bookshops do not sell soft-porn magazines because soft-porn books do not fit their marketing mix. Before those with strong church ties shout that it’s nothing to do with a marketing mix, that it’s because selling such filth is wrong, I would point out that that is exactly what I have just stated. Religious bookshops are normally aligned with a religious institution, an institution with a clear definition of ‘right’ and ‘wrong’ and since soft-porn material is for these outlets ‘wrong’, logically such literature would never be offered for sale in these premises. Additionally employees of a religious bookshop would not be comfortable selling such material and trustees would object strongly to any suggestion from an aspiring manager that magazines with lurid centrefolds might be a way of improving takings and profits. More importantly, seekers of soft-porn would never think of a religious bookshop as offering an exciting range of risque top-shelf glossies. Religious books shops are lucky; their marketing mix is determined by a power higher than that of the market place. The Dickson Case of 1927, a cause celebre for UK pharmacy, was slogged out in the courts to answer a simple question; has a UK pharmacist the right to sell in his pharmacy what is lawful even when his professional body, the society, disagrees? Dickson won his case and in doing so moulded community pharmacy into what we now see on the UK high street and beyond. Globally few pharmacies sell cigarettes: the US being the exception. On the sale of cigarettes it is easy to make an ethical decision; this highly addictive product kills 50 per cent of those who use it and since a pharmacy’s focus is healthcare it seems sensible not to stock or sell them. If our marketing mix tells us what the purpose of our business is then it would be easy to identify the products we should stock and those we should not. If pharmacy is about medicines, then any product offered for sale that does not comply with the requirements of quality, safety and efficacy should be
We are in an obesity pandemic that threatens over the next 20 years to swamp healthcare systems globally. If pharmacy wishes to play a part in stopping it there is a need to look at our OTC slimming aids.
reconsidered. Recently an eminent scientist here has admonished Boots for selling homeopathic remedies as they are ineffective placebos and he is right. OTC slimming aids have traditionally been supplied through community
pharmacies. Manufacturers view pharmacy as a key element of their product’s marketing strategy. There is a bewildering array of these products with ingredients thought to act by either increasing satiety or decreasing absorption or increasing fat oxidation, increasing metabolic rate or reducing lipogenesis. Ingredients include: L-carnitine and acetyl-L-carnitine, chitosan, chromium, fibre, hydroxycitric acid (HCA), seaweed, Green tea, conjugated Linoleic acid and lecithin. Overall there is little evidence to support the benefit in any ingredients contained in OTC weight control products. Formoline LU11, a German slimming product registered as a medical device within the EU and launched in the UK in 2008, claims to reduce calorie intake from dietary fats, assists long-term weight control and lowers LDL cholesterol. These claims are made on the basis of the medical device categorisation. Yet there appears to be no evidence to substantiate these claims. The Advertising Standards Authority (ASA) upheld a series of complaints about claims made for a similar product LIPObind. When queried by the ASA the Medicines and Healthcare Products Regulatory Authority (MHRA) accepted the fat-binding and weight management claims for LIPObind on the grounds that its performance was assessed by a ‘Notified Body’. A Notified Body is any group that are capable of assessing the claims and submitting evidence. On following up the evidence ASA found that the claims could not be backed up by rigours scientific trails in people. Both these products contain chitosan. So is there any evidence that chitosan is an effective weight loss product? Not according to any credible research currently available. Chitosan, a derivative of a chitin found in shells of invertebrates such as crabs and shrimp, has a highly adsorptive surface and for this reason is widely promoted as a ‘fat blocker’. In one study, seven healthy males consumed > 120g fat per day for 12 days and took chitosan prior to meals and snacks on days six to nine (15 capsules or 5.25g chitosan per day). Faecal samples were collected on days two to 12 and were analysed for fat content. Fat content of the faeces did not change from the chitosanfree period, and the authors concluded that the chitosan did not block fat absorption. Other scientific studies confirm these findings. We are in an obesity pandemic that threatens over the next 20 years to swamp healthcare systems globally. If pharmacy wishes to play a part in stopping it there is a need to look at our OTC slimming aids. Better regulation yes - but at this time we are failing the public and perhaps acting against the interests of public health by inferring such products work. We must keep standards high and only sell things we can stand over. To do anything else is as ridiculous as a religious bookshop selling soft-porn. IP References available on request.
Terry Maguire owns two pharmacies in Belfast. He is an honorary Senior Lecturer at the School of Pharmacy, The Queen’s University of Belfast. His research interests include the contribution of community pharmacy to improving public health.
Issue 6 Vol 10 June 2008
Drugs in sport The use of drugs in sport remains an ominous issue, according to research pharmacist Diarmuid Coughlan.
his summer the world will once again be transfixed by human sporting endeavour. Sporting events like the Tour de France and the Olympics will be watched by millions of people around the world. Unfortunately, the general public’s psyche has been scarred: whenever a tremendous individual feat has been achieved by a sportsperson, an element of doubt will creep into our minds – did they cheat? Was it determination or was it drugs?
Why drugs are used in sport “The overwhelming majority of athletes I know would do anything, and take anything, short of killing themselves to improve athletic performances.” (Harold Connolly, 1956 Olympic hammerthrowing champion, testifying to a United States Senate Committee in 1973) (Verroken 2005a).
The emergence of doping as a problem It is specifically since the introduction of anti-doping regulations and doping controls in the 1960s, that the practice of using performanceenhancing drugs has been regarded as unacceptable. Prior to then, using performance-enhancing drugs was generally tolerated. Central to the introduction of anti-doping regulations is the health of the athlete. Doping is a danger to an athlete’s health. Table 1 briefly details the consequence of drug use that led to drug testing. The first mandatory drug testing by the International Olympic Committee (IOC) was at the Winter Olympics in Grenoble, France (86 tests) in 1968 and in the same year at the Olympic Games in Mexico City (668) for all sports.
Table 1: Early drug users and their outcomes Year Name Sport/Event
Drug used & outcome
1896 Arthur Linton (ENG) Cycling Strychnine; death also associated with Drug use, or doping, as it is often referred typhoid fever to in sport is not a modern phenomenon. 1904 Thomas Hicks (ENG) Olympic Marathon in St. Louis Strychnine and brandy; life saved by In fact, throughout history there are doctors at the finish line. examples that athletes have sought a 1960 Knud Jensen (DEN) Cycling/Olympics Amphetamine and nicotinyl nitrate; died ‘magic potion’ to give them that extra after 100km team time trial edge. To help athletes take a short cut to Amphetamine, methylamphetamine and achieving a good performance or to enable 1967 Tommy Simpson (ENG) Cycling/Tour de France cognac; death them to compete under circumstances (Source: Mottram 2005a) when otherwise it might not have been possible, such as injury or illness. Ancient Egyptians used a drink made from the Development of sports medicine and performance enhancing hooves of asses, which had been ground and boiled in oil and flavoured drugs with rose petals and rose hips, to improve their performance. Ancient Greek Far from being one of the key bastions in the fight against the use of Olympians were on special diets of dried figs (Finlay and Plecket, 1976). performance-enhancing drugs in sport, sports medicine has actually Roman gladiators and medieval knights also used stimulants to continue been one of the major contexts within which performance-enhancing fighting after sustaining injuries (Donoghue and Johnson, 1986). drugs have been developed and used. Two of the most illustrative To gain an advantage is part of sport. Athletes will go altitude training cases are: to increase their lung capacity before competition. Countries like Australia • The use of drugs in some of the former communist countries of develop state of the art facilities like the Australian Institute of Sport (AIS) in Eastern Europe, especially East Germany Canberra. They will also recruit the best coaches to nurture and develop elite • The early development and use of anabolic steroids in the US athletes. This is all seen as ‘fair play’. The UK Sports Council in 1996 stated that ‘doping is cheating and is GDR (East Germany) contrary to the spirit of fair competition’. Definitions of doping actually Evidence of direct involvement of the GDR government demonstrated obscure the fundamental principle as explained by Sir Arthur Porritt, first not only the complicity of those in positions of trust but also the chairman of the International Olympic Committee (IOC) Medical Commission: way the athletes themselves, in particular females, unknowingly “To define doping is, if not impossible, at best extremely difficult, and yet took substances and have suffered the consequences (Franke and everyone who takes part in competitive sport or who administers it knows exactly Berendonk, 1997). For example, when Renate Vogel (1974 100-metre what it means. The definition lies not in words but in integrity of character.” (Porritt 1965) But why has there been an explosion of drug use in the modern era? The Panel 1: Ben Johnson, Seoul Olympics 1988 reasons most often cited for drug use are as follows: • Media pressure to win • He ‘won’ an Olympic Gold Medal in the 100m race in a time of 9.79s • The prevalent attitude that doping is necessary to be successful • Three days later, he was stripped of that medal for failing a drug test • Public expectations about national competitiveness for use of the banned steroid, Stanozolol. • Huge financial rewards of winning • This positive doping test was, in a number of respects, a watershed • The desire to be the best in the world in the history of doping in sport. The event generated huge media • Performance-linked payments to athletes from governments and sponsors coverage and it raised public awareness of doping in sport to a level • Coaching which emphasises winning as the only goal which was unprecedented. • Competitive character of the athlete • In 1989, at the Dubin inquiry; Johnson’s coach, Charlie Francis told the • Infallibility of the ‘medical’ profession to cure and improve performance inquiry that Johnson had been using steroids since 1981. • Psychological belief in aids to performance – the magic pill • Ben Johnson has been quoted as saying: “I did something good in my • The development of spectator sport life. My Mom and Dad saw me run faster than any human, and that’s it. • A crowded competition calendar Better than a gold medal.” (Verroken 2005b) 32
Issue 7 Vol 10 July/August 2008
Table 2: The main drugs abused by athletes and their main side effects
Doping as a danger to health
Tommy Simpson’s death on Mont Ventoux during the 1967 Tour de France with empty bottles of Amphetamines Heat-stroke, cardiac arrest, over-aggression, severe depression and amphetamines in the back pocket of dependence his jersey was a wake up call. Anabolic androgenic Cardiovascular, carcinomas, glucose regulation, sex-related side-effects, Table 2 highlights the main side steroids (AAS) tendon damage, behavioural effects and addiction effects of the most commonly Human growth hormone (hGH) Skeletal changes, enlargement of the fingers and toes, cardiomegaly, abused dugs. The side effects elephant epidermis, biochemical changes associated with androgenic anabolic Human chorionic Similar to AAS; incidence of gynaecomastia may be greater steroids are extremely serious, gonadotropin (hCG) particularly the consequences of Erythropoietin (EPO) Heart attack, thromboembolism, excess iron, increase risk of hepatic long-term or high dosage usage. carcinoma, cirrhosis Regrettably these side effects do not seem to have deterred athletes. It (Source: George 2005) is in the two groups of individuals who are most likely to derive benefit from muscular development breaststroke world record holder) defected to the West in 1979 she told that the greatest risk of toxic side-effects occurs. Women will undergo how steroids were handed round ‘along with the vitamin pills’ (Donohoe masculinisation, resulting in hair growth on the face and body, and Johnson, 1986). In the early 1990s, a systematic doping plan was irreversible voice changes and serious disturbances to their menstrual uncovered by German authorities in the in the files of the Stasi (secret cycle. Young males may experience stunting of growth. All users are likely police). The files showed that over 10,000 athletes received banned to experience severe acne on the face and body. drugs as part of the government’s policy to show that the new socialist government could produce impressive athletes. In 2000, two highranking East Germans were prosecuted for causing bodily harm to young Table 3: Sports and athletes athletes by doping them. involved in the BALCO drug scandal Drug Main side effects
Development and use of anabolic steroids in the US The former coach to Ben Johnson, Charlie Francis wrote in his book Speed Trap in 1990, that: “There are thousands of possible synthetic permutations of the testosterone molecule. The great majority of these steroids remain an unexplored frontier... private laboratories stand ready to synthesise any number of these steroids – and keep the athletes ahead of the game.” (Francis 1990) Panel 2 details the on-going BALCO fiasco, which first came to prominence in 2003. BALCO was one of those private laboratories that aimed to profiteer from athletes’ willingness to try any unlicensed, undetectable, ‘designer’ drug to be the best at their disciple. The use of anabolic steroids in the US started out in response to Soviet sport scientists’ use of testosterone. Dr John Ziegler, team physician to the 1956 US World Games in Moscow, returned home to test the anabolic (muscle-building) effects of testosterone. He aided the CIBA Pharmaceutical Company in the development of a cleaner anabolic steroid, Dianabol, or in generic terms, methandrostenolone. CIBA developed Dianabol for use in treating patients suffering from burns. Ziegler’s agenda was to persuade the US weightlifting coach to use Dianabol on three weightlifters. Their rapid improvement had other lifters clamouring for information. Dr Robert Voy, a former chief medical officer for the US Olympic Committee noted in his book, Drugs, Sport and Politics’that ‘with the introduction of Dianabol in the late 1950s, anabolic-androgenic steroids really got their initial use and became very popular very quickly’. In this context it must be reiterated that in the 1950s and early 1960s, taking pills to enhance performance was not considered unethical and was not against the rules of any sporting competition, for there were no anti-doping regulations at the time. Soon after Dianabol hit the market, Dr Ziegler knew he had created a monster, a fact he regretted for the rest of his life (Waddington, 2000). Panel 2: BALCO Fiasco, 2003 • Bay Area Laboratory Co-Operative, An American Company led by founder and owner, Victor Conte. • They developed tetrahydrogestrinone (THG), a then undetected performance-enhancing steroid. • In 2003, US Sprint Coach, Trevor Graham anonymously sent a syringe containing traces of the THG nicknamed “the clear” to the US Antidoping Agency (USADA). • Don Catlin, director of the Olympic Analytical Laboratory, succeeded in developing a testing process for THG. He tested 550 existing samples from athletes of which 20 proved to be positive for THG. • The fall–out of the scandal is still on-going. Five-time Olympic medallist, Marion Jones entered prison for a 6-month sentence in March 2008.
American Football Athletics Baseball Boxing
Oakland Raiders players Tyrone Wheately, Barrett Robbins, Chris Cooper CJ Hunter, Dwain Chambers (GB), Marion Jones, Tim Montgomery, Kelli White, Regina Jacobs Barry Bonds Shane ‘Sugar’ Mosley
The horrific consequences of the East German doping programme are beginning to emerge. Associate Professor Giselher Spitzer presented his research at the ‘Play the Game’ conference in Iceland in October 2007. Initially, 60 former athletes were involved, but by the project’s end, one had died and seven others withdrew from the study because of psychological problems. He investigated the 52 remaining athletes and their 69 children, many of them have some handicap. The lesson from the research is that doping has a danger not only to the athlete but also the second generation and maybe the third generation (www.abc.net.au). Two of the most suspicious deaths of athletes have been the Italian cyclist Marco Pantini in 2004 and Florence Griffith-Joyner (Flo-Jo) in 1998. Pantini died of cerebral oedema and heart failure brought on by acute cocaine poisoning. Flo-Jo, the fastest woman ever, direct cause of death was that she had suffocated in her pillow during a severe epileptic seizure. The coroner’s office was not allowed to test her body for drugs, steroids, or growth hormones. Both athletes, though never banned, were heavily linked to using performance-enhancing drugs.
Conclusion After the 1998 Tour de France debacle, the IOC decided to convene a World Conference on Doping in Lausanne, Switzerland, bringing together all parties involved in the fight against doping. Pursuant to the terms of the Lausanne Declaration, the World Anti-Doping Agency (WADA) was established on November 10th 1999 to promote and coordinate the fight against doping in sport internationally. WADA was set up as a foundation under the initiative of the IOC with the support and participation of intergovernmental organisations, governments, public authorities, and other public and private bodies fighting against doping in sport (www.wada-ama.org). The future integrity of sport depends on their success. Will this summer be another watershed? Will we have a summer dominated by achievements and glory or of drug scandal and deceit? Diarmuid Coughlan is a research pharmacist at the School of Pharmacy, UCC. He is the principal investigator on the 'Self Care' initiative (www. selfcare.ie) and has a keen interest in sport and exercise care. References available on request. Issue 7 Vol 10 July/August 2008
New Minesol Triple Defense by RoC Whether you are booked for the Mediterranean, to explore the Outback or are simply hoping for a sunny Irish summer, proper sun protection is an absolute essential. Most of us enjoy being outside when it’s sunny, but we all know that too much sun can do a lot of damage to our skin, which is why it’s so important to protect yourself and your family from harmful UV rays. The new Minesol Triple Defense range offers a three way defence against the sun’s harmful rays. It fights against three levels of damages: sunburn, premature skin ageing and skin cancer. RoC Minesol introduces two new products to their extensive range of sun protection; RoC Minesol Kids Spray SPF 50+ and RoC Minesol Multi-Position Atomizer SPF 50+. Block the sun, not the fun with RoC Minesol Kids Spray SPF 50+ Children’s skin is very sensitive to the sun’s rays so kids need a high
protection that lasts. Much of the sun exposure that causes skin damage occurs during childhood and adolescence. Developed for children’s delicate skin, this unique formula is enriched with moisturising glycerine and antioxidant Vitamin E. This children’s spray is highly water resistant, with an exclusive technology that maximises the resistance to water, sweat, sand and rubbing. Formulated to minimise the risk of allergies, with a light texture, RoC Minesol Kids Spray SPF 50+ provides lasting protection for sensitive young skins. It is quick and easy application for kids on the go... making sure that they are protected from head to toe. With each purchase of RoC Minesol Spray Kids €1 is donated to the Irish Cancer Society to help fund their research and involvement in helping cancer sufferers. Each RoC Minesol kids spray features a mini SunSmart code on the back – for top tips on protecting your skin in the sun. RoC Minesol MultiPosition Atomizer SPF 50+ protects hard to reach areas Men and women will now be able to choose their sun protection depending not only on its effectiveness, but also its ability to cover even the hard to reach areas of the body such as the back and the back of the legs. Light, invisible and water-resistant RoC Minesol Multi-Position Atomizer guarantees a continuous and even distribution of UVA – UVB filters on the skin. It sprays just the right amount of sun protection on all the awkward spots, even with the nozzle upside down. The results are impressive: 30% more hard to reach zones are protected versus using a regular sun cream. In addition, RoC Minesol is fully compliant with the European Commission’s guidelines on sun protection (evident from RoC Minesol’s use of the new UVA standardised labelling and categorising.
CervarixTM provides longest duration of sustained neutralising antibodies reported for any vaccine against HPV 16 amd 18 to date New data from an extended follow-up study shows that CervarixTM generates sustained high levels of neutralising antibodies against the two most common cervical cancer-causing virus types for up to 6.4 years. This is the longest duration of sustained neutralising antibody levels reported against both virus types HPV 16 and 18 with a cervical cancer vaccine to date. Experts believe that neutralising antibodies – socalled because they have the ability to neutralise cancercausing virus types and prevent them from infecting cells in the cervix – are essential for cervical cancer protection. The World Health Organisation has stated that neutralising antibodies are ‘considered to be the major basis’ of vaccine-induced protection from infection. In addition, the study found that the level of total antibodies induced by CervarixTM was sustained and 11 times higher
than the total antibody levels induced after natural infection for up to 6.4 years. This new data confirms previous findings from CervarixTM studies showing that, when total antibody levels are high, neutralising antibody levels are also elevated. “The high and sustained neutralising antibody levels seen with CervarixTM against both HPV 16 and 18 in this trial are encouraging and may be important for long-lasting protection,” said Professor Tino Schwarz, head of the Central Laboratory at the Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany. This trial included more than 700 women aged 15-25 years. During the same period that CervarixTM induced sustained high antibody levels for both HPV 16 and 18, the vaccine has been shown to provide 100 per cent efficacy against those cancer-causing virus types.
Motilium Fastmelts Mc Neil Healthcare Ireland Ltd is delighted to announce the launch of new Motilium Fastmelts, from Motilium - the No. 1 selling stomach remedy in pharmacy. Motilium Fastmelts are orodispersible tablets – they melt instantly on the tongue. The main benefits are that they offer greater convenience for your customers and are very discreet. With 50 per cent of the Irish population suffering from stomach discomfort, , Motilium Fastmelts, with it’s consumer-friendly format, will attract new users to the category. They work the same way as Motilium Tablets and they are as effective as ever against symptoms of dysmotility and nausea. Motilium Fastmelts are available in packs of 10s and 20s. Motilium Fastmelts are suitable for use in adults aged 16 years and upwards. The launch will be supported with a significant marketing campaign including heavyweight TV advertising, radio, press and POS. For further information please contact your Mc Neil Healthcare representative.
Issue 7 Vol 10 July/August 2008
Pure Plan Detox New Pure Plan detox peach and lemon helps eliminate toxins from the body. Thanks to the benefits of 11 pure plant extracts that act in synergy, Pure Plan Detox cleanses and purifies your body over a ten-day period. Pure Plan Detox, your ‘purification’ ally to get you back into shape through the natural detoxification of your body. Pure Plan Detox is also available in tablet format. For further information contact your local Kelkin representative or call the Kelkin offices on 01 4600400.
Pure Plan LipoSlim Pure Plan LipoSlim from Ortis laboratories is a new way to lose weight while staying in shape. LipoSlim is a complete and energising product that effectively uses calcium tablets derived from milk to limit fat storage and reduce body fat. The detox and energising phials help eliminate excess water and combat fatigue associated with diets. All the active ingredients in Pure Plan LipoSlim are 100 per cent natural. For further information contact your local Kelkin representative or call the Kelkin offices on 01 4600400.
Tooth sensitivity on the increase Figures released by the Irish Dental Association (IDA) reveal that almost one in five adults suffer from tooth sensitivity, with 70 per cent of dentists believing that incidences of sensitive teeth are increasing and 65 per cent warning that it is a serious oral health problem among Irish adults. The representative association of Irish dentists revealed that a survey of 150 Irish dentists, in association with GlaxoSmithKline, found a rise in the number of people attending dental surgeries with varying degrees of tooth sensitivity. The survey found that over half of dentists surveyed (53 per cent) now treat patients with sensitive teeth on a daily basis, a 7 per cent increase since 2002. The IDA warned that tooth sensitivity can be associated with receding gums; a serious oral health issue which can result in suffers experiencing symptoms such as discomfort after eating cold food, drinking cold liquids, or even breathing cold air. “The figures announced today show that tooth sensitivity is becoming more prevalent among Irish adults, and this trend looks set to continue,” said Dr Garry Heavey, IDA. “The most common causes of tooth sensitivity is gum recession, often due to vigorous or heavy handed brushing. Our gums are like protective blankets, covering the roots of the teeth. If this protective covering is worn away the roots, which are linked directly to the nerve, become exposed and painful. Many people don’t realise that brushing with too much pressure can result in receding gums, and eventually lead to sensitive teeth. “In order to stop the gums from receding patients should reduce the pressure on the tooth while brushing, use a soft bristled tooth brush, and set aside two to three minutes, twice a day to properly brush and floss all tooth surfaces. Treatment of sensitive teeth is a must and we recommend that anyone experiencing sensitivity consult their dentist. The IDA recommend that people experiencing pain use a special toothpaste, such as Sensodyne toothpaste which desensitizes the tooth nerve directly, in addition sufferers should use a fluoride mouthwash, and avoid acidic foods. Sensitivity should fade away in a matter of weeks. “The report also showed that people are becoming much more aware of their dental health, of the importance of taking care of their teeth and gums, and are attending their dentist on a more regular basis. We would further advise that people of all ages should make regular appointments for check ups with their dentist as this is the most effective way to prevent gum deterioration, the onset of gum disease, and the maintenance of good oral health.”
Gardasil indication to be extended to include prevention of precancerous vaginal lesions In addition to cervical cancer prevention, Gardasi will offer girls and young women protection against other HPV 6,11,16,18-related diseases affecting the cervix, vulva and vagina. The four-type cervical cancer vaccine Gardasil has received a positive opinion from the European Medicines Agency (EMEA) for an extension of its marketing authorisation to include the prevention of precancerous vaginal lesions. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) recommended that the prevention of precancerous vaginal lesions (VaIN2/3) due to human papillomavirus (HPV) types 16 and 18 be added to the licensed indications for Gardasil. HPV types 16 and 18 cause about 58 per cent of HPVrelated vaginal cancer. The EU Commission could now approve the extended marketing authorisation within weeks. “Precancerous vaginal lesions are difficult to detect. The treatment to avoid progression to cancer is challenging and often requires ablative therapy, partial vaginectomy and radiotherapy in the case of invasive cancer. Recurrence is common,” explains Elmar Joura, professor of gynaeco-oncology at the University of Vienna. “In addition, women may suffer from anxiety, depression, sexual dysfunction and poor self-image, resulting in broken lives.” The supplemental indication will add to the current indications for Gardasil, which are the prevention of cervical cancer, precancerous cervical lesions (CIN2/3), precancerous vulvar lesions (VIN2/3) and genital warts caused by HPV types 6, 11, 16 and 18. “This extension validates our comprehensive approach in addressing HPVrelated genital diseases and our robust clinical development”, says Patrick Poirot, vice-president for Medical and Scientific Affairs, sanofi pasteur MSD. “Providing protection to the vulva and the vagina in addition to the cervix widens the benefits of vaccination with Gardasil both for women and health authorities.” Final data from large phase II/III clinical studies confirmed Gardasil‘s high and sustained efficacy of 100 per cent against vaccine virus type-related precancerous vulvar (VIN2/3) and vaginal lesions (VaIN2/3). Issue 7 Vol 10 JulyAugust 2008
Continuing Herceptin treatment prevents disease progression in women with aggressive metastatic breast cancer: women with HER2-positive breast cancer benefit from nearly three extra months of life without progression New data presented at the American Society for Clinical Oncology (ASCO) annual meeting demonstrate that Herceptin (trastuzumab) helps women with advanced (metastatic) HER2-positive breast cancer live longer without their cancer progressing. The final analysis of the randomised phase III GBG26 study showed that Herceptin continued to work in women who needed additional treatment after their cancer progressed during previous Herceptin treatment. The key findings of the GBG26 study were: • Herceptin plus Xeloda prolonged survival without progression of the cancer (progression-free survival or PFS) by nearly three months compared to Xeloda alone (time to progression [TTP] from 5.6 to 8.2 months). • In addition, continuation of Herceptin nearly doubled the percentage of patients responding to treatment from 27 per cent to 48 per cent. GBG261 is the first randomised phase III study with Herceptin in women with HER2-positive breast cancer who require additional treatment for their advanced disease and have already received Herceptin as part of their initial therapy. The study confirms that Herceptin works across all stages of the disease and consolidates its position as the foundation of care for HER2-positive breast cancer. “It is rewarding to see that trastuzumab keeps working in women whose aggressive HER2-positive breast cancer progresses” said lead investigator Professor von Minckwitz, University Women’s Hospital, Frankfurt, Germany and MD of the German Breast Group “The GBG26 study results confirm that trastuzumab continues to target and shrink the cancer even beyond progression when combined with another chemotherapy.” Unfortunately, in the majority of women with advanced breast cancer, the disease continues to spread after initial treatment and patients are likely to receive several subsequent courses (or lines) and types of therapy. However, advanced breast cancer still remains essentially an incurable disease. The GBG26 study therefore addressed a very important question – do patients whose disease has progressed receive benefit from Herceptin when given it again? “The GBG26 study adds to the existing strong evidence that Herceptin extends survival throughout all stages of HER2-positive breast cancer.” commented William M Burns, CEO of Roche’s Pharmaceuticals Division, Basel, Switzerland “These results provide new hope for women whose breast cancer is difficult to treat.” There is mounting evidence, including the GBG26 study, confirming that Herceptin is the foundation of care for women with HER2-positive breast cancer. Herceptin works by activating the body’s own immune system to target and destroy the tumour, as well as by suppressing HER2.
Irish patients and Irish medicine involved in largest worldwide study of diabetes shows intensive glucose control saves lives Results from the world’s largest ever study of diabetes treatments, which involved Irish patients, show that intensive blood glucose control using an Irish made diabetes medicine can protect patients against serious complications of the disease. In particular, intensive treatment reduces the risk of kidney diseases by one fifth. The results of the ADVANCE (Action in Diabetes and Vascular Disease) trial, which were presented at the American Diabetes Association in San Francisco and published in the New England Journal of Medicine, show that this intensive treatment strategy has the potential to benefit millions of diabetic patients worldwide not to mention the 200,000 Irish patients living with the condition, particularly those at risk of kidney disease. The ADVANCE trial is the largest of its kind ever conducted with 11,140 taking part in the trial throughout 20 countries over five years. Ireland had 442 patients on the trial under the guidance of five Irish centres. This arm of the trial used the oral anti-diabetic medicine, Diamicron MR which is produced by the French pharmaceutical company Servier in its plant in Arklow Co Wicklow. The ADVANCE results go beyond existing evidence as they have now shown that reducing haemoglobin A1c level (a marker of blood glucose control) to 6.5 per cent is a safe and effective way to reduce serious complications, particularly the risk of kidney disease, one of the most serious and disabling consequences of diabetes, leading to death of one in five people with diabetes worldwide. The 6.5 per cent target in HbA1c was achieved with a Diamicron MR based therapy. Ninety per cent of the patients received Diamicron MR of which 70 per cent were on the maximum dose of 120 mg (four tablets at breakfast). Even with a majority of patients receiving the highest dose of Diamicron MR, the rate of hypoglycaemia was very low (2.7 per cent) and no weight change versus baseline was observed in the intensive glucose arm.
“The ADVANCE glucose results are good news for Irish patients with diabetes,” said Dr Richard Firth, consultant endocrinologist, Mater Misericordiae Hospital, Dublin, one of the Irish investigators involved in the ADVANCE trial. “This was a landmark trial considering that there are very few large controlled studies of this nature they really provide clear evidence that more intensive glucose lowering protects the kidney. “The trial also managed to resolve the issues of mortality raised in the Accord study which might have set back the care of diabetes by years. In ADVANCE not only were the combined macrovascular and microvascular achieved but the effects on nephropathy were extraordinary.” John Chalmers, ADVANCE Co-principal Investigator, the George Institute, Sydney said: “Results from the glucose lowering arm of the ADVANCE study show a reduction in the combined primary end points of both macrovascular and microvascular disease. The results show a substantial reduction of 14% in microvascular disease and that’s driven by a large one fifth reduction in kidney disease.” The main findings of Advance show that intensive blood glucose lowering treatment: safely controlled blood glucose to a mean HbA1c level of 6.5 percent, significantly reduced the overall risk of serious diabetes complications (by 10 per cent), with a one-fifth reduction in kidney disease (21 per cent) and 30 per cent reduction in the development of proteinuria, a well established marker of increased cardiovascular disease, and achieved a positive trend towards the reduction of cardiovascular death (12 per cent).
Issue 7 Vol 10 July/August 2008
New European surveys highlight high frequency and impact of otitis media Data presented at the European Society for Paediatric Infectious Diseases shows that the common middle ear infection, otitis media (OM), causes a substantial burden for clinical practice in Europe. Additional findings highlight that paediatric vaccination addressing the main bacterial pathogens causing OM could help to reduce antibiotic use, and could ultimately have an impact on the alarming rise of antibiotic resistant pathogens. A clinical abstract finding presented at ESPID highlighted that OM is recognised as common and difficult to treat; with the recurrent episodes placing further strain on healthcare resources. The international survey was conducted among 2000 paediatricians to assess the perceived burden of OM, disease awareness and management. Specific European data was obtained from a total of 800 paediatricians and family practitioners in Germany, Spain, Poland and France. Results demonstrated that the European physicians surveyed saw on average 29 children (range 17-45) each month with OM. Of these, 50 per cent (range 44-54 per cent) presented with initial episodes, 44 per cent (range 34-54 per cent) with recurrences and 17 per cent (range 8-41 per cent) of these children required referral to a specialist. The results of a separate survey conducted in seven European countries (France, UK, Germany, Spain, Italy, the Netherlands and Belgium) also presented at ESPID confirmed the burden of OM. Parents of 14,916 children less than five years of age who reported a child-illness episode completed the survey online. Of the 14,916 episodes, 10 per cent (1,479) were for OM, and of these 3.6-10.35 per cent required hospitalisation.
While almost all physicians surveyed (99 per cent) were aware that both Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. influenzae) are pathogens involved in acute OM, a smaller number of the physicians surveyed, 60 per cent (range 36-84 per cent), knew of the role of non-typeable Haemophilus influenzae (NTHi) in causing OM. NTHi and S. pneumoniae are the most common pathogens associated with OM. Antibiotic resistance is an issue of growing global concern that threatens to leave medical and public health workers virtually helpless in the treatment of bacterial infections. Increasing resistance due to over and misuse of antibiotics puts pressure on healthcare resources. According to the World Health Organisation (WHO) resistance has developed for many of the world’s antibiotics. Further data presented at ESPID revealed that the prescription of antibiotics for the treatment of OM in children aged less than five years is substantial in terms of both frequency and cost. OM is known to be one of the most frequent indications for the prescription of antibiotics. Therefore, prevention of OM by vaccination could have a significant impact, because of the potential to reduce antibiotic use. GlaxoSmithKline (GSK) Biologicals is developing a 10valent pneumococcal Haemophilus influenzae protein-D conjugate candidate vaccine (PHiD-CV) designed to provide dual-pathogen protection for children against invasive and non-invasive diseases caused by both S. pneumoniae and NTHi.7 Currently there is only one paediatric pneumococcal conjugate vaccine available (7-valent Prevenar from Wyeth).
New treatment approved to treat leading cause of death in hospital infections Pfizer Healthcare Ireland has announced the launch of anidulafungin (Ecalta) for the treatment of invasive candidiasis, a serious fungal infection occurring mainly in hospitalised patients and which in most cases is caused by the fungus Candida spp invading the bloodstream. Candida infections are often referred to as yeast infections or thrush and are common in women. In most circumstances they are mild and can be easily treated, but in seriously ill patients they are potentially life threatening. “Studies have shown that invasive candida infections are common in hospitalised patients, particularly those who are seriously ill and candida is now the fourth commonest cause of blood stream infection,” said Dr Edmond Smyth, consultant microbiologist at Dublin’s Beaumont Hospital. “Fungal infections have increased in frequency over the past two decades, largely as a result of the increasing complexity of medical care. Patients are now undergoing more aggressive cancer treatment, surviving serious trauma and complex surgery and organ transplantation is now relatively common. All the intervention required to support these patients increases their vulnerability to invasive fungal infections. “Anidulafungin (Ecalta) is an important advance in the treatment of invasive candidiasis. It is one of a novel class of antifungal drugs, which act against fungi in an innovative way and are both effective and
safe. Candida infections are difficult to diagnose and can progress rapidly. Early treatment is essential as the evidence suggests that one in four patients will die by day three, if treatment has not commenced.” In clinical trials, Ecalta was shown to be significantly better than fluconazole, the current standard of care for the treatment of many invasive candida infections. Further research has shown that Ecalta does not interact with other drugs and can be used in patients with liver and kidney damage, without the need to adjust the dose. Most importantly, data published in the New England Journal of Medicine has shown that Ecalta was successful in treating 75 per cent of patients with candida blood stream infection, which is a common cause of death amongst critically ill patients. A report commissioned by the Health Service Executive in 2007 estimated that 25,000 patients in Ireland develop health-care associated infection. According to the World Health Organisation (WHO), hospital infection are among the leading cause of death in hospitalised patients. “Pfizer is committed to developing innovative treatments for life-threatening infectious diseases. The introduction of Ecalta onto the Irish market marks a critical step forward in the treatment of fungal infections and now provides physicians treating seriously ill patients with an important new treatment option,” said Dr John Farrell, medical director, Pfizer Healthcare Ireland.
Roberta … rescues airport passengers! Roberta Rawat’s Rescue Team was on duty in Dublin Airport for Perrans Distributors Ltd this summer to rescue stressed out passengers with helpful advice on how to manage their travel stress and restore inner calm before going on board. In a major promotion, 10,000 Rescue Kits with the new branding ‘Rescue .. The essence of calm & tranquillity’ and containing Rescue Pastilles, the Rescue stress card and helpful advice for summer travel were distributed. “The summer months are the busiest time of the year with around 90,000 people going through the airport each day,” said Dublin Airport pharmacy manager Niamh Keating. “Air travel has never been more stressful and anything to help manage stress flies off the shelves – especially Rescue. You will find it in every home - it is a generic household name, something that’s been around for generations. People come back to it all the time simply because it works. There is the familiar spray and drops but for the summer travel kit we also suggested Rescue Pastilles, which contain the five Bach Original Flower Essences in Rescue Remedy. The naturally flavoured elderflower and orange pastilles come in a clever, handbag-friendly, click-shut tin ideal for travel. They are alcohol and sugar-free and safe for all the family including children; also Rescue Cream, an intensive moisturiser to hydrate and soothe dry, sensitive or rough skin and restore it to its natural condition. It is lanolin, paraben and perfume free.” Customers may be directed to visit www.rescueremedy.ie for more useful tips to help manage daily stresses. Issue 7 Vol 10 July/August 2008
Ymea - Ireland’s No. 1 menopausal food supplement Ymea, with 35 per cent market share, continues to be Ireland’s No. 1 menopausal food supplement in pharmacy. This success in part is due to the launch of Ymea Menopause & Silhouette to the Ymea range. In Ireland there has been a phenomenal value growth in the pharmacy menopausal category, indicating the growth potential available. Strong product offerings with increased pharmacy recommendations would appear to be meeting the needs of the menopausal consumer. Menopause is a natural step in a woman’s life cycle, yet the accompanying weight gain is an absolute concern. Many women gain weight due to the slow down of the metabolic rate. Ymea Menopause & Silhouette has a new formula providing helpful support during the menopause and slimming. This product includes kelp, which provides iodine, a mineral which plays a role in energy metabolism, as an important aid to slimming. Research indicates that nine out of ten menopausal women experience some degree of symptoms. Indeed, over two thirds of women suffer from more than one symptom. Of these over 40 per cent of menopausal women (aged 45-60 years) do not consult a GP. The majority would seek an alternative treatment such as a food or vitamin supplement from their local pharmacy. Ymea Menopause & Silhouette is a unique formulation. • Soya extract – soya is rich in natural isoflavones, Isoflavones are a form of phytooestrogen. • Kelp – provides iodine which supports the metabolism as an important aid to slimming. • EPO – may help maintain a healthy hormone balance. • Riboflavin – necessary for carbohydrate, fat and protein metabolism. • Calcium – maintain strong bones.
Ymea’s Menopause & Silhouette television campaign ‘Ymea - For The Time of Your Life’ will be back on TV from the end of June until August. Please ensure you are well stocked to meet this increased demand. POS is available for Ymea from your Chefaro Ireland Pharmacy Business Manager. For general enquiries please contact Chefaro on 01 879 0600 Ext 647.
Down 1 Garden of paradise one might need badly (4) 2 Each are confused due to otitis (7) 3 Reflection – of a statue, perhaps (5) 5 Titanic, Pinafore etc (3) 6 If you’ve got it……it! (6) 7 Relating to the end of the alimentary canal (4) 12 K.N. we hear, for a kind of pepper (7) 13 They are united in America (6) 15 Was B used as an absorbent pad? (4) 16 Pepper, Cinnamon or Posh perhaps (5) 17 Letter from Alpha to Gamma? (4) 19 Roadworthiness test for a Dublin girlfriend? (3)
last month’s CROSSWORD ANSWERS
across 1 It makes one sick to cite me backwards! (6) 4 He’s a cook (4) 8 Organ to start 2 down (3) 9 Am I sane, confused or suffering from loss of memory? (7) 10 A painful end to 2 down (4) 11 Missing Lord found in Co Dublin (5) 14 Head lock? (5) 16 It sounds like a pig-pen and is really an eyesore! (4) 18 Am in pit syncopating kettledrums (7) 20 Maiden name sounds like a leg joint (3) 21 Toss out drunkards! (4) 22 Mix me a doe for dropsy (6)
ACROSS: 6. one-eyed 7. Colon 9. Cuff 10. Thursday 11. Smoker 13. Itch 15. Iris 16. Eczema 18. Globulin 21. Neat 22. Anvil 23. Blusher DOWN: 1. Incus 2. Perfumes 3. Newt 4. Goes 5. Monarch 8. Quartz 12. Kneels 13. immunise 14. Ireland 17. Babes 19. Boil 20. Nile
ip crossword no. 7a
Congratulations to the winner of last month’s crossword, Ray O’Connell, The Pharmacy, Magazine Road, Cork. For a chance to win e70, please send completed entries to: The Editor, Irish Pharmacist, GreenCross Publishing, Lower Ground Floor, 5 Harrington Street, Dublin 8 or fax to 01 4789764. Closing date August 26, 2008.
Issue 7 Vol 10 July/August 2008
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References: 1. Vandewoude MFJ et al. Age and Ageing 2005; 34: 120–4. 2. Trier E et al. J Pediatr Gastroenterol Nutr 1999; 28(5): 595–6. 3. Silk DB et al. Clin Nutr 2001; 20(1): 49–58. 4. Elia M et al. Alimentary Pharmacology & Therapeutics. 2008; 27:120-145.
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fi n ta n m o o r e
The HSE’s roll-out of the primary care strategy leaves a lot to be desired.
espite the official line from the HSE’s Ministry of Truth, their rollout of the primary care strategy has moved along at the pace of a drunken snail. (If any drunken snails are reading this I apologise for the gratuitously insulting comparison.) If reports in the media are to be believed it seems that some of the original centres established are now losing staff, which they can’t replace due to the HSE’s recruitment freeze. I would imagine that the bureaucrats in the HSE who have the job of approving proposals for primary care centres will be getting less and less choosy about who they do business with. What follows below is a typical day in the life of HSE official, N O’Clu, as he meets various doctors to decide on the merits of their applications to set up primary care centres. DR MENGELE Mr O’Clu’s first meeting is with Dr J Mengele, a
very elderly but distinguished looking foreign gentleman. The conversation was recorded for training purposes and the transcripts accidentally made available online through typical HSE ineptitude. Dr Mengele: Guten tag, Senor. O’Clu: Good day to you, Dr Mengele. That’s an interesting accent you have there. Dr Mengele: Ja. I am originally from the German fatherland, but I had to leave for, let us say, personal reasons. I haff spent the last 60 years in South America. O’Clu: And why have you picked this time to move to Ireland to open a primary care centre? Dr Mengele: I haff waited years to move back to Europe, but there was no suitable country. They were all ruled by filthy socialists. Even Franco was such a disappointment. But then I saw how your leaders crushed the trade unions by using the Waffen Competition Authority, and I knew I had found a new Reich. I vant to be
here when you move to destroy the communists and the other untermensch. O’Clu: Very good, Dr Mengele. I don’t see any problem there. And how do you intend to fund your centre. Dr Mengele: I haff funds in a Swiss bank account, or if you prefer I can pay you with priceless vorks of art. They haff been stored most carefully since 1945. O’Clu: Money will do nicely, thanks. I look forward to doing business with you. Dr Mengele: A pleasure. If you meet your Minister, be sure to say Heil from me. DR FRANKENSTEIN Mr O’Clu’s next visitor, Dr Frankenstein, is also a European immigrant, from one of the newer accession states. Dr Frankenstein is accompanied by his servant, Igor, a hideously deformed hunchback devoted to his master. O’Clu: Good day, Dr Frankenstein. I’ve been reading your very interesting proposal for a primary care centre. Do you mind me asking why you want to move to Ireland? Dr Frankenstein: I have a number of reasons. I was influenced in my decision by what was best for Igor – he is a great admirer of how people of grotesque appearance can attain high political office in your country. Also, I am attempting to escape from a monster who is trying to kill me. O’Clu: A monster? Dr Frankenstein: Yes. In an experiment which went horribly wrong I created a monster which is now an out of control, rampaging beast. O’Clu: You should get together with Professor Drumm and form a self-help group. Please, continue your story. Dr Frankenstein: I am hoping that in Ireland I will be safe because the monster will not cross the sea. I want to continue my work here to try to bring dead bodies back to life. O’Clu: I see. Well, you’ll have no shortage of people dying. However, from a budgetary perspective, which is the only one that matters to us, we prefer to leave them that way. If you start to bring them back to life then they could be a drain on resources which are needed to pay for vital PR campaigns. Dr Frankenstein: Do not fear, my friend. They will not be alive, but will merely be undead – they will need no food or medical care. I hope to avoid previous mistakes and to create docile servants. O’Clu: I see. And why do you hope to set up your primary care centre in a remote mountainous village? Dr Frankenstein: I need to be up high to get the lightning bolts I need to animate the corpses. O’Clu: Right. That’s all fine, Dr Frankenstein. You can consider your application approved. Just remember to have a separate entrance for your pharmacy, and Bob’s your uncle. DR JEKYLL Next up is a well-spoken Englishman, Dr Jekyll, who is also interested in relocating here. O’Clu: Good day, Dr Jekyll. Your plans look somewhat different to the normal model of a primary care centre. Why do you need such a large area for the pharmacy? Dr Jekyll: I’m afraid that information is commercially sensitive. O’Clu: That’s fine - what we don’t know can’t be held against us later. I’m sure you’ve got a perfectly valid reason for a ten thousand square foot dispensary area with hundreds and hundreds of mysterious potions bubbling in glass vials, and a heavy-duty cage in the corner such as would be used to confine a large and dangerous wild animal. Dr Jekyll: Do you want my primary care centre or not? O’Clu: Oh yes, of course we’ll approve it. I’m just curious about one other little detail – you know this clause in the contract you drew up, indemnifying you against any liability for deaths in the vicinity of the centre caused by a ferocious nocturnal creature, which appears to be part man and part beast...? IP