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assistant - GreenCross Publishing
issue 3 volume 10 • march 2008 The independenT monThly for irish pharmacisTs the interview Pharmacist of the Year Professor Caitriona O’Driscoll the coalface David Jordan expresses his gratitude to Professor Drumm Q&a ronan Quirke Short StorY an inSpector callS Julian Judge claSh of cultureS fintan moore n duci o r t in g t n a t assis pharm acy pluS TraInInG CD Back, muscle and joint pain. special reporT Special General Meeting of the IPU Full text of Aidan O’Shea’s statement to the meeting. news news STATEMENT TO THE AGM OF THE IRISH PHARMACY UNION FROM AIDAN O’SHEA, FPSI. (This statement was read on behalf of Aidan O’Shea by Marie Hogan, Past President of the IPU, at the Special General Meeting held on the 5th March.) Despite having recently retired from community pharmacy for family reasons, I have been closely following the turmoil created by the decision of the HSE of September last to reduce the reimbursement price for dispensed drugs under state schemes by 8.2%. The HSE claims that this reduction, taken directly from the revenue of community pharmacies, would effect a budgetary saving of €100 million per annum. The substance and the manner of this decision breaches a number of fundamental principles underlying the relationship between community pharmacists and the state. The decision was taken without prior consultation with the IPU. Contractor pharmacists believe that it is prima facie a breach of the pharmacy contract. The HSE has compounded this turmoil by claiming that The Competition Act prevents it henceforth from negotiating terms and conditions of contract with the IPU. This claim has led to disengagement and the collapse of substantive direct dialogue with the IPU, the responsible Union which has acted for pharmacists for over 35 years. Consequent to this collapse of dialogue, the vacuum has been filled by a series of legal actions taken by the IPU itself and by individual members against the unilateral decision of the HSE. These actions put the parties in a sub judice mode, creating an even higher barrier to resolving the issues. The substantial amounts of money, time and energy spent on these legal actions should be channelled towards direct dialogue and resolution rather than legal confrontation. The Minister for Health and Children Mary Harney TD has recently set up an independent arbitration committee to urgently examine the professional and economic elements of the pharmacy contract, but the HSE obdurately insists on its price reductions as a non-negotiable precondition of the process. This precondition emasculates the scope of the arbitration, since the negative impact of the price reductions will intensify over time. Community pharmacists are struggling with the ethical dilemma of maintaining professional services at an economic loss, or degrading the quality of those services by cutting staff numbers and hours of service. At its most extreme, this process will ultimately lead to the closure of smaller independent pharmacies in communities with a high number of medical card holders. Marie Hogan, Past President, reading Aidan O’Shea’s statement to the packed Special General Meeting. This vexed and volatile situation calls for leadership and vision of a high order from our Government and the HSE who are our servants and not our masters, and from the IPU and PSI representing the profession. We must avoid personal abuse and protect patient care, in spite of the dangerous and provocative sequence of events. Ultimately everything is negotiable and competent of resolution in order to maintain and indeed enhance community pharmacy services. Parity of esteem, engagement and dialogue are the cornerstones of resolution. Irish Pharmacist is grateful to Mr Aidan O’Shea for permission to publish this statement. Issue 3 Vol 10 March 2008 3 The independenT monThly for irish pharmacisTs conTenTs ediTorial Stuck between a rock and a hard place? Firstly, we would like to apologise for the late arrival of this issue of Irish Pharmacist, but we felt it was important to cover the historic meeting of pharmacists which took place on Wednesday last. Anyone attending the Special General Meeting in the Ballsbridge Inn can have been in no doubt that pharmacists are angry. It remains to be seen if the mood of solidarity, and determination to take the fight to the HSE, which was shown in the morning session will hold up in the weeks and months ahead. Prior to the meeting, the union issued a statement saying it has left it up to individual pharmacists to choose their own particular course of action, taking into account their own circumstances and business arrangements. So, even though the meeting called for unity and collective action, the union has not chosen to impose its views on its members. How this will play out is difficult to predict. It would seem, however, that the HSE appears to think it knows pharmacists better than pharmacists know themselves; it looks as if the HSE is banking on the assumption that pharmacists will find it deeply unsettling to turn away the old and the chronically sick. A compunction, from which the HSE does not appear to suffer. But then as a number of speakers attested, the HSE seems to have decided that everything, even the health of the nation, must be sacrificed to the God of competition. It’s hard to believe that even Mary Harney and Brendan Drumm can be so ideologically driven that they believe competition rules must be obeyed in every circumstance. Despite the show of strength, there was a general feeling of weariness from many of the members at lunchtime on the day. Partly this must stem from the fact that pharmacists appear to be stuck between a rock and a hard place. However, they have been left with little option but to repress their professional instincts this time if they are going to bring the HSE to the table. As President of the IPU, Michael Guckian, made clear at the meeting: if pharmacists roll over this time, next time they will have nowhere else to go. GreenCross Publishing is a recently established publishing house which 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. GreenCross was recently appointed by the Irish Practice Nurses Association to publish their new title Nursing in General Practice. GreenCross will be introducing new titles over the coming months. sandyford industrial estate, dublin © copyright disclaimer Greencross publishing irish pharmacist endeavours to ensure accuracy 2008 of information given and of claims made in no part of this articles and advertisements. nevertheless, no publication may be reproduced, stored in a responsibility is accepted in respect of such retrieval system, or transmitted in any form by any information or claims. any opinions expressed means – electronic, mechanical or photocopy by contributors are entirely their own and do not recording or otherwise – whole or in part, in any purport to be the views of irish pharmacist. the publishers. report from the Special General Meeting of the IPU. 3 newS Statement of Aidan o’Shea to the Special General Meeting 15 ContraCt law What it means for pharmacists. Cormac o’Neill 18 the CoalFaCe David Jordan gives thanks to Professor Drumm. 20 Short Story An Inspector Calls Julian Judge 22 the interview Professor Caitriona o’Driscoll, Pharmacist of the year, talks to Irish Pharmacist. 24 FinanCe Paul A overy asks if all the predictions of doom and gloom amount to a hill of beans. 25 a view From above The role of the pharmacist in prevention is being taken seriously by our near neighbours. Terry Maguire 27 hoSpital pharmaCy Breast cancer: an overview In this article the authors outline the pathology of breast cancer and the role pharmacists can play in prevention and patient support. 33 meeting report The manufacture and use of biopharmaceuticals. Stephen Meyler epharmaCy 37 health in your hand Pharmacists can now use SMS to let patients know when their prescription is ready for collection. 39 weird and wonderFul world oF the web We go in search of the best web sites so that you don’t have to. Jay Curtis 41 produCt newS 45 travel Introducing Zara’s Planet – a travel company for the more discerning traveller. 42 Q&a our new feature provides a snapshot of the interests likes and dislikes of our readers and contributors. This month: ronan Quirke. 46 CroSSword 46 reCruitment Clash of cultures Fintan Moore says the HSE has completely failed to understand the mindset of pharmacists. publishing, unit 6, st Kieran’s enterprise centre, purposes without the prior written permission of 6 Cover Feature and SpeCial report 48 outSide edge irish pharmacist is published by Greencross form whatsoever for advertising or promotional issue 3 volume 10 • march 2008 EDITor: Maura Henderson PUBlISHEr: Graham Cooke CoNSUlTING EDITor: Stephen Meyler rEPorTEr: Jay Curtis SUB EDITor: Fran McDonagh CoNTrIBUTorS: David Jordan, Fintan Moore, Paul Shalvey, Terry Maguire, Niamh McSweeney, Cormac o’Neill, ronan Quirke. DESIGN: Donal larkin CArTooNIST/IllUSTrATor: John Corrigan PHoToGrAPHy: Audrey Hanley PrINTErS: Bairds lETTErS To THE EDITor: [email protected] Advertising: graham@ greencrosspublishing.ie or 0872222221 special report news Special General Meeting of the IPU Pharmacists urged to resist attack on their fundamental human rights Michael Guckian, President of the IPU, Marie Hogan, Past President, John Chave, Secretary General, PGEU, and Dr Martin Daly, Vice President of the IMO, in buoyant mood prior to the meeting. Marie Hogan, Past President, told the packed auditorium, that what is being missed in all the media coverage; “is that this isn’t a dispute about the issues, this is a dispute about the fact that one side will not talk.” T hey were expecting 500 but last Wednesday saw the largest gathering of pharmacists in the history of the state – more than 1000 – packed into the Conference Room of the Ballsbridge Inn. As well as past and current office holders of the IPU, the historic meeting was addressed by representatives from General Practice, Dentistry, the NUJ, and the PGEU. After a brief history of the dispute to date, Liz Hoctor, Chair of the meeting, said that the HSE, by their own admission, are taking 100 million from community pharmacists, thereby reducing the income of pharmacies by 30%. “They seem to think they can confiscate this money with impunity and without any consequences for patients or for pharmacy services,” she said. Ms Hoctor stated: “So today is very much about the rights of pharmacists to belong to this union in the face of unprecedented attacks by the HSE. Their new strategy is to try to divide and conquer. They will not succeed. The unity and solidarity within the profession is stronger than ever and will be more so after today.” Presidential address The President of the IPU, Michael Guckian, took up where Ms Hoctor left off: “For the past six months the pharmacy profession has been subjected to abuse, misinformation, innuendo and bullying by the HSE. However your presence here today sends a very strong signal that we will not roll over in the face of this unreasonable attitude. “We are not unreasonable people” he continued, “but we demand fair play and we demand respect. And we demand to be dealt with the same as all other organisations. We should expect it all the more when we are dealing with a state institution charged with delivering healthcare services.” Addressing the issue of patients Mr Guckian said: “We also have a duty to patients to ensure that they get the services that they deserve. And equally, we have a duty to tell them when these services are being threatened by the unreasonable behaviour of the HSE, and we make no apologies for doing so.” 6 Issue 3 Vol 10 March 2008 Liz Hoctor, Vice President, chaired the historic meeting. Seamus Dooley, Secretary of the NUJ, said: “the Competition Act has been interpreted to mean that certain workers cannot exercise their constitutional right to freedom of association…without fear of civil or criminal prosecution.” news special report “The HSE are forcing change on the sector without any regard to patient care and they ignore the advice of their own consultants about the need to implement changes in a reasonable and gradual manner. If they won’t listen to the consultants that they themselves employed out of taxpayers money what hope have we got of doing business with them?” Support from the Imo Dr Martin Daly, Chairman of the National GP Committee of the IMO and Vice President of the IMO, opened by remarking on the huge turnout, saying it reflected the critical nature of the crisis. “It is timely for all of us to reflect, in our respective representative organisations, on the situation in which community pharmacists find themselves placed. “In their haste to be seen to prevail – and remember this is all about optics – to prevail over community pharmacists, they are actively undermining a contract that has been entered into freely by the state.” Dr Daly stated that the competition law is being used as a tool to break pharmacists. He says the IMO has studied this area and has found that other countries in Europe have sought derogation from the competition law when it came to health services. However he continued “The HSE [are] the archetypal bean counters who know the cost of everything but the value of nothing.” Paraphrasing Thomas Paine, Dr Daly said: “If you don’t hang together, you will surely hang separately.” He told members that solidarity was the only option if they were to counter the HSE. ‘partnerShIp’ IS dead Marie Hogan, past president of the IPU, said she has watched in amazement and disbelief over the past 18 months as the relationship between the union and the HSE have disintegrated. “The thing that gets lost in all the media coverage is that this isn’t a dispute about the issues, – if we could get to talk about the issues we might have some hope – this is a dispute is about the fact that one side wont talk, they simply are not prepared to talk to our union. “There is no way we can accept going into a review with preconditions and a predetermined outcome, and where they have taken away a third of our income, and then they want us to discuss it! “The real reason they are doing this is that, like all bullies, they are cowards at heart. The HSE are behaving like this because they know their own arguments will not stand up. They know that any rational, really independent review will find against them and will not give them the result they want. They believe that might is right.” the CompetItIon aCt Seamus Dooley of the NUJ informed the assembly that the strict interpretation of the Competition Act has already been used to take away the fundamental human rights of Irish freelance journalists, photographers and Equity members. “The Act has been interpreted to mean that certain…workers cannot exercise their constitutional right to freedom of association, collective bargaining, nor can they conduct or comply with a collective agreement without fear of civil or criminal prosecution.” He concluded: “In our democratic society we must ensure that the creatures Dr Martin Daly, Vice President of the IMO, told the assembly: “What we have with the HSE is the archetypal bean counters who know the cost of everything but the value of nothing.” The packed auditorium gives John Burke a standing ovation after he speech urging members to unite and resist the HSE. of statute are kept under control. We must guard against the unintended consequences of the actions of creatures of statute.” european Support John Chave, Secretary General of the PGEU, whose organisation represents community pharmacists in 30 countries said that never in the history of the PGEU have pharmacist representatives, in any European country, been put into the position in which the IPU currently finds itself. “I’m amused by the HSE talking about the European average for this and the European norm for that, I have to tell [the HSE] that there is no European norm for trampling on collective rights. There is no European norm for putting pharmacists out of business, there’s no European norm for pharmacists to dispense at a loss, and there’s no European norm for having your lawyers running around finding excuses because you have made a political decision not to negotiate. “There are good reasons why these rights are called fundamental. They are fundamental because they can’t be disregarded for simple reasons of political expediency. They can’t be thrown in the bin because some bright spark lawyer cannot tell the difference between the letter of the law and the spirit of it,” said Mr Chave. Concluding the meeting, John Burke, founder member of the IPU, said that the only part of the health service which worked, and which was respected by the general public, was now under attack by the HSE and the Minister. If this service implodes, he warned, it will be “laid at the feet of Minister Harney.” He also cautioned members about attempts to divide pharmacists and predicted that things will worsen over the coming months. He said the best way to counteract this was to stay united, keep all lines of communication open and to talk regularly to fellow pharmacists. “Walk tall and be not afraid,” he urged, as the biggest gathering of pharmacists in the history of the state rose to their feet to give him a sustained round of applause. John Burke, founder member and Trustee of the IPU, and Seamus Feely, General Secretary. Issue 3 Vol 10 March 2008 7 news news “Start planning for an imminent flu pandemic” Speaking at a breakfast briefing attended by some of Ireland’s leading CEOs, Willie Walsh, CEO of British Airways said: “The threat of a flu pandemic is very real, so it is vital that businesses put the necessary controls in place now through proper continuity planning. As with all major adverse events, this planning means they will be prepared in advance and will help them to avoid major financial losses when it does happen. British Airways (BA) has taken this threat seriously by creating a business continuity plan for pandemic influenza, and I would recommend that Irish businesses do the same.” Mr Walsh was keynote speaker at a breakfast briefing entitled ‘The economic impact of an influenza pandemic – is your business prepared?’ which was held in the Shelbourne Hotel, Dublin, to discuss the importance of business continuity planning for adverse events. The event also heard a contribution from Dr Mary Horgan, Consultant in Infectious Diseases, Cork University Hospital, and was chaired by economist, David McWilliams. Dr Horgan updated briefing attendees on the current status of influenza and the need to stockpile antivirals. “The World Health Organisation has been monitoring the H5N1 strain of influenza (bird flu) for a number of years. This virus already has the ability to transfer from birds to humans, and we feel that it is only a matter of time before it, or a variant, can be transmitted easily from human-to-human,” Dr Horgan said. “I believe it’s important for businesses to have a pandemic preparedness plan which includes stockpiling antivirals, as these will play a key role in safeguarding the Irish population’s health during a pandemic before a vaccine is developed. Tamiflu is the antiviral of choice of the WHO. Waiting until an outbreak occurs to acquire antivirals is illadvised, as it will be impossible to stockpile after an outbreak occurs due to production and supply chain constraints.” A new economic impact assessment, commissioned by Roche Products (Ireland) Limited, was briefly discussed at the meeting prior to its official launch. The study estimates the cost of productivity loss to employers due to the effects of pandemic influenza on the Irish working population. This assessment shows a potential loss to the economy of e2 billion during a severe influenza pandemic. The new economic impact assessment was conducted from the perspective of employers in Ireland under two different scenarios – a moderate influenza pandemic and a severe pandemic. It is expected to be launched in late February/early March 2008. Expert PSI group to consider expansion of pharmacy services At its Council Meeting at the end of February the Pharmaceutical Society of Ireland, established a new group to look at how pharmacy services in Ireland can be expanded. The group is to be chaired by Mr Brendan Hayes, President of the PSI. The other PSI Council members on the Group are: Ms Cathriona Hallihan, the Managing Director, Europe, Middle East and Africa of Operations at Microsoft, Professor Peter Weedle, a lecturer in pharmacy at University College Cork, and Ms Ita Kelleher, a former nurse and a public interest nominee of the Minister for Health and Children, to the Council of the PSI. The Group will report to the Council of the PSI within three months and the PSI will then forward its advisory report to the Minister Harney. Announcing the composition of the group, the Registrar of the PSI, Dr Ambrose McLoughlin, said its work was timely. “The role of pharmacy in public healthcare is growing internationally. We need to focus more on what pharmacists can bring to patient value, especially in health promotion and prevention.” “This group will examine if pharmacy can deal more effectively than other parts of the health system with many patients’ concerns through health promotion and screening for certain chronic conditions, e.g. fingerprick testing for diabetes with referral to GPs when indicated; managing patients with stable long-term conditions, e.g. cardiac patients and patients suffering from respiratory diseases; advising patients on managing medications; managing minor ailments to reduce unnecessary visits to GPs and outpatient services; obesity and weight management; and to deliver a broader range of diagnostic and screening services, such as cholesterol testing.” He said such services were already available in the UK and there has to be a shift here towards rewards for quality and range of services provided. “Pharmacists are a highlyeducated profession with a widely dispersed network of pharmacies across the country. In our view, this has enormous potential to assist with bottlenecks and to be an effective weapon in improving the health of the population.” The group was appointed at the Council meeting today which for the first time was held at a school of pharmacy. The meeting took place at the Pharmacy School of the Royal College of Surgeons and was followed by a courtesy call by the Council on the Lord Mayor of Dublin. The PSI is to hold meetings at the other two schools of pharmacy, UCC and TCD, later this year. research update G spot spotted! The good news is that doctors in Italy have at last located the G spot; the bad news is that not all women appear to have one. Doctors at the University of L’Aquila in Italy claim to have located the whereabouts of the G spot. They say that scans show clear anatomical differences between women who say they experienced vaginal orgasms and a group of women who do not. The ultrasound scans identified a region of thicker tissue where scientists suspect the holy grail of the vaginal orgasm is thought to reside. This thicker tissue was not visible in the women who say they have never had a vaginal orgasm. The G spot is only thought to affect a woman’s ability to have vaginal orgasms, so if women do not have one they can still have a normal orgasm through stimulation of the clitoris, according to the Italian researchers. Lung cancer risk from Vitamin E People who take daily supplements of vitamin E have a greater risk of developing lung cancer, according to study carried out at the University of Washington in Seattle The researchers monitored 77,000 men and women over a four-year period and found that a number of vitamins failed to protect against lung cancer, but that daily vitamin E intake slightly increased the risk of developing the disease. The study suggested that taking 400mg of vitamin E for 10 years increases the risk of lung cancer by 28%. NE W 55937.02_ActAd_245x340-IrePharm:Layout 1 28/1/08 16:55 Page 1 In established postmenopausal osteoporosis Actonel 35mg Plus 1000mg Calcium Plus 880 IU Vitamin D3 3 in 1 packaging convenience1 In postmenopausal osteoporosis where 1000mg Calcium and 880IU Vitamin D3 is considered adequate supplementation Dosage instruction: Please refer to API below Actonel® 5mg or Actonel® Once a Week 35mg or Actonel® Combi (risedronate sodium 35mg Once a Week / calcium carbonate 1250mg) film-coated tablets or Actonel® Plus Ca & D (risedronate sodium 35mg Once a Week film-coated tablets + 1000mg /880 IU effervescent granules) ABBREVIATED PRESCRIBING INFORMATION: PRESENTATION: film-coated tablets contain the equivalent of: Actonel 35 mg (light-orange tablet): 32.5mg risedronic acid, Actonel 5 mg (yellow tablet): 4.64mg risedronic acid; Calcium Carbonate 1250mg (blue tablet in Actonel Combi): 500mg elemental calcium. Effervescent Granules (in Actonel Plus Ca + D): Each sachet contains: 2500mg calcium carbonate equivalent to 1000mg calcium and 22 micrograms (880 IU) colecalciferol (vitamin D3) INDICATIONS: 5mg, 35mg, Combi and Actonel Plus Ca & D: Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. 5mg only: Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis. To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses ≥7.5mg/day prednisone or equivalent. 35mg only (not Actonel Combi or Actonel Plus Ca &D): Treatment of osteoporosis in men at high risk of fractures. Actonel Plus Ca & D is only intended for use in assessed patients for whom the amount of calcium and vitamin D3 included is considered to provide adequate supplementation. DOSAGE AND ADMINISTRATION: Actonel 5mg: once a day orally. Actonel 35mg: once a week orally. Combi: Take one Actonel 35mg tablet on the first day followed on the next day by one calcium 500mg tablet daily for 6 days. The 7 day sequence is then repeated each week. Actonel Plus Ca & D: Take one Actonel 35mg tablet on the first day followed on the next day by one sachet of effervescent granules daily for 6 days. The 7 day sequence is then repeated each week. Actonel 5mg or 35mg: Take Actonel at least 30 minutes before the first food, other medicinal product or drink (other than water) of the day. Do not suck or chew the tablets. Actonel is to be taken while in an upright position with a glass of plain water (≥120 ml). Do not lie down for 30 minutes after taking Actonel. Calcium 500mg (in Actonel Combi): take with food and swallow whole. Effervescent granules (in Actonel Plus Ca & D): the contents of the sachet should be poured into a glass of plain water, stirred and drunk immediately once the fizzing has subsided. Children: Safety and efficacy has not been established in children and adolescents. CONTRAINDICATIONS: Actonel 5mg and 35mg: Known hypersensitivity to risedronate sodium, or any of the excipients, hypocalcaemia, pregnancy and lactation, severe renal impairment (creatinine clearance <30ml/min). Actonel Combi (in addition to those for Actonel): Hypersensitivity to calcium carbonate or any excipients, hypercalcaemia, hypercalciuria, nephrolithiasis. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi): hypersensitivity to colecalciferol or any excipients (in particular soya-bean oil), diseases associated with hypercalcaemia and/or hypercalciuria, Hypervitaminosis D. PRECAUTIONS: Actonel 5mg and 35mg: Caution should be used in patients who have a history of oesophageal disorders which delay oesophageal transit or emptying (e.g. stricture or achalasia) or who are unable to stay in the upright position for at least 30 minutes after taking the Actonel tablet. Hypocalcaemia should be treated before starting therapy. Other disturbances of bone and mineral metabolism should be treated at the start of therapy. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) may interfere with the absorption of Actonel. Strict adherence to dosing recommendations is necessary. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible. Limited evidence to support the efficacy of Actonel in very elderly women (>80 years) Actonel Combi (in addition to those for Actonel): In patients with mild to moderate renal impairment or history of absorptive or renal hypercalciuria, nephrolithiasis, kidney stone formation or hypophosphataemia, renal function, serum and urinary calcium and phosphate should be monitored regularly. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi): Vitamin D3 should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and another form of vitamin D should be used. During long-term treatment, serum and urinary calcium levels should be followed and renal function should be monitored through measurement of serum creatinine. In case of hypercalcaemia or signs of impaired renal function, treatment with calcium/vitamin D3 sachets should be discontinued. The dose of vitamin D3 in the sachets should be considered when prescribing other drugs containing vitamin D. Calcium/vitamin D3 sachets should be used with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite. Calcium/ vitamin D3 sachets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia. This medicinal product contains sorbitol and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicinal product. INTERACTIONS: Actonel 5mg and 35mg: No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials. Risedronate sodium is not systemically metabolised. Actonel Combi (in addition to those for Actonel): Thiazide diuretics can increase risk of hypercalcaemia and if used concomitantly serum calcium should be monitored. Systemic corticosteroids reduce calcium absorption. Calcium carbonate may interfere with absorption of tetracycline preparations. These should be taken at least 2 hours before or 4 to 6 hours after oral calcium intake. Hypercalcaemia may increase toxicity of cardiac glycosides and such patients should be monitored by ECG and serum calcium levels. If sodium fluoride is used concomitantly, this preparation should be administered at least 3 hours before the intake of calcium carbonate. Oxalic acid and phytic acid (found in some foods) may inhibit calcium absorption. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi): Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. USE IN PREGNANCY AND LACTATION: Actonel 5mg, 35mg, Combi and Plus Ca & D must not be used during pregnancy or by breast-feeding women. SIDE EFFECTS: Actonel 5mg and 35mg: The majority of undesirable effects observed in clinical trials were mild to moderate in severity. The following common adverse reactions were reported by the investigators as possibly or probably related to the medicinal product in ≥1%, <10% of patients and at an incidence greater than placebo in placebo controlled trials of Actonel 5mg, or in ≥1%, <10% of patients in trials of 35mg vs 5mg: constipation, dyspepsia, nausea, gastrointestinal disorder, abdominal pain, diarrhoea, musculoskeletal pain and headache. The following uncommon adverse reactions associated with bisphosphonates were reported by the investigators as possibly or probably medicinal product related in ≥0.1%, <1% of patients: iritis, gastritis, oesophagitis, dysphagia, duodenitis, oesophageal ulcer. Rare (≥0.01%,<0.1%): abnormal liver function tests, oesophageal stricture, glossitis. Early, transient, asymptomatic and mild decreases in serum calcium and phosphate levels have been observed in some patients. Reported during post-marketing use (frequency unknown): osteonecrosis of the jaw, iritis, uveitis, hypersensitivity and skin reactions, including angioedema, generalised rash, and bullous skin reactions, some severe. Actonel Combi (in addition to the above for Actonel): The following additional adverse events have been described; Uncommon: hypercalcaemia and hypercalciuria. Rare: flatulence. Actonel Plus Ca & D (in addition to those for Actonel and Actonel Combi): following additional adverse events have been described; Rare: pruritus, rash and urticaria. PACK QUANTITY: Actonel 5mg: 28 tablets, 35mg: 4 tablets, Combi: four blisters each with one Actonel 35mg tablet and 6 calcium carbonate tablets. Actonel Plus Ca & D: 4 Actonel Once a week tablets and 24 effervescent granules sachets. MARKETING AUTHORISATION NUMBERS: 5mg: PA170/20/1, 35mg: PA170/20/3, Actonel Combi: PA170/21/1, Actonel Plus Ca & D: PA170/22/1. LEGAL CATEGORY: POM MARKETING AUTHORISATION HOLDER: Procter & Gamble Pharmaceuticals UK Limited, Rusham Park, Whitehall Lane, Egham, Surrey, TW20 9NW, UK. In Ireland for further information, please contact: [email protected]. Refer to Summary of Product Characteristics before prescribing which can be found on IPHA @ http://www.medicines.ie/. Information about adverse event reporting can be found at www.imb.ie. Date of preparation Nov 2007. ACT-3653/ IE-RIS- 07.11.18 Reference: 1. Fardellone, Osteoporosis Int 2007; 18(Suppl 1): P365-366. *Therapeutic equivalence has been shown between 35mg and 5mg in terms of BMD. Date of document preparation: January 2008. ACT3799F/IE.RIS.07.11.08/55937.02 In Ireland for further information, please contact: [email protected]. Refer to Summary of Product Characteristics before prescribing which can be found on IPHA @ www.medicines.ie. Information about adverse event reporting can be found at www.imb.ie news news IPOS take HSE to court for breach of contract The Independent Pharmacy Ownership Scheme (IPOS) have announced that they are to take individual legal actions against the HSE in relation to its proposal to unilaterally reduce the reimbursable price of medicines payable to retail pharmacists by more than eight per cent. The 150 IPOS members believe that the HSE’s attempt to reduce the reimbursable price is in breach of their individual contracts with the HSE, which provide for the current level of payments. IPOS has strongly criticised the HSE’s proposals as putting at risk the future of community pharmacy in Ireland as it will significantly decrease pharmacies’ profits and turnover. A recent audit of the sector conducted on behalf of IPOS found that the HSE’s proposals – including the introduction of a flat rate dispensing fee of €5 per item – will reduce the profits of the average community pharmacy by 75 per cent. “It is clear that this short-sighted decision by the HSE has the potential to decimate community pharmacy in Ireland. Such a massive reduction in profits is not sustainable. This will lead to job losses and pharmacy closures, particularly in rural communities and high GMS areas, which will damage patient care,” said Tom Howard, Network Director of IPOS. “Community pharmacy is one of the few areas of the health sector that works. It plays a critical role nationally and locally by not only dispensing medicines and delivering the GMS scheme, but also providing healthcare advice and reducing the need for patients to attend A&E. This planned action by the HSE puts short-term gain ahead of the immediate and long-term benefits of excellent patient care,” added Howard. IPOS has called on the HSE to honour its contracts with individual pharmacists and for the Minister for Health, Mary Harney, to intervene with the HSE in order to protect the future of community pharmacy. “The contract that our members have with the HSE is clear and given the belligerent attitude of the HSE, who have consistently refused to engage with pharmacists on this matter, they have no choice but to instigate legal action to force the HSE to honour its contracts,” said Howard. MSc graduate in Pharmaceutical Medicine conferred in Trinity Ms Caitriona Scott was conferred by Trinity College Dublin with the MSc in pharmaceutical medicine in February. This course is one of two part-time courses in pharmaceutical medicine. Begun in 2004 by the Centre for Advanced Clinical Therapeutics, St James’s Hospital in association with Trinity College Dublin, these are the first such courses to be established in this specialty in Ireland. Dr MaryJo MacAvin Course Ms Scott who works in Medical Information in Co-ordinator, Ms Caitriona Scott MSc Graduate in Pharmaceutical Wyeth (Irel) said: “This course explained about Medicine , Dr Mary Teeling (Course medicines from all perspectives and the role of Director) at the conferring. the various stakeholders, including regulators, healthcare professionals, the pharmaceutical industry and patients in the regulation of medicines. and pharmaceutical industry. The MSc course is open It has been of great benefit to me in dealing with medical to physicians and health science graduates, while the information queries”. Postgraduate Diploma is open to physicians only. The courses cover topics such as drug development and licensing, clinical research, pharmaco-economics and drug More information on these courses is available from safety and are designed to enable healthcare professionals the Centre for Advanced Clinical Therapeutics, St James’s extend their professional role within the healthcare system Hospital (Tel: 01 4103671/[email protected]). Test your kidneys! World Kidney Day will take place on Thursday, 13th March, 2008. It’s focus is to raise awareness about the importance of early detection of kidney disease in slowing its progression as well as to highlight the increasing global pandemic of kidney disease. The Irish Kidney Association together with the Irish Nephrology Society are undertaking a ‘Know Your Kidney’ campaign to inform the general public about the incidence of kidney disease and encourage them to have a simple blood test taken to determine how well their kidneys are working. Visit website www.worldkidneyday.org Launching Organ Donor Awareness Week 2008 at the Mansion House, Dublin on Tuesday, 25th March, will be Minister for Health Promotion and Food Safety, Pat the Cope Gallagher. The annual Organ Donor Awareness Week campaign will take place from Saturday, 29th March until Saturday, 5th April. This campaign aims to 10 Issue 3 Vol 10 March 2008 highlight to the general public the ongoing need for organ donation for people awaiting life saving organ transplants including heart, lung, liver, kidney and pancreas. It is also a fundraising exercise for the Irish Kidney Association (IKA) and IKA volunteers will be out on the streets and in shopping centres throughout the country selling ‘forget me not flower’ emblems (the symbol of transplantation), flower pins and donor card keyrings. The campaign is organised by the Irish Kidney Association, the organisation charged with promotion and distribution of the organ donor card in Ireland. For the second year in a row, TV and radio personality, Ryan Tubridy, will endorse the campaign and will feature in radio advertising and on posters which will be distributed to pharmacies, GP surgeries and medical centres and around the country. The campaign will also include TV advertising and will be backed up by a public relations campaign. news in brief - UK Nurses – ‘grubby, drunken and promiscuous’ Lord Mancroft a Tory peer called British nurses “grubby, drunken and promiscuous” during a debate in the House of Lords on 29th February. In the debate he claimed it was a miracle that he was still alive after his stay in filthy wards at teh Royal United Hospital in Bath. He also claimed that the nurses chatted to one another about their sex lives and alcohol intake in front of patients, some of whom they regarded simply as “a nuisance”. The Royal College of Nursing said Lord Mancroft’s comments were “grossly unfair on nurses across the UK” and were a “sexist insult about the behaviour of British women”. Lord Mancroft, is a member of Pratt’s Club in St James’s, London. Costs awarded against Society in FTP case The Royal Pharmaceutical Society Costs had costs, estimated at £20,000, awarded against them recently following unsuccessful disciplinary proceedings against two pharmacists. The RPS had brought a case against two brothers who jointly owned a community pharmacy with their third brother. The RPS alleged the two brothers were guilty of misconduct because the third brother incorrectly endorsed a number of NHS prescriptions. The two brothers were not involved in the running of the pharmacy. Pharmacists reject child protection registration Pharmacy organisations in the UK say that pharmacists and pharmacy staff should be excluded from legislation which requires individuals working with children and vulnerable adults to register with the Independent Safeguarding Authority (ISA). They argue that pharmacists and registered pharmacy technicians are already regulated by the Royal Pharmaceutical Society and registration with the ISA would lead to unnecessary duplication of information and effort. As well as criticising potential duplication, the response also points to the lack of consistency in requirements across the UK. It suggests that working under two different schemes could lead to different levels of protection being provided to the public. pharmexx Ireland has arrived… Laurence Carroll, Pharmacy Business Manager, Ascent Healthcare; Steve Thomas, Sector Manager, Boehringer Ingelheim, Consumer Healthcare; Neil Lawrence, Divisional Director, Boehringer Ingelheim, Consumer Healthcare Steve White, Director, pharmexx UK; Nigel Mansford, Managing Director, pharmexx UK Steve White, Director, pharmexx UK; Aisling Dillon, Sales and Marketing Manager, pharmexx Ireland; Nigel Mansford, Managing Director, pharmexx UK; Jo Shields, Project Support Manager, pharmexx Ireland Steve Thomas and Aisling Dillon Colm Moran and Jo Shields Aisling Dillon, Sales and Marketing Manager, pharmexx Ireland; Jo Shields, Project Support Manager, pharmexx Ireland Europe’s Leading Contract Sales & Marketing Organisation Launched in January 2008 Pharmexx Ireland provides high quality contract sales and marketing services supporting prescription, OTC and general healthcare brands. Pharmexx provides a total portfolio of services to both large and small customers ranging from starting a completely new company for a client to providing bespoke solutions for large established pharmaceutical companies. Pharmexx has over 300 clients worldwide, 100 of whom are transnational, including 21 of the top 25 top pharma groups. Over 6,000 sales staff successfully market innovative products in 55 global markets. Pharmexx is the largest Contract Sales Organisation (CSO) in Europe and has won awards as one of Europe’s fastest growing companies. In 2006 Pharmexx achieved the status of No.1 CSO. Pharmexx has the capability to draw upon an international total service offering or to activate local expertise as required, backed by a strong management team with considerable industry experience . Pharmexx Ireland is based in Pharmapark, Chapelizod, Dublin. ‘Ascent Healthcare’ is the first pharmacy salesforce, now detailing and selling the Boehringer Ingelheim Consumer Healthcare Portfolio Trevor Lysaght (Munster) - 086 0456 817 Laurence O’Carroll (Leinster) - 086 0456816 Colm Moran (Connacht) - 086 0470989 Alternatively for more information on our services, please contact our office: Sales and Marketing Manager – Aisling Dillon – [email protected] Project Support Manager – Jo Shields – [email protected] Telephone: 01 – 630 5260 and Fax: 01 – 623 2414 Email: [email protected] news news UniPhar plc to make two acquisitions in Britain UniPhar plc announced on 28th February that it is to acquire Forth Medical and NorthStar Orthopaedics in Newbury, England for an undisclosed sum. Forth Medical specialises in the sales, marketing and distribution of implants and devices used in ENT surgery, neurosurgery and spinal surgery throughout Ireland and Britain. NorthStar Orthopaedics specialises in the marketing and distribution of orthopaedic implants and ancillaries throughout Ireland and Britain. The businesses employ 40 people between them. Making the announcement, Jim Canavan, CEO, UniPhar plc said: “These investments are a great fit for UniPhar, in terms of the core competences in sales, marketing and distribution of medical and surgical devices, and also the ethos of customer relationships, which is the cornerstone on which these businesses have been built. We look forward to investing in these successful businesses and delivering future growth to their principals and to the shareholders of UniPhar plc.” George Strang, Managing Director, Forth Medical and NorthStar Orthopaedics, said: “This is a very exciting time in the evolution of the Forth Medical and NorthStar Orthopaedics businesses. We look forward to working with UniPhar plc in developing and growing our customer relationships, driving growth in the businesses and further developing our footprint in Britain and Ireland.” UniPhar plc, headquartered in Dublin, was formed in 1994 and is owned by Community Pharmacists. Its core competencies are in the fields of distribution, marketing, sales and market-driven value added initiatives. The company consists of eight divisions, operating within the healthcare and health related sectors, and the products and services are designed to promote the ‘wellness’ concept for people, animals and the environment. Group turnover has grown to over €705 million and the company employs in excess of 700 people. news in brief – Us US scientist clones himself US scientist Samuel Wood, a researcher in La Jolla, California, has created a cloned embryo from his own skin cells. Wood used cells taken from his own skin and injected them into donated eggs that had been treated to remove their own genetic material. The eggs developed into very early stage embryos that were genetically identical to the scientist’s own DNA. This research would indicate that it will soon be possible to create supplies of embryonic stem cells genetically matched to patients, which could be used to regenerate diseased or damaged tissues without the risk of immune rejection. Sunshine protects against cancer A recent study carried out at the Brookhaven National Laboratory in the US suggests that the health benefits of vitamin D, could justify a modest increase in the amount of time we spend in the sun. The study showed that people with higher levels of vitamin D were more likely to survive cancers of the colon, breast and lung. Increased sun exposure may lead to improved cancer prognosis and, possibly, give more positive than adverse health effects according to the studythe researchers. There is growing evidence that people in Ireland and the UK not getting enough vitamin D. Experts recommend 5 to 25 mgs of the vitamin a day. 12 Issue 3 Vol 10 March 2008 See the Difference fibre can make in supporting your nutritionally compromised patients Fortisip Multi Fibre’s unique MF6TM blend of fibres is clinically proven to reduce laxative use, relieve constipation, reduce the incidence of diarrhoea and improve gut transit for patients requiring nutritional support.1-4 Recommend Fortisip Multi Fibre and see the difference for yourself. For advice, samples or more information, call Freephone 1800 923 404. Nutricia Clinical, Block 1, Deansgrange Business Park, Deansgrange, Co. Dublin. | Tel: +353 1 289 0283 | Fax: +353 1 289 0255 | Email: [email protected] 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. ALCHEMY FEB AD_FEB 08:Layout 1 14/02/2008 12:15 Page 1 ‘‘your formula to sourcing exempt medicinal products and manufactured specials” We ■ are a one-stop service for exempt sourced medicinal products1 ■ supply manufactured specials/extemporaneous products within 24-48hrs ■ have experienced support staff to manage the intricacies associated with handling exempt sourced medicinal products in an ethical and professional manner from the initial request, through to the supply of the medicine ■ source, import and supply irregular and once off products ■ no extra delivery charges using customers current delivery arrangements ■ provide a first class cold chain service If you are a hospital or community pharmacist, doctor, dentist or a veterinarian and you have a product enquiry or order, contact your local CMR telesales office or the Alchemy specialist team and we will then source, price and oversee the delivery of your order making sure you get what you need quickly and costeffectively. Working with Alchemy and CMR provides you with instant access to a multitude of international possibilities to fulfil your exempt sourced medicinal products requests. CMR & Alchemy operates in line with Irish Medicines Board (IMB) guidelines. 1 S.I. No. 538 of 2007: MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) REGULATIONS 2007, (SEC 2 (17)). Contact Details Dublin Sligo Cork Nóilín O'Hora (Dip Pharm Tech) Specialist Product Manager Alchemy email: [email protected] Cahill May Roberts Cahill May Roberts Cahill May Roberts Tel: + 353 1 630 5155 Fax: + 353 1 626 8164 email: [email protected] Tel: +353 71 9161801 Fax: +353 71 9161977 email: [email protected] Tel:+353 21 4965588 Fax: +353 21 4965669 email: [email protected] the law Contract Law – co r m ac o’n ei l l general principles The implications of contract law are inescapable for anyone who runs a business. C ontract law surrounds us all day every day and we generally go about our business without paying any attention to the fact that most of our transactions are governed by it. A restaurateur selling a meal, a publican selling a pint of beer and a pharmacist selling both prescription and non prescription medicines are all involved in transactions with contractual implications. When a pharmacist or a business enters into a contract it confers rights and responsibilities on all of the parties who have agreed to be bound by the contract. Perhaps the reason why so many pharmacists go about their business entering into countless number of contracts without ever paying much attention to contract law is because the vast majority of contracts are performed without much trouble. It is only when things go very wrong that a pharmacist will have to focus their attention on contract law. If businesspeople and pharmacists were more familiar with the basic provisions of contract law it would give them increased confidence when negotiating contracts, particularly the larger ones where they are more exposed to business and economic risks. Also if businesspeople are aware of contract law it may help them avoid conflict in the future and thus reduce significantly the number of cases ending up in the courts. An Agreement – not necessArily A contrAct It is important to understand that a contract is simply an agreement that legally binds the parties who have entered into it. The concept of agreement is the cornerstone upon which the contract rests. An agreement is reached after one party makes an offer to another and the other accepts the offer. Once this happens it is said that an agreement has be reached. However there is much more involved in a contract than an agreement. Many agreements are entered into by people every day where it is understood that neither party intends the agreement to have legal consequences. An example perhaps would be where one friend agrees to have another friend come to spend the night at their home with their family. Contract law principles do not “ A person must be able to show that there was consideration present before he can sue for breach of contract. normally follow this type of agreement. VerbAl Agreements The majority of contracts are known as simple contracts. They may be oral, written or inferred from conduct. It is often thought by people that oral contracts are worthless, this assumption is false. Oral contract is recognised by the law. Oral contracts have the obvious difficulty of proof of existence but this does not make such a contract invalid. Witness Contracts in writing may have their own difficulties associated with them. There are certain contracts required by law to be in writing, such as hire purchase agreements and contracts for the sale of land. Contracts of this nature, not witnessed in writing, are likely to face enormous difficulty with enforceability and are indeed invalid if not in writing. Pharmacists buying or selling premises will need to have all agreements in writing to be enforceable. legAlly binding After reaching an agreement the parties have concluded the first step in the process of forming a contract. The second step for both parties is to intend the agreement to be legally binding. The test which the court uses in assessing whether the necessary intention existed is to simply analyse the words used in the negotiations, the circumstances surrounding the negotiations and also to analyse the conduct of the parties and ask would a reasonable man come to the conclusion that the parties intended the agreement to have legal consequences. When analysing contracts for this purpose the courts draw a distinction between agreements of a commercial or business nature and those of a social or domestic nature. The presumption is that with commercial type agreements the parties do intend to be legally bound. However, if the necessary evidence can be produced in court this presumption can be rebutted. Conversely, where an agreement is of a social nature, the presumption exists that the agreement is not intended to have legal consequences. The courts may however allow admissible and relevant evidence to be submitted which shows that an agreement reached in a social setting was intended to have legal consequences. Therefore agreements reached in a domestic setting can have legal consequences in contract law. ‘considerAtion’ defined Once it is shown that an agreement was reached and the parties intended the agreement to have legal consequence, it must be demonstrated that consideration was present. The term consideration in contract law means that some advantage must have been promised by each party to the other party to the agreement. A person must be able to show that there was consideration present before he can sue for breach of contract. It can be difficult to identify Issue 3 Vol 9 March 2008 15 the law the consideration present in many contracts and it can be a difficult legal principle to understand. So perhaps an example would help to demonstrate. If a pharmacy or supermarket agrees to provide groceries to a client or customer for the sum of €100, it means that each party to the agreement has made a promise to the other. The shop has promised the groceries and the customer has promised €100. This is the consideration. A number of rules have been developed by the courts over the centuries regarding the essential element of consideration. 1. The consideration must be sufficient in law but need not be commercially adequate. This means it must exist but the courts will not investigate whether it was a good and fair deal for each party. 2. The consideration must have been supplied by the plaintiff. If the consideration was provided by someone else this will frustrate the claim. 3. The consideration must not be vague, illegal or impossible to perform. 4. The consideration must not be in the past, it must not have been provided before the agreement was reached. TerminaTion of conTracT Once a contract has been entered into there are a number of ways by which it will come to an end. The contract will be regarded as being discharged when all of the obligations of the parties have been performed. The most common way by which a contract reaches its conclusion is by performance. A contract is said to have been performed when the parties to the contract have fulfilled exactly all of their respective promises to one another. ‘SubSTanTial performance’ In the past the courts required that everything was to be done exactly as promised for the contract to be deemed to have been performed. This was known as specific performance. This rule was considered to be rather harsh and lead to some very harsh decisions. Over time a new doctrine emerged known as substantial performance. This requires that if the majority of the work has been done the majority of the price should be paid. Our judiciary now has judicial discretion in this matter and applies the rule which best fits the facts of a particular case. Their objective is to see that justice is done and judicial discretion in this matter allows judges to avoid harsh decisions as much as is practically possible. Contracts are entered into by way of agreement and so they can only be exited by agreement. If both parties agree that the contract has come to an end the courts will uphold such decisions and agreements reached by the parties to a contract. The parties can also agree to form a new contract. If they vary the terms of the original contract, and as long as consideration (discussed above) is present, a new contract comes into being. conTracT ‘fruSTraTed’ If something happens which makes it impossible for the parties to perform their tasks and duties under the contract, the law will allow the contract to come to an end. This is referred to as the contract being frustrated. If a shop was destroyed by fire and all of the stock was unavailable for sale then through no fault of their own there is nothing that the retailer can do to perform the contract. This is an example of a situation where the law is likely to recognise the contract as being frustrated. Any monies paid over (e.g. a deposit to a supplier) should be returned. However the law will allow for a deduction for any expenses incurred prior to the contract being frustrated. breach of conTracT Contracts are said to have been breached if one party indicates that he is unwilling to perform his promise. The innocent party may sue for damages immediately in such a situation or may wait to see if the wrongdoer performs his duties. A breach of contract may also occur if one party indicates that he is unable or unwilling to perform his duties by the agreed time. This too gives a right to the innocent party to sue for damages immediately. It is very important that the innocent party treats as a breach only that which involves a fundamental term of the contract. If a minor term is breached this will not give rise to a cause of action for breach of contract. damageS The innocent party may sue the wrongdoer for breach of contract and seek to recover damages for actual loss suffered. Damages are an amount of money awarded to the innocent party as compensation. Damages attempt to place the innocent party as much as possible into the position they would have been in had the contract been performed. The Statute of Limitations 1957 sets down specific time limits within which an injured party must commence their action. In general an action in contract must commence within six years. It is important to seek professional advice regarding limitations because some causes of action are now statute barred after one year. IP COrmAC O’NeILL is a barrister practising on the Dublin and South Western circuits. He is also a Chartered management Accountant with considerable experience in industry and banking. In addition Cormac lectures on Business and Law in the Institute of Technology in Tralee and can be contacted on 087 657 1124. 16 Issue 3 Vol 9 march 2008 Europe’s Leading Contract Sales & Marketing Organisation Q&A ró n A n Q u i r k e Rónan Quirke is the immediate past President of the Pharmaceutical Society and is a council member of the PSI. He operates a community pharmacy in Clonmel. He works in the Sports Department of Tipp FM Radio and presents a sports magazine show every Monday night. What other career might you have chosen? I have done a bit of sports journalism and really enjoy it. It is hard to make a living from it though. What figure in Irish life (living or dead) do you admire and why? I admire the late Dr Noel Browne. When he left the Department of Health, real and tangible improvements to the nation’s health had occurred. How many Ministers for Health before or since can claim that? What is the one thing you would suggest to improve the Irish health service? Acute beds must mean beds for the acutely ill. That means improving step down facilities, long term care and rehabilitation units. It also requires 7-day consultant cover, appropriate discharge planning and improvements in the primary and secondary care interface. Actually that’s not one thing is it? noted for its humour. Who or what is the greatest love of your life? Tara, Munster rugby and Tipperary hurling. The order is subject to change periodically. How do you relax? Really good red wine. Works every time. Favourite TV/Radio programme? Father Ted. Morning Ireland and Off the Ball. Favourite composer/entertainer/rock group? The Rolling Stones and The Stone Roses Favourite film and book? It’s a Wonderful Life and Stand up and Fight; How Munster Beat the All-Blacks. I would like to have this book on the Leinster school curriculum. What is your motto? Keep going. How would you like to be remembered? Like everyone would; as one of the good guys. IP What is your earliest memory? Running through a plate glass window aged 2. There wasn’t a mark on me but the window, and my mother’s nerves, were shattered. What is your greatest fear? Plate glass windows When and where were you happiest? Killarney, September 2002. Long story! Brendan Hayes was on the piano but it was a great night despite that. What would your super power be? The ultimate power of persuasion. It’s all about taking hearts and minds with you. What is the worst job you’ve done? I worked as a barman in England on New Year’s Eve 1992. It was carnage. What is your best trait? My perseverance. What is your most unappealing habit? My German ancestry means I have to be either early or on time for everything. That seems to irritate people. What trait do you most dislike in others? Arrogance. Do you use alternative medicine? What kind? I don’t use alternative medicines as such. I eat a lot of garlic in the hope that it may be doing me some good. Cat or dog? If I had time, I would love to have a dog. I regard cats as the spawn of Satan. What keeps you awake at night? I’m still sleep deprived after the last two years with the PSI. Nothing keeps me awake anymore. Who or what makes you laugh? My three friends, Owen, Ed and Kevin are the funniest guys I know. Unbelievably they are all pharmacists, not a profession Issue 3 Vol 10 March 2008 17 the coalface THANK YOU, PROFESSOR DUM DUM dav i d j o r da n If only the HSE had negotiated with the IPU they wouldn’t now be facing the prospect of negotiating with 1500 recently politicised pharmacists. T o start off, I would like to give thanks where thanks are due. Pharmacists by our nature tend to be professionally isolated. Standing, physically present in our dispensaries up to 60 hours per week, we get little enough chance to meet with our fellow pharmacists. Now however thanks to Prof Dum Dum and his cohorts I have been meeting with my fellow pharmacists on a weekly basis. I have got to know many more of my peers than I would have if I had I been left to my own devices. I find this to be empowering and for that I thank you Professor. This experience has also re-politicised me and for this my long suffering wife and family do not thank you! The HSE is essentially saying ‘trust us, we will give you a fair fee’. They will set the prices and decide how much you are to be paid regardless of how much you have to pay your wholesaler for an item or how much it costs to operate your pharmacy. If you don’t like it then tough, we can just terminate your contact at three months notice. I was detailing all this to a friend who had just returned to Ireland after a prolonged period in Africa. His reaction was, “that’s exactly what Mugabe is doing in Zimbabwe”. It’s ironic that the head of the HSE, appointed by those crusaders for the free market – the PDs, is trying to set up a command economy – we set the price, we tell you what you can do. The last time that was tried was back in the days of the old Soviet bloc. It didn’t work then and it won’t work now. Profit motive Being in business I have no problem with the notion that a business should make a profit. I take an income from the profits and pay my taxes. My taxes fund the government and they provide for the nation. If my patients don’t like the service that I provide then they can choose to take their prescriptions and custom elsewhere. As my patients can choose their pharmacy, I can choose my suppliers. We sit down, discuss terms, “ Nothing is this article should be used to imply that Professor Brendan Drumm of the HSE is in fact a communist. agree a price. Over the years I have built up relationships with my suppliers and patients. If something needs to change we discuss it and come to an agreement. This is called the free market. The HSE doesn’t seem to think that this works. Communist laCkeys As I ponder the HSE’s way of doing business and dealing with pharmacists it occurs to me that Prof Drumm might be a closet communist. As with the old communist states only trade unions that toe the state line are tolerated. Not much hope for the IPU there. I can see how the HSE might have a difficulty conducting 1500 sets of negotiations with pharmacy owners. Let’s not forget the smoke and mirrors argument about the Competition Act. Wouldn’t it be so much easier if 18 Issue 3 Vol 9 March 2008 there was just one body that they could discuss these things with? No wait, surprise, surprise, such a body exists. Can you guess who they are? Even SWMBO, Mary Harney, has done her bit by announcing that there is to be an independent body which will set remuneration rates for healthcare professionals. Suddenly the Competition Act mirror is broken. But still the HSE rush ahead with their new interim contract. They are obviously trying to pre-empt the independent commission. One wonders what they have to fear from an independent commission. Maybe, heaven forbid, it might be truly independent. Maybe it might be unwilling to rubber stamp whatever the HSE wants. Might there be a few flaws in HSE’s arguments? Have they not got enough confidence in themselves. Or maybe it might just say something they don’t want to hear. For they already have previous form when an expert body produces a report that is paid for by the HSE. It told them something that they didn’t want to hear. The HSE tried to bury the Indecon Report when it said that there should be no pre-emptive changes and that there should be consultation with all parties. It may be some consolation to Joe Higgins on losing his Dáil seat that there is an old style communist running the HSE. “When consultants mock and pharmacists jeer He’ll keep the red flag flying here.” Nothing is this article should be used to imply that Professor Brendan Drumm of the HSE is in fact a communist. I merely sought to compare the actions of the HSE to those of the totalitarian regimes of Honecker and Ceaucescu. However, like a clumsy cowboy the HSE has shot it self in the foot. And here’s how. the life of Brendan If they had negotiated a new pharmacy contract with the IPU, chances are that most pharmacists would have accepted whatever the HSE and the IPU agreed. There might have been a bit of grumbling but by and large it would have gone through. But by forcing us to go to law to get the current contract paid, they have made us all aware of the terms of our current contract. In Monthy Python’s Life of Brian the mob chants, “We are all individuals, we are all different”. So now when the independent body comes up with an economic fee, 1500 pharmacists will sit down and do their figures. They will all have to decide which deal is better for their pharmacy. The High Court has already decided that the HSE cannot unilaterally change the terms of our contract. So if the HSE want me to accept a new contract, then I will have to look and see what’s in it for me. While I support most of what the IPU does on my behalf, and have appointed them as my representatives in my dealings with the HSE, at the end of the day I will decide if Jordan’s Pharmacy Ltd is going to accept any new deal. And 1500 other pharmacists will have to make a similar decision. After watching the HSE’s performance in front of the Oireachtas committee last week I have one comment and one question. Who let them out with a gun and live ammunition – get the first aid box ready for their next performance. IP David Jordan has worked in community pharmacy since 1979, qualifying as a pharmacist in 1983. He was chairperson of the Community Employee Committee of the IPU from 1990 to 1998 and Treasurer from 1994 to 1996. His main stress relief is riding his motorbike with his friends from Irishbikerforum. com. Your energy and immune systems are at its lowest… metatone will help you fight and restore from winter ailments!! metatone tonic original flavour provides an essential Vitamin and Mineral complex in a liquid formula, giving a gentle boost during and after illness and when you are feeling tired and run down. ■ metatone tonic is suitable for Adults and Children over 6 years of age. ■ RRP: €7.49. Further information available on request. Chefaro Ireland Limited, Farnham Drive, Finglas, Dublin 11, Ireland. Tel: 01 879 0600 E-mail: [email protected] SHORT STORY An Inspector Calls ‘H e’s gettin’ into me! Oh God. He’s getting’ into me’. She just wouldn’t stop screaming. Jack stared. Everything looked perfect to him except to her it clearly wasn’t. She was panicking now and beginning to hyperventilate. ‘He’s getting’ into me. He’s getting into me’ Who was he? Where was he and how in the name of God was he getting in? His unfinished pizza was still in its box beside her. In the context it didn’t look right. He closed the lid over. It was the only thing to do that made sense. Jack’s world had crossed some strange boundary and was now in the surreal. Three of them had burst in moments earlier. Jack heard the slam. They had been held up recently but this was different. Teenage girls really could scream when they wanted to. One had her top open. The second held a bra. He saw that it was red. At first he just stopped until he realised that she was going to take her clothes off right there. Money, Crab and an elderly couple all froze. Something actually was going to happen here and fast. He motioned to her to go inside quickly. Always contain a problem. Some people call it taking charge. Whatever was going to happen next, it was not happening on the shop floor. He followed her into the office. She was now topless. ‘Look!! Oh please he’s getting’ in. He’s getting’ in.’ ‘Calm Down. It’s alright. Everything’s going to be okay.’ Always reassure. You may not know what’s wrong or even have the faintest idea but it sounds good and it gives you time to think. Always buy yourself time. But exactly what was wrong here? She held one up and really screamed ‘He’s getting’ in oh please.’ Jack still saw nothing wrong but now her panic was affecting him. Think Jack think, just what can be going on here. She grabbed his shoulder. ‘Oh please Help...Look...Ah he’s getting’ in Look’ He looked and looked again. Everything was still fine. Just exactly what did she want him to do? Hold it, feel it, weigh it, put it in his pocket, dispense it? And above all who was he? Jack was scared to ask in case he was missing something of the extremely obvious. ‘Look what’s wrong?’ 20 Issue 3 Vol 10 March 2008 ‘Oh he’s gettin’ in! It was then the reality of the situation or rather the lack of it hit Jack. He’d had a phone call from another that morning. ‘They had just been inspected and to watch out. She could still be in the area’. He had spent the rest of the day housekeeping in case she called. What if she called now? Maybe this was some sort of ethical test. Maybe this was a set up by The Inspector of The Pharmaceutical Society of Ireland. Perhaps this was the Inspector herself. Get backup in here now and fast. ‘Are you all right Jack’ said Crab. Her and Money were in the office. What did she think? ‘Money, get one of her friends in here now.’ Money came back. She had chosen the friend with the bra. That might come in useful. She could be clever that way. On the other hand Jack could never figure out Crab. She found it difficult to change from one thought process to another. Once she was on one track everything was ok but………… He had just sent her on a veterinary course and was impressed at what she had picked up. Last week she had dealt with a farmer and a difficult query regarding fleas. Then the phone rang. A guy asked her ‘What should he do with Crabs’ she said ‘As far as I know you just drop them in boiling water’. ‘It’s just there. Look’ said her friend and pointed. He followed her finger and there just in the centre and underneath was a tiny circle with two black sticks. J U L I A N J U D G E, M PS I ‘We thought maybe you could pull it out. You know, a tweezers. That’s why we came’. Jack tried to think. Maybe they could pull him out? A tweezers perhaps? It sounded good but this wasn’t quite the same as digging into his knee as a teenager. It might work but if it went wrong…? Suddenly Crab handed him a tweezers. She and Money held it and looked at Jack, eyes raised. They held it up and steady. The tweezers approached. Be careful Jack. Don’t go for this. The friend was right. This tick did not want to come out. In fact at the first brush of the tweezers it took off like Atlantis. She had been right all along. He was ‘getting into her’ and she could feel it. At this stage so could Jack. She screamed from some primal source and tried to grab it with her fingers. It was too small. Enough. Ring Doctor Wesley. He was closest and had given Jack a direct line last week. This was the first time he had used it. ‘Right send her up.’ Money took her in her car. He opened his pizza box lid. The whole episode had only taken about two minutes, so it was still warm. Jack tried but he wasn’t that hungry anymore. Then later a phone call. ‘Well Jack it was a little tick. It took a while but we got it out. Stubborn little….’ ‘Thanks Doctor’ ‘No problem. I’ve dressed it and told her to come back in a few days. She’ll be fine’ ‘Thanks Doctor’ ‘Oh Jack’ ‘Yes doctor’ It was really shiny and its two back legs were scrambling. It could have been a dog digging for a bone except that it wasn’t. Jack knew that on the inside there were more legs and a big pair of sharp front claws burrowing their way in. ‘One more thing’ A Tick. Well thank God for that. For a while, Jack thought something was really wrong. Julian Judge qualified as a pharmacist in 1990. He was recently accepted for a Masters in Creative Writing at the Department of English, UCD. Money reassured her. Jack reassured himself. Relief was a great thing. What to do now? They looked. Jack had had a few himself and used to squeeze them out. He knew they were quite obstinate and that it took an effort. ‘Have you tried squeezing it?’ Money asked. ‘We did but then he started wrigglin’ and goin’ in further’ said the friend. ‘Yes doctor’ ‘How many legs do those things have?’ This is the first of a series of short stories which Julian has written exclusively for Irish Pharmacist. These stories are based on his experience as a pharmacist but they are fictional and any similarities they might have to any persons living or dead is entirely co-incidental. The stories are based on a notional pharmacy in the East of the country. FIRST NEW CLASS in Hypertension for over 10 years A Breakthrough in Hypertension: The 1st D IRECT R ENIN INHIBITOR NEW RASILEZ ABBREVIATED PRESCRIBING INFORMATION Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Rasilez film-coated tablets containing 150mg and 300mg of aliskiren. Indications: Treatment of essential hypertension. Dosage: 150mg to 300mg once daily with a light meal, alone or in combination with other anti-hypertensive agents. No adjustment of initial dose require in elderly (>65 years), renal and liver impairment. Not recommended < 18 years of age. Contraindications: ◆ Hypersensitivity to the active substance or excipients. ◆ Pregnancy. Warnings/Precautions: ◆ Increased risk of DRI power that lasts. hyperkalaemia in patients receiving other RAS agents, and/or those with reduced kidney function and/or diabetes mellitus ◆ Caution in patients with heart failure ◆ Close medical supervision in patients with marked volume- and/or salt-depletion due to risk of hypotension ◆ Caution in patients with severe renal dysfunction, renal artery stenosis, a history of dialysis, nephrotic syndrome, or renovascular hypertension ◆ Not recommended during pregnancy or when planning to become pregnant, to be discontinued if pregnancy occurs. ◆ Not recommended in breastfeeding women. ◆ In event of severe and persistent diarrhoea, Rasilez should be stopped. Interactions: ◆ Monitoring when used concomitantly with furosemide ◆ Interaction with ketoconazole ◆ Concomitant treatment with drugs that may increase serum potassium levels ◆ Possible interaction with digoxin, irbesartan, St. John’s wort, and rifampicin ◆ Meals with high fat content substantially reduce absorption. Adverse Reactions: ◆ Common: diarrhoea ◆ Uncommon: Rash ◆ Rare: Angioedema ◆ Laboratory values: decrease in haemoglobin and haematocrit, increase in serum potassium. Please refer to SmPC for a full list of adverse events. ◆ Legal Category: POM ◆ Pack Sizes: 14 and 28 film-coated tablets ◆ Marketing Authorisation Holder: Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom. ◆ Marketing Authorisation Numbers: EU/1/07/405/2-3, 12-13 ◆ Full prescribing information is available on request from Novartis Ireland Ltd, Beech Hill Office Campus, Clonskeagh, Dublin 4. Tel: 01 2601255 ◆ Date of Revision of Text: August 22 2007 ◆ Date of Preparation: February 2008 ◆ NO1207619 interview Honoured by her peers Head of the School of Pharmacy at UCC and recipient of two awards at last year’s Pharmacy Awards, including that of Pharmacist of the Year, Professor Caitriona O’Driscoll discusses her work with Irish Pharmacist. i n t erv i e w by j ay cu rt i s s pec i a l co r r es p o n d en t P rofessor Caitriona O’Driscoll was honoured with no less than two awards at the recent Irish Pharmacy Awards, one of which was the ultimate accolade – Pharmacist of the Year. She is also the driving force behind the establishment of the first School of Pharmacy outside Dublin. Cork born Professor O’Driscoll spent most of her adult life in Dublin where she studied pharmacy at UCD. After graduating in 1976 she followed the transfer of pharmacy from UCD to Trinity College Dublin (TCD) where she did a PhD. Like most Cork people however, the homing gene proved very strong and following a successful career as a Senior Lecturer in Pharmaceutics at TCD – coupled with a 12 month sabbatical in the School of Pharmacy in Kansas in the US, where she worked on targeted drug delivery systems – Caitriona returned to Cork in 2003 to take up the position of Professor of Pharmaceutics and Head of the School of Pharmacy in UCC. first stuDents Professor O’Driscoll had just five short months between her home-coming in June to welcoming the first class of pharmacy students in October 2003. That same year UCC received accreditation from the Pharmaceutical Society of Ireland (PSI) for its four-year degree programme. Just 18 months later following a period in temporary accommodation, Cork University constructed a brand new building for its fledgling school. 22 Issue 3 Vol 10 March 2008 The Cavanagh Pharmacy Building is named in honour of Dr Tom and Mrs Marie Cavanagh. Dr Cavanagh, a UCC commerce graduate, is Vice-Chairman of the university’s Governing Body and a director of the Cork University Foundation. Located in the main UCC campus Professor O’Driscoll described it as “a terrific state-ofthe art building” with sophisticated teaching facilities and high-spec laboratories for the School’s 55 undergraduate, and increasing number of post graduate, students. Built at a cost of €22.3m, The Cavanagh Pharmacy Building comprises 5,600 sq metres of teaching and research laboratories, lecture theatres, seminar rooms and support space. It is home to both the undergraduate and postgraduate facilities of UCC’s School of Pharmacy, as well as the university’s Analytical and Biological Chemistry Research Facility (ABCRF). It also houses a dedicated industry suite to facilitate collaboration between UCC and the pharmaceutical industry. Commenting on the challenges associated with establishing the first School of Pharmacy outside the Capital, Professor O’ Driscoll gave huge credit to the support she received from the Cork College. “UCC were very supportive. They had been planning to establish pharmacy here in the University for several years. When I arrived that was one of the things I noticed, people were very enthusiastic for the new course. The university was very supportive …we got this terrific building within a very short period of time and they were very supportive in hiring staff…other disciplines are very keen to teach on the course and to help us, so everybody was very supportive.” Competition not ConfliCt The established School of Pharmacy at TCD and the relative new comer to pharmacy the Royal College of Surgeons in Ireland (RCSI) which set up its School in 2002, were also very welcoming of the new UCC degree. “I came from an established school,” Professor O’Driscoll said with a smile. “Everybody now knows and appreciates that competition is healthy and there really isn’t any conflict between us at all. In fact we just recently got together to collaborate on a Science Foundation Ireland (SFI) research cluster. There is a lot of interaction going on between the schools, it is all very positive. I also think it will be very good in the future, we will have an opportunity to share research and do more collaborative work.” Drug Delivery researCh In fact the UCC School of Pharmacy is already engaging in a highly successful collaborative research project. Together with the Conway Institute, UCD and the Schools of Pharmacy in TCD and the RCSI, UCC forms part of the Irish Drug Delivery Network (IDDN) which recently secured a massive €5.2 million Strategic Research Cluster from SFI. The grant is one of the largest ever given to a drug delivery consortium in the EU. Engaged in genuine translational science, the IDDN will make oral and inhaled formulations of biotech molecules that normally require injection. The molecules will be protected from break-down by capping with novel shielding polymers formulated as particles. The Industry partners are Genzyme Ireland, Sigmoid INTERVIEW Biotechnologies and Warwick Effect Polymers. “ I was very honoured to win the award. It is a great thing to be picked out by your fellow pharmacists for an award like this. Manpower shortage According to Professor O’Driscoll, the UCC School of Pharmacy was established to fulfil a manpower shortage in the profession, which had been identified in Ireland. While she believed that the shortage still existed, the Cork Professor told Irish Pharmacist that it would take some time before the full impact of the extra graduates from the new schools in UCC and the RCSI would be seen. “It’s very difficult to be exact about the manpower situation into the future because it is hard to quantify the degree of freedom of movement into Ireland from other European countries for example. If our economy isn’t as good in the future as it has been in the recent past, that might change. So there are a whole lot of other unknowns that can influence the manpower situation,” Professor O’Driscoll explained. Pharmacists are entitled under European Union (EU) free movement Directives to register in Ireland if they hold a qualification from an EU or European Economic Area (EEA) member state and are nationals of a member state of the EU or EEA. Despite increasing numbers of pharmacists coming to work in Ireland and the relatively recent arrival of two new pharmacy schools, Professor O’Driscoll said that a manpower shortage still existed particularly in community and hospital pharmacy. “At present over 80 per cent of graduates from all the schools probably go into community pharmacy. There are also huge opportunities for graduates in the pharmaceutical industry and they are growing all the time because the pharmaceutical industry has a very significant presence in the country,” she said. However Professor O’Driscoll added that the attraction of a generous salary in community pharmacy coupled with the demand for retail pharmacists has meant that Irish graduates have not fully exploited the opportunities in the industrial sector. A 2005 report in the Sunday Business Post stated that a newly qualified pharmacist could expect a starting package of €50,000 a year, with that salary scale escalating quickly to approximately €70,000 within seven or eight years. points prohibitive However, it must also be stated that the Leaving Certificate points required to study pharmacy are among the highest – 550 to 560 – and the course is demanding. Commenting on this Professor O’Driscoll said she would like to see pharmacy more accessible to those who may not achieve such high points, similar to the reforms currently underway in undergraduate medicine. “I would like to see it more accessible but we also have to be conscious that we don’t want to have too many pharmacists in the country which could result in unemployment, if you have too many graduates. So there is a balance there. Again I think it’s too early to see the effects of the new schools. In a few years time when we have been producing these extra numbers of graduates for a continuous number of years, then that may affect the points.” hospital pharMacy In relation to hospital pharmacy the UCC Professor said that a lot of graduates were interested in working in the area as “the career prospects and nature of the work has become very exciting.” However, she said that unfortunately current budgetary constraints that are affecting all other healthcare professionals mean that the number of jobs available in hospital pharmacy is limited. Coupled with community, hospital and industrial pharmacy Professor O’Driscoll added that the versatility of a pharmacy degree means that a number of alternative and varied career paths are open to graduates including research, science journalism and regulatory affairs. “From that point of view it is a very good degree because it opens up a lot of choices for graduates.” Doubly honoureD On the same night she was named Pharmacist of the Year, Professor O’Driscoll was also presented with the Award for Professional Excellence at the 2007 Pharmacist Awards. Her excellence is evident not only in her commitment to education but also through her extensive work in pharmaceutical research. A career in academia has allowed the Professor of Pharmaceutics to combine her two loves of teaching and research. Now that she has successfully established the new School, she intends to turn her attention to research. “Now that we have our new building and our courses up and running, we are turning our attention to developing research within the school. That will be our main driver for the coming years, to develop and extend our research and to interact more with the clinical profession and industry,” she stated. Professor O Driscoll’s own area of expertise is drug delivery with a particular interest in drug delivery following oral administration. “What we are really interested in, are drugs, for example, like peptide and protein drugs, a classic example would be insulin, and trying to work on non-injectable forms. The oral route of administration from a patient’s point of view is the most acceptable; their compliance would go up and it is generally a safe route. Patients could also self administer, so there are huge advantages to oral administration. But there are also some drugs that can’t – because of their chemical nature – be given by the oral route unless they are protected in some way. So that is what we are trying to achieve, protecting those drugs and making sure that they can overcome barriers in the gut and can be absorbed and travel to the disease site to treat only the cells that are diseased and avoid the healthy cells.” The Professor of Pharmaceutics explained that drugs can be protected in various ways including the use of excipients and the addition of a targeting ligend for particular cell types. biotechnology According to Professor O’Driscoll, novel drug delivery is “a very exciting area to work in” and she believes that we will see a number of very exciting developments in the area over the coming years particularly in the area of pharmaceutical biotechnology. “We also have a project ongoing here where we are looking at gene delivery. Who knows, in 10 or 20 years you might be able to go into the pharmacy and buy a gene delivery product. I think there are great opportunities for us now. It’s exciting. The research is great, I get great satisfaction from it and it complements the teaching as well.” Coupled with research in the area of pharmaceutics Professor O’Driscoll said there were a number of other research projects currently underway in the UCC School including pharmaceutical and medicinal chemistry, neuropharmacology, vaccine design and delivery and clinical pharmacy. In conclusion, Professor O’Driscoll expressed her delight at being named the 2007 Pharmacist of the Year. For the soft spoken pharmacist the recognition of her colleagues and peers was particularly special. “I was very honoured to win the award. It is a great thing to be picked out by your fellow pharmacists for an award like this. I was absolutely thrilled and very honoured. To be picked out by your fellow professionals is a very special thing.” IP Issue 3 Vol 10 March 2008 23 finance ‘Short Term Economic Outlook’ – Does it really matter? I “ Pau l a . Ov ery In market conditions such as today, you will see the professional investors purchasing from the nonprofessionals as those nonprofessionals let media hype scare them out of the market. f you have been reading the newspapers, listening to radio or watching TV recently, you could be forgiven for believing that we are in economic meltdown. Doom and gloom prevails as interest rates remain “high”, the “Sub Prime” problem remains “unsolved” and the world’s stock markets are “bearish”. Corrective action taken by some state institutions (the FED in the US for example) is described as “panicked” and the old stalwart of “cash is King” has been resurrected. Time To buy? All of these ‘issues’ are short-term and thus the question must be asked, in our client’s attempts to create sustainable ‘financial freedom’ over the long term, whether these short-term issues really matter? Sustainable financial freedom is built over the long-term (a recent internal survey suggests that, on average, our clients achieve their objective over an average of 11 years) and these short-term problems, in our view, represent much more of an opportunity than a threat. Today, you can buy certain blue chip shares, for example, at a far lesser price than just six months ago. The same is true of certain properties, both here in Ireland and overseas, and these lower prices must represent an excellent buying opportunity, as long as one believes that the markets will recover. Let’s look at a mathematical example on an investment property, using the example of a property being purchased today with 75% finance at an interest rate of 5%. If you pay €300,000 today for this property, which I will assume grows in value by 5% per annum over the next 15 years (i.e. sale price of €624,000) and on which you receive an average annual rent of €10,000, the Internal Rate of Return (IRR) on your investment will be: 14.57% p.a. Note: The IRR is based on the net, after all taxes, out of pocket expense to the investor over the 15 year term Now suppose, instead of buying today you wait for 6 months and purchase the same property for €270,000 (10% drop in price) and all other assumptions remain the same, what will be the IRR after 15 years? 14.84% p.a. Note: The IRR is based on the net, after all taxes, out of pocket expense to the investor over the 15 year term The six month delay, which in our example assumes you get the timing perfectly correct (i.e. you buy exactly at the bottom of the market), delivers an additional IRR of just 0.27% per annum. And here is the point I want to make; while short-term market fluctuations can be painful (as we watch our hard won assets decrease in value), and are made all the more painful by media reports, in the longer-term they make very little difference. Economic markets move in cycles, sometimes the cycle is in a downward phase, more often than not the movement is upwards. As long as you believe this is NOT the end of the world as we know it, recent market problems present more opportunities than problems. 24 Issue 3 Vol 10 March 2008 ‘Time’ is everyThing Not even the professionals can accurately call the bottom of a market and so for you to do so is most unlikely. However, we do not believe, where true financial freedom is your objective, that “TIMING is everything”, because in the race to accumulate sustainable wealth, TIME is the most important thing! “Timing is everything” is the battle cry of the product sellers because, quite frankly, they want you to BUY NOW. You have already seen in the example above that waiting for the property market to drop another 10%, makes a tiny difference over TIME. Indeed, in the market conditions that prevail today, the ordinary (lay) investor is often paralysed by financial fear as they consume more and more doom and gloom media reports. Such paralysis typically lasts far longer than the downward phase of the market, which means that these (lay) investors only re-invest when much of the losses have been regained (i.e. their financial fear being allayed by many more positive financial stories) and thus miss the opportunities that a recovery offers. WhaT are The professionals doing? So, in closing, our message to those clients who are making investments in an attempt to create sustainable financial freedom; is to ignore much of the negative market hype and to look for the substantial opportunities that such market conditions present. Remember, in any financial transaction there are two opposing opinions present. For example, if you own bank shares and decide to sell them due to recent losses, it has to be true that the buyer of those shares holds the opposite view to you. In market conditions such as today, you will see the professional investors purchasing from the non-professionals as those non-professionals let media hype scare them out of the market. For our clients, our suggestion is to mirror the actions of the professionals, rather than the actions of those who let financial fear and panic dictate their actions. Over the coming weeks and months we in Financial Engineering (FE) will be putting together a number of investments to take advantage of the opportunities presented by recent market conditions. As usual, they will be relatively long-term (3-5 years +) and will be structured in a manner to offer our clients the very best potential possible in as low a risk environment as we can negotiate. We look forward to discussing them with you as they come to market. IP Paul A Overy QFA, FLIA, is the co-founder of Financial Engineering Network Ltd, www.fen.ie Financial Engineering is regulated by the Financial Regulator. Paul is the author of the best selling book, The Tricks of the Rich Tel: 01 614 8000 FE will be holding a seminar in Days Hotel, Castlebar, Co Mayo at 6:15pm on 11th March Please contact Marie Fitzpatrick if you would like further information Tel: 01 614 8070 Email: [email protected] view from above Getting a grip The role of the pharmacist in prevention is being taken seriously by our near neighbours. I f I were to appear before the Statutory Committee and the case against me stated that I left the pharmacy during business hours and that I went to a public house where alcohol was being consumed and that there I asked men to feel their testicles then I should not be surprised if the Chairman of the committee instructed that my name be removed from the register. Most practising pharmacists would agree; such behaviour could only bring the profession into disrepute. Yet, at least one pharmacist from Northern Ireland did this very thing, and did it on more than one occasion, and rather than a trip to the Committee, he got paid by the Building the Community Pharmacy Partnership (BCPP) for his efforts. HealtH streams In the UK public health is at last becoming prominent within primary and secondary care. This means we are wakening up to the fact that the health services have to date consisted of primary care treating sick people and secondary care treating even sicker people. Sir Donald Acheson, Chief Medical Officer in 1997, gave us the “stream” metaphor for ill health suggesting that health services were very good at saving people “down-stream” after they had fallen in but not good at stopping them getting to this point. Prevention is better than cure and less expensive so why do we not offer more effective preventive services, Acheson asked. “ The Building the Community Pharmacy Partnership is without doubt the most innovative pharmacy-based public health initiative in the UK. Primary care services are difficult to re-engineer towards prevention activities and away from treatment and cure. What determines an individual’s health and the health of communities is complex and deficiencies often exist because of social inequalities. Prime Minister Gordon Brown, attempting to gain some selfrespect recently committed England to a Public Health initiative that amounts to screening and action based on results. This comes from the work of Derek Wanless who considered how the UK Health Service might pay for itself twenty years from now. Wanless, in support of Achenson 10 years earlier, asked for more “up-streaming” of health services, interventions that might stop people getting ill in the first place but Mr Brown’s approach is not near far enough “up-stream” since it does not engage with people early enough. The pharmacy-based model, the BCPP, is. t er ry m ag u i r e PHarmacy initiative The Building the Community Pharmacy Partnership (BCPP) is without doubt the most innovative pharmacy-based public health initiative in the UK. It is by far the best example of how community pharmacy can plug into public health and begin to make a difference. The BCPP has come a long way since it was first conceived by DHSSPS. The key was finding the funding; this came through Executive Funds made available by the first Executive. Flexibility in programme design and delivery and a partnership approach define the scheme’s success. The community if falling over itself to partner with a local pharmacy in securing funds. In December I was asked to become involved in three separate projects; work with street-drinking young men, medicines management for the housebound and obesity. The BCPP projects are at the heart of communities supporting individuals make healthy choices. I suppose the challenge now for BCPP is how to mainstream the BCPP projects. Fat is a Falls road issue Some years back I had a successful BPCC project addressing obesity in the local community. We partnered with the Falls Women’s Association as tough and proud a bunch as you’ll meet. They did not allow us to use the words “fat” or “obese” in any publicity material and who was I to disagree but it proved difficult. We innovatively came up with the Healthy Weight Challenge and enrolled 33 women with whom we worked for a year each had a body mass index of 35 or greater. This group became known affectionately as Terry’s Tubbies. Simply we set them targets, advised on food and exercise and followed them up every two weeks. Eleven lost 1-5 lbs, 10 lost 510 lbs and 12 dropped out and went back to Kentucky Fried Chicken. Back then, I found it difficult to continue with the work. I now can get continuation funding but I wonder how we might develop an evidence-base for specific successful initiatives. This would allow other pharmacies to adopt the service model defined by a national standard specification. It seems an unusual role for a pharmacist who should be dispensing prescriptions but if, as a profession, we really are committed to improvements in public health we will need to engage with people where they are and therefore it might make sense for pharmacists to, on occasion, leave the pharmacy and go to where people are. This might include showing men how to check themselves for testicular cancer and other things that will kill them if they don’t adopt healthier lifestyles. IP Terry Maguire BSc, PhD, FCPP, FPSNI, MRPharmS (Hon Member) FPSI. Dr Maguire owns and managers two pharmacies in Belfast, Northern Ireland. 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 3 Vol 10 March 2008 25 AROMASIN® Switch to Aromasin for improved survival1 ENHANCING LIFE’S EXPECTATIONS *17% reduction in risk of death versus continuing on tamoxifen. P=0.05 (1) 1. Coombes RC et al. Survival and safety of exemestane versus tamoxifen after 2–3 years’ tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet 2007; 369:559–70. 2. Goldhirsch A et al. Meeting highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005. Ann. Oncol 2005; 16: 1569-83. 3. Winer EP et al. ASCO technology assessment 2004. J Clin Oncol 2005; 23(3): 619-29. AROMASIN® Prescribing Information. Presentation: Coated tablet. Each tablet contains 25mg exemestane. Uses: Adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy and until completion of 5 years of combined sequential adjuvant hormonal therapy or tumour relapse. Treatment of advanced breast cancer in postmenopausal women, whose disease has progressed following an anti-oestrogen therapy. Efficacy has not been established in patients with oestrogen receptor negative status. Dosage and administration: One 25mg tablet to be taken once a day preferably after a meal. Contra-indications: Known hypersensitivity to the active substance or any of its excipients, pre-menopausal women and pregnant or lactating women. Warnings: Should not be administered to women with premenopausal endocrine status or patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency and should be used with caution in patients with hepatic or renal impairment. Tablets contain methylp-hydroxybenzoate which may cause allergic reactions (possibly delayed). Bone mineral density and risk of fracture should be assessed at the start of treatment. Treatment for osteoporosis should be initiated as appropriate and patients should be carefully monitored. Interactions: In vitro evidence showed that the drug is metabolised through CYP450 3A4 and aldoketoreductases. Co-administration of drugs and herbal preparations known to induce CYP 3A4 may reduce the efficacy of Aromasin. Use cautiously with drugs metabolised by CYP 3A4 that have a narrow therapeutic window. Should not be co-administered with oestrogen containing medicines. Side Effects: Adverse events were usually mild to moderate. The withdrawal rate due to adverse events in clinical trials was 7.4% in patients with early breast cancer and 2.8% in patients with advanced breast cancer. Very common (>10%) were: insomnia, headache, hot flushes, nausea, increased sweating, joint and musculoskeletal pain, fatigue. Common (>1%, ≤10%) were: anorexia, depression, dizziness, carpal tunnel syndrome, abdominal pain, vomiting, constipation, dyspepsia, diarrhoea, rash, alopecia, osteoporosis, fracture, pain, peripheral oedema. Uncommon (>0.1%, ≤1%) were: somnolence, asthenia. Thrombocytopenia and leucopenia have been rarely reported. An occasional decrease in lymphocytes has been observed, particularly in patients with pre-existing lymphopenia. Elevation of liver function test parameters including enzymes, bilirubin and alkaline phosphatase have been observed. Gastric ulcer was observed at a higher frequency in patients who received concomitant treatment with non-steroidal anti-inflammatory agents. Storage: 3 year shelf life. No special precautions for storage. Package Quantities: 30 tablets in blister strips. Marketing Authorisation Number: PA 936/35/1. Marketing Authorisation Holder: Pharmacia Ireland Limited, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24. Further information is available on request from: Medical Information at Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Tel: +44 (0) 1304 616161 Date of Preparation: September 2007 hospital pharmacy Breast cancer: AN OVERVIEW In this article Sandra Melville and Lucy Heycock outline the pathology of breast cancer and the role pharmacists can play in prevention and patient support sa n d r a m elv i l l e, lu c y h e yco c k B reast cancer affects almost 42,000 people in the UK each year and there are 12,700 deaths from the disease annually — it is the most common cause of death in women between the ages of 35 and 55 years. One in nine women in the UK will develop breast cancer and although the incidence is increasing, recent advances in prevention and screening together with new treatments have resulted in improved survival rates.1,2 Breast cancer also occurs in men, accounting for 1 per cent of cases in the UK. However, this article only applies to breast cancer in women. Pharmacists, particularly in the community, are ideally placed not only to give lifestyle advice about risk reduction, but also to act as a valuable resource for patients experiencing side effects during treatment. Structure of the breaSt The mature female breast is composed of fat, connective tissue and glandular tissue, and can be divided into lobes. On average, there are 15–20 lobes in each breast and, within these, many smaller lobules, which ultimately end in dozens of tiny milk-producing bulbs. A network of ducts, leading to the nipple link these lobes and lobules. The areola around the nipple has large glands around it which produce fluid to lubricate the nipple. Connective tissue, known as stroma, supports these structures and fat fills the spaces around the lobules and ducts. There are no muscles in the breast, but muscles lie under each breast and cover the ribs. The breast is responsive to a complex interplay of hormones (mainly oestrogen, progesterone and prolactin) that cause the tissue to develop, enlarge and produce milk. It also contains a network of lymph vessels which connect to lymph nodes, located mainly in the armpits, near the chest wall and over the collarbone and neck region. riSk factorS Breast cancer is an extremely complex disease. There are many types with differing histological, biological and immunological Table 1. Risk facToRs foR developing bReasT canceR • Age Incidence increases from 1 in 900 in those under 30 years old to 1 in 10 in those over 85 years. • Oestrogen therapy Oral contraceptives slightly increase the risk of breast cancer. Hormone replacement therapy increases the risk of breast cancer and decreases sensitivity of mammography.3 • Obesity Women who are obese, particularly post menopause, are at increased risk. Adipose tissue is the main body source of oestrogen after menopause. • Menstrual and pregnancy history Early menarche, late menopause, fewer pregnancies and shorter duration of breastfeeding are all associated with increased risk. • Race Variations are seen with age and race. In women under 40 years old, Caucasian women are more likely than Black or Asian women to develop breast cancer, while in women over 40 years, Black women are at increased risk compared with Caucasian or Asian women. Asian women of all ages are at a decreased risk. • Family history A small proportion of breast cancers have a strong genetic link. Carrying the BRCA1 or BRCA2 gene mutation leads to a 50-80 per cent chance of developing breast cancer. • Height at age 14 Women who were taller than 165cm at the age of 14 years are at increased risk and those under 150cm at the age of 14 years are at decreased risk. (Women in between these heights are at average risk.) • Birth weight Women who weighed over 4.43kg at birth are at increased risk and those weighing less than 3.18kg are at decreased risk. • Socio-economic status There is a positive correlation between risk and socioeconomic status — those of higher status are at greater risk. • Geographical location Women in urban areas are at higher risk than those in rural areas. characteristics. Many women mistakenly believe that most breast cancers are hereditary but, in fact, only five per cent of breast cancers have a genetic link. Generally, the greatest risk factor for developing breast cancer is age, with 80 per cent of cases occurring in women over the age of 50 years. Incidence in women under 30 years of age is rare. Table 1 describes risk factors for developing breast cancer but it should be noted that these are relative risks and having one or more of these does not mean that a patient will develop the disease. oeStrogen in breaSt cancer Levels of oestrogen vary during a woman’s lifetime and will influence her breast cancer risk. Oestrogen stimulates the growth and division of breast tissue cells and it is believed that the greater the growth rate, the greater the risk of cancerous mutations. Oestrogen levels change dramatically during puberty, pregnancy and the menopause, and are affected by hormone replacement therapy (HRT) and the oral contraceptive pill. Elevated oestrogen levels are linked to an increased risk of breast cancer, and is relevant in two-thirds of breast cancers. These are termed ‘oestrogen receptor positive’ (or ‘oestrogen responsive’). The million women study3 confirmed that both current or recent use of HRT can increase the risk of developing breast cancer. the Study alSo found that: • Users of HRT are at a 22 per cent relative increased risk of death from breast cancer compared with women who have never used HRT. • The relative risk of breast cancer varies significantly among the different Issue 3 Vol 10 March 2008 27 hospital pharmacy HRT types and is substantially greater in users of oestrogenprogestogen combinations than in users of other preparations. The use of HRT has to be balanced with the benefits of treatment (e.g. relief of hot flushes and night sweats, prevention of osteoporosis etc) and women should be encouraged to discuss the pros and cons fully with their GP before making a decision. Use of the combined oral contraceptive (COC) pill slightly increases the risk of developing breast cancer. The risk is highest for women who started using these pills as teenagers. However, 10 or more years after stopping COCs, the risk of developing breast cancer returns to the same level as women who have never taken them. In addition, the Committee on Safety of Medicines advises that a possible small increase in the risk of developing breast cancer should be weighed against the benefits and evidence of a protective effect against cancers of the ovary and endometrium. Prevention Obesity is one of the few modifiable risk factors for breast cancer. Recent evidence suggests that physical activity has a preventive effect on breast cancer although it is not clear if this is caused by exercise having a direct effect on hormonal and growth factor levels or simply as a result of it lowering body mass index. There is a significant association between alcohol intake and breast cancer. There is some evidence to suggest that animal fat intake may cause a small increased risk in breast cancer, but this is not thought to play as large a role as previously thought. Breastfeeding has an association with a reduction in risk, which is another reason for promoting it to young mothers who may seek advice. SignS and SymPtomS Early breast cancer can present with any of the following: • Breast or chest pain. • Palpable lump in breast or armpit. • Nipple inversion or discharge. • Puckering or dimpling of skin (‘peau d’orange’). • Change in size or shape of breast. Metastatic disease can present with bony pain or pathological fracture, breathlessness due to pleural effusion or jaundice. In addition to providing lifestyle advice, pharmacists are ideally placed to promote the importance of breast awareness. Recent research carried out by Breakthrough Breast Cancer found that 80 per cent of women had not checked their breasts in the previous month and the study highlighted that the main reason was that they simply did not know how. In fact, there is no special routine for breast examination. What is important is that a woman looks at and feels her breasts so that any changes are noticed. A check can be done in any way that feels comfortable, for example in the bath or shower or when dressing or lying down. Women should be encouraged to become familiar with their breasts, how they usually look and feel, and what is normal at different times of the menstrual cycle. If a woman notices anything unusual she should report it to her GP. It is worth stressing to women that 9 out of 10 lumps are not cancerous but it is vital that any breast changes are reported to their GP because early detection improves survival. The prompt detection of breast cancer offers the best chances of survival and pharmacists can help women by encouraging those between the ages of 50 and 70 years to participate in [Breast Check screening] so that a mammography can be performed. Mammographies can detect cancerous lesions before they are large enough to become palpable. diagnoSiS Mammography and ultrasound (performed after a mammograph if necessary) can help to detect a lesion or to confirm a lesion as suspicious. Diagnosis of the disease is by biopsy and pathological assessment to confirm type (e.g, adenocarcinoma, medullary, inflammatory, mucinous, Paget’s), hormone receptor status and HER2 status. For example, tests on a sample of breast cancer cells can show if they ‘respond’ to oestrogen. Breast cancers can be divided into two types: oestrogen responsive (ER+) and nonoestrogen responsive (ER–). Establishing this status is important because it determines whether or not hormone 28 Issue 3 Vol 10 March 2008 hospital pharmacy therapy is appropriate. Whether or not a breast cancer is progesterone receptor positive also affects how a woman will respond to hormone therapy, although to a lesser extent than being ER+. HER2 is a protein found on the surface of some cancer cells. It is made by a specific gene called the HER2/neu gene. HER2 is a receptor for a particular growth factor called human epidermal growth factor, which occurs naturally in the body. When human epidermal growth factor attaches itself to HER2 receptors on breast cancer cells, it can stimulate the cells to divide and grow. Some breast cancers have many more HER2 receptors than others. In this case, the tumour is described as being ‘HER2 positive’. It is thought that about one in five women with breast cancer will have HER2-positive tumours. These tumours have a worse prognosis than HER2-negative tumours and are more likely to respond to trastuzumab. If metastatic disease is suspected, computed tomography scans and bone scans are required. table 2. staging of breast cancer UICC staging TNM staging Tumour, nodes, metastases Stage 1 T1 N0 M0 Tumour <2cm, Node negative Stage 2 A T1/2 N0/1 M0 Tumour 2–5cm, or < 2cm with 1–3 nodes Stage 2B T2/3 N0/1 M0 Tumour 2–5cm with1–3 nodes or >5cm with no nodes Stage 3A up to T3 N1/2 M0 Tumour >5cm but free from chest wall 4–10 nodes Stage 3B T4 and N Tumour >5cm and fixed to chest wall, any node state Stage 4 M1 Distant metastases Staging and grading The stage of a cancer describes its size and whether it has spread beyond its original site. The grade gives an idea of how quickly the cancer could develop. (see Table 2). Grading is determined by the appearance of the cancer cells under the microscope. There are three grades: grade 1 (low grade), grade 2 (moderate or intermediate) and grade 3 (high). The higher the grade, the more abnormal the appearance of the cells and the more aggressive the cancer. Many women will know their grade of breast cancer and appreciate the significance of this, so an understanding of this terminology can provide a useful background for healthcare professionals involved in their care. typeS of breaSt cancer A breast cancer can be described as either in situ or invasive. In situ means there are cancerous changes in the cells but these are still limited to the lining of the glands or ducts, and have not begun to invade the surrounding tissue. Invasive implies that cancerous cells have broken through the lining layer and begun to penetrate the surrounding tissue from where they can gain access to the lymphatics and blood vessels for further dissemination. Most breast cancers are adenocarcinomas, originating in the epithelia of the ducts and lobes. About 80 per cent of breast cancers are invasive at presentation. Invasive ductal carcinomas account for around 90 per cent of these. These generally present with poorly defined hard lumps, peau d’orange or nipple inversion or both. Invasive lobar carcinomas account for the other 10 per cent of invasive breast cancers and these tend to be harder to detect without a mammography because they are relatively diffuse tumours. Pre-invasive carcinomas account for the remaining cases of breast cancer, and are known as ductal or lobular carcinomas in situ (DCIS or LCIS). The important considerations are: • Size of tumour. • Grade. • Margin of clearance (distance of tumour from edge of the healthy tissue that can be surgically removed — the more tissue that can be removed, the better). • Number of nodes involved. Issue 2 Vol 10 February 2008 29 hospital pharmacy • Oestrogen or progesterone receptor positivity. • HER2 status. “ how the positive and empathic approach of healthcare professionals can make a real difference. Studies show that patients often feel they Stage at diagnosis Survival (per cent) Prognosis are imposing on their doctor’s time if they 1 85 Outcome primarily depends on the intrinsic ask questions during appointments yet do 2 55 growth rate of the tumour (which can not seem to have the same reservations in 3 40 vary dramatically), the age at diagnosis the pharmacy. Pharmacists can encourage 4 <5 and numerous biological parameters (e.g. women to talk about their treatment and histology, grade, hormone receptor levels, side effects. proliferation rate and presence of tumour Just having someone listen can be suppressor gene p53) that ultimately define therapeutic in itself and also provides an the natural history of the disease. Simplistically, survival at 15 years opportunity for information to be gathered, which can be after diagnosis is linked to staging at diagnosis, as illustrated in used to direct patients to the most appropriate sources of Table 3. support. In addition, a review of patients’ medications in the light of their diagnosis can sometimes highlight valuable Successful treatment of early stage disease can still result anomalies, such as inappropriate continuation of oral in relapse, even as long as 30 years later. It is interesting that, contraceptives or HRT slipping through the net on repeat irrespective of the length of disease-free interval, the behaviour of prescriptions. tumours at relapse are similar and predictable. The average survival An understanding of current issues related to breast cancer at this point is around three years (but can vary from a few months in order to address fears fuelled by media scares (e.g. stories to five years). Women who are younger than 34 years at diagnosis linking antibiotic or antiperspirant use to breast cancer risk) generally have a worse prognosis, with less than half surviving at will also be useful, as will steering people away from less five years and most relapsing within three years. trusted sources of information, such as unreliable websites, Predicting prognosis can be aided by using the Nottingham and enabling them to make more objective choices. prognostic index (NPI). This is a formula that uses the size, stage and Signposting local sources of help can include support grade of a tumour to calculate a prognostic score: groups, breast care nurse specialists, hairdressers and wig suppliers and complementary health centres. NPI = (tumour size x 0.2) + grade + node status. National organisations include charities such as the Irish For example, for a 5cm, grade 3 tumour with two nodes, the NPI is Cancer Society provide written information, telephone (5 x 0.2) + 3 + 2 = 6. support and websites. Patients often need an extra bit of encouragement to take the step to access a support group or telephone a helpline and it is worth spending a little time encouraging them to do this. table 3: survival 15 years post diagnosis Just having someone listen can be therapeutic in itself and also provides an opportunity for information to be gathered, which can be used to direct patients to the most appropriate sources of support. The NPI can be used to advise patients of their chances of a cure and to help select appropriate pharmacological treatment options. For example, no chemotherapy is needed if NPI is less than 3.4. Those with a score between 3.5 and 5.4 will derive the maximum benefit from chemotherapy and for those with a score of more than 5.4, chemotherapy is essential. The lower the score, the better the prognosis. TreaTmenT oPTions Treatment of breast cancer depends on various factors, such as stage of disease, age, menopausal status, size and grade of the tumour and hormonal status. Pharmacy suPPorT As one of the most accessible members of the healthcare team, the pharmacist is ideally placed to provide cancer patients with the information and support they need to get through what can be one of the most difficult times of their lives. Testimonies of women who have undergone treatment for breast cancer tell us time and again 30 Issue 3 Vol 10 March 2008 summary Being diagnosed with breast cancer can be bewildering and frightening. Women can experience a range of emotions including fear, anger and anxiety. They have to deal with a vast array of different health professionals and negotiate a confusing maze of healthcare systems. During treatment, people can often be exhausted, nauseated and unwell. They may also be trying to come to terms with the loss of a breast. Then they often lose their hair during treatment, at a time when they are already feeling at a low point. The amount of distress that this can cause to women at a time in their lives when they are vulnerable should not be underestimated. Being aware of these issues will be invaluable when someone with breast cancer comes to the pharmacy. There is a vast amount of help and advice that pharmacists can offer to provide significant psychological support as well as improved pharmaceutical care. IP references 1. The Institute of Cancer Research. Chemotherapy clinical trials. Available at www.icr.ac.uk (accessed on 2 July 2007). 2. NHS Cancer Screening Programmes. Screening for breast cancer in England: past and future. Available at www. cancerscreening.nhs.uk (accessed 2 July 2007). 3. The million women study. Available at www.icnet.uk (accessed 28 September 2007). Sandra Melville, BSc, MRPharmS, is clinical pharmacist at Lorn & Islands District General Hospital, Oban, Argyll, and Lucy Heycock, MSc (cancer nursing), who is a Macmillan nurse specialist. This article first appeared in Hospital Pharmacy First-line treatment of metastatic breast cancer (mBC) Why anti-angiogenesis is so important... Life Itself. Vessels diminished.Survival extended.1,2 Doubles median progression-free survival (PFS) in first-line metastatic breast cancer2 References: 1. Hurwitz H et al. N Engl J Med. 2004;350:2335-2342. 2.Miller KD, et al. N Engl J Med. 2007:357; 2666-2676. ABRIDGED PRESCRIBING INFORMATION (For full prescribing information refer to the Summary of Product Characteristics [SmPC]) AVASTIN® (bevacizumab) 25mg/ml concentrate for solution for infusion Indications: In combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the colon or rectum (mCRC). In combination with paclitaxel for first-line treatment of patients with metastatic breast cancer (mBC).Avastin in addition to platinum based chemotherapy is indicated for first line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology. In combination with interferon alfa2a for first line treatment of patients with advanced and/or metastatic renal cell cancer (mRCC). Dosage and Administration: Physicians experienced in antineoplastic medicines should supervise administration of Avastin. Initial dose: 90 minute IV infusion; second dose: 60 minute IV infusion, if initial dose well tolerated; subsequent doses: 30 minute IV infusion, if second dose well tolerated. Do not administer as an IV push or bolus. Do not administer or mix with glucose solutions. Administer until disease progression. Not recommended in children or adolescents. No dose adjustment is required in elderly. No data in renal or hepatic impairment. mCRC: Recommended dose: 5mg/kg or 10mg/kg body weight given once every two weeks or 7.5mg/kg or 15mg/kg of body weight given once every three weeks. Dose reduction due to side effects not recommended. If indicated, therapy should either be permanently discontinued or temporarily suspended. mBC: 10mg/kg body weight once every two weeks or 15mg/kg body weight once every three weeks. NSCLC: Administer in addition to platinum based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression. Recommended dose: 7.5mg/kg or 15 mg/kg body weight once every three weeks. mRCC: Recommended dose: 10mg/kg body weight once every 2 weeks. Contraindications: Hypersensitivity to bevacizumab, Chinese Hamster Ovary cell products, recombinant human or humanised antibodies or any excipients. Pregnancy. Untreated CNS metastases. Warnings and Precautions: Increased risk of gastrointestinal (GI) perforation when taking Avastin. Intra-abdominal inflammatory process may be a risk factor for GI perforations in patients with mCRC - permanently discontinue in patients developing GI perforation. Increased risk of developing fistulae when treated with Avastin. Permanently discontinue Avastin in patients with TE (tracheoesophageal) fistula or any grade 4 fistula. Consider discontinuing Avastin in cases of internal fistula not arising in the GI tract. May affect wound healing; do not initiate for at least 28 days following major surgery or until surgical wound has healed. Withhold therapy for elective surgery and in patients experiencing wound healing complications during therapy until wound fully healed. Dosedependent hypertension observed. Preexisting hypertension should be adequately controlled before starting Avastin treatment.The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen. Permanently discontinue treatment in patients with medically significant hypertension that cannot be adequately controlled or in patients who develop hypertensive crisis or hypertensive encephalopathy. Monitor blood pressure during therapy. Risk of proteinuria, especially in patients with history of hypertension, may be dose-dependent; monitor patient before and during treatment; Permanently discontinue if Grade 4 proteinuria (nephrotic syndrome) occurs. Risk of arterial thromboembolic events including cerebrovascular accidents, transient ischaemic attacks and myocardial infarctions (especially if prior history of arterial thromboembolic events or age over 65 years – exercise caution with these patients). Permanently discontinue in patients developing arterial thromboembolic events. Increased risk of tumour associated haemorrhage; discontinue permanently if Grade 3/4 bleeding. Caution in patients with congenital bleeding diathesis, acquired coagulopathy or those taking full dose anticoagulants for thromboembolism prior to starting Avastin therapy. Risk of CNS haemorrhage in patients with CNS metastases not evaluated – do not use Avastin in these patients. Risk of congestive heart failure (CHF) in particular in patients with metastatic breast cancer who had prior anthracycline therapy, prior radiotherapy to the left chest wall or other risk factors for CHF, such as pre-existing coronary heart disease or concomitant cardiotoxic therapy. Symptoms range from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF. Exercise caution when treating patients with clinically significant cardiovascular disease or pre-existing CHF. In combination with some myelotoxic chemotherapy regimens, increased rates of severe neutropenia, febrile neutropenia or infection with severe neutropenia (including some fatalities). Risk of serious and in some cases fatal pulmonary haemorrhage/haemoptysis in NSCLC patients. Patients with recent pulmonary haemorrhage/haemoptysis (>2.5mL of red blood) should not be treated. Rare reports of Avastin treated patients developing signs and symptoms of Reversible Posterior Leukoencephalopathy Syndrome (RPLS), confirm by brain imaging, treat symptoms and discontinue Avastin. The safety of re-initiating Avastin in patients previously experiencing RPLS is unknown. Risk of developing venous thromboembolic events, including pulmonary embolism. Discontinue in patients with life-threatening (Grade 4) pulmonary embolism, patients with <Grade 3 need to be closely monitored. Drug Interactions: No clinically relevant pharmacokinetic interaction of coadministered chemotherapy on Avastin disposition has been observed. No difference in clearance of Avastin in patients treated with single agent Avastin compared to patients receiving Avastin in combination with the bolus-IFL regimen. The effect of other coadministered chemotherapies on Avastin clearance is considered not clinically significant. No significant effects of bevacizumab on pharmacokinetics of irinotecan and its active metabolite SN38, capecitabine and its metabolites, oxaliplatin, interferon alfa-2a and cisplatin. The impact of bevacizumab on gemcitabine pharmacokinetics is unknown. The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established. Pregnancy and Lactation: Contraindicated during pregnancy. No data on use in pregnant women. Animal studies have shown reproductive toxicity including malformations. May inhibit foetal angiogenesis and is suspected to cause serious birth defects if administered during pregnancy. Women of childbearing potential must use effective contraception during treatment and for six months after last dose. Discontinue breast-feeding during treatment and for at least six months after last dose as Avastin may harm infant growth and development. Side Effects and Adverse Reactions: Most serious adverse drug reactions (ADRs): GI perforations, haemorrhage including pulmonary haemorrhage/haemoptysis which is more common in NSCLC patients and arterial thromboembolism. Most frequently observed ADRs: Hypertension, fatigue or asthenia, diarrhoea and abdominal pain. The occurrence of hypertension and proteinuria with Avastin is likely to be dose dependent. NCI-CTC grade 3-5 reactions with >2% difference between the Avastin group compared to control group; Very Common (>10%): leucopenia, thrombocytopenia, neutropenia, peripheral sensory neuropathy, hypertension, diarrhoea, nausea, vomiting, fatigue and asthenia. Common (>1-<10%): sepsis, abscess, infection, febrile neutropenia, anaemia, dehydration, cerebrovascular accident, syncope, somnolence, headache, cardiac failure congestive, supraventricular tachycardia, thromboembolism (arterial), deep vein thrombosis, haemorrhage, pulmonary embolism, dyspnoea, hypoxia, epistaxis, intestinal perforation, ileus, intestinal obstruction, abdominal pain, gastrointestinal disorder, palmar-plantar erythrodysaesthesia syndrome, muscular weakness, proteinuria, urinary tract infection, lethargy and pain. All grade reactions with >10% difference between the Avastin group compared to control group. Very Common (>10%): anorexia, dysgeusia, headache, eye disorder, hypertension, dyspnoea, epistaxis, rhinitis, constipation, stomatitis, rectal haemorrhage, exfoliative dermatitis, dry skin, skin discolouration, proteinuria, asthenia, pain and pyrexia. For a full listing of adverse reactions, please refer to the SmPC. Legal Category: Limited to sale and supply on prescription only. Presentations and Marketing Authorisation Numbers: EU/1/04/300/001 for 100mg/4ml (Pack size of one); EU/1/04/300/002 for 400mg/16ml (Pack size of one). Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom. Avastin is a registered trade mark. Further information is available from Roche Products (Ireland) Limited, 3004 Lake Drive, Citywest, Naas Road, Dublin 24. Telephone: (01) 4690700. Fax: (01) 4690791. Date of Preparation: February 2008. P04/02/08. meetting report The manufacture and use of biopharmaceuticals s t eph en m e y l er The EMEA’s new guidance on biosimilar medicines attempts to deal with the issues that arise from the complexities of the manufacture, clinical use and regulation of biopharmaceuticals and biosimilars. S ince Genentech launched recombinant human insulin in 1982, the footprint of biopharmaceuticals in medicine has become ever larger. Biopharmaceuticals in use today include blood factors (Factor VIII and Factor IX), hormones (growth hormone, gonadotrophins, as well as insulin), erythropoiesis stimulating agents (ESAs like EPO), interferons and monoclonal antibodies. The global biopharmaceutical industry was estimated to be worth approximately $37 billion in 2006, with the ten largest biotech companies accounting for 85% of this figure. Biologics now play a crucial part in the treatment of people with previously intractable diseases such as chronic kidney disease. For example, of the 325,000 people on regular dialysis in the EU, 95% are treated with ESAs, typically with three injections a week for five to 10 years. These agents have characteristics in common that differentiate them from ‘traditional’ chemical drugs; these characteristics create challenges to manufacturers in terms of similarity, efficacy, safety and quality, both from batch to batch within one company and for companies attempting to produce post-patent follow-on drugs, or biosimilars, of innovator drugs. These challenges are reflected in regulation of biopharmaceuticals and biosimilars. The very name ‘biosimilar’ was coined and is officially recognised in EMEA literature because ‘biogeneric’ does not accurately describe the impracticality of making exact copy follow-on biopharmaceuticals. The gulf beTween aspirin and epO Biopharmaceuticals have particular characteristics that set them apart from purely chemical entities. The most basic difference is one of size. Most biopharmaceuticals are large proteins with a basic composition of several hundred amino acid residues; each one of these amino acids is comparable in size to a single molecule of aspirin. For example, EPO is approximately 30 kiloDaltons (kD), while aspirin is 0.2kD. This large size has implications at all stages of production as well as in clinical practice. The tertiary and quaternary structure of proteins is affected by conditions during inoculum development, fermentation, harvesting and separation. Physical factors such as temperature, pH, oxygen and CO2 concentration can affect a protein’s physicochemical structure; at an individual amino acid level and the degree of modification by glycosylation, sulphur bridging, Issue 3 Vol 10 March 2008 33 meeting report methylation, etc, as well as at a larger scale in the way the molecule folds. Production must also take account of enzyme activity both during and after fermentation; the release of proteases and other enzymes from damaged, dying and dead cells can alter the biopharmaceutical’s structure. The end result of each cycle of fermentation will be a population of proteins with a range of activity, half life, stability and immunogenicity that must be within defined parameters to meet EMEA standards. Ensuring that this is the case is one of the most challenging aspects of biopharmaceutical production and one that necessitates a different system of pharmacovigilance than the traditional one used for quality assurance in chemical drugs. EPO is regarded as a ‘typical’ biopharmaceutical. It was approved as recombinant human EPO (rhuEPO) in 1991 for the treatment of anaemia in patients with chronic kidney disease “ inadequate patient education about home injection for some products, or as a result of breaks in the cold storage chain in the re-importation trade that exists between the US and Canada. ImmunogenIcIty At the fermentation and purification stage, undesirable immunogenicity can be introduced if folding of the tertiary structure of the EPO protein occurs in the ‘wrong’ way. This may result from variations in a large number of factors as previously mentioned, such as pH, temperature and nutrient concentrations; as well as variations in the ‘natural’ population of slightly different proteins that are the result of each fermentation cycle. Although the ideal aim of each cycle is to reproduce an identical population of proteins, it is impossible to avoid single atom substitutions in such complex molecules; such changes may or may not affect the product’s characteristics. Beyond the translation Biopharmaceuticals have particular characteristics that set them apart from purely chemical entities. with or without dialysis. Unlike some other hormones such as insulin, it was never available from a host source, but has entered clinical use only as a recombinant molecule. It is a glycoprotein, requiring extensive glycosylation during production of a useful form. For this reason, EPO is produced in a Chinese Hamster Ovary (CHO) vector that has been modified with human DNA coding for EPO, in a very tightly controlled large scale eukaryotic cell fermentation. The CHO cell line is used because it is a highly characterised one, particularly for the glycosylation steps necessary for the production of relatively stable, active and safe EPO. Another factor that differentiates biopharmaceuticals like EPO from chemical drugs is immunogenicity. This is a critical issue for biotechnologically derived medicines. The risk of immune responses to recombinant proteins was made clear by approximately 200 cases of pure red cell aplasia (PRCA) in patients receiving Eprex, an EPO approved in Europe, in the years following 1998. These cases were traced to a small change in the formulation of the product – the removal of human serum albumin (HSA) – that eluded the rigorous controls in place at the time. The undesirable immune response occurred in patients who had EPO administered subcutaneously. However, the FDA in the US has also suggested that PRCA may be induced by incorrect storage of EPO products as a consequence of 34 Issue 3 Vol 10 March 2008 of DNA and RNA to protein sequences, glycosylation, essential to activity, also produces a population of isoforms, with marked differences in stability, half-life and bioactivity. Effective production of biopharmaceuticals aims to create with each cycle the same mix of variants with the same ‘mean’ activity. BIosImIlars not the same This leads to another challenge in the manufacture of biologics. Unlike chemical drugs, biopharmaceuticals and biosimilars, because of the complexity of the fermentation, purification and formulation processes, may differ slightly between batches of the ‘same’ product as well as between the innovator reference biologic and a follow-on biosimilar. For biosimilars, EU regulations require defined studies to show that the biosimilar medicine is similar and as safe and effective as the biological reference medicine. According to the EMEA, “These studies involve a step-by-step process starting with a comparison of the quality and the consistency of the medicinal product and of the manufacturing process. Studies are also conducted to compare the safety and efficacy of the medicines. These studies should demonstrate that there are no meaningful differences between the biosimilar and the biological reference medicines in terms of safety or efficacy. When the biological reference medicine is used to treat different diseases, the efficacy and safety of the biosimilar medicine may also have to be assessed using specific tests or studies for each disease.” However, a problem, particularly for biosimilar manufacturers who do not have access to the innovators’ databases and the history of incremental change they record, is just what particular analyses to apply to prove that their product is similar enough to be licensed. The advanced analysis methods currently available quite often reveal ever more physicochemical differences between batches as well as different companies’ products, and deciding which differences are relevant is challenging. Complete characterisation of complex molecules like EPO is impossible, so the historical data available to innovators becomes crucial when investigating biosimilarity. treatIng cKD The advent of biologics has allowed the development of highly targeted therapies to alter processes that lead to disease – cancer, rheumatoid arthritis, lupus and other auto-immune diseases. A number of conditions result in chronic kidney disease (CKD), notably diabetes, hypertension and glomerulonephritis. CKD is a growing problem in an ageing population; in some European countries the number of people requiring renal replacement therapy to support impaired kidney function as a result of CKD has almost doubled and one estimate is that over two million people will require dialysis worldwide by 2010. In the US, diabetes and hypertension account for 43% and 27% of all new late-stage kidney disease cases, respectively. The result of these disease processes is damage to nephrons and a subsequent decline in the glomerular filtration rate (GFR), the rate at which creatinine is cleared from the blood by kidneys. As kidney function declines, CKD’s role as a ‘disease multiplier’ kicks in, increasing the patient’s risk of hospitalisation, cardiovascular disease and overall mortality. Renal anaemia results as CKD progressively damages the ability of specialised kidney cells to produce erythropoietin. In normal kidney function, these cells detect relative oxygenation in red blood cells (RBCs) and produce erythropoietin in response to a decline in oxygenation. The hormone stimulates differentiation of RBCs (erythropoiesis) from unspecialised cells in the bone marrow. In CKD the loss of erythropoietin-producing cells results in anaemia as RBC production drops off in the bone marrow. The most significant cause of death in CKD is cardiovascular disease, the result of the extra burden to the heart of pumping sufficient oxygenated blood to the brain, liver and other organs. Globally, there are approximately one million deaths annually from endstage renal disease. Before the introduction of EPO, CKD-induced anaemia was treated with blood transfusions, with the risk of iron overload and bloodborne infections. When EPO came into clinical practice in the early 1990s, straightforward and effective anaemia management became possible for the first time. The first EPO product was Epogen/Eprex, introduced in 1989. A primary goal in the subsequent development of ESAs has been to overcome the problem of the rapid drop-off in erythropoietin levels after administration of the previous generations of ESAs. This results from the relatively high affinity of ESAs to cells in the bone marrow involved in RBC production, which can produce a pattern of spikes and troughs in haemoglobin levels that make it difficult to maintain clinical haemoglobin targets. Mircera, the first approved of a new generation of agents that act as continuous erythropoietin receptor activators have a reduced affinity for the receptors involved in RBC production. It binds to them less tightly and is absorbed more slowly. As a result, there is a more sustained stimulation of RBC production that closely imitates the natural control of the process. Mircera’s longer half-life (approximately 180 hours, three to five times that of other ESAs) means that it could maintain stable haemoglobin levels in patients with once-monthly or fortnightly administration. regulatory uncertaInty A problem for clinical ESA use remains regulatory uncertainty. As the early generations of ESAs and other biologics reach the end of their patents, the questions about pharmacovigilance of biosimilars is great. Will biosimilar manufacturers be allowed access to originator companies’ data for new indications? Biosimilar manufacturers would argue that this would allow them to more likely achieve the same standards of quality demanded of the innovators. However, aside from the economic implications to future biopharmaceutical development that such access would have, the innovators argue that even with the advantage of original data, each manufacturing location will continue to produce significantly ‘different’ products in terms of activity, stability and immunogenicity. Biosimilars will only ever be ‘similar’, never ‘generic’ or identical and the challenge for regulators, clinicians and manufacturers is to ensure that pharmacovigilance structures are up to the job of monitoring them, during development, manufacturing and for the entire life of the biopharmaceutical. Your recommended daily allowance needn’t always be a mouthful With its unique formulation, Rubex Essentials guarantees you the recommended daily allowance of the “Essential” vitamins, minerals and the amino acid lutein in a pleasant, easy to take form. Just pop one in a glass of water and ease your way into a busy day. For more information contact your pharmacy. e-pharmacy Health in your hand From medical compliance to pro-active health promotion, Short Message Service (SMS) is being used as an effective tool to create a more competitive and satisfactory patient experience. SMS text messaging allows you to communicate cheaply, effectively and quickly with patients. I Sponsored by Helix Health n the 1990s, mobile phones were seen by many as an optional extra. Today, mobile phone technology is a key part of our society with more mobile phones in Ireland than there are people. According to the latest figures from the Commission for Communications Regulation, mobile phone penetration in Ireland now stands at 114 per cent of the population. It is no surprise then that the mobile market is becoming hugely popular as a means of communicating with customers. This same logic is now being applied in the healthcare sector where mobile phone technology is changing the way healthcare professionals deliver services and communicate with patients. Vital signs With the growing computing capability of mobile phones, the potential benefits of this new and evolving technology are enormous. Currently, the US and Britain are leading the way in developments with this technology, where mobile phones are beginning to be used in a variety of ways throughout the healthcare sector. A unique system has already been developed which uses a mobile phone to transmit a person’s vital signs, including complex ECG, heart signal, blood pressure and oxygen to hospitals and clinics. Mobile phones that are now being developed can monitor your pulse and even double as glucose meters to monitor blood sugar levels in diabetics. Monitoring treatMent Another area benefiting from this technology is chemotherapy-associated side effects management. In October 2007, a feasibility study was undertaken in Oxford, which examined home monitoring of patients’ symptoms via a mobile phone. Cancer patients receiving chemotherapy entered symptom data onto screens on a mobile phone twice daily. This real time assessment of symptoms was then sent via a secured connection to a remote computer where the symptoms were then analysed. The study showed that the technology worked very well (Weaver et al 2007). Healthcare system providers are increasingly looking for developments in mobile phone communication technology; to help improve the services they provide to healthcare professionals and enhance patient care. One application within mobile phone technology, which is currently demanding attention in Ireland, is the use of SMS text messaging to patients. This application offers further opportunities to deploy the benefits of mobile phone technology and to improve access to healthcare and health information. According to UK based analysts (Wireless Healthcare) this mobile phone application is said to be an early indication of the move towards automated communication between the health provider and the patient. Confidentiality Short Messaging Service (SMS) or text messaging is a mobile phone technology that enables people to send and receive messages to mobile phones or computers. Such SMS technology allows for a previously unattainable level of communication with the patient and supports the fundamental tenets for the transfer of health information through the privacy, confidentiality and direct communication that it affords. Because we carry our phones with us at all times, text messages are a non-intrusive and personal Issue 3 Vol 10 March 2008 37 e-pharmacy convenience of patients and consumers. For example, St Luke’s Hospital uses SMS (texting) to remind patients about doctor/consultant appointments. The Blood Transfusion Board also uses SMS to text specific donors when there is a shortage of certain blood types.” An example of the SMS functionality in Helix Health’s QicScript Professional. way of communicating with patients. As well as being more efficient and cheaper than paper correspondence, SMS texting is also an instant way of getting information directly to the receiver. Current research shows that they are an especially successful means of communicating with people between the ages of 16 and 40, but the use of SMS is certainly not restricted to this target range. In a report by iReach, commissioned by O2 in 2007, Ireland ranked seventh out of the EU 15 in its use of online and mobile communications across the public sector. However, it found that Ireland was below average in the health category even though it was above average in all other areas. The potential benefits of SMS texting “ Pharmacists can also use SMS to let patients know when their prescription is ready for collection thereby reducing waiting times and enhancing the overall patient journey and pharmacy experience. applications will not be fully recognised until there is greater adoption of this mobile communication within the Irish healthcare sector. On-line medical advice Oisin Byrne of iReach states, “In order for the Irish healthcare system to become best in class and match leading countries such as Sweden, Denmark and Finland there needs to be a greater drive towards online electronic communications and integration between stakeholders such as patients, doctors, consultants and nurses, and public bodies. For example in Scandinavian countries integrated health IT systems allow booking of hospital beds and online medical advice.” Billy D’Arcy of O2 adds, “Some Irish health organisations are starting to exploit the immediacy and pervasiveness of mobile technology for the benefit and 38 Issue 3 Vol 10 March 2008 cOmpliance In healthcare, SMS has the potential to increase medication compliance, decrease the number of missed appointments and improve treatment outcomes. By using a patient management software system that has SMS technology built in, the healthcare professional, with the consent of the patient, can send individual reminders and batch information messages quickly and easily, directly from the software package using the patient details and mobile numbers they have already recorded. In situations where patients need to return for 6 monthly or yearly visits such as to their GP, specialist consultant or pharmacist, a reminder can be sent without the usual administrative work for the provider or an onus on the patient to remember distant appointments. Throughout primary care messages can be sent to inform patients when their lab results arrive to the surgery, when they are due a smear, a return visit, a medical assessment, a visit for a repeat prescription or even just to inform a large number of patients of a change to opening times in the practice. In pharmacy, SMS can be used to significantly increase medication compliance. It is estimated that as many as 50% of patients do not adhere fully with their medication, and therefore, do not get the full benefit of their medication therapies. A text message reminder service will prompt the patient to take their medication at the right time, limiting the potential for medication errors to occur. Pharmacists can also use SMS to let patients know when their prescription is ready for collection thereby reducing waiting times and enhancing the overall patient journey and pharmacy experience. Patients can be reminded not only when a new prescription is due but can also receive a text when their old prescription is running out, thereby significantly reducing the chance of a time lapse between repeat prescriptions. invitatiOn tO yOur custOmers An SMS text messaging service can also be used effectively to improve health promotion. Patients can be invited to special pharmacy themed days based on their medical conditions e.g. asthma clinics or diabetes days. Specific health campaigns can be greatly enhanced through the use of SMS. For example, during a quit smoking campaign individual patients that are signed up can be sent regular messages telling them the benefits of quitting smoking and suggestions on how to deal with withdrawal symptoms and cravings. While it is clear that SMS can be used effectively to benefit the patient it can also create cost savings and increase revenue for many healthcare providers. SMS texting can be of particular benefit to community pharmacies offering new pharmacy services such as immunisations and screening services. New developments and improvements are constantly evolving within the healthcare technology industry and the SMS text messaging application is just one of theses emerging technologies that can be used as an effective tool to create a more competitive and satisfactory customer experience. Its simplicity, ease of use and low cost, make SMS mobile technology an ideal application for any computerised pharmacist or healthcare professional. IP e-pharmacy The Weird and Wonderful World Irish Pharmacist reviews some of the better health related websites. A the Web lbert Einstein, Sir Isaac Newton, Sir Winston Churchill, Charles Darwin, Renoir and Pablo Picasso were all premature babies. Every year in Ireland, an estimated 2,000 babies are born prematurely and until now, there has been a dearth of specific information on caring for these tiny new borns. A new Irish Web site, www. prematurebaby.ie gives advice, information and tips for parents following the very early arrival of their new baby. A premature baby is one who has been born less than 37 weeks into a pregnancy. While many of the factors that cause babies to be born prematurely are still unknown the website lists some of the known risks which include: pre-eclampsia, abnormal placenta, anaemia, malnutrition and premature rupture of the membranes. According to the site the risk of giving birth prematurely is higher in women under 17 and over 35, those carrying twins or other multiples and women who have already had a premature baby. Divided into five main sections: General Information; While Your Baby is in the Hospital; Going Home; Keeping a Record; and For More Information – the web site gives advice on topics such as what to expect at a special care baby unit and the importance of touch in the development of a premature baby. The Web site also provides parents with a glossary of medical terms, along with practical advice, such as choosing an infant j ay cu rt i s, i t co r r es p o n d en t car seat and a shopping list of items they may require for their baby’s arrival. “Approximately five per cent of all deliveries in Ireland occur less than 37 weeks”, said Dr Eugene Dempsey, consultant neonatologist, at Cork University Maternity Hospital (CUMH). “It is hoped that this web site will provide parents of premature babies and their families with additional information to help them come to terms with having their baby in the intensive care unit, often for weeks or even months in some cases. This is a useful source of information to prepare them for the transition home and the immediate post discharge period.” Sponsored by Abbott, the website also provides a comprehensive account of the health risks to premature babies, along with a list of symptoms to look out for, and an overview of the treatment any such conditions require. New website for irelaNd’s 470,000 asthma sufferers The Asthma Society of Ireland has re-launched its website www. ashtmasociety.ie, providing vital information for Ireland’s 470,000 asthma sufferers. The updated site has new features including a Issue 3 Vol 10 March 2008 39 e-pharmacy “ section for parents with children suffering from asthma and for teachers who may have students with asthma, all presented in a colourful and easy-to-use format. www.ashtmasociety.ie offers users a wide range of information on asthma, including advice on how to develop good school asthma management guidelines and how best to manage asthma during exam times. Further information on asthma triggers, advice on medicines and treatment and best practice management in the event of an asthma attack is also available. The website further boasts a section, entitled ‘Airplay’, dedicated to educating children with asthma in a fun, child friendly manner. Airplay provides children with advice on managing and treating asthma and includes tips on exercise techniques that benefit asthma symptoms. The site also features a ‘Latest News’ section which contains all current and breaking news on asthma related stories. This section includes a direct feed from www.irishhealth.com which filters all asthma related breaking news stories to the website. The publications section of the site provides a library of material available to read online, download or order. Literature includes an ‘Asthma and Allergic Rhinitis’ booklet, ‘Top Tips on Exercising with Asthma’ and ‘Take Control of Your Asthma’, which provides a range of information for asthma sufferers. Sword swallowers “run a higher risk of injury when they are distracted… but injured performers have a better prognosis than patients who suffer iatrogenic perforation.” Find out what goes on ‘inside Your gut’ In January the Minister for Enterprise, Trade and Employment, Mr Michéal Martin launched a new interactive science website for primary school students and teachers http://microbemagic.ucc.ie Commenting on the new site, Minister Martin, said “Websites such as Microbe Magic are important tools in encouraging students to consider careers in science and engineering. By using resources like this we hope to have a positive impact on the next generation of scientists and engineers. Young people use computers for learning and entertainment and this website provides a tool to deliver both of these objectives.” Intuitively entitled Microbe Magic the new website will be a major information resource for students on body and health issues that will provide access to research undertaken by the Alimentary 40 Issue 3 Vol 10 March 2008 Pharmabiotic Centre (APC), the Science Foundation Ireland (SFI) funded research centre at UCC, in collaboration with Teagasc, Moorepark which conducts cutting-edge research at the interface between food and medicine. The site has informative links that explore ‘Your microbes’ and what goes on ‘Inside your gut’. The website also allows students to ‘Explore your body’ and provides information on ‘Healthy living’. There are a number of educational games to play online or students can download the computer game Gut Reaction, in which players travel through the intestines and have to harness the energy from probiotic (or good) bacteria in the gut in order to kill the bad bacteria, viruses and cancers before they kill the human host. ‘Ask a Scientist’ allows students to interact with scientists. With regular news and competitions and over 500 pages of scientific information, there is always something to interest students, teachers and everyone else who is curious about what goes on in our bodies. Professor Fergus Shanahan, Director APC, said: “Microbe Magic will provide a wonderful learning experience and resource for students and teachers to explore cutting edge research undertaken at the Alimentary Pharmabiotic Centre (APC) in UCC. It is a major information resource on biological science and supports the APC mission – to link Irish science with industry and society through excellence in research, education and outreach in gastrointestinal health”. ig noble Prize For a little light relief visit www.ignoble. com to check out the very weird and wonderful world of scientific research. The website features a list of Ig Nobel Prize winners from 1991 to the present day. Awards are based on silliness more than anything else, Ig Nobel Prizes honour achievements in scientific research that first make people laugh, and then make them think. The prizes are intended to celebrate the unusual, honour the imaginative and spur people’s interest in science, medicine, and technology. Commenting on the 2006 awards, Marc Abrahams, editor of Annals of Improbable Research, co-sponsor of the awards, said: “The prizes are intended to celebrate the unusual, honour the imaginative - and spur people’s interest in science, medicine and technology.” The 2007 Ig Nobel Prizes were awarded in October last year and you can watch archived video of the ceremony on the website. The 2007 Ig Nobel prize for Medicine was awarded to Brian Witcombe of Gloucester, and Dan Meyer of Antioch, Tennessee, for their penetrating medical report “Sword Swallowing and Its Side Effects” which was published in the BMJ in December 2006. (Reference: “Sword Swallowing and Its Side Effects,” Brian Witcombe and Dan Meyer, British Medical Journal, December 23, 2006, vol. 333, pp. 1285-7). The objective of the research was to evaluate information on the practice and associated ill effects of sword swallowing and the researchers wrote to 110 sword swallowers from 16 countries requesting information on technique and complications. Perhaps not surprisingly the research concluded that sword swallowers “run a higher risk of injury when they are distracted or adding embellishments to their performance, but injured performers have a better prognosis than patients who suffer iatrogenic perforation.” The study also revealed that perforations mainly involved the oesophagus and usually had a good prognosis. “Sore throats are common, particularly while the skill is being learnt or when performances are too frequent. Major gastrointestinal bleeding sometimes occurs, and occasional chest pains tend to be treated without medical advice. Sword swallowers without healthcare coverage expose themselves to financial as well as physical risk.” The 2008 Ig Nobel ceremony will take place on 02 October so there is still time to nominate someone you know or submit your weird and wonderful research projects for an illustrious Ig Nobel award. IP product news Gardasil demonstrates high efficacy against precancerous cervical lesions in longest follow-up of large phase III clinical studies A combined analysis of four phase II/III studies which enrolled more than 20,000 women confirmed that the quadrivalent (6,11,16,18) cervical cancer vaccine Gardasil has sustained 98% to 100% efficacy in the prevention of vaccine virus type-related precancerous cervical lesions in young women. These new data were recently at the 19th International Congress on Anti-Cancer Treatment (ICACT) in Paris, France. In light of the high and sustained efficacy of Gardasil, the independent Data and Safety Monitoring Board (DSMB) of the large phase III studies (FUTURE I & II) recommended last year that these studies be terminated as soon as feasible. Thus, the studies were ended after four years and the women in the placebo group have now been offered Gardasil, to give them the opportunity to benefit from vaccination. In the primary study population of young women (16-26 years), Gardasil prevented 98% of HPV 16/18related precancerous cervical lesions (CIN2/3 or AIS), according to the combined analysis. Supplementary analyses in a sub-population of young women (16-26 years) revealed 100% efficacy against HPV 16/18-related CIN2/3 or AIS. This subpopulation was chosen to approximate a population before sexual debut. Government funded HPV vaccination programmes have generally targeted young girls because it is thought that the maximum benefit and protection from HPV vaccination could be achieved from vaccination prior to the onset of sexual activity. The new results are consistent with previous results from the five years follow-up of the pivotal phase II study in a smaller population. “This extends the robustness of the data from a few hundreds to many thousand women,” adds Patrick Poirot, vice president for Medical and Scientific Affairs at Sanofi Pasteur MSD. “Phase III results are of greatest importance for regulatory and health authorities when they evaluate a vaccine”. In addition, the follow-up of the pivotal phase II study has ended after five years. The women in the placebo group have also been offered the opportunity to be protected with Gardasil. In addition to the robust follow-ups in phase II and III studies, Gardasil®has been demonstrated to induce immune memory. Demonstrating immune memory means demonstrating that the immune system has memorised the vaccine virus types and can be expected to provide protection when exposed again to these types, potentially even years later. Experts consider the demonstration of immune memory a hallmark of long-term protection. “With five years of follow up in phase II studies followed by the demonstration of immune memory plus the longest ethically acceptable follow up in our large phase III studies we have provided the three key elements to make mothers, young women, physicians and health authorities confident about long-term protection with Gardasil”, concludes Patrick Poirot. Perrans say Pants to Cellulite! There are over 1.3 million women in Ireland that suffer with Cellulite – Perrans has the answer! Clinically proven to reduce the appearance of cellulite and reduce inches, Lipo Contour is the only underwear garment that gives a constant micro massage! Developed by Professor Marco Gasparotti, from more than 20 years clinical practice and experience in the field of liposuction and liposculpture. Initially used as an elastic and compressive sheath in 4000 clinical cases, proving that the properties of the Lipo Contour sheath go beyond the mere effects of compression and support. What makes Lipo Contour different from all other compression garments is its patented fabric, giving a constant micro massage on those problem areas (hips, thighs, buttocks and stomach). Increasing circulation, that in turn helps break down cellulite. Resulting in firmer smoother skin, a reduction in the appearance of cellulite, and more importantly, inch loss. For clinical data information visit www.lipocontour. co.uk Lipo Contour available in two designs: Short RRP 75.99 (Trade 41.87) Euros, Body RRP 89.99 (Trade 49.58) Euros, 5 sizes, 10, 12, 14, 16 & 18. This exciting new product will be supported by a comprehensive PR and Advertising Campaign with an investment of over 100,000 euros. For further details contact Perrans Distributors on: 01 806 8666 Intrinsa patch significantly improves sexual desire in women The first licensed treatment for women concerned by low sexual desire following surgically-induced menopause is now available in Ireland. The female testosterone patch, called Intrinsa, is indicated for the treatment of low sexual desire associated with distress in women who have experienced an early menopause following hysterectomy involving a bilateral oophorectomy and are receiving concomitant oestrogen therapy. According to results from the Women’s International Study of Health and Sexuality (WISHeS) trial, approximately 40% of surgically menopausal women suffer from low sexual desire. Further results showed that 14% of these surgically menopausal women were classified as having low sexual desire with associated distress, also known medically as hypoactive sexual desire disorder (HSDD) Surgery to remove the ovaries during hysterectomy leads to a 50% decrease in testosterone, a naturally occurring hormone in women, that may be a key mediator of sexual desire. “It is very rarely mentioned that in young women testosterone levels are actually higher than oestrogen. Many of my surgicallymenopausal patients tell me they feel sexually numb and are really concerned about their relationships”, comments Dr Shirley McQuade, Medical Director, Well Woman Centre, Dublin. “Intrinsa offers real medical hope to these women as studies showed that the patch increases sexual desire and satisfying sexual activity, while reducing associated distress.” Clinical trials (INTIMATE SM1 and INTIMATE SM2) involving over 1,000 surgicallymenopausal women with low sexual desire and associated distress on concomitant oestrogen therapy, demonstrated significantly increased sexual desire (p=0.0006 and p<0.001) and satisfying sexual activity from baseline at six months with Intrinsa compared with placebo, as well as significantly decreased personal concern due to low sexual desire. In studies SM1 and SM2, Intrinsa increased sexual desire by 56% and 49% from baseline, increased satisfying sexual activity by 74% and 51% from baseline and reduced distress by 65% and 68% from baseline. In six-month studies, Intrinsa is generally well tolerated, with the most common side effects being considered mild and reversible. Few participants discontinued treatment because of side effects. Of the 79% of patients who completed the studies, 96% elected to continue in a six-month open label study. Further long-term safety studies are ongoing. Intrinsa is a thin, clear patch worn on the abdomen, applied twice a week, which delivers a low dose of testosterone (300 micrograms/24 hours) and achieves serum testosterone concentrations compatible with premenopausal levels. The testosterone used in the patch is identical to testosterone produced naturally in all women. Further information for healthcare professionals can be found at www.intrinsa. co.uk For further information please contact: Jane Quigley, Procter & Gamble Pharmaceuticals. Tel: +44 (0) 1784 474 436 Issue 3 Vol 10 March 2008 41 product news Quit smoking challenge With the increased availability of information through online, print and radio sources, consumers today cannot but be aware of the health risks associated with smoking. However, you may be surprised to learn that over 350,000 of current smokers do not want to quit with fifty one percent of current smokers enjoying almost every cigarette they smoke. This Lent, Nicorette asked smokers to take the ‘Lent Quit Smoking Challenge’ and see how much healthier they would feel giving up. With an average smoker smoking 17 cigarettes per day, he/she could have 782 fewer cigarettes smoked over the 46 days of Lent. New Irish research, carried out in November 2007, revealed that forty seven per cent of current smokers said the main reason they would give up smoking was to improve their health. The benefits of giving up smoking can be seen in just 20 minutes with blood pressure returning to normal. After 48 hours, nicotine is no longer detectable in the body, after 72 hours breathing becomes easier and energy levels increase. “Sometimes people forget how quickly the benefits of not smoking can be seen. This is a great incentive for people to try and quit. Make sure you get some help. You are more likely to succeed using a nicotine replacement therapy (NRT) over willpower alone so visit your local pharmacist who can give you advice on quitting”, commented pharmacist Owen Daly. Other key reasons current smokers gave for giving up smoking include: quitting to save money (40 percent) and feeling unhealthy (35 percent). Thirty two percent of parents said they would give up smoking as it is unhealthy for their children. Nicorette offers psychological and lifestyle advice through the Nicorette ‘Start Afresh’ programme, designed to support quitters throughout the quitting process. To order a free Nicorette ‘Start Afresh’ pack, log on to www.nicorette.ie or callsave 1850 430 530. Anti-inflammatory warning According to an NHS review (Cardiovascular and gastrointestinal safety of NSAIDs) into the safety profile of anti-inflammatory treatments in the UK, GPs should review the use of the most widely prescribed NSAID (diclofenac) and switch to ibuprofen or naproxen. The National Prescribing Centre’s review of cardiovascular risks associated with traditional NSAIDs and cox-2 inhibitors suggests that the high level of diclofenac prescribing should be ‘reconsidered’. According to the report, all patients taking diclofenac should be reviewed and switched to low-dose ibuprofen or naproxen if possible, to reduce their cardiovascular thrombotic risk. Dr Neil Maskrey, director of evidence-based therapeutics at the National Prescribing Centre, said reviewing NSAID use should be a priority for GPs. He said many patients could be shifted to other analgesics, or moved to an NSAID with a better safety profile. “It has taken a while to become clear – but we do know that ibuprofen 1,200mg a day or naproxen 1,000mg a day don’t carry the increased cardiovascular risk, so they would be the first and second choice NSAIDs, weighing up gastrointestinal and cardiovascular safety,” he said. 42 Issue 3 Vol 10 March 2008 Astellas receives positive opinion Mycamine(R) for the treatment of serious fungal infections Astellas Pharma Europe Ltd announced recenly that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion by consensus, recommending a marketing authorisation for Mycamine(R), a treatment for systemic fungal infections, which are very serious, life-threatening conditions. The CHMP’s positive recommendation is a critical step in the approval process, and Astellas expects to obtain the European Commission decision in March. Mycamine(R) is a novel treatment for a serious fungal infection known as invasive candidiasis, and its efficacy and safety have been demonstrated in an extensive and robust clinical development programme including more than 3,500 patients in 16 clinical trials. These trials not only cover large Mycamine(R) patient numbers but a broad range of patients including nearly 300 children. Mycamine(R) is the market leader in Japan where it was launched in 2002 (Brand Name in Japan: Funguard(R)), and in the US, where Mycamine(R) was launched in 2005, the product has already achieved a 20% market share. In these two major markets more than 350,000 patients have been treated with the product. Contacts for enquiry or additional information: Astellas Pharma Europe Jeannine Nolan Communications consultant Mobile: +44(0)7785508478 Email: jeannine.nolan@ eu.astellas.com Dry Mouth – awareness is key! Dry Mouth (Xerostomia) caused by a decrease in saliva production is a common complaint affecting over 10% of the population. The prevalence rises as the number of prescribed medications taken increases and with the number of medical conditions present. Indeed, as many as 25% of people over 65 suffer from dry mouth rising to almost 50% among institutionalised elders. While the aetiology of dry mouth maybe multi-factorial many dry mouth cases are drug related with over 400 commonly prescribed medications know to be xerogenic. Among the most commonly implicated are tricyclic antidepressants, antipsychotics, atropines, antihistamines, beta blockers, bronchodilators and diuretics. Dry mouth can also be brought on by cancer treatments (radio and chemotherapy) as well as conditions like diabetes, renal failure, cystic fibrosis, Sjogren’s syndrome etc. Other common causes include mouth breathing, stress, tobacco and alcohol. There is a lack of awareness of dry mouth both among sufferers and health professionals. Despite the number of sufferers and its adverse effects on their quality of life it is often not talked about or explained. If not recognised and treated it can cause difficulty when speaking/ swallowing and can lead to gum disease, bad breadth and tooth caries. Biotene is the original and world leader in bio-enzymatic oral care technology for dry mouth, providing both relief and protection. All Biotene products are sodium laurly sulphate and alcohol free. Biotene uses the same natural bio-active enzyme systems as healthy saliva that restore and boost saliva’s natural antibacterial defences to maintain a healthy mouth. Biotene is made in Ireland and is available through United Drug and Uniphar. The range includes: Toothpastes (original, gel & sensitive), Mouthwash, Oral Balance Gel, Chewing Gum and Oral Balance Moisturising Liquid (*new). For further information and free samples contact Europharma Concepts Ltd. Clara, Co. Offaly. Tel. 057 9364950, Email [email protected] or Website www.epc.ie (click on Products). Target your customers with the * No.1 selling over the counter brand For 25 years Nurofen - the brand which introduced Ibuprofen - has been recognized and trusted by pharmacists and customers alike. With a presence in all three analgesic categories, Adult, Paediatric and Cold & Flu, Nurofen's range of targeted pain relievers continues to achieve double digit growth within pharmacy. More innovation, more of your needs met, more pain relieved. That’s our ongoing target! Full prescribing information available on request from Reckitt Benckiser Ireland Ltd., 7 Riverwalk, Citywest Business Campus, Dublin 24. Nurofen products are available through pharmacies only. *IMS OTC IRL Quarterly Jan 08 product news Perrans takes over Nourkrin, Europe’s leading ‘hair recovery natural supplement’ Perrans Distributors Ltd, leaders in the natural healthcare market in Ireland, has taken over sales, marketing and distribution for Nourkrin, Europe’s leading ‘hair recovery natural food supplement’. “First introduced 12 years ago, the Nourkrin natural food supplement range reduces hair loss by nourishing thinning hair and promoting existing growth”, explains Peter Noone, general manager, Perrans Distributors Ltd. “It is now Europe’s leading hair recovery natural supplement. “With an estimated one in three women suffering hair loss at some stage in their lives and given the growing interest and demand for evidence-based ‘natural and safe treatments’, it is no surprise that the market for Nourkrin has grown dramatically. Sales in Ireland and the UK have grown from just 1,500 units a month in 2003 to 42,000 units per month last year – a €55 million retail market. “With an estimated 50 per cent of men suffering hair loss before the age of 50 and 70 per cent of men over 50 also suffering hair loss, there is already a significant market for Nourkrin Man.” The two key products in the Nourkrin treatment programme range are Nourkrin Extra Strength for women and Nourkrin Man. There is also a maintenance product (Nourkrin Maintain), shampoo, conditioner, scalp lotion and scalp sun block. In a recent independent study conducted on Nourkrin, published in ‘The Journal of International Medical Research 2006’, participants showed an increase in hair growth of 35.7 per cent after a six month treatment programme. The key ingredient in Nourkrin is a marine protein extract which is blended with an organic, soluble silica and vitamin C. Nourkrin is approved by the Irish Medicines Board (IMB) and MHRA (UK). Dr David H. Kingsley, an internationally renowned trichologist and author of “The Hair-Loss Cure: A Self-Help Guide” said, “Hair loss is a devastating problem to have - especially for women. I see so many people whose self-esteem is rock bottom because of problems with losing their hair. What I like about Nourkrin is that all the ingredients are naturally based giving people an alternative that will have no side effects” Nourkrin will be running a significant media campaign in 2008 featuring movie legend Britt Ekland. Nourkrin Extra Strength and Nourkrin Man retail for €69.95 for a one month supply (60 tablets). For more information about The Nourkrin Natural Hair Recovery Programme Range please contact Perrans Orders at 01.806.86.66 or at perransorders@ tpwhelehan.ie or contact your local Perrans representative. Also see www. perrans.ie Torisel now available Wyeth Pharmaceuticals Limited have announced you that TORISEL (Temsirolimus) 25 mg/ml concentrate and diluent for solution for infusion is now available. TORISEL is the first mTOR inhibitor indicated for the treatment of advanced renal cell carcinoma (RCC). For further information on TORISEL please refer to the Summary of Product Characteristics available at www.medicines.ie or contact Wyeth Pharmaceuticals Medical Information Department on 01 4493524. 44 Issue 3 Vol 10 March 2008 Teva Pharmaceuticals Ireland announce launch of Rispeva Filmcoated Tablets, a newly available risperidone branded generic Rispeva, a selective monoaminergic antagonist is now available to prescribers. Rispeva Film-coated Tablets are presented in ‘patient friendly’ packaging to aid compliance and offer a variety of presentations. Prices per pack size, together with colour description, are as follows: Rispeva 1mg 20 pack, white tablet €13.48 Rispeva 1mg 60 pack, white tablet €40.40 Rispeva 2mg 60 pack, pale brown tablet €79.73 Rispeva 3mg 60 pack, yellow tablet €117.24 Rispeva 4mg 60 pack, pale green €154.74 Rispeva Film-coated Tablets are round, bevelled and biconvex in shape. Teva’s excellence in quality standards is assured. For more information call the Teva Customer Service FREEPHONE 1800 201 700 Trial shows positive outcome of lacosamide in patients with diabetic neuropathic pain UCB Pharma recently announced positive results from a Phase III trial evaluating lacosamide (400 mg per day) in the treatment of diabetic neuropathic pain. With a standard titration regimen, the trial met its primary objective with sustained and statistically significant reduction in average daily pain scores. The randomised, double-blind, placebo controlled trial in 551 patients with diabetic neuropathic pain was designed to evaluate the efficacy and safety of lacosamide (400mg per day) in two different titration schemes: a standard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day 8. The primary efficacy results showed that the change in the average daily pain score as measured from baseline to the last four weeks of the 12-week maintenance period, was significantly greater with lacosamide 400mg per day given in standard titration than placebo (p=0.0410). The change in pain score with the lacosamide fast titration regimen was numerically better than placebo but did not reach statistical significance (p=0.2902). The median time to achieve sustainable pain relief was 10 and 11 days for the lacosamide standard and fast titration regimens, respectively compared with 31 days for the placebo group. Lacosamide was generally well tolerated. The incidences of adverse events were higher in the lacosamide fast titration group than in the standard titration group. The most common adverse events in this trial were dizziness, nausea, headache, nasopharyngitis and vertigo. The results from this trial will support the dossiers filed for lacosamide in diabetic neuropathic pain which were submitted to the European and U.S. regulatory authorities in 2007. Data from this trial will be submitted for presentation at upcoming international scientific meetings. About Diabetic Neuropathic Pain: Diabetic Neuropathic Pain is a painful and potentially debilitating condition, resulting from damage or dysfunction to the peripheral nervous system as a result of diabetes or impaired glucose tolerance. The condition is often characterized by a stabbing or burning sensation in the legs, feet, and/or hands. With the overall prevalence of diabetes in the U.S. estimated at 20.8 million people, it is thought that as many as 7.7 million have some degree of diabetic neuropathic pain. About lacosamide: lacosamide has a novel and dual mode of action. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target - collapsin-response mediator protein-2 (CRMP-2). For further information contact Fergal Egan on 01 4637395 or e mail [email protected] Small Group Authentic Adventures Irish Pharmacist is proud to introduce our readers to one of the most dynamic new travel companies operating out of Ireland – Zara’s Planet Ltd is a 100% Irish owned, fully bonded and licensed travel company (No:0643) offering small group adventure and cultural trips with monthly departures throughout the year. Zara’s Planet provides discerning clients with a deeper local insight into the place they visit. We bring you to places slightly off the beaten track but without sacrificing comfort or style. A long weekend in South West France for Wine Lovers and Foodies Price: €545 (includes all taxes) per person based on double/twin share. Single supplement: €150 Travel Dates: 19 - 22 April 2008 South Africa – Safari Adventure Price: €1,699 (includes all taxes) per person based on double/twin share Single supplement: €150 Dates: 13 June - 22 June or 30 June – 9 July 2008 Summary of Trip Our hideaway is in the stunning malaria-free Waterburg region north of Johannesburg. You will be staying on an estate in a beautiful, authentic, thatched African cottage full of antiques. You will be looked after from the moment you arrive in Johannesburg where your group will be met and transferred to your cottages which are set in a stunning rose garden. Relax in the heated pool which is gated for safety. We have put together an itinerary which includes game drives with the best guides in the area, bush walks, GPS game tracking, astronomy/star gazing nights, and water volleyball for the active as well a host of other options. Let yourself be immersed in true South African hospitality and be awe inspired by the wild zebras, giraffes, elephants and rhinos at some of the best game parks normally only reserved for guests staying at 5* lodges Ask us about a Cape Town, Mozambique or Victoria Falls add on… Included: Flights to Johannesburg, all transfers, game drives and trips as per itinerary, 3 self catering cottage accommodation (some share but private bathrooms), full time guides and hosts. Excluded: Meals, tips **Full board option available with delicious home style cooking (organic beef, chicken, salads, BBQ, pototatoes etc) for €199 per person. Summary of Trip On the French side of the stunning Pyrenees mountains lies the highly coveted appellation of Irouléguy, This little know treasure sits in the heart of the Basque country and is a must for any wine lover. Come on the trip and find out more about these magnificent wines and their history while taking our vineyard tour. You will be staying in the picturesque seaside town of Capbreton. Staying at the 3 star Hotel L’Oceane chosen for its comfort and great location – you will be able to step out to the beach every morning. The marina is wonderful to explore and the huge variety of cafes and restaurants won’t leave you wanting. Your Irish host speaks both languages and will happily introduce you to the local community and give you advice on the best entertainment. He will also be on hand to make bookings and act as a concierge for the trip. Your host will accompany you on all transfers and pre-organised excursions. The highlight of the trip will be a wonderful guided tour of Le Cave Irouléguy deep in the Pyrenees which is home to some of the most exciting wines to be found in France. Included: Flights with Ryanair to Biarritz, all transfers and trips in minibus, 3 nights bed and breakfast in Hotel L’Oceane, excursion to La Cave Irouleguy vineyard and St. Etienne De Baigorry for lunch, full time guide and host. Excluded: Other meals, tips For more information on these exclusive trips, please call: (01) 440 7477 to book or log on to www.zarasplanet.ie Issue 3 Vol 10 March 2008 45 ip crossword no. 3a 3 4 6 5 7 Across 6. New hernial gizmo for treating asthma? (7) 7. Cabs involved in tax issue! (5) 9. Jumper on dog can be irritating! (4) 10. A musical US state? (8) 11. It is bound to keep a bone in place! (6) 13. The agony of French bread! (4) 15. A rash place for a bee to live? (4) 16. One gets foot-sore in this bally place in Kerry (6) 18. A word of 26 letters (8) 21. A bit of leg, we hear, in Kildare (4) 22. South American range (5) 23. Colourful fabric for Rev. Ian (7) 8 9 10 11 13 12 14 15 16 17 18 19 22 20 22 21 Down 1. An elk, surprisingly, just over one foot (5) 2. A rotten papal bed could spoil the whole barrel! (3,5) 3. Animal doctor gets nought for prohibition (4) 3. Swear it’s a hot mixture! (4) 5. Par Avion letters (7) 8. Let gun off, aggravating ceoliac disease (6) 12. Drink mixed mebbii! (6) 13 Slap rope around to show downward displacement of organ (8) 14. Aer Lingus or trachea, perhaps (7) 17 It always comes between two and four! (5) 19. Despicable person under 1 Down? (4) 20. A sucker, but that’s an udder matter (4) Name: Across 1. Biceps 4. Ague 8. Who 9. Tallyho 10. Cell 11. Ovary 14. Dwarf 16. Edit 18. Relapse 20. IRA 21. Drew 22. Larynx Down 1. Bawl 2. Cholera 3. Petal 5. Guy 6. Eponym 7. Alto 12. Acidity 13. Adored 15. Fops 16. Enema 17. Manx 19. Lee 2 LAST MONTh’S CROSSWORD ANSWERS 1 Congratulations to the winner of last month’s crossword, Nora McGrath, The Square, Cappawhite, Co Tipperary. For a chance to win e70, please send completed entries to: The Editor, Irish Pharmacist, Unit 4, St Kieran’s Enterprise Centre, Sandyford Industrial Estate, Dublin 18. Closing date: 24th March. Address: e-mail: We are currently recruiting supervising Pharmacists for positions with Excellent Retail Pharmacies throughout Ireland for immediate start. Candidates must have 3 years post qualification experience preferably in the Irish market. To place your recruitment For more details or to apply please forward CVs to [email protected] or call Ann-Marie on 01 4188117. 46 Issue 3 Vol 10 March 2008 advert here contact graham@ greencrosspublishing.ie Helix Health - helping to manage your Pharmacy Dispensing QicScript Professional is a progressive Windows-based system that will help you to run your dispensary more efficiently and free up time to spend with your patients. By switching to QicScript Professional you can benefit from ... GMS Claims 2 Integrated Monitored Dosage Support Fast simple dispensing with editable prescriptions and Drug Usage Review Full integration with Tosho, Willach Consis and ARX Robotics Advanced Stock Control and ordering to reduce overstocking and eliminate stock outs Cheap, quick and effective communication with Patients through SMS and email “Business Intelligence” - Full reporting functionality available online and much more... Consider Qicscript now and get 10% off with free data migration QicScript professional is pharmacy software built for the future QicScript p professional Helix Health Limited, 52 Broomhill Road, Tallaght. Dublin 24 T: 01 4633 000 F: 01 4633 011 E: [email protected] W: www.helixhealth.com GOLD CERTIFIED Partner outside edge Clash of cultures “Yes, as through this life I’ve wandered, I’ve seen lots of funny men, Some will rob you with a six-gun, And some with a fountain pen.” Woody Guthrie At the time of writing I have just seen news of Mary Harney’s announcement regarding the setting up of an independent body to review fees in the pharmacy sector. She’s presenting it as the light at the end of the tunnel but I think it may just be another train. Time will tell. What I do know is that from the outset of this dispute there seems to have been a failure at a high level of management in both the HSE and the Department of Health to understand the mindset of pharmacists. They seem unable to appreciate the depth of the fury they have unleashed, or that the reasons for this fury go way beyond the threat of financial loss. I will try to explain my reason, which I think echoes the sentiments of many other pharmacists. Let me start by telling a story. Pickaxe vs hammer About two years ago, a drug addict came into my shop with a scarf over his face, carrying a hammer. He came behind the counter to the girl at the till and told her to open it. I was in the dispensary and had seen him come in. I have always kept a pickaxe handle in the dispensary for such an occasion, but this was my first time to need it. When I bought it nearly a decade ago I choose the biggest one in the hardware shop – it weighs probably close on ten pounds. I took it in my hands, lifted it above my shoulder and stepped around the corner of fi n ta n m o o r e the dispensary to within range of the raider. He tensed and made a shape with the hammer, and I did likewise with the pickaxe handle. The standoff ended in seconds because he had the sense to see he was outgunned and left my shop. If he had pushed events the other way and attacked me I would have splintered his skull without a second’s hesitation. My reason for going to the edge had nothing to do with him wanting my property – I am not particularly materialistic. Nor is it the fact that I was being threatened with violence – that threat merely determined my choice of response. My reason was quite simple; my shop is my turf and I don’t take crap from people on my turf. If you talk to pharmacists, or many other small business owners, they will usually cite their reason for ‘going out on their own’ as being a desire to make their own decisions about their working life. Given the extra hours involved and all the extra hassle, a lot of proprietor pharmacists would actually earn more money if they put in the same effort working for somebody else. But most will say that they simply prefer to be their own boss. As a friend of mine put it ‘It’s my ship and I decide what way it runs.’ And it’s not about taking a power trip and giving orders to people – it’s about not having to take orders from anybody above them. De haut en bas Hence the anger among pharmacists at being dictated to by the HSE and the Department of Health. A bunch of suits with calculators are attempting to set financial constraints that will determine whether or not your pharmacy will survive, what staff levels you can budget for, what hours you can afford to open, whether you can afford the security guard you need to keep your methadone patients, if you can pay the wages of the employee pharmacist who runs your diabetes clinic...the list goes on. All these decisions regarding your working environment had been made by you based on the contract you have, but you will have to re-evaluate all of them. civil servant vs entrePreneur Maybe the apparent inability of HSE management to understand pharmacists is down to a cultural divide between a civil service mentality and an entrepreneurial one. I have never worked in the civil service so I’m just guessing here, but I suppose the hierarchical structure accustoms people to taking orders from above and relaying them below. Pharmacists on the other hand have complete responsibility for their piece of turf and the buck starts and stops with them. The obvious example of where this culture clash had very negative consequences was when pharmacists withdrew from the methadone protocol. This was a drastic measure driven by desperation and anger, but up to the eleventh hour the HSE seemed to believe that pharmacists would stop at the brink. As a result the HSE’s contingency plans were woefully inadequate. If there was a proper understanding of our state of mind then a better alternative service could have been provided. To paraphrase Mario Puzo’s famous line in the Godfather ‘It’s not just the business – it’s personal.’ IP