Wednesday, December 7, 2011

A "respectable" addiction

Drug addiction has a hidden face. The stereotypical image of a down-and-out heroin addict desperate for another fix can obscure the less familiar figure of the 40-something mum who secretly pops painkillers, watching the clock until its time for her next dose.

“Respectable addiction” is not an emerging societal problem, as some might believe, it has been prevalent for many years. International research spanning well over a decade has suggested that a surprisingly high number of people are knowingly or otherwise abusing over the counter (OTC) medication, and there is a widespread awareness of this problem among both the general public and the professionals – doctors and pharmacists – alike.

Non-prescription analgesics containing codeine - a short acting opium based drug that belongs to the same family as heroin and morphine – are the most commonly identified OTC medicines being abuse in Ireland, but problems have also been linked to products containing dextromethorphan (cough suppressant), pseudoephedrine (decongestant), and laxatives.

Although the true extent of OTC misuse/abuse and addiction in Ireland is unclear, all indications are that it is relatively widespread and increasing. In a 2007 survey of over 100 pharmacists in Ireland, the vast majority (94%) believed that some customers, estimated at an average of four per day, who purchased products containing codeine, were addicted to codeine.

According to the National Drug Treatment Reporting System, maintained by the Health Research Board, the numbers entering treatment for codeine as a problem drug have increased considerably in recent years, from 40 in 1998 to 180 in 2009. In addition, between 1998 and 2007, codeine, either alone or in conjunction with another drug, was implicated in the cause of 90 fatal poisonings.

In an effort to reduce the risk of overuse and addiction, the Pharmaceutical Society of Ireland (PSI) published guidelines in May 2010 on the safe dispensing of non-prescription products containing codeine. The new rules have succeeded in removing these products off display and into the dispensary, so that they are not only sold under the direct personal supervision of the pharmacist but the pharmacist is required to counsel the consumer and where prudent, suggest an alternate method of analgesia.

However, a public health academic in the UK is now calling for further protective steps to be taken by the pharmacy profession, recommending that the OTC sales of opiates, including codeine-based painkillers, should be recorded and monitored as a way of tackling drug misuse by so-called "respectable addicts”.

Dr Richard Cooper, a lecturer in public health at the University of Sheffield, recently published research that revealed the frustration of community pharmacists that they are unable to track the supply of these opiates to customers from other pharmacies. The study also highlighted the concerns of pharmacists and other health professionals in relation to the current lack of treatment and support options for individuals affected by OTC medicine abuse.

These concerns are shared by many pharmacists across Ireland, including David Carroll, supervising pharmacist in Boots, Grafton Street, Dublin, who introduced tight restrictions on codeine sales two years ahead of the PSI guidelines, including direct consultation with customers warning them of the side-effects of codeine, its addiction potential and how it should be used for no more than three days.

He devised these protocols after becoming increasingly troubled that a high proportion of analgesic sales in his store were made up of products containing codeine.

“By far the biggest problem we have with regard to the abuse of OTC medicine in Ireland is with codeine-combination pain killers, such as Nurofen Plus and Solpadine,” he told Modern Medicine of Ireland.

“The bottom line is codeine medication is really only appropriate for short term use, for a couple of days. It’s ideal for a person who has had a wisdom tooth out, for example, and they are in bad physical pain; that’s fine, take it for a couple of days and be done with it.

“But the fact is many people who abuse codeine-based painkillers don’t even realise how addictive it is; they may not even realise that they are addicted. If they were shooting up heroin or doing lines of cocaine to get high then it would be quite clear in their heads that they have a problem, but if they’re just taking something to kill a bad headache, they think ‘what’s the harm?’”

David cited recent findings of a large survey of self-described codeine addicts where approximately 70% of them had never been told the medicine was addictive, and a similar proportion were taking more than the recommended dosage on a continuous basis.

“The paracetamol and codeine combination has only a slightly better analgesic effect but the codeine has that calming and euphoric effect that’s chilling them out and calming them down a little bit more, and they think it’s the only thing that can make them feel better. They can’t stop taking it because if they do they experience very unpleasant withdrawal symptoms and the pain comes back – it’s literally a withdrawal headache and they’ve been feeding a cycle,” he explained.

Like all opioids, continued use of codeine induces physical dependence and can be psychologically addictive. Some symptoms of OTC opiate withdrawal include anxiety, nausea and vomiting, flu like symptoms, tachycardia and hypertension, and dysphoria.

“When a person is withdrawing from the codeine and they need it, you can actually see it in their eyes. They come in looking for Solpadine or Nurofen Plus and nothing else, and they will use any excuse to get it,” David remarked. “You can offer them alternatives but nothing else will do because it’s the only thing they want and they can become very irrational and irate about it. And still, some of them may not realise that there is any kind of addiction there.”

He makes an important distinction between the types of people who misuse OTC medicines: a small number will conscientiously disobey the user instructions to get a ‘kick’, but there are also people who have inadvertently become addicted to these products and are aware of their dependence but cannot beat the addiction. Finally, there are some who are completely unaware that they are misusing these products – they keep within the recommended limits both frequently and regularly to treat drug-induced headache, for example.

“It can be difficult to spot a person who is misusing or abusing an OTC medicine but there are some red flags to watch for. Asking for a product by name, for example. The vast majority of people will say they want something for a dry cough or a tickly cough, but a telltale sign can be if someone asks specifically for a named product such as Benylin original, which contains a sedating antihistamine that can be abused if taken in large quantities. Or someone who asks for a 24 pack of Solpadeine Soluble, which gets you a hit more quickly and they want the bigger pack.

“Also, people who get incredibly irate when you start asking them questions. On the one hand they’ll say they only take it every six months, but there they are losing the head with you - if they only have this conversation twice a year, why is it annoying them so much? Are they having this conversation regularly in other pharmacies?”

With regard to laxative abuse, David said that the typical profile of a misuser is a person with eating disorders. Mental alarm bells should ring for the pharmacist if a very thin person requests the 60 or 100 pack of Senokot, for example.

The abuse of some OTC products has become a serious and fast-growing public health problem. A 2005 survey of members of the public in Northern Ireland found that almost one third of participants had personally encountered OTC abuse.

The seriousness of the problem in Ireland was underscored last year in a study at St Patrick’s University Hospital, Dublin, where 20 people were admitted during the course of a year for OTC opiate abuse treatment. The authors said that the patients’ self-reported codeine intake of 261 milligram per day – which they suggested was a deliberate under-estimation of usage - would mean a dangerously large amount of paracetamol or ibuprofen would be simultaneously ingested in combined compounds, putting the patient’s health at serious risk.

The authors pointed out that the availability of OTC opiates and the covert nature of this form of substance abuse means individuals can easily misuse OTC opiates by accident.

Since instigating safe sale of codeine practices in his pharmacy, David has spoken with people who admitted that they knew they had a problem but that since nobody had confronted them about it they were reluctant to deal with it. He has also encountered many people who never realised, until their consultation in the pharmacy, that they might have a codeine addiction problem.

In these situations the pharmacist can advise on how to deal with codeine withdrawal, usually through gradually reduce their codeine medication under the supervision of their GP or at a drug treatment centre.

“But it’s never as simple as saying ‘I’m going to stop that now’. I know of at least one person who had to go on methadone to help him come off codeine, and most people with problems may have to be referred to their doctors to help them come off it in a very controlled way,” he added.

At the end of the day, the community pharmacist has to rely on his or her own judgement as to when referral is necessary and to whom, often trusting the word of the individual that they will seek help for their addiction, as there is no formal referral pathway and refusal of supply may simply drive the client to another unsuspecting pharmacy.

There is also no system of quantative measurement available to track the level of abuse/misuse, either locally or nationally.

“Codeine is highly addictive and OTC medications containing codeine should be limited to very restricted use or eventually, if it continues being abused here, it will be made prescription-only. That would be unfair though as the vast majority of people are using these drugs safely and as directed. It would be unfair to punish the majority because of a small number who misuse them,” said David. “We need to create and sustain greater awareness about the safe use of these medications and it is important that pharmacists and doctors remain ever vigilant.”


Thursday, November 24, 2011

Organ donation: a new model for Ireland?

A surge in the efforts of hospital staff to approach the families of recently deceased patients about donating their organs is being credited with a dramatic increase in the number of donor organs and transplantations so far this year.

We are a generous nation; new data from the European Commission reveal the willingness of 64% of Irish people to donate their organs immediately after death, and almost 60% would agree to donate an organ from a deceased close family member, if they were asked in a hospital.

But this ultimate act of charity could be lost without the timely and sensitive intervention of fully trained organ donor co-ordinators in hospitals around the country.

That’s the message from a recent European Commission (EC) workshop on organ donation and transplantation in Brussels, during which the heads of transplantation organisations in Europe alongside organ recipients expounded the importance of streamlining national donor and transplant systems to maximise organ availability and save more lives.

Croatia’s remarkable achievements in this regard were held aloft as an example for Ireland and other countries whose donation and transplantation rates in 2010 were well below the EU average.

A country similar in size to Ireland, Croatia managed to transform its national transplant system, climbing from 14th to 2nd place in Europe for deceased organ donations, just behind Spain, in only one year.

In 2010, Croatia’s donor numbers exploded, increasing by an astonishing 64.9%, and the total number of organs transplanted from deceased donors increased by 54%. This remarkable result has been largely attributed to Croatia having placed trained donor coordinators in all their major hospitals and offering financial incentives to donor hospitals.

This new system is based on a model pioneered in Spain in the 1990s, which has more than tripled organ donor numbers and elevated Spain to the world’s highest ranking country for organ donations at 32 per million of population last year.

By sharp comparison, Ireland fell to 22nd place in Europe in 2010 because of a drastic drop in deceased donations of over one third in 12 months from 90 to 58 deceased donors.

However, the level of deceased donations so far this year has already surpassed 2010 figures. Thanks to the generosity of 77 deceased donors and their families willingness to donate their organs, there have been 137 kidney transplants, 49 liver transplants, 6 pancreas transplants, 4 heart transplants, and 8 lung transplant operations. This year will also mark a record year for living transplantation with 24 living kidney transplants carried out, as of mid-October.

With the establishment of Ireland’s transplant authority - the HSE National Organ Donation and Transplant Office - in March this year, and a report of the first external review of our organ donation and transplantation services expected by the end of November, it appears that Ireland is taking its obligations under a new European Union (EU) Directive on Organ Transplantation very seriously.

According to the new rules, which will be transposed into national law by July 2012, all EU member states must have a national authority responsible for maintaining quality and safety standards for organs intended for transplantation. The first undertaking by Professor Jim Egan when he was appointed Director of the Organ Donation and Transplant Office in March this year was to convene a National Transplant advisory group. He also instigated the first external expert review of Ireland’s organ transplantation service in October.

Professor Jim Egan
Prof Egan told Modern Medicine of Ireland that his office, in partnership with the Intensive Care Society of Ireland and the National Organ Procurement Office, are in talks to further develop a network of donor coordinators in hospital Intensive Care Units (ICUs) around the country, which will “bring Ireland to a level comparable to international practice”.

He indicated that these individuals would be drawn from “existing voluntary expertise” at a medical and nursing level. Under discussion at the moment are the number of donor co-ordinators to be appointed nationally, in which hospitals they will be based, and what protocols and training will be appropriate for these crucial and challenging posts.

Expanding the network of hospital donor co-ordinators is a key priority in the new EU Directive and accompanying 10-point action plan. It is considered the first step in developing a proactive donor detection programme and optimising the entire process of organ donation.

Whether these individuals should have a medical, nursing or psychology background is under debate. For example, in the UK, the majority of donor transplant co-ordinators are registered nurses that have experience in critical care. Mr Mark Murphy, Chief Executive of the Irish Kidney Association, maintains that the donor co-ordinator would benefit from a background in bereavement counselling. In Spain, more than half of the donor co-ordinators are doctors.

“Our philosophy is that the transplant co-ordinator should be a doctor and should be based in the hospital,” Dr Rafael Matesanz, who is Director of Spain’s hugely successful National Transplant Organisation (ONT), told Modern Medicine of Ireland.

Dr Rafael Matesanz
“I know there are many countries who have a different philosophy, some have nurses, some have social workers or psychologists, but our philosophy in this, and what we tell all the countries who have asked us how do you organise this, is that the system which works is to have an in-house medical coordinator.”

He continued: “The European Directive requires all 27 countries to have a competence authority to be in charge of organ donation and to guarantee quality and safety of transplantation. But in fact this competence authority should be responsible for creating a system of co-ordinators, which is the system in place in Spain, in Belgium, in France, in Italy, in all of the countries that have been improving organ donation levels.”

Dr Matesanz outlined the chain of organ donation and transplantation, which begins with donor detection and moves systematically on to donor maintenance, brain death diagnosis, family consent, local and organisational factors, procurement and, finally, transplant. He stressed that the two weakest links in this chain are donor detection and family consent.

“Approaching the family is probably the key point in this process and is a very sensitive topic. When the family is approached they can say yes or they can say no, the difference this makes is that many people can be transplanted or they cannot. And the decision they make relies primarily on the skill of the person who makes the approach about organ donation,” he told delegates at the workshop in Brussels.

Meeting families’ support needs during this traumatic time is an obligation and a challenge for critical care staff. Results of research spanning over 30 years on the effects of families’ hospital experiences on their decisions about organ donation for a relative have generated compelling evidence regarding the significance of families’ satisfaction with hospital care, their understanding of brain death, and the timing of the donation request.

Some of the issues raised include the importance of families’ being given time to bring up concerns with staff, receiving clear information about their relatives’ condition and the organ donation process, not being pressured to make a decision, and being shown respect and compassion.

Dr Matesanz advised Europe’s cash-strapped national health authorities that focusing on the management of the donor/transplant process at hospital, regional and national level would be the most effective use of resources.

“It is unwise to have too much confidence in direct publicity campaigns aimed at the general population,” he cautioned. “Apart from some anecdotal observations, there is no evidence in medical literature documenting that direct publicity campaigns are really able to influence positively the attitude of the public to organ donation.”

He illustrated this point by highlighting two national polls – conducted 13 years apart – that gauged the attitudes of the Spanish population towards organ donation. Between 1993 and 2006, despite ongoing organ donor awareness campaigns, the number of people willing to donate their organs remained static. However, the number of actual donors during this period more than tripled from 550 to 1,606, due to a restructuring of the Spanish organ donor and transplant system.

Ms Charlotte Möller, coordinator for donation and transplantation at the National Board of Health and Welfare in Sweden, offered a qualified agreement on this point, arguing that expensive “blanket” organ donor publicity campaigns are not effective but a carefully devised and focused campaign does work and is much cheaper by comparison.

She explained how, over a three year period, the Swedish government spent €2.7 million on TV, radio and newspapers campaigns to raise people’s awareness about organ donation. The outcome was only a slight increase in the national donor registry numbers and donor frequency.

So, a new communications strategy was developed in 2010, culminating in a weeklong awareness campaign in October that year. A special team was assembled to work with the new strategy; a central web portal was set up; online social networks were utilised; media kits were developed, focus was placed on patient stories and their families, along with other initiatives.

The donor awareness week resulted in a blitz of TV and radio interviews, more than 100 articles and massive activity on Facebook, Twitter and Blogs. By the close of the campaign, the number of people who registered as an organ donor rose by over 25%. The total cost was only €70,000.

Dr Axel Rahmel

While main barrier to successful organ transplantation is a serious shortage of donated organs, Dr Rahmel was confident that organ donation could be improved by a well-organised and structured approach.

“A perfect example, Croatia has achieved another increase in organ donation again this year. I assume Croatia will be the European champion in organ donation in 2011 and that was from starting with a donation rate below 10 per million population a few years ago. So what did they do? They adopted some of the Spanish model and put [donor] co-ordinators in the hospitals, focused on organ transplantation and introduced legislation on presumed consent,” he said.

There is currently no legislative framework in Ireland governing the use of or consent relating to the donation of organs, in contrast with most of Europe. At present, a person has to indicate their willingness to donate their organs by carrying a donor card. The Programme for Government promises to legislate for an opt-out system, which assumes everyone is an organ donor unless they have expressed otherwise.

During the lengthy public consultation and preparation of a Human Tissue Bill in 2009 and 2010, the Department of Health explored the case for ‘opt-in’, ‘opt-out’ and ‘mandated choice’ systems of consent for organ donation. While legislation was expected to be published soon after, nothing happened. Health Minister Dr James Reilly told the Dail in October that he intended to “bring legislative proposals for a Human Tissue Bill to Government early next year”.

The new EU Directive acknowledges that several models of consent to donation coexist across Europe and it does not recommend the adoption of any particular model. Mr Mark Murphy, who represented the European Kidney Patients' Federation at the workshop in Brussels, stated that legislating for one donor consent system or another was immaterial.

“None of this directly impacts on the level of organs donated in a country,” he said. “What makes the different is how you approach a grieving family in the hospital about donating a loved one’s organs. The right to say yes or no ultimately rests with family members and no one in a hospital is going to challenge them on that issue, regardless of the legal framework.

“We have to recognise that this is a very difficult time for families and we need specially trained donor co-ordinators in the hospitals who can approach them sensitively, listening to them, answering their questions and explaining the process. That will make the difference.”






Pharmacists Crucial In Chronic Disease Management


Chronic diseases – such as heart disease, stroke, COPD, and diabetes – are among the most prevalent, costly, and preventable of all health problems. And they’re on the rise in Ireland, in tandem with our ageing population and unhealthy lifestyle choices.
The Institute of Public Health in Ireland (IPH) forecasts a 40% increase in the number of people living with these chronic conditions in the Republic of Ireland by 2020 - that’s more than 1.7 million people - making the prevention and management of chronic diseases the greatest actual and future challenge to our healthcare system.
At present, for many individuals with a chronic disease, care is reactive, sporadic, and usually occurs within the costly hospital system. In fact, chronic diseases account for a massive 80% of all healthcare costs. Both government and individual caregivers recognise that this is unsustainable. The axis of care must shift and a new approach developed that puts chronic disease management programmes in a central position to prevent, treat and delay the onset of complications for those with a chronic condition.
The fact that people with chronic conditions managed by medication have more contact with community pharmacists than any other healthcare professional, places pharmacists in an ideal position to detect early changes in condition and identify at-risk patients well before they reach the hospital revolving door.
“There is so much benefit to be had by involving the pharmacist in the management of a patient’s chronic disease, whether it’s asthma, diabetes or a heart condition. We know these patients, some of them for many, many years; we see them every time they get a prescription filled. There are opportunities for health screening, medicines management, health promotion, and incentive-based self-management. We’re a logical part of the solution,” said Professor Peter Weedle, adjunct Professor of Clinical Practice at the School of Pharmacy, University College Cork (UCC) and a community pharmacist from Mallow, Co Cork with over 25 years’ experience.
“In Ireland, we are clogging up our hospitals with people who have chronic diseases. We knew they had a chronic disease and they were being treated for their chronic disease and yet they end up in hospital because we have failed or they have failed to manage their condition correctly.”
Prof Weedle has long maintained that pharmacists can make a significant impact on critical areas of patient care. He published a paper in the British Journal of Pharmacy Practice in 1983 in which he defined pharmaceutical care. “What we were saying back then was that pharmacists need to start talking about pharmaceutical care; not talking about medicines, not about medicine management or medicine use review, but talking about patients. In the same way you talk about medical care or nursing care, we needed to start talking about pharmaceutical care.”
“That was nearly 30 years ago and not much has changed in the interim, but hopefully, with the establishment last year of the HSE’s new Clinical Care Programmes under the Clinical Strategy and Programmes Directorate (CSPD), led by Dr Barry White, we have an opportunity to explore how pharmaceutical care can fit into and benefit a new integrated approach to acute and chronic disease management,” he said.
A panel of pharmacists with an interest and expertise in chronic diseases was recently selected to participate in the chronic disease CSPD Clinical Care Programmes, which include heart failure, stroke, COPD, asthma, diabetes and care of the elderly.
Professor Peter Weedle
Prof Weedle, who was involved in the selection process in his capacity as Chairperson of the National Pharmacy Reference Group (NPFG), remarked: “We got a phenomenal and enthusiastic response from the profession of pharmacy when we looked for expressions of interest to participate in these programmes. Almost immediately we had about 70 or 80 people volunteer to get involved in the various programmes.
“It’s very exciting to see the various experts, be they consultants, GPs, nurses, pharmacists, physiotherapists, dieticians, all meeting together and looking at what are the gold standards for the treatment of any particular chronic disease, and how these complimentary professions can work together. Taking one example, heart failure, there are new and compelling data which suggest that an integrated, collaborative approach to care involving GPs and pharmacists can improve the long-term outcomes for patients. I believe this is a very exciting development for patients and our profession; it’s a natural evolution and a golden opportunity just waiting to be tapped.”
The reality is that people with chronic conditions managed by medication have more contact with community pharmacists than any other healthcare professional.  Poor adherence to medicines affects 30-50% of patients and often it is the pharmacist who directly observes this. Consequently, community pharmacists are well placed to monitor the patient’s medication adherence, encourage self-management, and also detect early warning signs and changes in the person’s medical condition.
“In an ideal world, the pharmacist has a role in at least three important areas of chronic disease management. First, pharmacists see a wider group of patients to GPs and hospital doctors and can screen the population widely for undiagnosed chronic disease. Secondly, pharmacist can carry out therapeutic drug monitoring and self-care,  checking that the patient’s condition is properly controlled. For example, a patient with diabetes, who is monitoring their blood glucose levels on a daily basis and recording that information, could bring their self-care records into the pharmacy with their prescription for repeating on a monthly basis. Thirdly, because several chronic diseases tend to co-exist in the same patients, pharmacists can help identify important pharmaceutical care issues, with complex drug-drug and drug-disease interactions a growing problem.”
“The pharmacists can chat with the patient, review their records and condition, and if everything is fine the prescription is dispensed. If not, they can be referred back to their GP. But, at the moment, the pharmacist cannot tell if the patient is managing their condition optimally and could be repeating the prescription for six months when in fact the patient really needs to see their doctor to have their treatment reviewed.”
“This is just one example. Specialist training is being developed for pharmacists, who are interested in running clinics for a specific condition, at which patients can be monitored, their medication reviewed, and perhaps running group education sessions. This will be carried out, where possible, in conjunction with the CSPD programmes. It too early to say how the CSPD programmes will work, but the potential is vast,” Prof Weedle stressed.
Effective medical therapy is a key factor in good chronic disease management programmes. Half of all people with chronic conditions fail to take their medicines properly and 10% of hospitalisations may be due to older people’s inability to manage drug therapy.
The rates of non-adherence to prescription medication therapy have remained stagnant over the past three decades and recent research has shown that as many as 40% of patients still do not adhere to their treatment regimens and up to 20% of all new prescriptions go unfilled.
Medication non-adherence is a problem that applies to all chronic diseases, diminishing the ability to treat diabetes, heart disease, cancer, asthma and many other conditions, and resulting in suffering, sub-optimal utilisation of healthcare resources and even death.
“If we want to improve patient adherence to prescription medication, it is clearly imperative that we involve pharmacists as part of a multi-disciplinary approach to patient care. Recent Irish work has shown that non-persistence of vital medicines affects 30% of a well-educated heart failure population and is associated with worse outcome and increased healthcare costs. This highlights the importance of regular, on-going, professional management of adherence issues.”
“We’ve seen situations of medication being returned, unused - not in small carrier bags but in black bin bags - when a patient has died. For example, a few years ago a lady’s family brought back her medicines. We were able to take out a product she received regularly, used in the treatment of osteoporosis, and place all 24 unopened packets in the order in which they had been dispensed. None were missing. She had not taken them in two years yet was still getting the prescription.The cost of those medicines was €1,200. Not only was this money wasted but the patient’s condition was going untreated and unmonitored,” Prof Weedle pointed out.
He maintained that chronic disease management in community pharmacy deals primarily with control and prevention. Medication compliance, monitoring of disease parameters and complications, health education, lifestyle modification advice and identifying situations to seek help from health professionals, are key components in the management of chronic diseases in community pharmacy. A pivotal element in this partnership is pharmacist-led patient self-management.
“I’m a great believer in self care,” said Prof Weedle. “The patient needs to take responsibility for their own health, their own treatment. However, the emerging evidence suggests that regular, on-going professional encouragement and coaching is key. The bottom line is our population is aging and we have to accept the growing chronic disease burden.  But having a disease does not mean you cannot live long and well. “
“Provided the patients themselves are coping well, we should get away from this idea that only health professionals can manage their condition. The patients themselves should be taking an active role in controlling their disease and we should be helping, coaching, advising the patient in the management of their own chronic care.”
With the regulatory framework in place, by way of the Pharmacy Act 2007, the role of pharmacy is set to expand exponentially, enhancing pharmacists' responsibilities in the delivery of health care and disease management.
In order to facilitate this pharmacist-led approach and integrate the pharmacist in the multi-disciplinary care of patients with chronic diseases, it may be appropriate to allow pharmacists access to electronic health records, as well as deregulation of more prescription-only medicines to pharmacy-only medicines, as seen recently with the emergency hormonal contraception.
These are all details that will be teased out over the coming months by members of the clinical care programmes for chronic diseases, and their deliberations will have widespread implications for the future training and practice of pharmacy in Ireland.
“This is an ongoing process; there won’t be an official launch date for pharmacy’s involvement in the management of chronic diseases, it will happen gradually. It’s happening now and it’s gathering pace all the time,” said Prof Weedle.
“As the clinical programmes report we will start to see how the national parameters by which we treat a particular disease category – the gold standards - will change and how this will impact on the role of the pharmacist in the management of chronic diseases in the community.”
“I believe when we look back in perhaps two years from now we will see that we’ve implemented a huge range of initiatives in pharmacy in this regard, including possibly legislative change where time-limits on prescriptions are concerned. The potential for pharmacy is huge, as are the benefits for the individual patient and our health service as a whole. These are very exciting times don’t you think?”

On the rise: Chronic diseases in Ireland

High blood pressure
In 2007 nearly 852,000 adults (25.1%) had high blood pressure. By 2020 this is expected to rise to over 1,192,000 people - an additional 341,000 adults (a 40% increase in less than 15 years).

Coronary Heart Disease (CHD)
In 2007 nearly 131,000 adults (3.8%) had ever had a Coronary Heart Disease (CHD, angina and heart attack). By 2020 this is expected to rise to over 195,000 people - an additional 65,000 people (a 50% increase in less than 15 years).

Stroke
In 2007 almost 59,000 adults (1.7%) have ever had a stroke. By 2020 this is expected to rise to almost 87,000 people – an additional 28,000 adults (an increase of 48% in less than 15 years).

Diabetes (Type 1 and Type 2 combined)
In 2007 nearly 144,000 adults (4.5%) have diabetes (Type 1 and Type 2 combined). By 2020 this is expected to rise to over 233,000 an additional 89,000 adults – (a 62% increase in less than 15 years).

Source: Institute of Public Health in Ireland

A Prescription for Change

The underutilised profession of pharmacy has become the sleeping beauty of our health services but not for much longer. 
Historic changes are underway that promise to awaken a new dynamic in pharmacy practice in Ireland, enabling pharmacists to reach their full potential in delivering an enhanced range of services to patients as part of inter-professional multi-disciplinary healthcare teams.
New legislation has provided scaffolding around which the profession recently commenced a major restructuring of pharmacy education and training in Ireland, which will lead to a significant and major expansion of the role of pharmacy practice.

The scope of untapped potential in the profession is extensive, ranging from health screening and vaccinations to pharmacist prescribing and clinical specialisation.

And pharmacists around the country are keen to embrace this new direction, according to the Pharmaceutical Society of Ireland (PSI), the pharmacy regulator. A recent PSI Study of Community Pharmacy Practice in Ireland that found most pharmacists want to provide new and enhanced services, such as lung capacity screening, sexual health services and structured medicine use reviews. They told researchers that they feel pharmacy is under-valued and under appreciated in current healthcare structures.

The springboard from which the profession is launching itself into a bright new future is the Pharmacy Act 2007. Replacing legislation more than 130 years old, the new Pharmacy Act provides modern and robust regulations that will make the profession more transparent, patient-centred, and focused on patient safety.

A key aspect is the introduction of mandatory continuing professional development (CPD) for pharmacists in Ireland. Currently, in order to be accepted for continued registration, all pharmacists now sign a declaration on an annual basis that they will maintain competency and continue to bring new knowledge and skills to their practice.

In line with the recommendations contained in its Review of International CPD models, the PSI is currently implementing a new system of mandatory CPD for pharmacists.

Kate O’Flaherty, PSI Acting Head of Pharmacy Practice Development, explained that this new CPD system is not based on a traditional points system or accumulation of contact hours. Instead all pharmacists will be encouraged to adopt a more reflective approach to learning and to identify their own learning and development needs based on the skills and competencies required for their particular professional practice.

“Our new CPD model is largely based on a model that has been in place for the last 13 years in Ontario, Canada, for pharmacists. Patient safety is at its core, and it’s a self-reflective peer-supported model. We are currently developing a CPD portfolio, which will be most likely an online portfolio that will serve as a template for pharmacists to help them assess their learning needs and enable them to record, evaluate and demonstrate their professional development.”

The new CPD system will also take into account the many types of learning in which pharmacists can engage in order to progress their professional development. These range from Informal Learning, such as practical, “on-the-job” learning from experience that traditionally does not lead to certification but enhances the individual’s professional knowledge and skills; through to Formal Learning by participation in quality-assured, structured programmes of education training.

“We’re also developing a competency framework for pharmacists which will help with, for example, communication and consultation skills. There are patient consultation areas in all pharmacies now, so possibly many pharmacists will feel they need to develop their communication and consultation skills to maximise the benefits to patients of consultations, and learn how to deal with new and challenging scenarios. They may need new skills or to develop the skills that they already have,” said Kate.

“Another aspect of our CPD model is the peer support and peer review system. Pulling this all together is the imminent establishment of the first Institute of Pharmacy in Ireland. The various medical specialties all have their own colleges or institutes, such as the ICGP or the College of Obstetrics and Gynaecology. Similarly, the Institute of Pharmacy will manage our new CPD system,  a quality assurance process and an assessment process that would be based for the most part on peer assessment.

“The exciting potential of this new Institute is that it will also offer a platform for the development of specialisation in pharmacy. For example, in other countries where this has been developed you would have consultant pharmacists in oncology or cardiology, and they would be part of a wider multi disciplinary healthcare team. Many of those pharmacists would also have specialist prescriptive authority.”

This is a ground-up restructuring initiative for the PSI, starting with an overhaul of the current undergraduate programme, which has long been a four-year pharmacy degree with a further one-year pre-registration training period. The new education model that will replace the old system, possibly as early as 2012, is a five-year integrated Masters programme, which allows pharmacy students to contextualise theory and knowledge in structured placements in a variety of pharmacy fields.

“The students will be regularly placed on work experience in pharmacies, whether it’s in the community or hospital or pharmaceutical industry, which will make what they’re learning in the lecture or the lab more relevant to them. It’s much more integrated and they get to experience what it’s like to work with real patients and as part of a multi-professional healthcare team.

“This model will also create new roles for a lot of established pharmacists who, under the new system, will become teacher practitioners. As well as running a pharmacy and looking after patients, their pharmacy will become a teaching pharmacy; they will take on student pharmacists for on-the-job learning,” said Kate.

A new Tutor Training and Accreditation Programme (TTAP) was developed in 2010 by the Royal College of Surgeons in Ireland (RCSI) on behalf of the PSI to train and accredit tutor pharmacists who oversee the workplace training of pharmacy interns.

November of the same year saw the first cohort of 139 students graduate from the inaugural Masters-level MPharm programme, delivered by the RCSI, marking the first significant milestone of the education reform agenda.

“What’s exciting is that this initial masters programme gave us a start on developing the curriculum for the new integrated five-year masters so that it incorporates new emerging trends and the expanding role in pharmacy. It brings Irish pharmacy in line with international best practice.

“For example, all of the new Masters’ graduates are trained in vaccination skills and they all participated in an inter professional prescribing sciences module alongside medical students, which was not on the curriculum previously.”

Pharmacists are playing an increasing role in direct patient care
The PSI, through its Pharmacy Ireland 2020 initiative, is also encouraging and facilitating greater involvement of pharmacists in the delivery of integrated health services in the community and has established an expert National Pharmacy Reference Group to progress this agenda. A key initiative is to support pharmacy engagement in the work of the HSE Clinical Stategies and Programmes Directorate on implementing new clinical and disease management programmes in pharmacy.

This desire to actively engage more with local multi-professional groups in the care of patients was voiced by 94.6% of pharmacists who responded to the PSI Study of Community Pharmacy Practice in Ireland.

Many respondents felt that the pharmacist is currently underutilised and that there is potential to expand the role of pharmacy in healthcare services to patients. Screening and diagnostic services, medicine use reviews, minor ailment schemes, and vaccinations, were some of the suggestions for the pharmacist to contribute more to patient care.

“For a lot of people, the first contact they have with the health service per se is when they walk into their local pharmacy looking for advice and information. It’s very important that pharmacy is linked with the rest of the health service, fully participating in national public health initiatives, and maintaining close links with multidisciplinary care teams,” observed Kate.

Arising from the recent reclassification by the Irish Medicines of the formerly prescription-only emergency contraceptive pill which is now available directly from pharmacists without a prescription, she envisaged the potentially more medicines could be considered for switching from prescription control so they can be accessed from a pharmacist.

“In other countries there are more nedicines available through pharmacists, essentially the patient will be getting their medication from a different healthcare professional who is perfectly competent, and has the appropriate consultation environment and training,” she pointed out.

In the UK and other countries, medicines such as oral fluconazole for thrush in women; some of the triptans for migraine; statins; low dose aspirin, and certain antibiotics are available from pharmacists.

In addition, more than 50 Boots pharmacies nationwide provided a flu vaccination service last winter, with other pharmacies expected to follow in the coming year. In countries where seasonal flu vaccinations are available in pharmacies, uptake levels have increased by up to 50%.

“Why stop with the flu vaccination? Pharmacy could link in with other public health vaccinations, such as the cervical cancer vaccine. Pharmacists need to be integrated more into the greater wider health service. It’s not the pharmacist or the GP working in isolation, we should be working together to capture all patients who need vaccinations.”

And Kate added: “Up to 2007, when the new pharmacy Act was introduced, the argument against pharmacists vaccinating or making the morning after pill available in pharmacies, or pharmacist prescribing was that we didn’t have the regulatory framework to protect the public. There was no fitness to practise if anything went wrong; you didn’t have robust regulations that would give guidance to pharmacies; and we didn’t have mandatory CPD so there was no way of assuring that pharmacists were continually ensuring their skills were up to date.

“But now we have all of those requirements and safeguards in place or imminent, those arguments against expanding the role of pharmacists are essentially gone. Our future pharmacy graduates are going to be trained to the highest international standards. All of the markers are in place - the regulatory framework, new education and training initiatives, and the appetite to expand our role in the community - the catalyst for this development to take off in a big way is here and ultimately patients and the health system will benefit.”


Monday, July 18, 2011

Breakthrough therapy for pancreatic cancer?

A potential new therapy that targets not the ‘bricks’ but the ‘mortar’ of pancreatic cancer may offer new hope to patients. The research is led by an Irish doctor, writes Eimear Vize.
 
With less than 5% of pancreatic cancer patients surviving the first five years after diagnosis, this notoriously aggressive disease typically has a very poor prognosis. So when news was released earlier this year about the discovery of a novel immune therapy for pancreatic cancer, the medical world sat up and took note.

Researchers, led by an Irish doctor Peter O’Dwyer, not only found that an experimental antibody caused pancreatic tumours to shrink significantly in a small cohort of patients, they also believe their findings - and the novel way in which they uncovered them - could lead to quicker, less expensive cancer drug development.

Until now, it was assumed that the immune system needed to attack the cancer cells directly in order to be effective, however, this new research from the University of Pennsylvania's (Penn) Abramson Cancer Center revealed that CD40 antibodies could trigger the patient’s own immune system into shredding the structural “scaffolding” that holds tumours together.

And they made this groundbreaking discovery by happy accident.

In the clinical trial, led by Prof Peter O'Dwyer, professor of medicine at Penn, and Dr Gregory Beatty, instructor in medicine, 21 patients with surgically incurable pancreatic ductal adenocarcinoma (PDA) were treated with standard gemcitabine chemotherapy as well as an agonist CD40 antibody - an experimental antibody manufactured by Pfizer Corporation.

“The micro-environment of the pancreatic tumour is a hostile and inflammatory environment, fuelling the malignant process and preventing access of anti-cancer drugs to the tumour cells,” explains Prof O’Dwyer. “The essence of using an antibody such as CD40 is to engage the immune system and try to activate one’s normal immune responses to recognise the tumour cell as something that ought not be there and eliminate it.

“Our hypothesis was that the antibody would bind and stimulate a cell surface receptor called CD40, which is a key regulator of T-cell activation. The CD40 antibodies would then turn on the T cells and allow them to do their job and attack the tumour. That was our theory, anyway.”

In a departure from the usual sequence of experiments, a unique mouse model of pancreatic cancer - developed at Penn - was used concurrently by Prof O’Dwyer and his colleagues to fully understand the human response to the immune therapy.

Unlike older mouse models that were simplistic models of human disease, these genetically engineered mice develop spontaneous cancers that are very close reproductions of human tumours.

Prof Peter O'Dwyer
“This model recapitulates the process by which most pancreatic cancers seem to occur in people. Even though it’s a very difficult model to work with, it’s a much more reliable model to mimic what’s going on in people. It means we can perform preclinical trials in these mice with the same principles we use in our patients,” Prof O’Dwyer adds.

The research team found that the experimental treatment appeared to work, with some patients' tumours shrinking substantially and the vast majority of tumours losing metabolic activity after therapy, although all of the responding patients eventually relapsed.

However, the real surprise came when investigators examined post-treatment tumour samples from the mouse models, which had been treated with the identical regimen. They expected to find swarming T cells busy doing their job but there were no T cells to be seen. Instead, they discovered an abundance of another white blood cell known as macrophages, which usually get co-opted into helping the tumours.

Closer inspection revealed that the macrophages had turned traitor and were attacking the tumour stroma - the supporting tissue around the tumour.

Pancreatic tumours secrete chemical signals that draw macrophages to the tumour site, but if left to their own devices, these macrophages would protect the tumour. The Penn researchers found that treating the mice (or patients) with CD40 antibodies seems to flip that system on its head.

"It is something of a Trojan horse approach," remarks senior author Dr Robert Vonderheide, an associate professor of medicine at Penn. "The tumour is still calling in macrophages, but now we've used the CD40 receptor to re-educate those macrophages to attack - not promote - the tumour."

While the current focus of immunotherapy is to strengthen the immune response to launch a direct attack on tumour cells, this new research suggests that attacking the dense tissues surrounding the cancer is another approach.

Dr Vonderheide says this tactic is “similar to attacking a brick wall by dissolving the mortar in the wall”.

He continues: “Ultimately, the immune system was able to eat away at this tissue surrounding the cancer, and the tumours fell apart as a result of that assault. These results provide fresh insight to build new immune therapies for cancer."

Prof O’Dwyer agrees that their research highlights the importance of designing treatments that focus not just on tumour cells but also on the neighbouring tissue that helps them survive and grow. This hold particularly relevance in pancreatic tumours as the surrounding tissue is very dense, fibrotic, and hostile, which is one of the main reasons standard therapies for this disease often work so poorly.

“There was evidence of response in most of the patients, which you wouldn’t ordinarily see in this cohort,” he notes. “The study is very preliminary, and it’s important not to over interpret results from a relatively small clinical trial, which this was, but I would say that these results are promising and interesting and they need to be verified by additional studies.”

Prof O’Dwyer and colleagues are now working on ways to capitalise on their novel information, testing ways to super-charge the macrophage response and to get the T cells into the tumour micro-environment.

It is also possible they may be able to speed up clinical research by running pilot trials in the mice to test potential therapeutics. Once they understand responses in the mice, then they can use that information to design better human trials.

Beyond the current research conclusions relating to pancreatic tumours, the Penn investigators believe these findings point to a new approach for drug development in cancer - one where state-of-the-art mouse models are used for preclinical trials to guide which trials should be carried out next in patients. This approach could prove faster and cheaper, giving researchers a head start in the clinical trials.

Prof O’Dwyer is naturally excited about the study results; it’s implications for the development of immunotherapy in treating pancreatic cancer as well as other cancers, potentially.

“Our trial was the first round of human tests. It was really designed to figure out the dose that we could safely administer this antibody along with standard doses of gemcitabine. In fact, there was a very small range of doses; almost everyone on the trial received doses that we thought were going to be effective and well tolerated.

“The CD40 antibodies appear not to be terribly toxic; the patients did not have much more in the way of side effects than they would have had from the chemotherapy by itself,” he notes.

The big question is whether the results in this preliminary trial in pancreatic cancer patients could be reproduced across the cancers. “The answer should be yes but we don’t know. Those studies have to be done,” says Prof O’Dwyer.

“With regard to pancreatic cancer, a number of exciting changes in how we treat this disease have emerged in the last two years or so. Some of the chemotherapy treatments have changed and become more effective, and others are in the pipeline. Also, targeted compounds are being investigated in patients with pancreatic cancer. It seems likely to me that the standard treatments for this disease are going to change fairly markedly in the next five years, with significant improvement in patient outcome,” predicts Prof O’Dwyer.

“I believe that activating the immune system, if it really is going to work, is going to be a part of a multi-dimensional approach to the management of this disease; chemotherapy will be important, as will targeted therapies, perhaps by attacking the tumour’s blood vessels or the growth signalling pathways within the tumour. The combined use of these with immunostimulatory approaches is likely to be the most fruitful in combating this disease and the best tolerated by the patient.”



The research paper - CD40 Agonists Alter Tumour Stroma and Show Efficacy Against Pancreatic Carcinoma in Mice and Humans - was published in the journal Science (25 March 2011: 1612-1616).



Clinical trials in Ireland



Professor Peter O’Dwyer, who co-led groundbreaking research in the US on a novel immune therapy that targeted tumour stroma in the treatment of pancreatic cancer, says Ireland offers an attractive potential location for further research on the experimental CD40 antibody.

The Irish doctor, who is vice-chairperson of Eastern Co-operative Oncology Group (ECOG) in the US, is working closely with members of the All-Ireland Cooperative Oncology Research Group (ICORG) on a number of other clinical trials in Ireland.

“There are several cancer trials ongoing at the Irish research sites that are being conducted through ECOG. We have been building a strong relationship with ICORG members for three or four years now and we are hoping to expand this activity significantly over the next two years.

“There are no immediate plans to involve ICORG in a further study of the CD40 antibody but it would be our goal,” he says.

He pointed out that ICORG is the only full European member of ECOG.

Prof O’Dwyer serves as Professor of Medicine in the Haematology-Oncology division at the University of Pennsylvania and Director and Program Leader of the Experimental Therapeutics Program in the Abramson Cancer Center of the University of Pennsylvania.