Final RCSI MiniMed Lecture

Royal College of Surgeons in Ireland (RCSI) MiniMed Open Lecture Series concluded with lectures discussing ‘What can my Pharmacist do for me?’ and will also focus on generic medicines and internet pharmacies.

Professor Paul Gallagher, Head of the RCSI School of Pharmacy, gave the opening talk of the evening with a lecture entitled Potions, Lotions and Health Promotion - What can my Pharmacist do for me? 

Gallagher said, “The role of the pharmacist in modern healthcare delivery is changing and there is a growing acceptance of the need to shift the model of healthcare toward service delivery in the primary care setting. Pharmacists are a relatively under-utilised resource in the community whose expertise, if properly exploited, could make a valuable contribution to improving the health and well-being of the Irish people and their families. We will also provide some key information to the public in regards to generic medicines and internet pharmacies.”

A pharmacy ‘Brown Bag’ event ran parallel to the second lecture at RCSI. The lecture allowed members of the public to bring all of their medication and supplements to an appointment with an RCSI pharmacist. The pharmacist sat down with each participant and reviewed the medication they are taking and gave some advice.

Speaking on the Brown Bag medicine review event, Professor Gallagher continued, ‘The aim of such an event is, ultimately to improve participants’ understanding of their medicines, answer any questions they have and improve communication and the relationship between patients and their pharmacist.’ The Brown Bag event was co-ordinated by Michelle Flood, Lecturer in the School of Pharmacy.

Special attention asked be paid to the prescribing of NOACs

The HSE’s Medicines Management Programme (MMP) has highlighted that attention should be paid by to the prescribing of  New Oral AntiCoagulants (NOACs) particularly in relation to appropriate dosing and the potential for drug interactions.

Over 13,000 patients receive treatment with NOAC drugs under the Community Drugs Schemes in Ireland. This represents a threefold increase over the past 2 years as prescribers consider the potential benefits including the predictable anticoagulant effect without the requirement for regular monitoring, lower rates of intracranial hemorrhage and the reduction in potential drug interactions.

The HSE said, “The NOACs are not without adverse effects and of course the most important is hemorrhage. The risk of major gastrointestinal hemorrhage may be even greater with NOACs as compared with warfarin and no antidote has been proven to immediately reverse the effects of these new agents. In March 2013 patient safety issues with the NOACs was highlighted in the Irish Medical Journal, with the recommendation that prescribers (frequently in the hospital setting) would need to carefully select their patients to optimize safety and efficacy.”

 In relation to rivaroxaban (Xarelto), currently there are 7,460 patients who receive the drug, with some 4,590 patients (62%) receiving it as long term therapy and over 16% of these patients (769) receiving the drug at a prescribed daily dose of just 10 mg.

The recommended dose for atrial fibrillation is 20 mg daily reducing to 15 mg daily for patients with renal impairment. Administration of rivaroxaban 10 mg daily is not indicated for atrial fibrillation and renders such patients susceptible to stroke.

When reviewing dispensing data (January – October 2013 inclusive) the MMP sought to identify prescribing patterns of NOACs in Ireland.

They specifically aimed to determine dosages prescribed to patients receiving long term NOAC therapy (treatment exceeding 35 days) and to investigate potential drug interactions. It was found that over 80% of prescribing of NOACs is for the atrial fibrillation indication and 60% of patients treated with NOACs are aged 75 years or more.

Over 28% of patients treated with rivaroxaban received medications that would be expected to interact with the anticoagulant. Over 100 patients were co-prescribed dronedarone which should be avoided given the limited clinical data available.

Some 25% of patients received medications where caution is advised e.g. NSAIDs and platelet aggregation inhibitors. This co-prescribing places patients at greater risk of hemorrhagic complications.

Smoking ban has led to better health of general population

March marked the 10th anniversary of the introduction of the workplace smoking ban in Ireland. Since 29th March 2004, smoking is prohibited in most enclosed workplaces under the Public Health (Tobacco) Act 2002.

The workplace ban had a significant impact internationally, with several countries, including the UK, following Ireland’s example. 

Research in Ireland by the National Tobacco Control Office shows that compliance with the legislation is 97%. 

The Minister for Health, Dr James Reilly T.D noted that Ireland is regarded internationally as a leader in the area, ranked second out of 30 European countries in terms of tobacco control.

He said, “Ireland has a strong track record in the area of tobacco control policy, and we are actively engaged in building on past successes. I was very pleased that we received approval from Government last November to proceed with the drafting of a Bill that will introduce standardised packaging for tobacco products similar to what is in place in Australia. We are also working towards introducing legislation to prohibit smoking in cars where children are present.” 

Research published only last year, found that the smoking ban was associated with a number of immediate reductions in ill-health in the general population: 

· an immediate 13% decrease in all-cause mortality 

· a 26% reduction in ischaemic heart disease 

· a 32% reduction in stroke, and 

· a 38% reduction in COPD (chronic obstructive pulmonary disease). 

Dr Angie Brown, Medical Director of the Irish Heart Foundation said, “The rapid reduction in heart attacks after the introduction of the workplace smoking ban may be surprising to the general public but it makes sense when we consider the immediate effect tobacco smoke has on the body. The poisons in smoke pose a danger right away. Sudden blood clots, heart attacks, and strokes can be triggered by tobacco smoke. This means that just sitting in a smoke-filled bar would raise a person’s chances of a heart attack. The reduction in heart attack admissions here shows that Ireland’s courageous move as the first country to have a comprehensive smoking ban led to a vast improvement in the nation’s heart health.”

Increased role for pharmacists with migraine sufferers

The Migraine Association of Ireland’s (MAI) Chief Executive Patrick Little has asked for an increased access to appropriate headache medications and advice for pharmacists.

Little said the Irish Medicines Board (IMB) was considering whether Sumatriptan, also used to treat a rare condition called cluster headache, should be available off-prescription.

Little said pharmacists had a key role to play in improving services for migraine sufferers.

He said pharmacists could be trained so they could identify migraine sufferers who would benefit from taking the fast-acting drug, that is 80% effective if taken early in the attack when the pain is milder. 

According to MAI, it is essential for pharmacists to obtain an accurate headache history from the sufferer before any treatment is recommended. 

Past patients should be encouraged to return to the pharmacy for a review of the severity of their illness and response to treatment of their headaches/migraine on a regular basis.

Sumatriptan is available in a nasal spray or tablet. The spray is recommended for people with nausea and is classed as an over the counter medicine in the UK.

Migraine is the most common neurological condition in the world with around half a million people suffering from migraine in Ireland. Irish Pharmacy Union (IPU) President Rory O’Donnell said most migraine sufferers would have been diagnosed with the neurological condition by their doctor. 

O Donnell said, "The majority of migraine sufferers have already been diagnosed with migraine by their doctor and, for regular or severe sufferers, have more than likely been previously prescribed Sumatriptan as a treatment.”

He continued, “Once a migraine headache starts, the sooner this medicine is taken, the more effective it is. As pharmacists are the most accessible part of the healthcare system, they are ideally placed to provide the assistance needed and to support the sufferer in treating their migraine attack in a timely fashion."

The MAI held a seminar to celebrate their 20th Anniversary on the latest migraine and headache treatments. Some of the world’s foremost neurologists, researchers and headache experts attended the Conference.

Patient’s call for better understanding of medication

A new report into non-adherence to medicines has revealed that non-adherence is costing EU governments an estimated €125 billion and contributing to the premature deaths of nearly 200,000 Europeans annually.

Mr Stephen McMahon, 

CEO of the Irish Patients' Association

The report, titled ‘A Report on Patient Non-Adherence in Ireland’ reviews existing international literature on medication adherence and outlines results from an Irish survey examining adherence in Ireland and the factors which hinder it and promote it.

Non-intentional non-adherence is significantly more common that intentional non-adherence with ‘forgetfulness’ the main reason patients report for missing their medication. Other reasons patients are intentionally non-adherent include patient perception that they don’t need the medication any more , they feel better, they are anxious about the side effects or they don’t believe that the medication was effective.

Patients who were reviewed by healthcare professionals within the last month tended to be more adherent to their treatment than patients who had longer time intervals between reviews.

Rory O’Donnell, President of the IPU said “Pharmacists are among the most accessible and most consulted healthcare professionals and are therefore ideally placed to tackle non-adherence to medication, by educating patients, helping them make informed decisions about their medicines and supporting them in adhering to their prescribed therapy, thus ensuring that, by taking the right medicines in the right way at the right time, patients achieve the optimum benefit.”

A number of recommendations to help improve adherence levels among Irish patients are outlined in the report. These include personalised interventions to overcome non-adherence, access to training for healthcare professionals, a collaborative approach involving the patient in their health management and increasing the use of memory aids to help patients increase adherence. According to the survey, 76% of Irish patients claim to have no formal method or system to help them monitor or remind them to take their medicines.

The three factors ranked most important in ensuring people do take their medication are talking regularly to the doctor, having a good understanding of the illness and having a good understanding of the medication.

Speaking about the launch of the report, Mr. Stephen McMahon, CEO of the Irish Patients’ Association said “This report is another step forward in patient safety by making us aware of the level that Irish patients do not adhere to their prescription medication regimes. It is evident that all those involved with the patient i.e. the doctor, the pharmacist, the nurse, the payer, the policy maker and the manufacturer, should play a role in promoting the importance of adhering to prescribed medication. As a patient advocate with a passion for embedding a culture of patient safety everywhere, my call to action to patients is: Take your medicines as advised. And to healthcare professionals at every opportunity ask your patients “Have you taken your medicines today?”

Cancer research group discovers resistance to therapy

A cancer research centre has discovered that many patients, whose tumours were positive for the estrogen receptor in addition to the Her2 protein, were more likely to develop resistance to the commonly used Herceptin therapy.

Breast cancer patients who test positive for high levels of the Her2 protein are usually treated with Herceptin, which has vastly improved the outlook for this group of patients.

These findings come just six months after the founding of BREAST-PREDICT, the Irish Cancer Society’s first Collaborative Cancer Research Centre (CCRC), which are aimed at improving integration of cancer research and cancer care in Ireland and internationally.

Estrogen receptor (ER) positive breast cancer, which accounts for 70% of all breast cancers, is generally very treatable and has an excellent prognosis. However, some patients develop resistance to the more common therapies over time, leading to recurrence of the primary tumour, and in some cases, metastasis and eventual death.

Led by Professor William Gallagher, an Associate Professor of Cancer Biology at University College Dublin, BREAST-PREDICT researchers have discovered that patients whose primary tumours express a protein called PRDX1 are more likely to develop a recurrence in the future. This finding may have implications for future breast cancer care, where it could be used to help guide treatment decisions in these patients

More than 50 researchers are working on this research programme which will run for a period of five years, with an investment of €7.5 million from the Irish Cancer Society. At the heart of the study is the development of a national breast cancer biobank and database which includes tumour tissue, blood samples and patient information collected, with permission, from almost every breast cancer patient in the country. BREAST-PREDICT is using this data to improve its understanding of how breast cancer can spread and become resistant to treatment.

Doing less with less - The Resilience Project

The final seminar of a three year Health Research Board funded research project by academics in the Centre for Health Policy in Trinity College Dublin which took place on March 31 2014 has revealed a transferring of cost from the State on to people, for example, prescription charges, hospital charges this affects the oldest and sickest most.

The Resilience Project is a three year research programme (2012-2014) assessing the resilience of the Irish health system during the economic crisis.

The research has also found that increased efficiencies in the health system between 2008 and 2012. According to the research, the health system that now has to do less with less.

Dr Steve Thomas, Associate Professor, Centre for Health Policy and Management in Trinity who led the Resilience Project spoke about the economic context within which this study was conducted. He said, “A new government came to power in March 2011 with the most radical proposals for health system reform in the history of the Irish state, including improving access to healthcare, free GP care for all by 2015 and the introduction of Universal Health Insurance after 2016. All this was to be achieved amidst the most severe economic crisis experienced by Ireland since the 1930s, resulting in severe cuts to the health budget.”

The research showed a system that managed ‘to do more with less’ from 2008 to 2012 using increased efficiencies such as clinical care programmes, agreements between health service management and unions which allowed for increased flexibility and productivity; reduced professional fees and drug cost savings. They also found that some of the efficiencies were achieved by transferring the cost of care onto people and through significant resource cuts.

Key Figures about the Irish Health System:

· Approximately €2.7 billion has been cut from the Irish health system since 2009.

· There are over 12,000 fewer Health Service Executive (HSE) staff in December 2013 than there were at the height of public health sector employment in 2007.

· By December 2013 there were 1,890,465 with medical cards, the highest number in the history of the state, (over 600,000 more now than in pre crisis 2007) reflecting lower incomes and higher levels of unemployment.

Heart attack test developed

A new diagnostic test will help doctors evaluate if a person is having a heart attack within two to four hours. 

ARCHITECT STAT High Sensitive Troponin-I (hsTnI) may help doctors improve the diagnosis and prognosis of patients presenting with symptoms of a heart attack, which could be particularly beneficial for women, who are often under-diagnosed. 

Developed by Abbott, the hsTnI test is a two-step immunoassay to determine the presence of cardiac troponin in blood. The test uses chemiluminescent technology and measures the Relative Light Units (RLUs) of the reaction in the sample. A direct relationship occurs between the amount of cardiac troponin in the sample and the RLUs detected by the ARCHITECT instrument.

Cardiovascular disease is the most common cause of death in Ireland, accounting for 33 percent of all deaths. Almost 5,000 Irish women die from cardiovascular disease each year, and women are seven times more likely to die from heart disease than breast cancer. Women often show different symptoms from men when it comes to heart attacks, leading to more women being under-diagnosed and under-treated for heart attacks. 

Dr. Maria Fitzgibbon, Consultant and Head of the Clinical Biochemistry and Diagnostic Endocrinology Department at the Mater Misericordiae University and Mater Private Hospitals, Dublin, said, “While Abbott’s high sensitive troponin test benefits both men and women with earlier detection of an acute myocardial infarction, the significant increase in sensitivity of the assay has the potential to increase early diagnosis amongst women which is particularly important."

The hsTnI test will be used initially at the Mater Misericordiae University and Mater Private Hospitals, Dublin, and it is anticipated that it will be subsequently adopted at other key cardiology centres throughout Ireland.

Dr. Niall Mahon, Consultant Cardiologist, Mater Misericordiae University and Mater Private Hospitals, Dublin said, “"Use of this test may help physicians speed up the process whereby patients with suspected acute coronary syndromes are evaluated. Not only does this help physicians ensure that high-risk patients are identified and treated at the earliest opportunity, but also that low-risk patients can be reassured and discharged. This has obvious benefits for both patient care and resource utilisation,"

Furore over e-cigarettes

The EU is set to introduce a system whereby companies manufacturing e-cigarettes can either opt to sell their products under the official Medicines' Regulations or they can be regulated in a similar way to tobacco products.

However, the pharmaceutical industry, including pharmaceutical giant GSK, would like to see the introduction of medicines' licences being mandatory for e-cigarettes.

GSK said in a letter to the UK Health Minster that regulating e-cigarettes as medicines would “clearly set out that the recreational use of e-cigarettes to reinforce tobacco dependency is unacceptable from a public health viewpoint.”

The company added, “We also need to establish the application of marketing practices that mitigate the risk of non-tobacco nicotine-containing products becoming a gateway to tobacco products.”

It is already known the e-cigarettes contain nicotine, which is a highly addictive and dangerous drug. 

Minister Reilly intends to regulate the e-cigarette market in Ireland.  This will include banning their sale to Under 18s. However when asked by Irish Pharmacy News for a comment, the Department of Health was unable to give a time line for the commencement for the ban.

The UK has already put a ban in place for the sale of the products to the Under 18s. The UK’s Chief Medical Officer, Sally Davies said in a statement, "We do not yet know the harm that e-cigarettes can cause to adults, let alone to children but we do know they are not risk-free."

In Ireland the current position is that if these products are not presented as medicinal products for smoking cessation or as medical devices with a therapeutic purpose, they do not fall under the medicinal products or medical devices legislation.

The battery-powered products contain a cartridge filled with nicotine that has been dissolved in propylene glycol or vegetable glycerol and water. As e-cigarettes do not contain tobacco, they are currently not regulated under Irish tobacco legislation.
 

Euromonitor estimates that the global market for e-cigarettes is more than $2billion or €1.4 billion. 

Tony Geraghty, Production Director of Rossport Pharmaceuticals told The Irish Independent that he estimates that 50,000 smokers in Ireland have switched to using e-cigarettes since their introduction. 

In order to harmonise the way EU Member States regulate e-cigarettes, the new Tobacco Products Directive that has been voted in by the European Commission will provide for their regulation. It is anticipated that the Directive will be adopted formally by Council later this year, following the vote in the European Parliament in February 2013.  Member States will have two years to transpose the Directive.

It is thought that the Directive will set mandatory safety and quality requirements for e-cigarettes that will not fall under the definition of medicinal products.  

The new Directive will make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e-cigarettes, impose stricter rules on advertising and the monitoring of market developments.  The Directive will also enable Member States and the European Commission to react in the case of any identified health concerns related to these products. 

The EU has also proposed that e-cigarettes be banned entirely if three or more member states ban their use in their own countries.

Reilly said, in answer to a parliamentary question in January on e cigarettes, 'Tobacco Free Ireland', Ireland’s Tobacco Control Policy states that the general consensus at European level is that there is a lack of research in relation to the long term health effects of e-cigarettes and a lack of sufficient evidence that they aid with smoking cessation. I have asked my Department to review the issue, in order to inform policy and regulation in this area."

CARA Pharmacy Group collaborating with Waterford Institute of Technology

CARA Pharmacy Group is collaborating with Waterford Institute of Technology (WIT) in a €2 million research project, known as CODEMISUSED.

Dr Marie Claire Van Hout (WIT),
Pádraig McGuinness (CARA Pharmacy)
 and Carole Boyd (CARA Pharmacy)
pictured at the recent signing of the
 CODEMISUED partner agreement

The research will be investigating codeine use, misuse and dependence in Ireland, the UK and South Africa. The project hopes to design protective mechanisms for pharmacies to be able to track, monitor, support and refer for treatment. These mechanisms could include pharmacy based brief interventions and continuing staff training.

During the 48 month period of research, staff from WIT and the CARA Group will second to each other’s teams, along with the international partners in the UK and South Africa. There will be no change for patients buying codeine during this time.

Pádraig McGuinness MPSI, Lead Researcher and Pharmacy Services Manager at the CARA Pharmacy Group said, “We are excited to be involved with the research, as it is all part of our ongoing commitment to our core values of care and safety of our patients. Codeine misuse remains a sensitive issue for our pharmacists and for many patients throughout Ireland, and as a pharmacy team who values patient care and safety above all else, we hope the results will ultimately improve the care patients receive from Irish Pharmacy as a whole. CARA is a progressive group of pharmacies with a twenty strong team of pharmacists, and we are delighted to be involved in this internationally recognised research.”

Codeine sales are already subject to Pharmaceutical Society of Ireland (PSI) regulation. According to the PSI regulations, a pharmacist must be satisfied that the supply of the particular non-prescription medicine is safe and appropriate, and the pharmacist must use their professional judgement and expertise in deciding how best to deal with the individual patient’s needs. This may involve the supply of a medicine, referral to a GP or other healthcare professional or other advice or information.

There are additional considerations due to the fact that codeine is a controlled drug and the regulations also require that these medicines (along with prescription-only medicines) are not accessible to the public for self-selection. Therefore the PSI recommends the dispensary as the proper location for these medicines.

The advertising of codeine to the public is prohibited – this includes window displays, in-pharmacy displays, shelf stickers and promotional leaflets.

The project Principal Investigator is Dr Marie Claire Van Hout, has extensive experience in the field of drug addiction, and has consulted for the European Monitoring Centre for Drugs and Drug Addiction.

Van Hout said, “Given the difficulties in estimating the extent of this respectable form of addiction, CODEMISUSED is intended to promote the rational use of codeine products amongst the public as well as those involved in prescribing and dispensing. Ultimately we intend to design several innovations to support and educate customers, and empower pharmacies as custodians of codeine medicines. I am delighted to work with CARA on this project given the importance of having academia and industry working side by side to improve patient outcomes”.

WIT, as lead partner, is also collaborating closely with other partners, Kings College London, UK; Medical Research Council, South Africa; Weldricks Pharmacy, UK; and Leading Pharmacy Group, South Africa. Dr Van Hout’s team at WIT consists of Prof John Wells, Dr Michael Bergin, Dr Martina Gooney and Michelle Foley.