Diverting care of minor ailments

The old model of healthcare provision in Ireland is in flux; the powers-that-be are advocating a shift to treatment at ‘the lowest level of complexity’ with GPs being asked to man the front lines in the care of chronic diseases as our hospital services creak at the seams.

As at least 20% of a GP’s daily workload is taken up treating minor health problems, it can be difficult for a doctor to find more time to focus on those patients with complex conditions who really need their input. The solution, according to the Department of Health, is to encourage people to take control of and responsibility for their health through self-referral to the most appropriate primary care team member.

For a number of minor ailments, the first port of call is usually the community pharmacist, who is trained to deal with minor illnesses and already spend a good proportion of his or her time advising on these self-limiting conditions.

Minor health complains are every day aches and ills that generally require little or no medical intervention, such as hay fever, constipation, dyspepsia, minor skin irritations, pain and inflammation, coughs and sore throats. A survey by the Irish Pharmacy Union (IPU) confirmed that almost 60% of people regularly rely on their pharmacist’s advice to solve their minor ailments.

By giving appropriate advice and recommending effective over-the-counter (OTC) products, community pharmacists have an important role to play in diverting minor illnesses from the GP surgery. Pharmacists are also trained to distinguish between minor illness and major disease so they can act as a filter for referral where a GP consultation is needed.

Rory O’Donnell

“All community pharmacists, to one degree or another, provide this service to their customers. Every pharmacy has a consultation room in Ireland, some of these consultations require a one-to-one conversation in private and, for other consultations it is just as appropriate to have them at the counter or to one side of the counter. It just depends on the circumstances and on the patient,” says Rory O’Donnell, who runs a busy pharmacy in Derrybeg, Co Donegal. He is also President of the IPU.

Pharmacists in Ireland provide approximately 15 million items of advice on minor health problems each year – a number that is growing annually as more individuals struggle with the cost of attending their GP, particularly for minor illnesses. Now, more than ever, there is considerable scope to develop the current level of professional services delivered by local pharmacists into a more comprehensive and structured service to the community.

Both the IPU and the Pharmaceutical Society of Ireland have long advocated for the introduction of a National Minor Ailments Scheme in community pharmacies, as currently exists in other countries including Scotland and the UK.

A minor ailments scheme works by providing non-prescription medication, where appropriate, to medical cardholders free of charge, without them having to go to their GP for a prescription.

“Under the current system, a medical cardholders with minor complains, such as a cold sore or hay fever, has to make an appointment with their GP and sit around in the waiting room so that their doctor can prescribe Zovirax or an antihistamine. This is time consuming for both the patient and the doctor and is an unnecessary drain on GP resources,” explains Rory. “A more progressive attitude to community health care would see pharmacists providing these medicines with appropriate advice on their use.”

At the IPU National Pharmacy Conference in Galway recently, union officials called on the Minister for Health James Reilly to actively engage with them on establishing a National Minor Ailment Scheme. The Minister was reminded of the IPU survey (2006), which revealed that 86% of medical cardholders are in support of this initiative.

In March this year, the Welsh Government announced plans to introduce a minor ailments service in community pharmacies across Wales. The first services will be in place by March 2013 with phased rollout beginning later that year.

Lesley Griffiths.

“By visiting pharmacists rather than GPs for minor ailments, patients will not need to make an appointment, but they will still be able to get any necessary medicine without charge. This will free up GP time for dealing with more complex conditions, and may also decrease waiting times for appointments,” remarked Welsh Health Minister Lesley Griffiths.

This endeavour to promote a more appropriate use of GP and community pharmacy skills has proved successful in Scotland and the UK. Under the Scottish system, which was introduced in 2006, patients register voluntarily in a pharmacy of their choice and the patient's GP is informed. This enables individual patient usage to be monitored through the pharmacy. There is a potential patient safety benefit and the risk for abuse of the scheme is removed, since patients can only use one pharmacy.

Payment is on a capitation basis determined by the number of patients registered, plus reimbursement for the cost of medicines supplied.

After just two years in operation, a review of the service found that there were 70,000 consultations per month in Scottish pharmacies that previously would have taken place in GP surgeries, and the average cost of medicines prescribed by pharmacists under the scheme was lower than those prescribed by GPs under the same circumstances.

In the UK, the public has been able to access free NHS treatment at local pharmacies in a large number of Primary Care Trusts for some minor conditions since 2005. Key features of existing minor ailment schemes is that the community pharmacist supplies the medication for a set list of minor ailments from a limited formulary and patients exempt from prescription charges receive these medicines free of charge.

According to research in the UK, this service has proved particularly beneficial in areas of deprivation, since patients in socially disadvantaged areas are more likely to receive OTC medicines on prescription than patients in more affluent areas.

Some members of the medical community have voiced concerns that there may be a real potential for excessive use of medicines where a health professional is both prescriber and dispenser. However, when the ‘Care at the Chemist’ study, conducted by the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester, evaluated a minor ailment service in a deprived area of Merseyside, researchers found its introduction did not lead to an increase in medicine costs.

Rory O’Donnell points out that one of the biggest barriers to setting up a minor ailments service in Ireland is the limit of non-prescription medicines that are available to Irish patients through their pharmacy.

“This is only opening up gradually for us here in Ireland – they’re way ahead in the UK where there is a whole plethora of extra medicines available without prescription for a wide variety of minor medical conditions. The availability of the morning after pill without prescription from pharmacies was a welcome addition but, needless to say, we would welcome and call for a greater extension of switches like that - medicines such as fluconazole for thrush and sumatriptan for migraine.”

But, he says, in terms of the ability of Irish pharmacists to deliver this service, they are absolutely capable and willing.

“I believe that pharmacists have the skills, it’s part of our core competence already but any extra training that may be required would certainly be provided,” he suggests. “Firstly, we would have to agree the parameters of this service, involving all key stakeholders at an early stage - protocols and standard operating procedures for the scheme would need to be developed by a multi-disciplinary working group.

“As well as deciding on the list of formulary drugs, consideration would need to be given to what guidelines and advice should be included in the formulary, such as inclusion and exclusion criteria for treatment with the drug, and when to refer to the GP.

“We’re ready to engage at any time in that discussion. The package would have to be a win-win for everybody: The patient would have greater access to healthcare advice; it would reduce congestion in GP surgeries; the health service would benefit by targeting resources and making savings, and of course, schemes such as this promote the role of the community pharmacist not only as a medicines expert but as professionals who are trained to recognise and treat minor ailments and give healthcare advice.”

Fighting Cancer Fatigue

“I'm like a Lexus with a one-gallon tank: Wherever I go and whatever I do, I run out of gas while others - even my 81-year-old mother - are still going strong. It's more than just being sleepy; I am headachy and irritable. By mid afternoon, my IQ seems to be slipping 10 points per hour…if I keep pushing past my limits, I get flustered easily and appear angry when I'm not. It's hard to think, act or be like the real me,” says Dr Wendy Harpham - a well-known American doctor, author and cancer survivor – describing her daily experience living with what she calls ‘post-cancer fatigue’.

Patients expect to feel tired, weak or exhausted while undergoing rigorous cancer treatment, such as high-dose radiation or chemotherapy requiring bone marrow transplant, and they are cautioned that these symptoms may persist for a year or more.

But many are unprepared for the reality that about one-third of cancer survivors will continue to experience severe chronic fatigue for many months and even years after curative treatment.

Numerous studies have demonstrated that fatigue is a significant issue long into survivorship; ranging from five to ten years in 34% of breast cancer survivors to between six and18 years in more than half (56%) of long-term survivors of bone marrow transplantation.

Fatigue is also identified as one of the three most negative issues affecting quality of life in post treatment survivors.

While there are numerous theories to explain the etiology of fatigue in the patient undergoing treatment, and to describe the impact of that treatment on quality of life, many do not apply to the post-treatment population. Nonetheless, chronic fatigue for the cancer survivor can have a serious impact on normal life, preventing people from returning to work, leisure activities and socialising with friends.

It may also trigger a range of negative emotions including sadness, anxiety, irritability and, in some cases, guilt or depression.

Cancer-related fatigue is a common problem seen by Dr Sonya Collier, Principal Clinical Psychologist and her colleague Dr Anne-Marie O’Dwyer, Consultant Psychiatrist, at the Psycho-oncology Department in St James’ Hospital – the first multi-disciplinary service of its kind in Ireland, opened in 2003, which pioneered an innovative model of care to address the psychological problems that can emerge when a patient is diagnosed with cancer.

Over the course of almost ten years helping many thousands of patients, they identified long-term fatigue in cancer survivors as a major issue that is frequently under reported, under diagnosed and under treated.

Drs Sonya Collier (left) and Anne Marie O'Dwyer 

The pair responded by developing the first known self-help programme for persistent cancer-related fatigue in the world, which was launched earlier this year.

Entitled “Understanding and Managing Persistent Cancer-Related Fatigue”, the easy-to-use manual and accompanying DVD is structured on cognitive behavioural therapy (CBT) techniques and is made up of eight different chapters tackling issues such as inactivity, low mood, sleep problems, worry and reclaiming life after cancer.

Irish rugby star Gordon D’Arcy and well-known TV personalities Eddie Hobbs, Rachel Allen, Kathryn Thomas, Miriam O’Callaghan and Pat Kenny, along with cancer experts and former patients from St James’s Hospital, all contributed to the accompanying DVD to introduce, summarise and explain each chapter of the manual. 

“When we first set up the psycho-oncology service in St James’s, patients were being referred to me for a variety of problems, such as low mood, anxiety or body image problems, as would happen in a cancer setting, but there was frequently this common denominator which was a problem with persistent fatigue,” explains Dr Collier.

“In CBT, often one of the first exercises we do is we work with the patient to create a ‘problems and goals’ list, then we look at how we might try to solve them. Repeatedly fatigue was coming up on these lists and it was quite clear that the problems were overlapping – there were cases where the fatigue was actually causing the low mood and other times the depression was causing the fatigue.

“It was quite clear to me that some of the problems that I was use to working with, such as persistent worry following cancer - fear that it was going to come back - when I started treating those problems a lot of the fatigue issues would lift. The same with insomnia; 50% of breast cancer patients suffer from insomnia, but again, when I started working on their insomnia, the fatigue started to lift. Treatment in one area was impacting positively on the fatigue and we became very aware that this is a multi-factorial problem.”

The absence of textbooks and relative dearth of published research in the then embryonic subspecialty of psycho-oncology meant that Dr Collier had to adapt techniques from within established psychotherapeutic practice in devising strategies that worked for her patients. Over time, she could see which approaches worked on particular patients and on specific difficulties to help alleviate the ever-present and often debilitating fatigue.

“It was through working individually with patients that we developed this programme, and we could see that it was working very well, to the point that we felt the next logical step was the development of a home-based intervention for patient with mild to moderate problems,” she says.

“It’s interesting, when I started looking at this area first, back in 2003, the only real suggested intervention was medication for patients with persistent fatigue following curative treatment,” Dr Collier adds. “But treatment guidelines have since changed and now the first level intervention in the National Comprehensive Cancer Network’s (NCCC) guidelines is exercise and psychological therapy, namely CBT.”

She highlights a Dutch study that was pivotal in the re-evaluation of the NCCN guidelines. Researchers from the Radboud University Nijmegen Medical Centre in the Netherlands were among the first to demonstrate the effectiveness of CBT especially designed for fatigue in cancer survivors. Clinically significant improvement for the CBT group compared with the waiting list group was seen in fatigue severity (54% versus 4% of the patients, respectively) and in functional impairment (50% versus 18% of the patients, respectively). The study was published in the Journal of Clinical Oncology, 2006.

“We are a national centre here in St James’s and people come to us from every corner of the country – Cork, Kerry, Donegal, and the Aran Islands. These are people who have very limited amounts of energy in the first instance and they are using huge amounts of that energy to get up to Dublin and get home again, on the train or trying to battle traffic. Some have not been able to attend because they simply couldn’t manage the journey.

“The problem we were struck with was we felt their persistent fatigue was very treatable, it was something that we could help with, yet psycho-oncology is still a relatively scarce resource in Ireland. So we felt that if we could develop our programme into a self-help version it would be an effective intervention for people with mild to moderate problems,” says Dr Collier, pointing out that patients with more severe difficulties would still require one to one therapy.

The resulting and recently launched self-help programme consists of two main components - a workbook-style manual and a DVD - that are used in conjunction, chapter by chapter.

Dr Collier elucidates: “The patient is to use the manual and the DVD in a very structured way, which is made clear in the introduction to the manual. The entire programme is eight chapters long. Each chapter on the DVD has a corresponding chapter in the manual, similar to a distance-learning programme.

“Each chapter has myself and Ann-Marie explaining the programme. We also have one of the cancer consultants talking about the particular problem, and we have a contribution by an Irish celebrity that has some connection with the topic. For example, Rachel Allen does the section on good nutrition following cancer, Gordon D’Arcy does the stepped return to activity following injury or illness, and Eddie Hobbs does the energy economics piece. We’re hoping this approach will help engage people in the programme and make it more interesting for them.”

Although many studies document the incidence of fatigue in those who are no longer receiving cancer treatment, the specific mechanism of fatigue remains unknown. Researchers have suggested that such fatigue may be due to persistent activation of the immune system or to other factors such as late effects of treatment on major organ systems.

“It’s one of those problems that is hard to unpick, it is multifactoral; for different people it can be different things. In some people there may be a medical problem related to anaemia, for example, which can be treated once diagnosed by a doctor. For other patients, there are a whole host of factors that are feeding into it, some of those factors are psychological and that’s where our programme comes in,” she says.

“Most patients become very unfit and de-conditioned as a result of their treatment and being out of action for so long. Some are anxious to reclaim their old lives and try to do too much too soon; they wait an arbitrary period of time - it could be one month, six months or a year, depending on the person - and then they hurl themselves back into action and expect to be able to perform in the way that they did before, but of course their bodies can’t cope.

“Others sit and wait very patiently for their energy to return. They’re sitting, minding their energy so carefully but the more they do that the more they become deconditioned, getting less and less fit - we call this ‘use it or lose it’ economics - their beliefs are interfering with getting back and getting active again.

“In the self-help programme we try to educate people around this concept of energy economics and really encourage people to go back to activity in a stepped approach, little by little.”

She says it’s universal that cancer survivors ask why, now that their disease is gone, can they not return to their ‘normal’ life. “Questions like this are a huge part of what the manual focus on. Our beliefs, expectations and how we think about things can actually feed into vicious cycles of fatigue, anxiety and low mood, which can all negatively impact our quality of life. Each chapter in the manual offers cognitive behaviour techniques to help the patient overcome these.”

The self-help programme has already received praise from international experts in the field of psycho-oncology. Professor William Breitbart, Chief of the Psychiatry Service at the world’s oldest and largest private cancer centre, the Memorial Sloan Kettering Cancer Centre in New York described the programme as “incredibly comprehensive and extraordinarily helpful, full of practical information and interventions”.

Specifically designed for patients who are disease-free and who completed their treatment for cancer at least six months previous, the manual and DVD package is being distributed to regional oncology units and their patients nationwide, thanks to a funding from Roche Products Ireland.

Dr Collier and Dr O’Dwyer are hopeful that their home-based intervention will provide cancer survivors with information and strategies that may help them to better understand and manage their fatigue.

Dr Wendy Harpham

In her book After Cancer, Dr Harpham, who was diagnosed in 1990 with non-Hodgkin’s lymphoma and has since struggled with limited stamina and fatigue, reminds each patient that their recovery pattern is unique.

She advises survivors to work towards developing a new sense of well being and good health, as opposed to trying to get back to where they were before cancer, and to focus on ways to improve energy levels:

“Post cancer fatigue is one of the after effects that requires patience and hopefulness.”

The big-screen picture

With more monthly visits to pharmacies than to any other element of the primary healthcare services in Ireland, the potential to roll out screening is immense, writes Eimear Vize

When it comes to your health, sometimes what you don’t know can hurt you. A person who will later be diagnosed with diabetes could have had their elevated blood glucose levels detected up to 10 years earlier. While the initial symptoms appear harmless enough and could be easily ignored, this delay can result in serious complications that could have been avoided with a simple blood sugar test, one that can be delivered quickly and easily in a community pharmacy.

This kind of opportunistic screening can also benefit people with high cholesterol or high blood pressure, who might otherwise remain relatively healthy and symptom free for years, all the while significant and, in some cases irreversible damage may be done.

Health screening is an invaluable low-cost service that can identify individuals at risk and decrease the time it takes to diagnose as well as helping people to make informed choices about the improvement of their health.

The Pharmacy Society of Ireland (PSI), through its strategy document Pharmacy

Ireland 2020 and related implementation body, the National Pharmacy Reference Group (NPRG), is striving to support and facilitate pharmacy screening services through greater involvement in integrated health care under the interdisciplinary national clinical care programmes. These include the chronic diseases programmes dealing for diabetes, heart failure, asthma, and stroke.

The PSI maintain that health screening and promotion activities in Irish community pharmacies have the potential for relatively high penetration into the population, given that there are more visits to the 1,600 or so community pharmacies around the country on a monthly basis than to any other element of the primary healthcare service.

A recent survey reported three quarters of the adult Irish population use community pharmacies at least once per month, with more than 10 million visits/consultations per year.

Although there is no current HSE policy on health screening in community pharmacy, pharmacy-based screening initiatives have spread across the country in recent years. They may be ad-hoc, unsupported and not audited – as described by the PSI - but they nevertheless playing a vital roll in disease prevention, disease management and public health improvement.

In almost every pharmacy in Ireland, customers can avail of some form of health screen, whether it’s checking blood glucose levels, taking blood pressure readings, BMI assessment, or full lipid profile, among others.

Cicely Roche

“A more integrated approach to healthcare in Ireland is the way forward and our Government and the professionals involved in delivering healthcare acknowledge this. Almost all of the national clinical care programmes will have a screen related to it, which will feed into the strategy of integrated care. Pharmacy has a major role to play here,” says Cicely Roche, Associate Professor at the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, and member of the NPRG.

“Health screening in the pharmacy is about catching people who wouldn’t otherwise go to the GP; for example, those people between 30 and 50 that would not cross a doctors threshold if they can avoid it. The pharmacy is a different environment with a different focus; you don’t have to present with a health complaint, you don’t have to perceive that there is anything ‘wrong’ with you at all to justify accessing a pharmacy’s services.

“As a pharmacist, what you’re trying to do is give the patient a little more information and move them into care quicker, where required. You want to catch them before they end up in the A&E,” she stressed.

Cicely has spent much of her career working as a community pharmacist, the first five years of which were in Ontario, Canada. In 2004, she sold a successful pharmacy business in Gorey, Co Wexford, to focus on her academic career and a consultancy business, which focuses on health screening and medicine's usage review training and consultancy.

Her interest in health screening initially developed while researching her Master’s thesis, completed in 2001 and entitled ‘The extension of the Pharmacist's role in Health Promotion and Health Screening’. Over the course of three months she linked up with 250 ladies from a local Unislim group, testing their blood pressure and blood glucose, and performing body fat analysis and BMI calculations as they engaged in the weight loss programme.

“From my early experience it was clear to me that there is a huge role for pharmacists in health screening. When I owned the pharmacy in Gorey we ran opportunistic screening event days, always liaising closely with local GPs so that they were aware of what we were trying to achieve.

glucose test

“For example, every second year we held a one-day event on diabetes in the pharmacy where all the windows were dressed around the theme of diabetes and people were invited in to have their blood glucose screened on that day.

“The last time we did that we had over 400 people screened - in a rural town, that’s a good number. Of those 400 people, we identified 2% who required referral, and I still remember some of those patients who simply had no idea that their blood glucose was out of line; they had no motivation to go to the GP to get it checked and why would they? They didn’t feel unwell,” she explained.

Cicely pointed out that screening is not a replacement for the diagnostic processes required to confirm the presence of disease or to confidently predict prognosis.

“What you’re doing in an opportunistic screen is simply giving people the factually accurate information. It is screening, it is not diagnosis; that’s not our role in community pharmacy,” she stressed.

“Screening provides an indicator that there may be something requiring further investigation. This opportunistic approach is likely to get people into appropriate healthcare or to their GP for full diagnosis and prescribing, if required, at a much earlier time.”

It is widely acknowledged that several chronic diseases, including diabetes, are under-diagnosed and therefore under-treated. There are up to 30,000 people with undetected type 2 diabetes in Ireland and approximately 146,000 people with undetected pre-diabetes, according to findings in a recent VHI Healthcare study.

“It is important to help identify someone with undetected diabetes before their disease progresses, as this can lead to worse outcome for them and increased healthcare costs. You might catch those patients during a special event day, as I have described, or perhaps through observing and chatting to them about symptoms that could raise your suspicion, such as frequent urination, feeling tired and weak, needing to drink more water. Then you might invite them back for a fasting blood glucose,” Cicely  suggested.

There are some basic screens that a pharmacist should be able to do competently and with no problems, such as BMI calculation, blood pressure and blood glucose measurements, how to take a peak flow meter reading, and carbon monoxide testing for smokers.

Many pharmacists have developed the dexterity to operate equipment involved in standard screening service provision such as blood pressure monitors or peak-flow meters. Blood glucose screening introduces a greater level of complexity to the process in that it requires a ‘finger-prick' blood sample and attention to the associated health and safety issues and biological waste management.

However, a full heart screen, which includes a full lipid profile, which includes total cholesterol, HDL-cholesterol (‘good’ cholesterol), LDL-cholesterol (‘bad’ cholesterol), and triglycerides, introduces a mix of invasive and non-invasive operations, for which the pharmacist will require training in a number of procedures.

They will also need to have a system in place so that the quality of the equipment used 'at that point in time' is assured, which requires external validation and internal control procedures.

“I’m not sure whether that would be applicable to every pharmacy in the country. They just wouldn’t be doing enough of those tests to maintain their skill base or to justify the cost of maintaining the equipment.

“Also, to complete a full lipid profile screen you need 20 minutes protected time, so you can’t be the only pharmacist in the pharmacy in that situation, but you can be to do blood pressure, peak flow etc.

“So screening might be absolutely validly within the competency of pharmacists around the country but the pharmacy might not be geared up in such a way that it makes sense for every pharmacy to provide,” Cicely said.

But there’s more than one way to provide credible pharmacy services, she proposed. It is perfectly feasible for a pharmacy to bring in a suitably qualified and experienced consultant pharmacist to run special screening days, which would have been previously advertised by the pharmacy and a schedule of patient appointments arranged for the screening day.

“This is something that can work and work well, and gives pharmacists another option where it may not be feasible for them to run certain screening services.

“I did it myself in 2007; I visited five pharmacies in Cork over five days as part of a pilot project in order to establish whether a screening service could work and if I could support them in setting up their own screening service. I did the full heart score for patients in the five pharmacies. It was very successful.”

She added that no discussion on screening services would be complete without mention of medicines usage review (MUR) and the sobering statistic that up to half of patients do not take their medication as prescribed or as intended. 

Interpreting a patient's screening results in conjunction with a printout of the medications currently being dispensed has potential to both identify therapeutic interventions that are not achieving their objectives and to highlight for patients how they might make better use of their medicines.

“Pharmacists use their clinical skills, combined with patient medication records, to interpret the results in the context of the patient's existing therapy. This is what makes community pharmacies unique in their particular brand of service offering,” Cicely said.

She urged pharmacists considering the introduction of screening services to know that guidelines are in place, which will structure their approach to the initiation of extended and advanced services in a professional manner. The Pharmacy Practice Guidance manual is available on the PSI website (www.thepsi.ie), and Royal Pharmaceutical Society guidance on screening services is also available online (www.rpharms.com).

Also, Cicely produced a series of twenty-one screening templates in 2009, supported by a GSK educational grant, which cover inhaler technique review, peak flow, BMI, blood pressure, blood glucose, lipid profile etc. These templates are available from GSK and on the IPU website (www.ipu.ie) and can be obtained in adaptable electronic format, which can be personalised to the particular pharmacy.

“Through health screenings and health education, pharmacists play a key role in prevention as well as speeding up access to care. But I would emphasise that these services do not work well in a vacuum. We must work closely with our medical colleagues; write to your GPs and tell them of your intention to run a screening day, send them a copy of the screening template so that if they have any questions or recommendations you can discuss them well ahead of the planned screening day.

“It’s not just about communication and professional courtesy, it’s about preserving the important patient relationship also. If a patient goes from me with an outcome of a screen on a medicines usage review, for example, and they arrive into their GP with this one page review and I’ve just surprised their doctor, I would have damaged the doctor/patient relationship, and I’d have damaged my relationship with both of them,” Cicely cautioned.

“Pharmacy-based health screening services have several advantages in terms of reach, accessibility and cost effectiveness, but the key message is that we need to work together to provide integrated healthcare in order to secure the best outcome for our patients and for us as professionals.”

Pod weighs in to aid health

Professor Louise Kenny standing by the Pea Pod

As obesity levels in Ireland rise, assessing neonatal body composition with the sophisticated Pea Pod instrument could have a major impact on the health of the nation, writes Eimear Vize  

We are what we eat, and  that old adage rings true even before we are born. Numerous studies have already confirmed that babies born to overweight and obese women have a higher risk of birth defects and even death. Irish doctors are now exploring how the weight and diet of a mum-to-be influence their unborn babies, from the infant’s weight and physical condition at birth, to the long-term health impact.

This investigation of thousands of babies and their mums is being made possible through two major research efforts underway at the Cork University Maternity Hospital (CUMH) and University College Cork (UCC) - the SCOPE study, which records important information about mothers from early pregnancy, and the BASELINE study, in which these infants are monitored as they grow and develop.

“Since these studies began in 2008, we now have data on more than 2,000 babies in Cork who were born to 2,000 first-time pregnant mums,” says Prof Louise Kenny, principle investigator of the Health Research Board funded SCOPE study, Professor of Obstetrics at UCC and consultant obstetrician and gynaecologist at CUMH.

“We have very detailed information about the mums including their weight, body mass index and skin fold thicknesses, and we’re tracking their babies from 15 weeks gestation and birth, through to the age of five, and hopefully on into adulthood.

“We’re looking at how early life influences, such as in utero experiences, and how they are fed immediately after delivery, affect their future health and wellbeing.”

A key tool in this endeavour is the charmingly named Pea Pod – the world’s only air displacement plethysmography (ADP) system to determine body composition (fat and fat-free mass) in infants between birth and up to six months of age.

Essentially a scaled down version of the adult-sized Bod Pod, this sophisticated instrument is used to measure and monitor changes in body fat stores of infants. The Pea Pod measurement takes about two minutes to complete and provides information can be used to better define the nutritional requirements needed to support healthy growth, as well as possibly providing early identification of children at risk for obesity.

Cork University Maternity Hospital was the first in the country to take delivery of the Pea Pod system in 2009, as part of the SCOPE study. A second device was installed soon after at the Coombe Women and Infants University Hospital in Dublin.

“Air displacement plethysmography is the technique of measuring body fat, as opposed to total bodyweight. This technology been around for over a decade but was used only for adult patients, called the Bod Pod. It basically assesses not just how heavy a patient is but how much fat they have on board. Weight is quite a crude way of looking at someone’s general health and wellbeing because you can be heavy but tall and quite lean, and obviously that’s not the same as being short and mainly covered in fat,” Prof Kenny remarks.

“So the Pea Pod is a mini version of the Bod Pod, and it’s used for assessing neonatal body composition. It can be used in newborns up to about two to three months of age, certainly no further than six months. After that they start getting a little too big to fit in.”

Researchers in Cork have thus far completed the world’s largest series of baby measurements in the Pea Pod. At one point, they were assessing up to five babies a day.

“Well over 1000 babies have been measured in the pod, and of those infants, most have been measured twice so we’ve actually done well over 2,000 measurements. As we are the first group to have assessed that many babies, we’re building up a good general idea of what body composition is in newborns. For example, in our Pediatrics paper*, The BASELINE team, funded the National Children's Research Centre and led by Dr Deirdre Murray, found that girl babies are a little bit fatter than boys, and that fat is very much dependent on gestational age. Put simply, the longer you are left inside perhaps not surprisingly the more fat you have. And this is information that is new.”

While female infants had a greater percentage of body fat than male infants at each gestational age, the researchers found that male infants had actually heavier at birth than their female counterparts, meaning that this increase in weight in male infants was due to increased fat-free mass.

Utilising the results from their study of the first four days of life of almost 800 infants, the Cork team created a centile chart for body fat percentage in male and female infants that will assist doctors and researchers in the interpretation of measured neonatal body fat percentage.

“Epidemiologic studies have demonstrated reduced glucose tolerance and increased obesity, cardiovascular disease, dyslipidemia, and obstructive airway disease in adults who were exposed to inadequate nutrition in utero. This foetal programming for adult disease begins in utero, and estimation of percentage body fat at birth may have a role in identifying infants at risk,” the authors suggest.

Overweight and obesity is a serious problem in Ireland affecting between 18% and 27% of Irish children. In fact, Ireland currently ranks second highest in obesity rates in the European Union. Minister for Health James Reilly says he is determined to introduce strong measures to tackle childhood obesity, telling the Dail recently: “If we do not address it, we may end up the first generation to bury the generation behind it.”

As a result, the prevention and treatment of obesity has become a top research priority and the Pea Pod body composition tracking system is a critical tool in this endeavour.

The air displacement plethysmography (ADP) used by the Pea Pod unit is similar in principle to hydrostatic (or "underwater") weighing but uses air instead of water to measure body volume, based on the physical relationship between pressure and volume. Obviously, air is more convenient, safe and comfortable than water, particularly when assessing infants.

Once body volume is determined, the principles of body density, or densitometry, are used to calculate body composition. In densitometry, the more dense a body is, the lower the percentage of body fat; the less dense a body is, the higher the percentage of body fat.

By all accounts, the Pea Pod is a non-invasive and comfortable environment for infants. The baby is placed in the PEA POD test chamber tray and enters a warm, pressure-controlled chamber the size of a crib for a two-minute volume measurement. During the entire period the infant is clearly visible through the unit window. The test results are then computed, displayed and printed.

Research using the Pea Pod at the Coombe Women and Infants University Hospital in Dublin confirmed that neonates of mothers with a normal BMI have significantly less body fat than neonates of overweight and obese mothers. However, there was a wide range in body fat percentages for infants of both maternal BMI groups, which was not fully explained by the parameters of birth weight and neonatal abdominal circumference alone. The Coombe research team are currently investigating other maternal factors that may determine neonatal body fat percentages.

Meanwhile, researchers in Cork are examining how body composition, or fat, changes in early childhood.   

“With regard to childhood obesity, obesity in adolescence and obesity in adult life, there is a lot of evidence now that the seeds are sewn in the early days of life, even in the womb, but certainly in the first few months of life,” says Prof Kenny.

“We’re using the Pea Pod to measure the babies as soon as they are born to see how much of their body composition is proportionally fat, and how that affects their health and growth and wellbeing as they develop. These babies are part of a large birth cohort that we’re following until they are five and hopefully into adulthood,” explains Prof Kenny.

There are a number of birth cohort studies worldwide, but few, if any of them will have such detailed information about the babies from before they are even born, right back to the first weeks of pregnancy.

Prof Kenny is also peripherally involved in another study that is examining how body fat composition changes in premature infants depending on the feeding regime they are put on.

“The Pea Pod is an important academic instrument. It is used primarily for research purposes at the moment but I can see a time then the Pea Pod might be of clinical use. For example, if we knew that a particular baby was of a certain birth weight but had a higher fat composition that would be a red flag and may call for earlier intervention to prevent childhood obesity.”

*Hawkes C, Hourihane J, Kenny L et al. Gender- and Gestational Age–Specific Body Fat Percentage at Birth. Pediatrics 2011; 128(3): e645-e651

Made to Measure: Personalised cancer medicine

Doctors have long known that two patients with the same type of cancer may respond very differently to the same treatment; a person’s susceptibility to a disease as well as treatment success or resistance can vary from one person to another, even within family groups. But a greater understanding of our genetic information at the individual level is facilitating new approaches in the detection, treatment, and prevention of cancer and other diseases, which are more tailored to the needs of each patient.

The ‘one size fits all’ approach where a patient’s therapy was selected based on average results from randomised clinical trials is increasingly being replaced by targeted therapeutics and their related molecular diagnostics. The age of personalised medicine, first signalled in the 60s, is here and now and offering new hope for cancer patients.

The mapping of the human genome, completed in 2003, and recent advances in genome technologies have laid the groundwork for understanding the roles of genes in disease development. All diseases have a genetic component, whether inherited or resulting from the body's response to environmental stresses like viruses or toxins. Detecting these subtle mutations, or biomarkers, is a complex and ongoing challenge.

Most types of cancers are not single diseases. There can be over a dozen subtypes within a breast cancer diagnosis, for example. An ever-growing number of molecular diagnostic tests are becoming available commercially, aimed at identifying genetic mutations within a particular cancer that might be treatable with certain drugs. These gene tests can also detect errant genes in people at risk of developing certain cancers.

Using this genetic information to develop targeted cancer therapies is revolutionising how drugs are being designed and how patients are being treated.

“Put simply, personalised medicine is about making the treatment as individualised as the disease,” capsulates Dr David Gallagher, a medical oncologist and medical geneticist who returned to Ireland from the world-renowned Memorial Sloan-Kettering Cancer Centre in New York in 2010. He established the Cancer Genetics Clinic at the Mater Private Hospital, which opened in February 2011.

“Cancer genetics and personalised cancer medicine are closely related but not exactly the same thing. Personalised medicine is about individualising therapy for patients: taking a biopsy of a patient’s tumour and looking for molecular changes; genetic mutations and different expressions of proteins within the tumour that may allow you to select a tailored treatment for the individual based on the molecular makeup of their actual tumour.

“This is often what people are referring to when they talk about personalised medicine and it forms a major part of my daily work as a medical oncologist. Cancer genetics focuses largely on prevention; genetic testing for potential abnormalities before an individual gets cancer. If we find these genetic ‘red flags’ we can initiate a strategy of either early detection, which involve regular screening, or cancer prevention, which involves chemo prevention or surgical prevention.

“This personalised approach to cancer diagnosis and treatment is increasingly where medical oncology is trying to go and genetics is at the very centre of that. I dual trained as both a geneticist and an oncologist because that’s where I think the future of this field lies,” he tells Cancer Professional.

“In the oncology clinic, when a person is diagnosed with cancer, depending on their diagnosis there may or may not be a treatment that is available for their particular cancer subset. We can test for a protein marker or genetic marker that may influence their response to a drug, and if the individual has this biomarker they will go down one treatment paradigm, and if they don’t they may go down a different treatment route.”

The first step toward more individualised drug treatment for patients was taken over half a century ago with the identification of oestrogen receptors by Elwood Jensen at the University of Chicago in 1958. This discovery was followed by the introduction of the anti-oestrogen drug tamoxifen in the 1970s, which enabled a more individualised approach to the treatment of breast cancer patients.

About a decade later, researchers found that some women who had particularly fast-growing breast cancers expressed extra copies of a gene called HER-2 (Human Epidermal growth factor Receptor 2). The genes were producing many copies of a protein that appeared to be driving the growth of the cancer cells.

This discovery led to the development of another targeted therapy in the 1990s, the monoclonal antibody trastuzumab, which effectively latched onto the HER-2 proteins on the surface of a cancer cell and slowed or stopped cancer-cell growth in the 20% to 25% of breast cancer tumours that contained an amplified HER-2 gene.

Since then, numerous targeted anticancer therapies, covering a wide variety of targets in tumour tissue or the tumour's environment, have become the subject of extensive research and development activities worldwide. Clearly, pharmacogenomics is now a booming industry.

Already dozens of targeted agents have been approved for use in specific cancers including drugs that interfere with cell growth signalling (imatinib, gefitinib, etc) or tumour blood vessel development (bevacizumab, sunitinib, etc), as well as drugs that promote the specific death of cancer cells (bortezomib, pralatrexate, etc), stimulate the immune system to destroy specific cancer cells (rituximab, ipilimumab, etc) and deliver toxic molecules to cancer cells (brentuximab vedotin, ibritumomab tiuxetan, etc). 

Oncologists and their patients in Ireland are fortunate to have access to some of the most exciting, lead candidate drugs in cancer through participation in clinical trials directed by the All Ireland Cooperative Oncology Research Group (ICORG).

ICORG’s growing portfolio of member-generated clinical trials of some of top targeted agents from global market leaders, including the GlaxoSmithKline (GSK) B-RAF melanoma study. A total of 600 Irish patients were screened and 140 of these enrolled onto the trial last year. The drug is designed to attack a genetic mutation B-RAF that is found in half of patients with melanoma, and in other cancers such as colon and thyroid.

“In the lab the new treatment had yielded remarkable results, shrinking tumours and keeping them at bay. One Irish patient has also seen remarkable results that started within a week of taking the drug. On returning for the first scan six weeks after taking the drug there was a 50% reduction in the disease in his body and on recent scans there was a further 40% reduction and no new disease,” an ICORG spokesperson told Cancer Professional.

She also revealed that ICORG anticipates it will be working with between eight and ten of the most promising of the new targeted agents by the middle of 2012.

Another illustration of Ireland’s burgeoning leadership in this field is the recent announcement that St James’s Hospital is the leading European site in the crizotinib trial. This news is all the more exciting when examining early data for this drug. In the early phase studies more than 60% of lung cancer patients who received crizotinib were alive after two years, according to data released in June 2011.

“We are increasingly moving away from the ‘one size fits all’ approach to treating cancer, but it still how most patients are treated,” says Dr Gallagher. “However, every year this is changing, more and more. We are crossing the traditional tissue defined definition of cancer to a more molecular defined era of cancer, so breast cancers are being treated like stomach cancers because they have a similar molecular profile. That would never have happened in the past.”

Dr David Gallagher

He points out that even if targeted therapies are available, they cannot be delivered to "the right patient at the right time" without access to sophisticated diagnostic tools, making molecular diagnostics a key driver in personalised medicine.

Dr Gallagher remarks: “Molecular diagnostics is about analysing the tumour for different markers, whereby patients are ‘stratified’ into subgroups according to their biomarker profile and likely response to a specific treatment. Molecular tests are referred to as either predictive markers to guide treatment or prognostic markers that are used to inform prognosis after treatment.”

OncotypeDX, for example, is indicated for women for node negative, hormone receptor positive and HER 2 Neu negative invasive breast cancer, and provides a risk score that helps determine whether a woman should proceed with curative adjuvant chemotherapy in addition to hormone therapy.

The National Cancer Control Programme (NCCP) announced in October 2011 that breast cancer patients could now avail of the benefits of OncotypeDX in the public health service. The clinical data published for the use of this test has indicated that up to 30% of women who would otherwise have received chemotherapy will now be considered as low risk and as a result will be spared the toxicity and long term side effects of treatment. The NCCP expects around 300 women annually to undergo the test, with around 100 women subsequently excluding chemotherapy from their treatment plan.

For most drugs, such as tamoxifen and trastuzumab, the companion diagnostic tests are used to select the patients who are most likely to benefit from treatment; but such tests can also be used to predict toxicity. For example, irinotecan is one of the first widely used chemotherapy agents that is dosed according to the recipient's genotype. Genetic polymorphism of the UGT1A1 gene is related to severe toxicity caused by the drug, such as leukopenia and diarrhoea. In order to identify the group of patients with aberration of the UGT1A1 gene who will need a reduced dose of irinotecan, a pharmacodiagnostic test was developed (Invader® UGT1A1 Molecular Assay). Another, similar genetic test to predict toxicity of 5-fluorouracil or capecitabine, and helps guide physician dosing decisions, was recently introduced (TheraGuide 5-FU).

Investigating mechanisms of sensitivity and resistance to new molecularly targeted cancer drugs is the principle aim of a recently established consortium of scientists, clinicians and industry partners in Ireland. Molecular Therapeutics for Cancer Ireland (MTCI) has already attracted huge investment, including a €6 million award by the EU to investigate possible treatments for difficult-to-treat types of breast cancer.

“At present, there is a lack of targeted therapies for two poor-prognosis subtypes of breast cancer namely ‘triple negative’ breast tumours and invasive lobular carcinomas of the breast,” says MTCI Investigator Professor William Gallagher, an Associate Professor of Cancer Biology in the UCD School of Biomolecular & Biomedical Science and a UCD Conway Institute, who is leading this research. “Together these subtypes make up almost 25% of all breast cancers. Our research will explore the role of kinases – the key regulators of cell function - in these types of breast cancer in order to develop therapeutic targets that may inhibit the rate of activation of kinases in cancer sufferers.”

Other national developments include the establishment of Ireland’s first Breast Cancer Tissue Bio Resource in 2010, which should enable speedier discoveries and ultimately more effective and personalised treatments for patients. In addition, a Germline DNA Bio Bank has just been set up at the Cancer Genetics Clinic in the Mater Private. The Clinic also expects to launch a new prostate cancer screening study in early 2012.

Although Irish efforts with regard to investigating and promoting more personalised cancer treatment is laudable, European health authorities see considerable scope for improvement throughout the EU. The Health Research Directorate of the European Commission organised a series of workshops on personalised medicine in 2010, culminating in a two-day conference in Brussels last year, where key opinion leaders addressed recent achievements in health related research leading to personalised medicine and identified priorities for future actions needed at the European level.

Arising from this, the European Commission is currently exploring whether a French cancer initiative could be applied in other EU countries. Under the French programme all cancer patients can be tested, free of charge, for the molecular characteristics of their particular tumours. Once tested, patients can be prescribed with the most appropriate medicine as soon as possible. This initiative is now in its sixth year.

Dr Fabien Calvo, Deputy Director-General and Director of Research at the French National Cancer Institute, explains: “The goal of the French programme is to offer each cancer patient access to a molecular test as soon as possible following the regulatory approval of a new targeted cancer therapy. For example, in 2008 the institute allocated €2.5 million for KRAS testing in colorectal cancer. This was not long after regulatory authorities approved cetuximab and panitumumab for patients with colorectal cancer with the non-mutated (wild-type) KRAS gene.

“Similarly in 2009, the institute allocated €1.7 million to the regions to test patients with activating mutations of the epidermal growth factor receptor (EGFR) in their tumours. This followed regulatory approval of gefitinib for metastatic non-small cell lung cancer in patients with activating mutations of EGFR.

“Although there is a cost to the government in offering these tests, there has also been a savings on the cost of medicines,” he stresses. Dr Calvo says that EGFR testing for patients with lung cancer has saved a massive €69 million for the health insurance system because only those patients who could benefit from gefitinib have received the treatment. 

Mr John Dalli, Commissioner for Health and Consumer Policy, European Commission, agrees that the high costs for personalised medicine should be offset by efficiency gains. He told the conference: “By offering personalised medicines to patients, healthcare providers can avoid trial and error and reduce adverse reactions. This offers the potential for major benefits to patients and to the healthcare system as a whole. At the moment, this potential is largely unexploited. Efforts by academia and industry need to be stepped up.”

The first article ever published that coined the term ‘personalised medicine’ (the Wall Street Journal/the Oncologist, 1999) predicted, “The race is on to come up with tailor-made drugs that will treat people based on their individual genetic makeup.” After many years of development, personalised health care is increasingly moving into clinical practice. Apple CEO Steve Jobs and maverick author Christopher Hitchens, who both recently succumbed to cancer, were among a select few patients to have their entire genomes sequenced in the hope of tailoring each man's cancer treatment to their specific genetic mutations within the cancer. Even still, the attempted treatments fell short of cures.

The era of personalised medicine is here, albeit in its infancy, and we have already seen the first important results. The promise of  “targeting drugs for each unique genetic profile” as outlined in the 1999 article is tantalisingly close but as of yet, far from being fulfilled.

A jab in the right direction

The involvement of pharmacists in Ireland in the seasonal flu vaccination programme is a recent and welcome development. Community pharmacists are well placed to overcome many obstacles to increasing vaccination rates and Government officials estimate that transferring the administration of the flu vaccine from GPs to pharmacists will trim between €5 million and €13 million every year off the State immunisation bill.

Health Minister James Reilly is also convinced that this new convenient and cheaper service offered by pharmacists will achieve greater penetration into the community of vaccine uptake, which will consequent reduce the annual winter surge in hospital admittances and in busy GP surgeries.

Influenza is a highly infectious acute respiratory illness that is self-limiting and short lived in most healthy adults but in high-risk patients, including the very young and the elderly, the effects of influenza can be severe and can cause serious illness and death. 

In such patients, serious respiratory complications can develop, including pneumonia and bronchitis. Tragically, between 300 and 400 people die annually from influenza and its complications.

Prevention is the key; influenza immunisation prevents between 70 to 90% of influenza-specific illness among healthy adults and reduces severe illnesses and complications by up to 60%, and deaths by 80%, in the elderly.

Health Minister James Reilly (and halo)

Minister Reilly’s announcement last July of plans to introduce a new pharmacist-led influenza vaccination service was widely welcomed by the general public and healthcare professionals, although the Irish Medical Organisation, which represents most of the country’s doctors, voiced some reservations concerning aspects of the new regulations that allow pharmacists to deliver the flu vaccine.

The profession of pharmacy was more than ready and willing to embrace this new challenge and expanded role. Following the Minister’s announcement almost 1,000 pharmacists enrolled in accredited national vaccination training courses. In fact, hundreds of pharmacists had already received this training in the 12 months prior to the Minister’s formal confirmation of their involvement in the 2011/2012 seasonal flu campaign.

The Boots pharmacy chain had tested the proverbial waters in 2010 with what was effectively viewed by health authorities as a ‘pilot’ flu vaccination service in its 60 stores nationwide.

A subsequent satisfaction survey revealed that almost 100% of people who received their flu jab from Boots pharmacists were delighted with the service. Significantly, about a third stated they wouldn’t have received the vaccination but that the option to “drop in” to a local pharmacy for the flu shot was too convenient to miss.

“The skill set of pharmacy and the spread of pharmacy - the penetration into the community – have long been underutilised in our health services, but I think we’re beginning to see that this is changing for everyone’s benefit,” says Mary Rose Burke, Director of Pharmacy at Boots Retail (Ireland) and a member of the National Pharmacy Reference Group which advises the Pharmaceutical Society of Ireland (PSI) on practice development policy.

Although the necessary legislative amendment was only introduced in mid October last year, which permitted pharmacists in Ireland to administer the flu jab, Boots Ireland was able to introduce its new service in 2010 through a Patient Group Direction (PGDs).

A PGD is a written direction relating to the supply and or administration of a prescription only medicine (subject to specific inclusions and exclusions) and is developed, authorised and signed by the Boots Medical Director, Dr Graham Marshall.

“We put between 6 to 12 months of work into defining a flu vaccination service and developing it to higher clinical governance standards because we knew obviously it would come under a lot of scrutiny. We looked at best international practice, examining the protocols, training and experience of other countries that offer a pharmacy-led vaccination service was introduced, such as in the UK and Portugal, and determined a framework that we felt was consistent with Irish legislation. We set ourselves to be the gold standard that any change in regulation would model itself on the way we had done it,” explains Ms Burke.

She is quick to point out that this early initiative by Boots and the recent involvement of pharmacists nationwide in the influenza vaccination programme by no means reinvents the wheel; “all protocols and procedures are identical to receiving the vaccine in your GP surgery, except that you don’t necessarily need an appointment and our opening hours are more flexible. It’s all about ensuring broader uptake of the flu vaccine so that those who need it can get it.”

Under the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011, registered pharmacists can now supply and administer the seasonal influenza vaccine to patients, and if necessary adrenaline injections for the emergency treatment of anaphylactic shock arising from the flu jab – although this latter provision is a very rare occurrence with the Irish Medicines Board reporting that only three patients out of millions who had received the “ordinary” seasonal flu vaccine (excluding the ‘09/’10 pandemic swine-flu jab) suffered anaphylactic-type reactions over the past decade, and there have been no related death during that period.

Mary Rose Burke

In 2010, more than 5,000 people received their flu vaccine in Boots pharmacies around the country. While this figure wasn’t sufficient to detect any measurable impact on hospital attendances for influenza-related complications, Ms Burke notes that it will be interesting to see what the overall outcome of the first national pharmacy-led flu vaccination campaign has had on uptake levels and hospitalisations.

“If somebody isn’t sick it can be hard to get them into a doctor’s surgery. A flu vaccination is one of those things that a person could just keep putting off, even thought they know it’s very important. But if you make it so easy and so accessible and convenient and at a time of their choosing, there’s a far greater chance that these at-risk groups will get their flu shots.

“We saw this in our Boots campaign; about a third of the people who received their flu vaccination in our pharmacies said they wouldn’t have got them otherwise. If this pattern is repeated in the new national flu vaccination programme, we could see an increase in uptake levels of more than 30%. In fact, that figure could be higher because it’s even more convenient now that there are so many more pharmacies involved.”

The lower cost should also prove an incentive. While there is no set price in pharmacy for the flu vaccine – the Competition Authority prohibits price setting among independent enterprises such as pharmacies – the overall fee for the vaccine and consultation ranges from €20 to €35 approximately. Of course, the flu vaccine in pharmacies is free of charge for people over 65 years of age with a valid Medical Card, GP Visit Card or Health Amendment Act (HAA). Customers over 65 years of age not eligible for any of those schemes will be asked to pay a reduced amount of approximately €15. This charge is for administering the vaccine, as the flu vaccine is free to all at-risk groups.

“I think there is a huge scope for pharmacists within the vaccination area. It’s pretty much straight forward; there is no diagnosis involved and most vaccinations are part of national programmes so I believe pharmacists can play a significant role in making sure that as a country we meet the WHO hurdles of penetration rates. Pharmacists could successfully offer other vaccination programmes such as for cervical cancer, possibly even childhood immunisations, although that may be somewhere further down the road, not least because you’d need waiting room facilities and the infrastructure in pharmacy would need to be right for that, but there’s no reason why we wouldn’t look at all of those services,” says Ms Burke.

More than 1,600 pharmacists have now received training in vaccination techniques from Hibernian Healthcare, which was initially commissioned by Boots in 2010 to provide training for their pharmacists on vaccination consultation, administration of the vaccine and post vaccination issues and complications. The training company’s programme was devised in conjunction with the Irish Pharmacy Union and is accredited by the School of Pharmacy and Pharmaceutical Sciences at Trinity College Dublin.

However, the pharmacy flu vaccination service hit a bump on the road early on when it emerged towards the end of November that an inadequate dose of the vaccine had been administered in error, requiring about 800 people – approximately 20% of patients vaccinated by pharmacists at that time – to be recalled to receive a booster jab.

“Unfortunately some pharmacists who attended a particular training course by Hibernian Healthcare were shown a DVD on how to administer the vaccine but which demonstrated the paediatric dose not the adult dose. As soon as this error came to light, within Boots, and I believe replicated around the country, we went back to our records, identified which pharmacists were at the training day, and ascertained from those pharmacists if they followed that incorrect procedure or not,” recounts Ms Burke.

“Many had realised that what they were shown didn’t make sense and had corrected their technique so we identified the pharmacists involved, pulled the records of any of the vaccinations they had administered, contacted the patients and invited them to come back. Many patients had seen the news reports and they understood the issue, so most of them came back in the next couple of days for revaccination.

“It’s a very unfortunate and regrettable incident but I think we have a lot to learn from that, and fortunately nobody came to harm, everybody was contacted. It has demonstrated the robust method of record keeping as we were able to do a very rapid follow up and contact the patients to get them back in very, very quickly. But absolutely we need to recognise that there was a number of issue that led to this happening and we need to address these and ensure that, for the next service that develops in pharmacy, we build in steps that would make sure that something like this would not happen again with something potentially more serious.”

As Director of Pharmacy at Boots (Ireland), Ms Burke leads all pharmacy activities in Boots, including future strategy and development. She maintains that travel vaccination is a potential new service that could be accessed through pharmacies in the near future.

“This is certainly an area that Boots is looking very seriously at. The growing popularity of long haul holidays means that more people may need these travel vaccinations, but often they can get swept away with the excitement and glamour of their trip and may neglect to think about the various vaccines they need.

"I think pharmacy would have a big role to play in making travel vaccinations available to people in a way that fits in with the planning of their holiday. Again, it’s the convenience factor that makes it easier for them to access this service as pharmacy has a higher penetration rate into the community so that everyone who is going abroad to those high-risk destinations would firstly know that they need to get vaccinated and secondly, we’d make it easy for them to avail of it,” she says.

Pharmacists in Ireland are expected to inject new vigour into the national flu vaccination programme, with the involvement of pharmacy in other immunisation programmes increasingly likely in the future as health authorities explore options for the safe, efficient and cost-effective delivery of public health services. This and similar service development will no doubt see pharmacy change over the coming years from community drugstores to community health destinations.