Tuesday, April 3, 2012

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