nurse and midwife prescribing in general practice · comissioning editor judith leavy designer...
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The Journal of the Irish Practice Nurses AssociationIssue 1 Volume 4 January/February 2011
EPIlEPsy: dIAgNosIs
ANd TrEATmENTSinead Murphy
mINImIsINg PsEudohyPErkAlAEmIA
IN cold wEAThErDarina Lane
sTrucTurEd PATIENT EducATIoN For PEoPlE wITh TyPE 2 dIAbETEs Sally-Ann McLaughlin
dIAbETEs ANd dEPrEssIoNElaine Newell
Q ANd A lIsA NolANIPNA Administrator
NursE ANd mIdwIFE PrEscrIbINg IN gENErAl
PrAcTIcERuth Morrow
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1
editorial
By the end of January, we will have received our first pay cheque with the December
2010 budget changes. We are now working harder than ever for less money and
no doubt there are more cuts down the line. More and more work is being landed
on us in primary care. We are being asked to carry out monitoring of patients
on chemotherapy, drug therapy such as methotrexate and other disease modifying
drugs. Our surgeries are bulging at the seams with seasonal viral illnesses and infections
which are prevalent at this time of year. Not to mention, the volume of work including
cervical screening, childhood immunisation, influenza immunisations and chronic illness
management that we all take in our stride everyday.
My public health nursing colleagues tell me the same is happening in the public health
arena with earlier discharges and lack of respite services. This coupled with reduced home
care support services and cuts in mileage allowance challenges the public health nurse on
a daily basis. Frequently, I ask myself, how much more is going to be pushed into primary
care and how much more can be taken on without adequate funding and resources. Do we
have to wait until a serious incident occurs before managers realise that it is human life and
standards of care that are being affected?
I fully support the idea that the majority of healthcare is best delivered in the community,
particularly the areas of health promotion, illness prevention, lifestyle management, and
the management of long term conditions. Many practice nurses have up-skilled themselves
through ongoing professional development in their own time and at their own expense.
I often wonder have we up-skilled and professionally developed ourselves so much to
our detriment? In other words, have we invited all this extra work into primary care?
Many patients over the years have said to me that the reason they joined our practice was
because there was a practice nursing service as they had already experienced the service in
the UK or elsewhere in Ireland.
Despite the constraints we find ourselves working within, we must continue to provide
a standard of care to our patients which we would like to receive ourselves. To do this will
be challenging and stressful. We must also remember to look after ourselves within all this
mayhem and maintain our own optimal health.
I wish you all a happy, healthy and peaceful 2011.
Ruth Morrow
has up-skilling resulted in overkill?
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ROI Freephone: 1800 42 62 82Email: [email protected] Web: www.kora-health.comBabyD is a food supplement
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Issue 5 Volume 2 september / october2009
ContentsThe Journal of the Irish Practice Nurses Association
Nursing in General Practice is published by GreenCross Publishing, 7 Adelaide Court, Adelaide Road, Dublin 2. Tel: 4189799 Fax: 4789449Email: [email protected]
EDITORMaura Henderson
CONsUlTING EDITORsDarina lane and Ruth Morrow
COMIssIONING EDITORJudith leavy
DEsIGNERBarbara Vasic
PUBlIsHERsGraham CookeMaura Henderson
DisclaimerThe views expressed in Nursing in General Practice are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.
Issue 1 Volume 4 January/February 2011
1 EdITorIAl
4 NEws
12 brANch NEws
rEvIEw
14 NursE ANd mIdwIFE PrEscrIbINg IN gENErAl PrAcTIcE
ruth morrow
21 EPIlEPsy – dEFINITIoN, dIAgNosIs ANd TrEATmENT
sinead murphy
27 sTrucTurEd PATIENT EducATIoN For PEoPlE wITh TyPE 2 dIAbETEs
sally-Ann mclaughlin
32 dIAbETEs ANd dEPrEssIoN Elaine Newell
25 Q ANd A lisa Nolan, IPNA Administrator
IN PrAcTIcE
36 mINImIsINg PsEudohyPErkAlAEmIA IN cold wEAThEr
darina lane
38 IPNA EducATIoNAl bursAry 2010
mulTImorbIdITy – ThE PrAcTIcE NursE PErsPEcTIvE
Jane campion
AbsTrAcTs
45 osTEoPorosIs
46 ProducTs
49 crossword
*GreenCross Publishing is a recently established publishing house which is jointly owned by Graham Cooke and Maura Henderson.
© Copyright GreenCross Publishing 2011The contents of Nursing in General Practice are protected by copyright. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means – electronic, mechanical or photocopy recording or otherwise – whole or in part, in any form whatsoever for advertising or promotional purposes without the prior written permission of the editor or publishers
Baby D is a paediatric food supplement of cholecalciferol(Vitamin D3)
Baby D is suitable for newborns during the first 12 months
Baby D can be accurately measuredusing the oral dosing syringe provided
Each 0.2ml dose provides 5µgof vitamin D3
Baby D is odourless and tasteless
Baby D is available in all pharmacies
Baby D is manufactured in Ireland
ROI Freephone: 1800 42 62 82Email: [email protected] Web: www.kora-health.comBabyD is a food supplement
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news
NEc mEETINgs 2011 Ashling Hotel, Parkgate street, Dublin 8.
Wednesday 2nd February 2011Wednesday 4th May 2011Wednesday 7th september 2011Friday of Conference weekend – October 2011.
For more information contact: lisa Nolan, IPNA Administrator. Tel: 042-9692403 e-mail: [email protected]
NEC NEWs
Uniphar Group, a provider of services to the healthcare and pharmaceutical sectors, has announced the creation of 20 new high-tech nursing jobs over the next two years. In so doing Uniphar has agreed to a long-term partnership with high-tech primary care network Point of Care.
The partnership follows a successful round of investment in Point of Care. and is likely to result in an increase in Point of Care’s distribution network across Ireland.
“This agreement will allow Point of Care to expand our community care services for our patients, as well as creating 20 new high-tech nursing roles over the coming 18-24 months.
“The partnership strengthens our distribution network and pharmacy capabilities across Ireland,” said Jim Joyce, CEO, POC.
POC provides one-to-one nursing care within the local community and delivers patient services through infusion, injection and vaccinations, helping patients to deal with illnesses such as arthritis, Crohn’s disease and Ms.
The education programme was piloted in the HsE West and was externally evaluated for the purposes of the national roll out. The evaluation report details a comprehensive account of the views of the participants and facilitators’ experience of the programme content and delivery. The impact of the programme on staff knowledge and attitudes to dementia along with managers’ views on the impact of the programme, on their organisation/area of work is also captured in the report.
Mary Manning, Project Manager, National Dementia Programme said, “We are delighted to launch the three publications here today. It is very encouraging that the findings from the pilot programme indicate that the participants’ attitudes and knowledge towards dementia were positively influenced by the programme.”
Dr O’ siobhan O’Halloran. Director of the Office for Nursing & Midwifery services Directorate warmly welcomed the development of the dementia education programme. she said “The programme content and design of the generic programme reflects the areas identified in the national needs analysis study carried out as part of the project. This is the first time, on a national level, that we have, such comprehensive informationgathered and analysed from staff, working across all care groups, on their educational needs in dementia care. I wish it every success in its implementation.”
dr siobhan o’ halloran director of the office for Nursing & midwifery services directorate; Josephine mcdonald – service user; minister mary harney Td; Professor diarmuid o’shea – clinical lead for the Elderly care Programme consultant geriatrician, st vincent’s hospital and mary manning – Project manager National dementia Programme.
Jim Joyce, cEo, Point of care at the announcement.
Twenty high tech nursing jobs over next two years
HSE National Dementia Education Programme launchedThe HsE National Dementia Education Programme launched in December is a generic education programme designed and developed to identify gaps in dementia specific education and training to nurses and non-nursing staff working across all care services.
The programme is supported by a National Dementia Education Needs Analysis Report and Evaluation pilot programme, the findings of which informed the Dementia Education Programme Manual: An Introduction to Dementia Care which was also launched at the event. The manual will guide the implementation of educational programmes in care settings nationally.
Professor Diarmuid O’shea, Clinical Care lead for the Elderly Care Programme and Consultant Geriatrician, st Vincent’s Hospital chaired the launch of the National Generic Education Programme and welcomed the official launch of the three publications.
5
news
Dentists believe that the increased levels of bruxism – the medical name for teeth grinding – are due to stress brought on by patients’ financial worries.
Experts believe one in five people will grind their teeth at some time, most commonly at night but dentists here say they are seeing numbers far in excess of that in many surgeries.
The symptoms of bruxism include; headaches, damage to teeth, earaches, and mouth and jaw pain.
Dr Dermot Canavan of the Irish Dental Association says the condition is often linked to anxiety and stress, as well as excessive smoking, alcohol use and the consumption of too much coffee.
‘While we don’t have exact figures I know from my own practise and from talking to other dentists that there has been a substantial increase in the number of patients suffering from this condition. From talking to patients it is clear many are facing severe financial pressures’ Dr Canavan said.
He pointed out that recreational drug use, particularly amphetamines, cocaine and ecstasy, are also believed to lead to increased clenching and grinding activity and this can cause an increase in tooth wear up to eight times greater than that seen in other bruxers.
‘stress and drug use are a dangerous combination at the best of times but people often do not realise the effect this can have on their dental health not to mind their mental health. If people are suffering from any of the symptoms outlined above then not only should they see their medical doctor but also they should visit their dentist for a check up as soon as possible as bruxism can cause long term damage. There are a variety of treatments available including splints and fitted mouth guards, but damaged teeth may need to be restored’ Dr Canavan concluded.
The national HsE ‘Guidelines for the Management of Pre-gestational and Gestational Diabetes Mellitus from Pre-conception to the Postnatal period’ were launched recently by Professor Richard Firth in August this year.
The guidelines were brought about through the HsE Diabetes & Pregnancy project which aims to enhance services for women with diabetes in pregnancy and to increase awareness of the possible risks associated with diabetes and pregnancy to both health professionals and women of child-bearing years.
The guidelines are aimed at all health professionals who care for women with diabetes and those at risk of gestational diabetes and they have been endorsed by all the relevant professional groups.
The guidelines are available on the following HsE sites:
http://hsenet.hse.ie/library/HsE_Publications/
http://www.hse.ie/eng/services/Publications/
http://www.hse.ie/eng/services/Publications/topics/Diabetes/
http://www.lenus.ie/hse/handle/10147/112890
Gestational diabetes mellitus guidelines launched
Stress caused by financial worries leading to increased levels of teeth grinding
BreastCheck – The National Breast screening Programme recently published its 2009-2010 Programme Report providing screening statistics for women who were invited for screening in 2009.
Free mammograms were provided to 121,160 women aged 50-64 – the highest number of women screened by the programme to date, and almost double the number of women screened in 2007. The overall acceptance of invitation to screening was 75.7 per cent, in excess of the programme target of 70 per cent.
Of the 121,160 women screened, 5,600 were re-called for assessment. Eight hundred and forty-five women were diagnosed with breast cancer, representing 7.0 cancers per 1,000 women screened, compared to 7.3 cancers per 1,000 in 2008.
Over 65,000 of the women screened were new to the programme and 55,588 women had previously received at least one BreastCheck mammogram.
The uptake of first screening invitation continues to be highest in the youngest age group (50-54) and the majority of women screened for the first time are in this age bracket.
For subsequent invitations (women who have previously been screened by BreastCheck), there is little difference between the age groups, with a high rate of uptake recorded across all.
Commenting on the publication of the report, Tony O’Brien, Director of the National Cancer screening service said: “The expansion of BreastCheck into the south and west of the country has resulted in BreastCheck providing free mammograms to almost twice as many women in comparison to the number of women screened in 2007. Over 121,000 women attended a BreastCheck appointment, representing a 32 per cent increase on 2008 and an 82 per cent increase on 2007. The programme is performing consistently well against the majority of commitments in the BreastCheck Women’s Charter. While the programme faced some challenges in expanding the service nationwide, I am delighted that we are now offering a fully quality assured breast screening service to all eligible women aged 50-64, regardless of their location”.
To date, BreastCheck has provided over 690,600 free mammograms to over 325,700 women and detected over 4,300 breast cancers.
over 120,000 women receive breastcheck mammogram
Guidelines for the Management of Pre-gestationaland Gestational Diabetes Mellitus from Pre-conceptionto the Postnatal period
Changing practice to support service delivery
6
news
Amputee Ireland (Amputee Disability Federation Ireland) has launched a brochure of essential information on the services and supports available to the over 4,000 amputees in Ireland. The purpose of the new resource is to provide essential information and support to an amputee on adjusting to the loss of a limb, using a prosthesis and managing pain and other sensations. The resource also provides information on the support available for the families and carers of amputees.
Mr Michael McWilliam, Amputee Ireland commented: ‘Amputee Ireland is a charity representing the interests of over 4,000 amputees in Ireland. An amputee needs specific support structures to help adjust to the loss of a limb. Experiencing an amputation is traumatic. However, an amputee in Ireland is not alone. There are a number of agencies who can help and support an amputee to continue
to live their life independently. I am delighted that we can, for the first time, now provide amputees with this essential information in one resource. This booklet aims to support and to empower amputees to help them on the road to recovery and independence.”
The booklet, written in simple language and approved by the National Adult literacy Association provides specific information on medical costs and the financial supports available, adapting a home or office, dealing with transport and driving, working and individual rights.
The information brochure can be downloaded at www.amputee.ie or is available on request from [email protected].
Amputee Ireland was set up to help amputees achieve independence, participation, social and occupational integration in the life of the community and encourages new members to join. Membership is free and an application can be downloaded at www.amputee.ie. The charity is currently campaigning for the provision of free prostheses to amputees in Ireland.
For more information contact: Amputee Ireland (01) 679 3580. Email: [email protected]
New support for amputees and carers
The first group of registered nurses who can independently prescribe medical ionising radiation in Ireland have graduated at a ceremony in stewarts Hospital, Palmerstown recently.
66 registered nurses in Ireland from 20 hospital sites across the country have completed the nurse education programme for Nurse Prescribing X-Ray. The nurses who have completed the programme represent the various grades of nurses to include staff nurses, clinical nurse managers, clinical nurse specialists and advance nurse practitioners who are in various departments such as emergency departments, orthopaedic, out patients, critical care, medicine and oncology.
Nurse prescribing of medical ionising radiation (x-ray) enables the nurse to prescribe x-rays independently within the agreed list. This practice enables nurses to provide a more responsive, accessible, effective, timely and efficient service that improves and expedites the patient journey within the healthcare service leading to increased levels of patient satisfaction. In addition, it provides an exciting opportunity for registered nurses to expand their roles within the area of practice to meet the needs of the patients in a person-centred manner.
The Nurse Prescribing X-Ray Education Programme was introduced in 2009 following the completion of a HsE national framework (The Guiding Framework for the implementation of a Nurse Prescribing of Medical Ionising Radiation/HsE) by the national advisory committee lead by Dr.] siobhan O’Halloran, Office of the Nursing services Director. The educational programme was devised by a multi disciplinary team to include nursing profession consultant Radiologists, Radiographers and physicists.
A robust evaluation and auditing of the nurse prescribing of medical ionising radiation will take place at each hospital
site. The educational programme has been validated by HETAC and the role out has commenced in two accredited centres based at Connolly Hospital and the Midland Regional Hospital at Tullamore. A new cohort of 33 participants commenced the programme in October this year. It is anticipated that 220 nurses will complete the programme by 2012.
First nurse group can independently prescribe x-ray
At stewarts hospital, Palmerstown, with minister mary harney for the hsE Executive Nurse Prescribing of medical Ionising radiation presentation of certificates Award ceremony, were: Frank Philpott lloyd, from mercy hospital, cork; dr siobhan o’ halloran, director, office of the Nursing & midwifery services hsE – clinical care and Quality directorate; Audrey daly, orthopaedic dept. mid western regional hospital, limerick; siobhan rothwell, Emergency dept. our lady of lourdes hospital, drogheda and dr risteard o’laoide, consultant radiologist, Programme lead, hsE.
* Danone Actimel is a probiotic food containing the exclusive probiotic culture Lactobacillus casei DN 114 001. Danone Actimel helps strengthen the natural defences when consumed daily as part of a healthy diet & lifestyle.
1 McFarland LV. Diarrhoea associated with antibiotic use. BMJ 2007; 335: 54-55 doi: 10.1136/bmj.39255.829120.47.2 Parkes GC, Sanderson JD and Whelan K. The mechanism and effi cacy of probiotics in the prevention of Clostridium diffi cile-associated
diarrhoea. Lancet Infect Dis 2009, 9: 237-244.3 Barbut F and Petit JG. Epidemiology of Clostridium diffi cile-associated infections. Clin Microbiol Infect 2001; 7: 404-410.4 Hickson M, Muthu N, Rogers TR, Want S, Rajkumar C, Bulpitt CJ. Use of probiotic lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. BMJ. 2007 Jul 28; 335(7612): 171.
Probiotic Support*
Antibiotic EffectsIt is well known that antibiotic intake may have an effect on the gut microfl ora leading to diarrhoea. Antibiotic Associated Diarrhoea (AAD) may develop in up to 30% of patients treated with antibiotics, and rates have been increasing due to use of broad-spectrum antibiotics1. Clostridium diffi cile Associated Diarrhoea (CDAD) accounts for up to 25% of cases of AAD, most occurring in older patients2,3.
Probiotic SupportAccording to an independent clinical trial conducted at Hammersmith hospital, London and published in the British Medical Journal, drinking Actimel twice a day while on antibiotics in hospital, signifi cantly reduces the incidence of Antibiotic Associated Diarrhoea by 22% and Clostridium diffi cile Associated Diarrhoea by 17%4 in the elderly.
For more information visit www.probioticsinpractice.ie
Diarrhoea by 17%
Antibiotic associated diarrhoea 4 C. diffi cile associated diarrhoea 4
50
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Actimel0
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Placebo
17%-17%
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Placebo
34%-22%
50
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17%-17%
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Incidence of Antibiotic associated diarrhoea and C. diffi cile associated diarrhoea in Actimel and Placebo Groups.
p= 0.007 p=0.001
Probiotic Support*Probiotic Support*Probiotic Support
Published in BMJ
Actimel HCP_210x297.indd 1 14/12/2010 13:30
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news
The portrayal of older people in advertising; the use of technology to enable older people to live independently; bridging the digital divide through intergenerational learning; and genetic susceptibility to Alzheimer’s disease – these are just some of the topics related to ageing being investigated by researchers in Ireland, as documented in a new publication launched at end of last year by the Centre for Ageing Research and Development in Ireland (CARDI).
The publication, ‘A Picture of Ageing Research’, outlines – for the first time ever – major collaborative ageing research projects underway on the island of Ireland. It profiles ageing research work being carried out by the leading academic institutions in Ireland, North and south, and also includes details of projects funded under CARDI’s Research Grants Programme.
Commenting on the publication, Dr Roger O’sullivan, Director of CARDI, said it would serve as a useful resource for politicians and policymakers, in addition to researchers, older people and others with an interest in ageing.
“The island of Ireland is an ageing society with nearly one million people aged 60 years or older,” he said. By 2041, the number of people aged 85 years or older will rise almost fivefold. Ageing on this scale is unprecedented and will have significant consequences from both a societal and an economic point of view.
“Policy, practice and resource allocation decisions must be made on the best available information, and it is essential
that ageing research plays a part in planning for demographic change. In order to adapt, we must better understand the role of older people as citizens, consumers, carers and – increasingly – as workers.
‘A Picture of Ageing Research’ is available to download from: www.cardi.ie Hard copies of the publication may be requested by emailing [email protected] or telephoning 0044-28-90690066.
The HsE (through st. Patrick’s Hospital in Cashel, Co. Tipperary) and the European Pathways Association joined forces recently to jointly host their second annual Conference at the Cashel Palace Hotel, entitled True Compassion.
The Conference was, in the words of the organisers, “hugely supported” by patient advocates and healthcare professionals. The European Pathways Association is an international not-for-profit organization of clinical/care pathway networks, user groups, academic institutions, supporting organisations and individuals who want to develop, implement and evaluate clinical and care pathways.
Mr. séamus Moore (local Health Manager for south Tipperary, HsE) said: “This prestigious Conference in Cashel occurred at a very opportune time, as healthcare staff grapple with the current economic crisis. We had a varied, high quality line up of speakers to assist us in developing the theme. The purpose of the conference was to open up avenues which healthcare staff might find useful in maintaining a sense of purpose of their role in healthcare and to further develop the health, wellbeing and safety of the patients, residents and clients in their care. The values outlined help to connect healthcare staff with their own internal personal goals, strengths, motivation and job satisfaction needs, transcending personal status to focus on internal personal motivation to do the best job for something (their patients) which is greater than themselves. Compassion, of course, plays a central role in all of this.”
Ms Mary Prendergast – as Director of Nursing – said the staff and everyone associated with the elderly care facility in Cashel were pleased to have helped organise a second annual Conference, as st. Patrick’s Hospital was founded on connecting care and efficiency. Ms. Prendergast added:
“True Compassion is not just an emotion but a firm
commitment. We were delighted to read a message to the Conference from the famous actor Brendan Gleeson, who wrote that compassion was the heartbeat of the health service and therefore requires, of the most part, time. Time to comfort, time to reassure,time to understand, time to console, time to analyse, time to diagnose and time to rehabilitate.”
Josie sheehan, a retired woman from dublin 8, helps to launch a new publication documenting ageing research in Ireland by the centre for Ageing research and development in Ireland.
At the launch of compassion Footprint for healthcare were dr stephen smith (lead Nurse, leadership in compassionate care Project, the Nhs/Napier university, Edinburgh, scotland); ms Antoinette doocey (Programme director, Integrated care, National Transformation Programme 1, hsE); ms mary Prendergast (director of Nursing, st Patrick’s hospital, cashel); Prof claire hale (Professor of clinical Nursing, university of leeds, yorkshire, uk); mr brian crowley mEP; mr michael brophy (consultant in Personal Excellence, barrister at law, formerly senior Investigator with office of the ombudsman) and mr ben Totterdell (school of healthcare studies, university of leeds, yorkshire, uk).
conference on ‘true compassion’
New publication gives picture of ageing research in Ireland
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A4 in Nursing in General Practice – 297 x 210, 3mm bleed
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10
news
A new medication review system has the potential to reduce the pre-scription of unnecessary, or potentially harmful, drugs to older people in hospital, thereby improving patient safety and substantially reducing prescription costs.
Researchers in UCC have confirmed the validity of a new medication review system, called sTOPP (screening Tool of Older Persons’ poten-tially inappropriate Prescriptions) and sTART (screening Tool to Alert to Right Treatment).
It was created to help doctors and pharmacists avoid potential prescribing errors in older patients and to highlight when practitioners do not prescribe medication that would actually be of benefit to this age group.
The research looked at clinical and prescription details relating to more than 700 older patients in an acute hospital setting and applied the sTOPP/sTART criteria.
“We found that one in every three of these patients received at least one potentially inappropriate drug,” said lead researcher Dr Paul Gal-lagher.
“A third of this group displayed symptoms attributable to adverse side effects of inappropriately prescribed drugs. We also found that over 40 per cent of patients were not receiving appropriate medication for common conditions including diabetes, stroke and osteoporosis.
”By comparing the findings with similar cohorts of patients in six other European cities and getting similar results, the UCC group has helped to highlight the issue of inappropriate prescribing internation-ally as part of the global need to improve the quality and safety of prescribing practices.
sTOPP/sTART recommendations and criteria have now been im-plemented as an audit tool in several countries, resulting in significant improvements in prescribing quality. Further research is underway to find out if routine application of sTOPP/sTART criteria reduces adverse drug reactions and prescription costs among older people admitted to hospital.
Funded by the Health Research Board (HRB) the information on this research is contained in ‘The Picture of Health’ a snapshot of the posi-tive impacts and outcomes from HRB funded research in 2009.
some 97 percent of parents of children treated for asthma believe their child’s symptoms are well controlled or partially controlled, despite the fact that 10 percent of these children still cough or wheeze on a daily basis,13 percent on a weekly basis and 49% on a monthly basis. The results are part of a survey of 271 parents of asthmatic children (under 1-18 years) carried out by MsD Ireland through Irish parenting website, RollerCoaster.ie.
Despite significant advances in managing the condition, results show that asthma continues to be inadequately controlled in over 26% of those affected. One in four asthmatic children are found to experience reduced levels of activity, such as lower participation in sport, while the condition results in 27% of those affected being absent from school on a monthly basis (or more frequently).
According to the survey, the most common difficulties faced by parents include an inability to control triggers that affect their child’s symptoms (e.g. pollen, dust and air pollution), difficulties in knowing how best to treat the condition and difficulties in administering the medication.
recent research carried out by msd shows that over 26 per cent of asthmatic children in Ireland could benefit from better management of their condition. results show that one in four asthmatic children experience reduced levels of activity, such as lower participation in sport. Pictured on a day out at the park are TJ hannify (aged 3), mark Turley (aged 9) and rebecca walsh (aged 4) from dublin.
Asthma poorly controlled in childrensTOPP/sTART – better prescribing for patient safety
Nurses and GPs throughout the island of Ireland are invited to participate in a research project. An all-Ireland project led by researchers in University of Ulster and National University of Ireland, Galway are conducting a survey of health professional attitudes to body weight status. The key project objectives are as follows:1. To assess the attitudes, current practices/behaviours and knowledge of key health professional groups on an all-island basis; 2. To assess the health professional groups’ ability to identify body weight categories in both adults and children.
The health professional groups that are invited to participate: 1. Public Health Nurses (community; postnatal home/clinic visits
and developmental checks); 2. Public Health Nurses (schools); 3. GPs and Practice Nurses (primary care); 4. Occupational health nurses (workplace).Nurses and GPs are required to participate in the following studies:
1. Telephone interviews with GPs (10 mins) – to gain an in-depth insight into the views of health professionals in assessing body weight status.
2. Focus group with nurses (max. 1.5 hour) – to gain an in-depth insight into the views of health professionals in assessing body weight status. The focus groups will take place in health clinics/
centres, hospitals or universities within the greater Belfast or Galway areas.
3. survey (mainly on-line but also paper-based; 10-15 mins) – to determine the attitudes, current practices/behaviours and knowledge of health professionals in assessing body weight status.
4. Online study (45 mins) – an on-line programme will be developed to assess health professionals’ ability to identify the body weight category of adults and children.
If you participate in any of the above studies, you will be part of a valuable project, which will contribute to assessing health professionals’ ability to identify body weight categories in both adults and children. Ethical approval has been obtained for this project.
contact detailsIf you would like further information or to discuss participating in any of the above studies please do not hesitate to contact the Weight Care Team using the following contact details:
Website: www.science.ulster.ac.uk/weightcareprojectE-mail: [email protected]: +44 (0) 28 9036 6282Dr. Anne Moorhead (Principal Investigator) & Weight Care Team
Nurses and GPs required for obesity study
11
news
Pictured at st James’s Hospital for the donation of essential medical equipment to the hospital by Roche Products were Ciara O’loughlin, Rheumatology Nurse specialist, Dr Gaye Cunnane, Consultant Rheumatologist, D. Barry O’shea, Consultant Rheumatologist, all with st James’s Hospital, Dublin, and Catherine Moynagh, Roche Representative.
As part of their ongoing commitment to Irish healthcare, Roche Products (Ireland) limited donated the equipment to the Rheumatology Day Care Centre of st. James’s Hospital, Dublin. The equipment donated consists of a blood pressure monitor and an infusion pump, enabling more patients to gain access to rheumatology treatments.
United Drug plc., presented a cheque for €31,000 to special Olympics Ireland recently. United Drug were Official Medical supplier to the Games this year. speaking at the cheque presentation, United Drug Chief Executive liam FitzGerald said:
“I am delighted and proud that United Drug, as part of our ongoing corporate responsibility and community engagement programme, was very actively involved and an Official supplier for the 2010 special Olympics Ireland Games.In addition to the medical supplies, expertise and monetary contribution, a large number of employees also gave their time to be volunteers for this uniquely worthy cause. This was an exceptional opportunity for us to contribute to the success of the Games and the celebration of Ireland’s talented athletes”.
staff members of united drug, including chief Executive liam Fitzgerald and partnership co-ordinator bronagh boyd presenting the cheque to Joe Feehily special olympics athlete and matt English cEo special olympics Ireland.
Roche donate rheumatology equipment
The launch of the free Astellas Pharma living with Prostate Cancer information pack took place in December. The pack was launched by actor Tom Hopkins (aka Christy in Fair City), John Dowling, prostate cancer survivor, lillian McGovern, CEO of The Marie Keating Founda-tion and Ms Aine Brady, Minister for Older People and Health Promo-tion.
With over 2,500 men diagnosed with prostate cancer in Ireland each year, the initial diagnosis period can be difficult for the patient and their family to take in all the information they need. In answer to this Astellas Pharma produced the free prostate cancer information pack which provides easy to read, understandable, friendly and essential reading for sufferers, family and friends of those affected with prostate cancer.
Entitled living with Prostate Cancer – The Patient support Pack it is available free of charge by calling 01 6697684. The patient sup-port pack covers a number of key information areas. The additional aim of the Pack is to heighten awareness of the symptoms in order to encourage potential prostate suffers to seek treatment, increase their knowledge of support services available and also to be used as a patient information tool.
“We welcome this initiative and are pleased to support Astellas in a campaign to provide prostate cancer sufferers with information that is provided to them rather than the patient or his family members having to seek and find. Information at the time of diagnosis is crucial; it can help to keep emotions calm during a difficult period. This booklet will allow a sufferer or their family member to sit down at their own pace and review the road ahead” said Jim scott, chairman of Men Against Cancer (MAC).
United Drug supporting the special Olympics
Free information pack for prostate sufferers and carers
12
NEWs FOR IPNA BR ANCHEs COUNTRy WIDEregional newscAvAN/moNAghANPATRICIA JENKINs
Our November meeting was held in Cavan Crystal Hotel and the topic was COPD. This included current guidelines for diagnosis and an update on current approaches to COPD. Dr James Hayes, consultant respiratory physician at Cavan General Hospital gave the talk which was sponsored by Deirdre O’Doherty from Pfizer. This was followed by our branch meeting and was very well attended.
Our Christmas meeting which was to be held on 8th December was unfortunately cancelled due to poor weather conditions.The HsE provided update days in January and February on diabetes for those nurses who have previously undertaken the Bradford
Diabetic Diploma course. Our meetings have been very well attended over the past year and I personally look forward to seeing you all again in 2011. On behalf of
Cavan and Monaghan members I wish you all a happy and peaceful 2011.
clArEAINE lAlly
The Clare branch would like to wish everyone a healthy and happy new year. We held our AGM in November and were delighted to re-elect Anne Akamnonu as Chairperson, Patricia Dolan and liz Ryan as joint secretaries and Carmel Killeen as our Treasurer. We would really like to thank Anne and the girls for their great work and support during the last year and look forward to all that the new year brings.
Our November meeting at the Old Ground, Ennis was kindly sponsored by Chris Kenny of Johnson and Johnson. We had a very information talk on smoking cessation by Mary McMahon of Clare Health Promotion services. We do need to remember to make use of smoking cessation officers in our localities. For our December meeting we danced the night away at our Christmas party in Dromoland Castle. For our next meeting on January 18th we plan to have a CPR refresher for all our nurses.
cork ElAINE GOGGIN
On behalf of the Cork Branch Committee I want to wish you all the very best of health and happiness for 2011. Our branch AGM was held in November in the Rochestown Park Hotel kindly sponsored by Rose Howard from Milupa. The speaker was Margaret Byrne, Infant Nutri-tionist, who gave a very informative presentation on the role of prebiotics in infant feeds. The meeting was very well attended and a new Cork Branch Committee was duly elected. The committee would like to take this opportunity to thank all of their predecessors for their hard work and commitment throughout the past year and also many thanks to those who stayed on for another year. Guest speaker, lor-raine O’Hagan, was invited by the Branch and gave a very interesting presentation on how best to encourage and support breastfeeding. There was such a level of interest in this area, that lorraine has agreed to do a saturday morning session in the near future.
Unfortunately due to the extreme weather conditions our December meeting which was also our Christmas night had to be cancelled. We would hope to reschedule this now that the weather has settled down.
There is a busy schedule of meetings are planned for spring 2011 so we hope to see you all at the next Cork Branch meeting which will take place in the Rochestown Park Hotel on Wednesday the 9th February and will be kindly sponsored by sara Hyde, McNeil Health. Guest speaker is Joan O’sullivan, smoking Cessation, Coordinator, HsE.
kIlkENNylEONIE FINNEGAN
Unfortunately, our last branch meeting and educational session was postponed due to the severe snow and ice in Kilkenny and its sur-rounds. However, we would like to take this opportunity to thank all members for attending throughout this year.
We look forward to the coming year for ongoing support, networking opportunities and educational presentations. looking forward to seeing you all soon in 2011. We always welcome new regional members at any time so please feel free to contact our secretary Úna by email; [email protected]
NorTh dublIN brANchlIz HEAly
Happy New year to everyone! The North Dublin branch has been up and running since August of last year. It has been given this name as the meetings are being held on the north side of Dublin, mainly in the Hilton Airport Hotel, Northern Cross and the Bewley’s Hotel, Clon-saugh, with easy access from the M1/M50. We welcome all practice nurses from Dublin and at present we have 33 members.
Our meeting in November was sponsored by Pfizer, with our guest speaker giving an excellent presentation on childhood obesity. December’s meeting was an informal affair, sponsored by Novartis, with a talk on COPD.
Topics for 2011 will include: Infertility, Vitamin D, Immunisations, Osteoporosis and Fractures, Menopause, Haemochromatosis.Best wishes for 2011.
13
NEWs FOR IPNA BR ANCHEs COUNTRy WIDE regional news
souTh TIPPErArysIOBHAN JORDAN
Happy New year to all IPNA members – here’s hoping 2011 will see our branch grow in strength and numbers. Although we are one of the smaller IPNA branches our meetings are well attended and we are all working hard to bring new members to the group by provid-ing interesting educational sessions which will encourage us all to leave our cosy homes during these colder months.
Our next meeting will be held on 12th January in the Clonmel Park Hotel and is kindly sponsored by Karen O’sullivan of smith and Nephew. The presentation will cover wound care, profore dressings and layered bandaging systems; our AGM will follow. A full list of scheduled meetings, educational sessions and upcoming events in south Tipperary is available on the members’ page of IPNA website.
The national conference and AGM will be held this year in the Tullamore Court Hotel, Co Offaly. After careful consideration the south Tipperary branch is pleased to be the first branch to host the national conference at a centralized location. Although members will not be travelling to the premier county, we can guarantee you all that south Tipp will be very pleased to welcome you in Tullamore. A few busy months ahead of us as we work with Grainne lynch conference co-ordinator to encourage as many of you as possible to attend this year, …. And no, it is not a long way to Tipperary!
wIcklowMARy FINNEGAN
Happy New year to all! Hope everyone had a wonderful Christmas and New year, in spite of snow!We started our branch ‘year’ with a meeting on 20th september. The topic for the night was Women’s Health, HRT, Menopause,
Contraception. Our excellent speaker was Dr Deirdre lundy from the Bray Women’s Health Centre, who has worked in this area for over 20 years – 16 of these with IFPA. Deirdre also lectures for ICGP, IFPA and RCsI on Women’s Health issues. she gave a wonderful presentation, and was more than happy to answer all our questions. The meeting and speaker were very kindly sponsored by Brenda Blewitt from Bayer Healthcare, our Mirena Rep for this area. Brenda opened the meeting with an update on Mirena, and her colleague, Colleen Murray, gave us an introduction to Qlaira, the new OCP.The meeting was very well attended, with 28 of our 49 members present.
We had our second meeting booked for 29th November, but the snow decided otherwise! We had no option but to cancel, and we rescheduled for 13th December. Our topic that night was childhood obesity. Guest speaker was Kizzy Moroney Paediatric Dietitian Temple street Hospital. Kizzy runs the ‘Weigh to Go’ programme for children. The meeting and speaker were sponsored by Jennifer Dalton Infant Nutrician Advisor sMA
A special thank you to both Kizzy and Jennifer, for making themselves available for 13th after we had November meeting at very short notice! The topic was very interesting, and informative, as we had not been aware of this programme, or how to refer a child to it.
Embarrassingly, only five out of our 49 members attended that meeting! Both speaker and sponsor were disappointed at the very poor attendance.
Our Branch AGM was planned for 13th December, but due to poor attendance, we were unable to hold it, and it had to be rescheduled for the new year.
By time you read this, we will have held our January meeting on 17th. This meeting is very kindly sponsored by Jacqueline Jennings from GsK, who will open the meeting with a presentation on Prolea, the new Osteoporosis Rx. Our guest speaker is Dr Anne Manley, from the Osteoporosis society, who will speak on Treatment and Management of Osteoporosis in Ireland.
Our rescheduled Branch AGM hopefully, will have taken place on 17th January,and a new Committee elected!The next Branch meeting will be held on Monday 28th February, with two more planned for April and May. Details of all meeting
dates were sent to members in August last year, and are also up on the IPNA website, should you forget!several of our members had requested a CPR/AED (Bls) course at the september meeting, as their current certification was due to
expire. I was delighted to be able to organise this for them, with the help and thanks of the Nurses in the Cardiac Unit in sCH, who have also very kindly offered the course, on a once off basis, at a reduced rate. The course is limited to 12 participants, and will be held on saturday 29th January in sCH, running for 4 hours.
As mentioned before, we now have 49 members in the Branch, a big change from our previous 18! Again, I would like to welcome all new members to our branch, and look forward to meeting you all at the meetings. Over the past few months as numbers increased, the meetings have become more interactive, with a lot of sharing of information and networking has taken place which is particularly helpful if you are new to practice nursing, or work alone in a small practice.
Feedback from new members has been very positive, and I thank you all for your kind words!
If yOU have not already come to one of our educational meetings, perhaps you might join us this year? We are a very friendly, informal branch, and meetings usually only take two hours!
Wishing you, and all your families peace, friendship, good health and no worries for 2011!
North dublinApologies for our failure to publish the North Dublin news as written by liz Healy in the last issue. sorry for any disappointment caused.
clare branchAlso in the last issue we inadvertently put ‘Tipperary’ instead of Clare as the heading over the Clare branch news. Apologies for the mix-up.
CORRECTIONs
14
in practice
In 2009, we decided to introduce nurse and midwife prescribing into the practice. The main reasons for its introduction were:
• To assist in the provision of holistic patient care which is timely, accessible and efficient
• To assist in cost-effective prescribing within the practice• To ensure patient safety in medication management• To assist in the professional development of the Advanced
Nurse Practitioner (ANP)• To assist in further development of the ANP role and ANP
services within the practices as outlined by the National Council for the Professional Development of Nurses & Midwives (2008).This article aims to inform you about the introduction of
nurse prescribing in the general practice setting and the experiences I had during the process. From the beginning, to signing my first prescription, took 14 months in total. The required education programme is of six months duration with the remainder of the time being spent on accessing the Drugs & Therapeutics ((D & T) committee and the development of the Collaborative Practice Agreement (CPA) (An Bord Altranais, 2007a). One of the key components of nurse and midwife prescribing is governance and accountability and this will be discussed further in the article.
Nurse prescribing is guided by legislation, regulation and rules which include:• Irish Medicines Board (Miscellaneous Provision) Act 2006
(No. 3 of 2006) (section 10(1(ii)).• Irish Medicines Board (Miscellaneous Provisions) Act 2006
(Commencement) Order 2007• Medicinal Products (Prescription and Control of supply)
(Amendment) Regulations 2007, statutory Instrument No. 201 of 2007
• Misuse of Drugs (Amendment) Regulations 2007, statutory Instrument. No. 200 of 2007
• Nurses Rules (An Bord Altranais, 2007b).• Irish Medicines Board (Miscellaneous Provisions) Act 2006
(Commencement) Order statutory Instrument No 67 of 2009.
guiding framework A number of steps have been suggested by the Office of the Nursing services Director in the Guiding Framework (2008)
for the implementation of nurse prescribing. This document is primarily aimed at HsE sites. However, it can be adapted to meet the needs of general practice. The adapted steps and how we addressed these in our practice are illustrated in Table 1.
An Bord Altranais provide Registered Nurse Prescribers with practice standards which must be adhered in order for the RNP to retain his/her nurse prescribing registration (An Bord Altranais, 2010). The following is a synopsis of the practice standards:
Practice Standard 1: clinical decision-making processThe RNP documents the treatment plan including the prescribed medication, monitoring/evaluation and follow-up care and ensures continuing care/discharge plan is completed for the patient. RNPs are guided by the Decision-Making Framework (An Bord Altranais, 2007c).
Practice Standard 2: communication and history takingCommunication and history-taking are essential in safe and effective prescribing to ensure accurate diagnosis, effective treatment, concordance and safety. Medication history is important to reduce the possibility of prescribing errors. This includes the patient’s use of over the counter preparations, herbal remedies, homeopathic remedies, vitamin/dietary supplements, medications which have been prescribed for others, alcohol & illicit drug use (An Bord Altranais, 2010).
Practice Standard 3: documentationIt is the responsibility of the RNP to record the prescribing consultation. This allows for communication with other health professionals, keeps an accurate record of the consultation and ensures safety of the patient. This also includes the documentation of allergic reactions or adverse drug reactions (An Bord Altranais, 2010).
Practice Standard 4: Prescription writingThese regulations require the prescription to:• Be legible• state the name of the person issuing it and include the
registration number (PIN) assigned to the nurse by An Bord Altranais
• The prescription (including computer-generated
Nurse and midwife prescribing in general practiceruTh morrow, MsC, BNs, RGN, RNP, ADVANCED NURsE PRACTITIONER
15
in practice
prescriptions) must be in ink/indelible• The prescription must be dated and signed by the registered
nurse prescriber with her/his usual signature• The full name and address of the patient/service-user must
be on the prescription • If a patient/service-user is under the age of 12 years, the date
of birth is required. (An Bord Altranais, 2010)
Practice Standard 5: Prescribing self, family and significant othersAn Bord Altranais (2010) state that “prescribing for self, family and/or significant others is not acceptable professional practice. There should be an established nurse/midwife to patient/service-user relationship when prescribing for another individual. A blurring of professional and personal boundaries of care and accountability results and represents a conflict of interest. Writing and issuing a prescription for personal use or for a family member or significant other must not be undertaken by the registered nurse prescriber,
regardless of circumstances. The individual requiring a prescribed medication should be referred to/directed to another appropriate registered prescriber (e.g. family general practitioner) or where health services are provided”.
Practice Standard 6: repeat prescribingIn general practice, the RNP may be required to issue repeat prescriptions. An Bord Altranais (2010) state that “the registered nurse prescriber should be knowledgeable of the medicines regulations relating to the supply/dispensing of medications in instalments for the duration of individual prescriptions. Repeat prescribing may arise in situations where the original issued prescription was issued by another prescriber and the patient/service-user requests or requires a continued course of medication. This may typically occur in the treatment of chronic health conditions. In instances of repeat prescribing for continued treatment, the registered nurse prescriber should have a valid relationship with the patient/service-user and undertake an appropriate assessment of the need for
sTEP HOW THE sTEP WAs ADDREssED WITH IN THE PRACTICE
1 Prepare to lead the development
Access various documents from An Bord Altranais , colleges, PDC for Practice Nurses.
2 Initiate local discussions with stakeholders
In my practice, this was with the GP and the Professional Development Co-ordinator for Practices (PDC). In the absence of a Director of Nursing, the PDC can fulfil this role.
3 undertake service needs analysis
Discussed with key stakeholders the benefits for the introduction of nurse prescribing to enhance patient care and my ANP role.
4 Establish governance mechanisms
The governance aspect of nurse & midwife prescribing is overseen by the Drugs & Therapeutics committee in our area. The committee was established for this purpose and includes the PDC for practice nurses, the primary care unit pharmacist, representative from the Primary Care Unit , the specialist in Public Health Medicine. The committee has access to the clinical risk advisor.
5 Identify mentor In our practice, the mentor’s role was undertaken by the GP who attended an information session facilitated by the college to prepare for the role.
6 Identify a prescribing site co-ordinator
In the absence of nurse management in general practice, the PDC for practice nurses undertook this role
7 submit application to college
When applying for the education programme, the student must agree to have step 4 in place by the end of the course.5 and 6 must be completed and submitted on the application form.
8 complete six month education programme with clinical supervision
Whilst completing the education programme, I began the process of developing the Collaborative Practice Agreement (CPA) which requires the nurse to identify the list of drugs he/she will be prescribing from. The CPA must be submitted to the D & T committee for approval before registering with An Bord Altranais. I also developed a Nurse Prescribing policy within the practice to support the CPA. The PCCC policy for nurse prescribing (HsE, 2009) can be adapted to general practice.
9 registration with An bord Altranais
Registration form, CPA with attachments A, B, & C and fee submitted to An Bord Altranais.
10 commencement letter I received communication from An Bord Altranais stating that I am on the Nurse Prescribing register.
11 communication The practice sent a letter and a copy of the CPA to all local pharmacies informing them of the introduction of nurse prescribing within our practice. The D & T committee also communicate to local pharmacies and hospital consultants.
12 monitor, audit, evaluation I maintain a weekly activity report of nurse prescribing which I submit to the D & T committee on a monthly basis. Audit will be carried out three monthly by two members of the D & T committee during the first year.
Table 1: steps involved in becoming a registered Nurse Prescriber (rNP)
16
in practice
continued treatment with the prescribed medication. This decision-making should be documented. It should include a discussion with the patient/service-user of perceived effectiveness and adherence to the treatment plan. The registered nurse prescriber should acknowledge her/his scope of practice for prescribing, recognising any limitation of competence/knowledge and refer the patient/service-user to the appropriate practitioner for evaluation concerning the repeat prescription if required”.
Practice Standard 7: Prescribing of licensed medicationsThe Medicinal Products (licensing and sale) Regulations, 1998 (s.I. 142 of 1998) provides statutory authority for a medical practitioner to treat a patient under her/his care, using unlicensed medicinal products. It does not extend to authorising a registered nurse prescriber to issue a prescription for an unlicensed medication. This action is at present outside the nurse’s/midwife’s scope of practice for prescriptive authority. A patient/service user need for a prescription for an unlicensed medication should be referred to the appropriate medical practitioner. The CPA should note this restriction in prescribing of medications (An Bord Altranais, 2010).
The RNP may now prescribe off-label i.e. the RNP may prescribed an authorised medication outside the terms of its product authorisation (An Bord Altranais, 2010).
Practice Standard 8: Prescribing by means of verbal/telephone, email or faxIssuing or communicating a prescription by verbally, telephone, email or fax is not considered acceptable prescribing practice for a registered nurse prescriber and should not be conducted under any circumstance. The prescription for a medicinal product must be documented in writing, as required by the medicines regulation and health service provider/employer. Practice standard 1 should be adhered to (An Bord Altranais, 2010).
Practice Standard 9: separation of responsibilities in the medication management cycleThe registered nurse prescriber should separate the activity of prescribing a medication and the subsequent actions of supplying and/or administering the medication. Another individual should undertake the supply/administration component of the medication management cycle, especially in
the case of MDA drugs. This is safe practice, providing for the typical safety checks within the medication management cycle (An Bord Altranais, 2010).
The registered nurse prescriber should not undertake to both prescribe and dispense the medication as part of providing episodes of patient/service-user care. There should be clear separation of these activities. There may be circumstances arising when the registered nurse prescriber may be required to supply a medicine without previous dispensing of the medicinal product by a pharmacist. In these situations, the prescriber should be aware of her/his responsibilities with this practice in the overall management of medications (An Bord Altranais, 2010).
Practice Standard 10: Influence of outside interests (relationships with pharmaceutical representation or similar organisations)The registered nurse prescriber should prescribe in an appropriate, ethical manner, based on the best interests of the patient/service-user only. she or he should not be influenced by factors such as financial support by pharmaceutical and/or health care interests (An Bord Altranais, 2010).
Practice Standard 11: continuing professional development and continued competenceThere is an obligation for the registered nurse prescriber to commit to, and engage in, continuing professional development relating to assurance of competency for her/his prescribing practices. This is affirmed in the CPA. Health service providers/employers have a responsibility to provide support and access to continuing professional development and assessment of competence. The CPA signed by the registered nurse prescriber, medical practitioner and the health service provider/employer requires the involved parties to be aware of the professional regulatory and organisational requirements for the registered nurse prescriber’s continued competence for maintaining prescriptive authority (An Bord Altranais, 2010).
developing and writing an organisational policy for prescribingCurrently, the ANP is guided by a practice developed Guideline for Good Practice for Medication Management which is underpinned by An Bord Altranais Guidance for Medication Management (An Bord Altranais, 2007d). This guideline will continue to be in operation alongside the Nurse Prescribing policy to support the ANP with medication management with drugs which are not included in the CPA. With the introduction of nurse prescribing into the general practice setting, an organisational policy has been developed and signed off which is based on the PCCC policy (PCCC Nurse Prescribing Policy, 2009). The main issue which arose during this process was in relation to risk management – an incident report form was developed for reporting of medication errors (PCCC Nurse Prescribing Policy, 2009) and the RNP will report any adverse events using the Irish Medicines Board reporting system. This form addresses the changes in practice which should occur as a result of an error being made so as to avoid a repeat of such an error
collaborative Practice Agreement (cPA)The RNP must complete a CPA, submit it to the Drugs & Therapeutic committee for approval and then submit it to An Bord Altranais to be entered on the nurse prescribing register. The CPA contains details about the nurse prescriber, the service and three attachments. The first attachment contains information about the practice and the patients for
The rNP may prescribe for...asthma, coPd, diabetes, hypertension, chd, hyperlipidaemia, influenza/pneumococcal vaccine [and]... smoking cessation, weight reduction drugs and antibiotics.
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18
in practice
whom the RNP will be prescribing. In this practice, the RNP may prescribe medicinal products and appliances for people with asthma, COPD, diabetes, hypertension, coronary heart disease, hyperlipidaemia and those who require influenza/pneumococcal vaccine. Also, included are smoking cessation, weight reduction drugs and antibiotics.
The second attachment contains a list of the aforementioned drugs and appliances. To date, there are 70 products on this list. Drugs and appliances may be added or removed from the list as the need arises subject to approval by the D & T committee.
The third attachment is mainly concerned with the procedures in place for governance and audit. The RNP maintains a weekly prescribing activity report which is submitted to the Drugs & Therapeutics committee monthly. During the first year, a member of the Drugs & Therapeutics will audit twenty prescriptions every three months to ensure that An Bord Altranais standards are being adhered to. Patients will also be asked about the service they received in relation to nurse prescribing. These procedures will be reviewed annually.
role of the drugs & Therapeutics committeeThe role of the D & T committee is to assure appropriate patient drug therapy and outcomes. The purpose of the committee is to ensure that the processes used in prescribing and administration of medicines to patients in our practice is in accordance with best practice and current clinical evidence.
medical indemnityThe Medical Protection society (MPs) provides the practice (GP and ANP) with medical indemnity. We have informed the MPs to extend our indemnity for Nurse Prescribing and also informed the MPs of the GP’s role in supporting nurse prescribing (PCCC Nurse Prescribing Policy, 2009).
conclusionThis article has sought to address the requirements of a nurse who wishes to become a Registered Nurse Prescriber. It addresses the requirements sought by An Bord Altranais and how our practice addressed these. It should be remembered that education programmes are developing and changing and will become more widely available as they develop and are integrated into Post-graduate Diploma programmes.
Introducing nurse prescribing in our practice has been exciting and challenging. I signed my first prescription on 26th August 2010 which gave me a sense of personal and job satisfaction in that I was in an autonomous position to complete the consultation and provide the patient with holistic assessment, diagnosis, education and treatment of their condition.
AcknowledgmentsA special thank you to Kathy Taaffe, Professional Development Co-ordinator for Practice Nurses in HsE West sligo/leitrim for all her support and assistance in introducing nurse prescribing in our practice.
referencesAn Bord Altranais, 2010, Practice Standards for Nurses and Midwives with Prescriptive Authority, An Bord Altranais, DublinAn Bord Altranais, 2007a, Collaborative Practice Agreement (CPA) for Nurses and Midwives with Prescriptive Authority. An Bord Altranais, DublinAn Bord Altranais (2007b). Nurses Rules 2007. An Bord Altranais, Dublin.An Bord Altranais, 2007c, Decision-Making Framework for Nurse & Midwife Prescribing. An Bord Altranais, DublinAn Bord Altranais, 2007d, Guidance to Nurses and Midwives on Medication Management, An Bord Altranais, DublinHealth services Executive, 2009, National Policy for Nurse and Midwife Medicinal Product Prescribing in Primary, Community and Continuing Care. Health services Executive, DublinIrish Medicines Board (Miscellaneous Provisions) Act 2006 (Commencement) Order Statutory Instrument No 67 of 2009, stationery Office, DublinIrish Medicines Board (Miscellaneous Provision) Act 2006 (Commencement) Order 2007. stationery Office, DublinIrish Medicines Board (Miscellaneous Provision) Act 2006 (No. 3 of 2006) (section 10(1(ii)). stationery Office, DublinMedicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007, statutory Instruments No. 201 of 2007. stationery Office, DublinMisuse of Drugs (Amendment) Regulations 2007, statutory Instruments No.200 of 2007 stationery Office, DublinNational Council for the Professional Development of Nursing and Midwifery, 2008, Accreditation of Advanced Nurse Practitioners and Advanced Midwife Practitioners, 2nd Edition, National Council for the Professional Development of Nursing and Midwifery, DublinOffice of the Nursing services Director, 2008, Guiding Framework for the Implementation of Nurse and Midwife Prescribing in Ireland. Health services Executive, Dublin
There is an obligation for the registered nurse prescriber to commit to, and engage in, continuing professional development relating to assurance of competency for her/his prescribing practices.
Titration is important1,2
1 downward pump
per day
2 downward pumps
per day
3 downward pumps
per day
4 downward pumps
per day
ORAL SOLUTION
BeforeFIRST use
you must prime the pump with 5 downward pumps
and discard the liquid
TABLETS
0.5ml 1ml 1.5ml 2ml
DOSAGE: FROM START TO MAINTENANCE3
Approved from the moderate stage of Alzheimer’s Disease onwards3
Abbreviated Prescribing Information: For full prescribing information refer to the Summary of Product Characteristics. Name: Ebixa Active Substance: Memantine Hydrochloride. Indication: Treatment of patients with moderate to severe Alzheimer’s disease. Dosage & Administration: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Treatment is orally either as tablets (10 mg) or solution (5mg/pump) taken with or without food at the same time every day. The solution should only be dosed onto a spoon or into a glass of water using the pump. Maintenance dose is 20mg/day, (two tablets or 2ml solution [4 downward pumps] once daily). Treatment starts with 5mg/day (half a tablet or 0.5 ml solution [1 downward pump] once daily) for the fi rst week; the 2nd week 10mg/day (one tablet or 1 ml solution [2 downward pumps] once daily); the 3rd week 15mg/day (one and a half tablets or 1.5ml solution [3 downward pumps] once daily) and the 4th week 20mg/day (two tablets or 2ml solution [4 downward pumps] once daily). Moderate renal impairment 10mg/day (one tablet or 1 ml solution [2 downward pumps] once daily), if well tolerated after 7 days the dose can be titrated up to 20mg/day (two tablets or 2 ml solution [4 downward pumps] once daily). Severe renal impairment- dose is 10 mg/day (one tablet or 1 ml solution [2 downward pumps] once daily). Mild-moderate hepatic impairment- no dose adjustment. Severe hepatic impairment- no data available: Not recommended. Children & Adolescents: Not recommended. Contraindications: Hypersensitivity to the active substance or any of the excipients. Pregnancy and Lactation: Pregnancy: Memantine should not be used in pregnant women unless clearly necessary. Lactation: Memantine should not be used in women who are breastfeeding. Special Warnings and Precautions for use: Caution is recommended in patients with epilepsy. Caution is advised in patients with raised urine pH as this may elevate plasma levels. Clinical trial data are limited on patients with recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension and patients with these conditions should be closely supervised. Avoid concomitant use of NMDA antagonists (see also interactions). Oral solution only: Patients with rare hereditary problems of fructose intolerance should not take Ebixa 5mg/pump oral solution as it contains sorbitol. Tablets are lactose free. Patients should be warned to take special care if driving and using machines as Ebixa has minor to moderate infl uence on these tasks. Interactions: Effects of L-Dopa, dopaminergic agonists and anticholinergics may be enhanced. Effects of barbiturates and neuroleptics may be reduced. Concomitant administration of Ebixa with antispasmodic agents e.g. dantrolene and baclofen can modify their effects, dose adjustments may be necessary. Increased plasma levels could occur with concomitant use of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine. Co-administration with hydrochlorothiazide (HCT) may lead to a reduced serum level of HCT. Concomitant use of NMDA antagonist- amantadine, ketamine, dextromethorphan or phenytoin should be avoided. Close monitoring of prothrombin time or INR is advisable for patients treated concomitantly with oral anticoagulants. Adverse reactions: Common (≥1/100 to <1/10) headache, somnolence, hypertension, constipation, dizziness, dyspnoea and drug hypersensitivity. Uncommon reactions (≥1/1,000 to <1/100): cardiac failure, fatigue, fungal infections, confusion, hallucinations (mainly in severe Alzheimer’s disease), venous thrombosis/thromboembolism, vomiting, gait abnormal. Very rare (<1/10,000): seizures. Not known: Isolated cases of pancreatitis and psychotic reactions have been reported post-marketing. Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with memantine. Overdose: Symptomatic treatment. Elimination: Mainly in unchanged form via the kidneys. Legal Category: POM. Marketing Authorisation Holder: H.Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark. Marketing Authorisation Numbers: EU/1/02/219/005 Ebixa 5mg/pump oral solution-50ml bottle. EU/1/02/219/006 Ebixa 5mg/pump oral solution-100ml bottle. EU/1/02/219/007 Ebixa fi lm-coated tablets 10mg, 28 pack size. EU/1/02/219/008 Ebixa fi lm-coated tablets 10mg, 56 pack size. Further information may be obtained from: Lundbeck (Ireland) Ltd., 7 Riverwalk, Citywest Business Campus, Dublin 24.Date of Preparation: January 2011
References:1. Jones et al. 2007. Intl J Geriatr Psychiatry 22: 258-362. 2. Massoud et al 2010. Current Neuropharmacology 8;69-80. 3. Ebixa Summary of Product Characteristics.
EB4/1/11
Titration is important1,2
ebixa_MIMs.indd 1 17/01/2011 17:11
21
clinical review
The word epilepsy comes from the Greek word epilamabanien which means to seize or attack. It is the most common neurological disorder (after migraine) affecting 50 million people worldwide. Irish prevalence figures would suggest there are
36,844 people (over the age of 5) in Ireland affected by the disorder.1 An estimated 10,000 of whom are women of childbearing potential.2
It is a condition associated with a great deal of stigma, which is recognised by the people with the condition. Epilepsy occurs in all social groups. People with epilepsy are often made to feel very different and as a result are very reluctant to reveal their illness. The health service is now beginning to recognise the need for more intervention to educate and support those affected by the condition.
ThE rolE oF ThE commuNITy EPIlEPsy NursEThis new role was brought about by the partnership of the Health services Executive, Brainwave – The Irish Epilepsy Association and Beaumont Hospital. The result was the appointment of the first Clinical Nurse specialist in Community Epilepsy services in the country and to date there are now three specialist epilepsy nurses working with Brainwave.
I commenced the post of Community Epilepsy Nurse on the 10th June 2002. One of the primary aims of this post was to improve the links between Beaumont Hospital and the primary health care sector, including general practitioners, public health nurses, practice nurses, P]pharmacists and other allied health professionals as proposed by the National Health strategy 2002.
The overall aim is to improve patient care and increase awareness of the services provided by Brainwave.
dEFINITIoN oF EPIlEPsyEpilepsy is a clinical condition characterised by recurrent unprovoked seizures. It is classified by both syndromes and seizures. One seizure does not constitute epilepsy. It is a very common condition affecting approximately one in 115 people. Five per cent of the general population will experience one seizure in their lifetime.
A seizure is a disturbance of the brain cell function in which a brief period of altered awareness or consciousness occurs. The seizure itself is usually short in nature and maybe followed by a period of tiredness or confusion.
TyPEs oF sEIzurEsThe International league Against Epilepsy designed a classification system in 1981.
They defined seizures as:
Partial seizures• simple partial – sometimes also referred to as focal seizures
or auras – consciousness is not impaired. • Complex partial – consciousness is impaired.• secondary generalisation.
Generalised seizures• Absence (formally known as petit mal)• Tonic clonic (formally known as grand mal)• Myoclonic (serial jerking movement of limbs, sometimes
trunk can be affected)• Atonic (sudden loss of muscle tone)
Generalised tonic clonic seizures are what were formerly referred to as grand mal seizures. These are the type of events that the general public associates with epilepsy.
cAusEsFor some people there is no known cause and this is called ‘idiopathic’ epilepsy. sometimes however the reason is found; it could be because of a structural abnormality, brain damage caused by a difficult birth; a head injury; a stroke; or an infection of the brain such as meningitis/encephalitis. Very occasionally the cause is a brain tumour. Epilepsy with a known cause is called ‘symptomatic’ epilepsy.
dIAgNosIsThe most important part in the diagnosis is the clinical history. This should be accompanied by an eyewitness event such as;
Epilepsy – definitions, diagnosis and treatmentsINEAd murPhy, ClINICAl NURsE sPECIAlIsT IN COMMUNITy EPIlEPsy sERVICEs
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clinical review
• What was the person doing prior to the event? • Could they communicate during the event?• What happened during the event? • How long did it last?
Where possible the person should be encouraged to bring in a recording of a seizure into their consultant neurologist or epilepsy nurse. After the clinical history is completed some other investigations may be ordered including an electroencephalography (EEG) which is the recording of electrical activity along the scalp produced by the firing of neurons within the brain and magnetic resonance imaging (MRI), or nuclear magnetic resonance imaging (NMRI), which is primarily a noninvasive medical imaging technique used in radiology to visualise detailed internal structures and limited function of the body.
TrEATmENTsOnce a definite diagnosis has been made, the individual is usually commenced on an anti-epileptic drug (AED). The exact drug and the dose prescribed depend on the nature of the particular person’s epilepsy, taking into consideration the person’s age, sex, medical history and lifestyle. This medication may need to be changed or altered until a satisfactory one or combination of medication is found. some patient’s epilepsy may become refractory to medication after a period of time and require further investigations and interventions as a result.
Other treatments to be considered include surgery; this can include the removal of the focal point (only suitable in partial epilepsy). For individuals not suitable for surgery a vagus nerve stimulator may be an option.
The vagus nerve stimulator (VNs) is a device used for the treatment of intractable partial or generalised epilepsy i.e. those people not suitable for epilepsy surgery and for those
who fail to respond to two or more AEDs. Mechanistically, the VNs is unlike any other previous treatment for epilepsy. After appropriate evaluation, a patient may undergo surgical implantation of a VNs, usually performed at a specialised epilepsy centre.
EmErgENcy TrEATmENT oF sEIzurEsIt is well documented that the longer a seizure persists the more difficult it is to bring under control. A new product by the name of Epistatus (buccal midazolam) has been introduced to the Irish market. The aim of this medication is to terminate any seizure lasting longer than 5 minutes, cluster seizures or different than usual seizures, thus endangering the person’s life. some previous remedies include rectal – diazepam and oral – Ativan. However, as buccal midazolam is administered via the buccal cavity of the mouth or the nose, it is a lot easier to administer and does not impact on a person’s privacy and dignity.
lIFEsTylE ImPlIcATIoNsThere are many issues that need to be addressed with the individual and their family. some of the most important issues that should be addressed include, driving, fertility issues, triggers, mood changes, memory problems, education, employment, social issues, disclosure, stigma, and personal safety to include sUDEP (sudden Unexplained Death in Epilepsy). Informing the individual about adopting these changes into their lifestyle can help them take control of their epilepsy and thus educate them to highlight the particular concerns they are having to their nurse and or doctor.
suddEN uNExPlAINEd dEATh IN EPIlEPsyIf a person with epilepsy dies suddenly and no obvious cause can be found after a post mortem examination has been carried out, it is called sUDEP.
It is difficult to know exactly how many people with epilepsy die each year, but it is estimated that there is between 60-80 epilepsy deaths in Ireland each year.
The causes of sUDEP are not well understood. some studies have suggested that the part of the brain that controls breathing may be affected. This could cause the person to stop breathing during a tonic-clonic seizure. For most people, the breathing would start again once the seizure ends, but some are not so lucky. We don’t know yet whether these things happen because the person with epilepsy already has a weakness to their heart or lungs, or whether it is related to the epilepsy itself.
At the launch of the brainwave – Irish Epilepsy Association’s Nurses’ Information Pack were: cora Flynn, Advanced Nurse Practitioner in Epilepsy, beaumont hospital; Therese danaher, lecturer in Intellectual disability Nursing, dcu; sinead murphy, community Epilepsy specialist Nurse, brainwave and beaumont; maria keegan, Epilepsy clinical Nurse specialist, our lady’s children’s hospital; Aisling Farrell, director of services, brainwave, the Irish Epilepsy Association and geraldine dunne, National Information officer, brainwave The Irish Epilepsy Association.
It is well documented that the longer a seizure persists the more difficult it is to bring under control.
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24
clinical review
There is some suggestion that some people may be more at risk then others. These may be people who: • Have poorly controlled seizures• Have generalised seizures during their sleep• Have a learning disability• Are young adult males• Are not taking their prescribed antiepileptic medication • Are having frequent or sudden changes to their antiepileptic
medication.
rEducINg ThE rIsk oF sudEPThe following will help reduce the risk of sUDEP• If seizures are not well controlled, the patient should be
referred to an epilepsy specialist for their epilepsy and medication to be re-assessed.
• Advise your patient to continually take their prescription medication.
• Advise your patient to never make changes to, or stop, medication without talking to a doctor/nurse first.
brAINwAvE – ThE IrIsh EPIlEPsy AssocIATIoNThroughout their existence Brainwave – the Irish Epilepsy Association has worked tirelessly to educate the wider general public and allied healthcare professionals through a variety of settings. specific information leaflets and publications have been produced for general practitioners, employers and teachers. In 2008 a steering group was established to put together a Nurse’s Information Pack. This group was made up of Brainwave staff and some of the specialist adult and paediatric epilepsy nurses working in Ireland.
This very comprehensive pack includes a variety of information for nurses from all disciplines caring for people with epilepsy to include posters on how the brain works, medication posters for adults and children and the International Classification of Epilepsies and Epileptic syndromes. It addresses the specific needs of individuals with epilepsy to include those working with special needs, children and women with epilepsy.
hElPINg ThE PATIENTIn particular the group put together a ‘helping your patient’ section. This is the kind of information gathering that is particularly important to the doctor in the hospital setting. It gives an insight to the type of information that is most beneficial: documenting of seizures in a seizure diary, particularly recording the persons activity prior to, during and post the seizure. It also highlights the importance of an eyewitness account and value of having that person
accompany the individual to their hospital appointment. The pack has included a suggested patient checklist for the consultant appointment and what to bring to that appointment. It also informs nurses about the long Term Illness scheme and how all persons with a diagnosis of epilepsy are entitled to their epilepsy medication free of charge.
Finally the helping your patient section gives an insight into the particular lifestyle implications to discuss with your patient such as e driving and safety issues that may affect patients with epilepsy in general.
It is hoped that this pack will be an invaluable reference tool to all the nurses caring for individuals with epilepsy and that patients with epilepsy will benefit greatly from this sharing of information.
If you would like a copy of the Nurse’s Information Pack to download please send an email to [email protected] or contact Brainwave’s head office on 01 4557500.
references:1. Christine linehan et al (2009)
Examining the prevalence of epilepsy and delivery of epilepsy care in Ireland. Epilepsia. 51 (5); 845-852
2. liggan, B and Delant, N (2002) Epilepsy and Pregnancy. Modern Medicine. 32 (10); 23-28.
A seizure is a disturbance of the brain cell function in which a brief period of altered awareness or consciousness occurs.
25
Q&A
so what’s the best thing about living in carrickmacross?Fresh air, peace and quiet, lovely rolling drumlins.
what’s the downside?Can’t get radio, tv, mobile phone or broadband signals – due to aforementioned drumlins.
who’s your hero?Frontline staff in Medicin sans Frontiers – when everyone else is running away from situations - they are running in.
Nursing hero?Any of the nursing pioneers throughout history and, (of course!!), Practice Nurses who are so motivated to provide great care that they educate and update themselves in their own time and at their own expense.
who’s a villain?Anyone who knew about any cases of child abuse who didn’t shout and scream about it from the rooftops. What’s wrong with them?
what’s the best thing about practice nursing?Getting to know the patients and their families over time – it allows for fantastic continuity and means Practice Nurses really do provide totally holistic care.
do you miss actual practice nursing?yes, I miss it a lot. The bravery shown by the vast majority of patients is awesome.
And the downside?The unfairness of self-funding education and CPD so that the best care can be provided to all patients, and being expected to take on vaccination programmes and care of chronic diseases – but at the same time being conveniently labelled “privately employed” by the Department of Health whenever issues such as study leave or funding for education arise.
what would you change in your job if money, time and red tape were not a factor?If I had more time etc, I would like to find a way around all the barriers and get IPNA educational meetings officially accredited and recognised in a meaningful way for Practice Nurses.
what are your hobbies?shopping, cinema and doing fun stuff with my kids. I also get enormous satisfaction from de-cluttering sprees (sad but true!).
current favorite book?“Under the Duvet” by Marian Keyes.
current favorite film?My all-time favourites are “you’ve Got Mail” and “Me, Myself and Irene”.
clothes shop?Pamela scott or Dorothy Perkins – where normal healthy women are welcome!
what would you like to see in the future for practice nursing?Equal educational opportunities and/or more online programmes, and better recognition of the impact Practice Nurses have on patient care.
Administrator: lisa Nolanlisa first took on the duties of IPNA National secretary in February 2002 and in January 2006 her role was formally established as that of a Part-Time Administrator with an employment contract and salary in line with those of public service.
she carries out the general administration of the Association. Prior to this role, lisa worked full-time as a Practice Nurse (RGN, H. Dip in Midwifery UK) with 4 GPs in an ICGP-approved CME Training Practice and was also secretary of the Practice Nurse section of the INO. In the past she has worked in various Medical PA and Practice Manager roles. she holds an ECDl, a City & Guilds IT Diploma and a Professional Practice Certificate in Effective Voluntary sector Management, (Roehampton University, london). she works 29 hours per week for the IPNA
Abbreviated Prescribing InformationVictoza® 6 mg/ml solution for injection in pre-filled pen (liraglutide). Pleaserefer to the Summary of Product Characteristics for full information. Victoza® 2 x 3ml pre-filled pens. Victoza® 3 x 3 ml pre-filled pens. 1 ml of solution contains 6mg of liraglutide. Indication: Treatment of adults with type 2 diabetes mellitus incombination with metformin or a sulphonylurea, in patients with insufficient glycaemiccontrol despite maximal tolerated dose of metformin or sulphonylurea monotherapy; orin combination with metformin and a sulphonylurea, or metformin and athiazolidinedione in patients with insufficient glycaemic control despite dual therapy.Dosage: Victoza® is administered once daily by subcutaneous injection and can beadministered at any time independent of meals however, it is preferable that Victoza®
is injected around the same time of the day. Victoza® should not be administeredintravenously or intramuscularly. Recommended starting dose is 0.6 mg daily. After atleast one week, the dose should be increased to a maintenance dose of 1.2 mg. Basedon clinical response, after at least one week the dose can be increased to 1.8 mg tofurther improve glycaemic control in some patients. Daily doses higher than 1.8 mg arenot recommended. When used with existing metformin therapy or in combination withmetformin and thiazolidinedione therapy, the current dose of metformin andthiazolidinedione can continue unchanged. When added to existing sulphonylureatherapy or in combination with metformin and sulphonylureas, a reduction in the doseof sulphonylurea may be necessary to reduce the risk of hypoglycaemia. Victoza® canbe used in the elderly (>65 years old) without dose adjustment but therapeuticexperience in patients ≥75 years of age is limited. No dose adjustment is required forpatients with mild renal impairment (creatinine clearance 60-90 ml/min). Due to lackof therapeutic experience Victoza® is not to be recommended for use in patients withmoderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinineclearance below 30 ml/min), patients with end stage renal disease, patients with hepaticimpairment and children below 18 years of age. Contraindications: Hypersensitivity
to the active substance or any of the excipients. Warnings and Precautions for use:Victoza® should not be used in patients with type 1 diabetes mellitus or for thetreatment of diabetic ketoacidosis. Limited experience in patients with congestive heartfailure New York Heart Association (NYHA) class I-II and no experience in patients withNYHA class III-IV. Due to limited experience Victoza® is not recommended for patientswith inflammatory bowel disease and diabetic gastroparesis. Victoza® is associated withtransient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.GLP-1 analogues have been associated with pancreatitis; patients should be informedof symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitissuspected, Victoza® and other suspect medicinal products should be discontinued.Thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasmreported in clinical trials particularly in patients with pre-existing thyroid disease. Riskof hypoglycaemia in combination with sulphonylureas; lowered by dose reduction ofsulphonylurea. Signs and symptoms of dehydration, including altered renal functionreported with Victoza®. Patients should be advised of potential risk of dehydration inrelation to gastrointestinal side effects and take precautions to avoid fluid depletion.No studies on the effects on the ability to drive and use machines performed. Patientsshould be advised to take precautions to avoid hypoglycaemia while driving and usingmachines, in particular when Victoza® is used in combination with a sulphonylurea.Substances added to Victoza® may cause degradation; in the absence of compatibilitystudies Victoza® must not be mixed with other medicinal products. Pregnancy andlactation: Victoza® should not be used during pregnancy or during breast feeding. Ifa patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza®
should be discontinued; use of insulin is recommended instead. Undesirable effects:During clinical trials with Victoza® the most frequently observed adverse reactions whichvaried according to the combination used (sulphonylurea, metformin or athiazolidinedione) were: Very common: nausea, diarrhoea, hypoglycaemia when usedin combination with metformin and a sulphonylurea and headache when used in
combination with metformin; Common: hypoglycaemia when used in combination witha thiazolidinedione, vomiting, constipation, abdominal pain, discomfort and distension,dyspepsia, gastritis, flatulence, gastroesophageal reflux disease, gastroenteritis viral,toothache, headache, dizziness, nasopharyngitis, bronchitis, anorexia, appetitedecreased, fatigue and pyrexia. Gastrointestinal adverse reactions are more frequent atstart of therapy but are usually transient. Very few hypoglycaemic episodes observedother than with sulphonylureas. Patients >70 years or with mild renal impairment(creatinine clearance 60-90 ml/min) may experience more gastrointestinal effects.Consistent with medicinal products containing proteins/peptides, patients may developanti-liraglutide antibodies following treatment but this has not been associated withreduced efficacy of Victoza®. Few cases reported of angioedema (0.05%), acutepancreatitis (<0.2%) and injection site reactions (approx. 2%). Injection site reactionsusually mild. Thyroid neoplasms, increased blood calcitonin and goitres are the mostfrequent reported thyroid adverse events – rates per 1000 subjects years of exposurewere 6.8, 10.9 and 5.4 of liraglutide treated patients in comparison with 6.4, 10.7 and2.1 of placebo treated and 2.4, 6.0 and 1.8 of total comparator treated. The Summaryof Product Characteristics should be consulted for a full list of side effects. Overdose:In the event of overdose, appropriate supportive treatment should be initiated accordingto the patient’s clinical signs and symptoms. MA numbers: Victoza® 2 x 3ml pre-filledpens EU/1/09/529/002. Victoza® 3 x 3ml pre-filled pens EU/1/09/529/003. LegalCategory: POM. For complete prescribing information please refer to The Summary ofProduct Characteristics which is available on www.medicines.ie or by email [email protected] or from Medical department, Novo Nordisk Limited, 3-4 UpperPembroke Street, Dublin 2, Ireland; www.novonordisk.ie. Date created: Jan 2011.
Information about adverse event reporting is available at www.imb.ie. Adverse events should be reported to the Novo Nordisk Medical department:
Tel: 1850 665 665.
Victoza® and the Apis bull logo are trademarks owned by Novo Nordisk A/S.
Date of preparation: January 2011. IR/LR/0111/0018
References: 1. Victoza® Summary of Product Characteristics. 2. Nauck M et al; for the LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride,and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009;32(1):84-90.
Once-daily Victoza® (liraglutide), in combination with metformin,impacts on multiple factors associated with type 2 diabetesproviding, from baseline:1,2
Reductions in HbA1c: up to 1.30%1,2
Reductions in weight: up to 2.8kg1,2
Reductions in systolic blood pressure1,2
Improvements in beta-cell function1,2
Further Information is available from: Novo Nordisk Limited
3/4 Upper Pembroke StreetDublin 2, IrelandTel: 01 678 5989 Fax: 01 676 3259
Lo Call: 1850 665 665www.novonordisk.ie
Victoza NurinGenPrac Jan 2011(1):Layout 1 17/01/2011 15:06 Page 1
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clinical review
There is currently an estimated population of 130,000 people (4.3%)1 living with diabetes in the Republic of Ireland and this number is expected to rise by 37% over the next five years. Diabetes is a costly condition both for the patient, in terms of quality of life and
long term complications and for the health system, in terms of economic burden. The healthcare cost of looking after people with diabetes is very high – accounting for 5-15% of our health expenditure.2
sTrucTurEd EducATIoNEducation of adults with diabetes is changing; in response to validated scientific evidence that promotes what is now termed a ‘structured’ approach to diabetes education. Research shows that structured education programmes, as defined NICE (2003),3 based on client centred models of care increase and promote self management. People with diabetes are empowered to become actively involved in their treatment by increasing confidence, skills and knowledge.
self management is a vital component of a high quality diabetes service.2,4,5 People with diabetes see a health professional for approximately three hours a year and rely on themselves for the other 8,757 hours.
The X-PERT programme is one example of a structured patient education programme successfully being rolled out across Ireland by the community nutrition and dietetic services.
ThE x-PErT ProgrAmmEX-PERT aims to empower clients to make informed decisions regarding their diabetes self-management.
The X-PERT (Expert Patient Education versus Routine Treatment) programme is a dietitian led, group-based, structured education programme for people with type 2 diabetes (2.5 hour sessions x 6 consecutive weeks (15hrs)). The delivering dietitians are quality assured adult educators skilled in different education/teaching methods, behavioral therapy, motivational interviewing, adult learning etc.
It is an evidence-based, audited, quality assured, HsE national achievements award winner (2008) and meets the NICE key criteria for structured patient education and is NHs approved.3
X-PERT has been evaluated via randomised controlled trial 6,7,8 and impacts positively on clinical, lifestyle and psychosocial outcomes.
whAT Is ThE x-PErT ProgrAmmE All AbouT?This new to Ireland patient-centered, group-based approach to patient education actively encourages participants to discuss and explore their own experiences of living with diabetes. This helps participants to adapt the key messages of diet and lifestyle modification and apply them to their personal circumstances.
After the six week programme, participants are offered refresher sessions within the following six months and an annual update session thereafter. This continuing education and support of lifestyle changes is in line with strong evidence for the value of patient follow up in chronic disease management.9
x-PErT IrElANdIn 2005 the Community Nutrition and Dietetic service, HsE south, began liaison with the X-PERT UK to adapt the programme for Ireland. To date (Figures taken from data entered by May 27th 2010), 79 community dietitians from the four HsE regions of Ireland have been trained as X-PERT Ireland Educators. 101 programmes have been delivered across the Republic of Ireland, educating 1189 people with type 2 diabetes. 88.1% of clients have attended four or more of the six sessions. The mean number of session attended is five out of six. The mean participant evaluation score for the programme was 95.8%. Clinical and empowerment data, as displayed in Table 1, shows positive improvements in biochemical and physiological parameters, similar to those seen in Irish and UK trials and in line with audit standards set out for X-PERT.
HsE investment in promoting X-PERT has highlighted the importance of linking with health professionals who are supportive of integrated diabetes care in the wider primary care network. X-PERT has also raised professionals’ awareness, knowledge, confidence, diabetes management skills and partnerships in improving the care and service’s for people with type 2 diabetes.
structured patient education for people with type 2 diabetes – the x-PErT Programme sAlly-ANN mclAughlIN, sENIOR COMMUNITy DIETITIAN, COMMUNITy NUTRITION AND DIETETIC sERVICEs OF THE HEAlTH PROMOTION DEPARTMENT, HsE DUBlIN NORTH EAsT
28
clinical review
summAryThe X-PERT programme is proven to be cost, time and resource efficient. Clients are extremely happy with the service. 89% of clients (surveyed in the Dublin North East region) reported that having attended X-PERT, it has inspired them to support others with diabetes in their community. Clients are now actively involved in their own treatment. They are taking responsibility and action for their health and lifestyles and maintaining changes for one year and longer after participating on the programme.
commENTs From PArTIcIPANTs AFTEr ATTENdINg ThE x-PErT ProgrAmmE
“For the first time in my life I feel like I am the one in control of my diabetes.”
“The programme really helped me and my family take a better look at our lifestyle.”
“After 23 years with type 2, it’s the first time I’ve really been informed in detail about my condition.”
“Without this programme I would remain ignorant to my diabetes.”
commENTs From gP whosE clIENTs ATTENdEd ThE x-PErT ProgrAmmE
“We undoubtedly feel our patients are more empowered to take proactive steps in managing their disease (with improved knowledge, compliance with drugs, increased awareness about diabetes) and are hopeful this will significantly improve the disease burden for individuals and health providers in the future”.
week content
week 1 What is diabetes? self monitoring of blood glucoseUnderstanding medicationDiabetes health results – what do they mean?
week 2 Weight management; energy balanceHealthy eating and portion controlPhysical activity
week 3 Carbohydrate awarenessWhat are carbohydrates?How starches and sugars affect blood glucose levelsDispelling myths of the sugar-free diet
week 4 Reading food labels (supermarket tour).A virtual supermarket is created giving clients an opportunity to ask questions, read labels and become more informed about the foods they eat.
week 5 Possible complications of diabetes – short – and long-termPrevention of complicationsliving with diabetes
week 6 Are you an X-PERT? Game designed to recap on main messages of the programme in a fun way while helping to increase skills, knowledge and confidence in making informed decisions regarding diabetes self-management. Questions and answersComments and feedbacksharing of resources
refreshers and annual sessions
Recap on aspects of 6 week programme as per patient requestsFurther goal setting
20 minutes at end of each week – goal setting with five step empowerment model.
For patients not at goal on metformin aloneIn clinical studies of patients with type 2 diabetes,
Powerful and sustained HbA1c reductions over 1 year1,2
Weight loss and less hypoglycemia vs an SU* + metformin (with sitagliptin 100 mg + metformin)3
3-D Control: comprehensive mechanism of action targets 3 key defects of type 2 diabetes1
JANUMET® for powerful glucose reductions1
(sitagliptin/metformin)
Changing the course to glucose control.
Janumet 50mg/850mg and Janumet 50mg/1000mg film-coated tablets (50 mg of sitagliptin as phosphate monohydrate and 850 mg or 1000mg of metformin hydrochloride).ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing.PRESENTATION Janumet 50mg/850mg film-coated tablets: Capsule-shaped, pink film-coated tablet with “515” debossed on one side con-taining 50 mg of sitagliptin as phosphate monohydrate and 850 mg of metformin hydrochloride. Janumet 50mg/1000mg film-coated tablets: Capsule-shaped, red film-coated tablet with “577” debossed on one side containing 50 mg of sitagliptin as phosphate monohydrate and 1000 mg of metformin hydrochloride. USES For patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphony-lurea. Janumet is also indicated as triple combination therapy with a PPARγ agonist (i.e., a thiazolidinedione) as an adjunct to diet and exer-cise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. Janumet is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control. DOSAGE AND ADMINISTRATION The dose of antihyper-glycaemic therapy with Janumet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin. For patients not adequately controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. For patients switching from co-administration of sitagliptin and metformin, Janumet should be initiated at the dose of sitagliptin and metformin already being taken. For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia. For patients inadequately controlled on dual combination thera-py with the maximal tolerated dose of metformin and a PPARγ agonist, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin, the dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combina-tion with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia. All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet. Janumet should be given twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin. Use in renal insuffi-ciency: Janumet should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min). Use in hepatic insufficiency: Janumet should not be used in patients with hepatic impairment. Use in elderly: Janumet should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis. Limited safety data on sitagliptin is available in patients > 75 years of age and care should be exercised. Use in children: Not recommended for use in children below 18 years of age. CONTRAINDICATIONS • hypersensitivity to the active substances or to any of the excipients • diabetic ketoacidosis, dia-betic pre-coma • moderate and severe renal impairment (creatinine clearance < 60 ml/min) • acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents • acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure recent myocardial infarction, shock • hepatic impairment • acute al-cohol intoxication, alcoholism • lactation. PRECAUTIONS Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. Lactic acidosis: It is a very rare serious metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors. If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately. Renal function: As met-formin-related lactic acidosis increases with the degree of impairment of renal function, serum creatinine concentrations should be deter-mined at least once a year in patients with normal renal function and at least two to four times a year in patients with serum creatinine levels at or above the upper limit of normal and in elderly patients. Decreased renal function in elderly patients is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID). Hypoglycaemia: Patients receiving Janu-met in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia. Therefore, a reduction in the dose of the sulpho-nylurea or insulin may be necessary. The use of Janumet in combination with insulin has not been adequately studied. Hypersensitivity reac-tions: Postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue Janumet, assess for other potential causes of the event, and institute alternative treatment for diabetes. Surgery: As Janumet contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia. Janumet should not usually be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal. Administration of iodinated contrast agent: The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure which has been associated with lactic acidosis in patients receiving metformin. Therefore, Janumet should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal. Change in clinical status of patients with previously controlled type 2 diabetes: A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of either form occurs, Janumet must be stopped immediately and other appropriate corrective measures initiated. Drug interactions: Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes. There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Janumet. Consumption of alcohol and medicinal products containing alcohol should be avoided. Cationic agents that are eliminated by renal tubular secretion (e.g., cimetidine) may interact with metformin by competing for common renal tubular transport systems. Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered. The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. Therefore, Janumet should be discontin-ued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal. Combination requiring precautions for use: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity. The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products. If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation. ACE-inhibitors may decrease the blood glu-cose levels. If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation. Effects of other medicinal products on sitagliptin: Clinical data described below suggest that the risk for clinically meaningful interactions following co-administration of other medicinal products is low. Cyclosporin: A study was conducted to assess the effect of cyclosporin, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin. Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of cyclosporin increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively. These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful. The renal clearance of sitagliptin was not meaningfully altered. Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors. In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin. Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD. For this reason, it is pos-sible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal insufficiency or ESRD. The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study. In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3. OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low. Concomitant administration of OAT3 inhibitors has not been evaluated in vivo. Effects of sitagliptin on other medicinal products: In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes. In clinical studies, sitagliptin did not meaningfully alter the pharma-cokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propen-sity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT). Sitagliptin had a small ef-fect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein in vivo. Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations. Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %. No dose adjustment of digoxin is recommended. However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly. Use in pregnancy and lactation: Janumet should not be used during pregnancy or breast-feeding. Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported. Patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with other sulfonylurea agents or with insulin. SIDE EFFECTS There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demon-strated. Sitagliptin and Metformin Adverse reactions considered as drug related reported in excess (> 0.2 % and difference > 1 patient) of placebo and in patients receiving sitagliptin in combination with metformin in double-blind studies are listed below. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Sitagliptin with Metformin In a placebo-controlled 24-week study of sitagliptin 100 mg once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin added to ongoing metformin compared to treatment with placebo added to ongoing metformin was 9.3 % and 10.1 %, respectively. Investigations Uncommon: blood glucose decreased Nervous system disorders Uncommon: somnolence Gastrointestinal disorders Common: nausea Uncommon: upper abdominal pain, diarrhoea. In a 1-year study of sitagliptin 100 mg once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin added to ongoing metformin compared to sulphonylurea added to ongoing metformin was 14.5 % and 30.3 %, respectively. In pooled studies of up to 1 year in duration comparing sitagliptin added to ongoing metformin to a sulphonylurea agent added to ongoing metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (> 0.2 % and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: Metabolism and nutrition disorders Uncommon: anorexia Investigations Uncommon: weight decreased Sitagliptin with Metformin and a Sulphonlylurea In this 24-week place-bo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with glimepiride and metformin, the overall in-cidence of adverse reactions considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment with glimepiride and metformin was 18.1 % compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1 %. Gastrointestinal disorders Common: constipation Metabolism and nutrition disorders Very common: hypogly-caemia COMBINATION WITH A PPARγ AGENT (rosiglitazone) and METFORMIN In this study of sitagliptin 100 mg once daily in combination with rosiglitazone and metformin, which continued through 54 weeks, the incidence of adverse reactions considered as drug-related in pa-tients treated with sitagliptin combination compared to treatment with the placebo combination was 15.3 % and 10.9 %, respectively. Other drug-related adverse reactions reported in the 54-week analysis (frequency common) in patients treated with sitagliptin combination occur-ring in excess (> 0.2 % and difference > 1 patient) of that in patients treated with the placebo combination were: headache, cough, vomiting, hypoglycaemia, fungal skin infection, and upper respiratory tract infection. Nervous system disorders Common: headache Metabolism and nutrition disorders Common: hypoglycaemia Gastrointestinal disorders Common: diarrhoea, vomiting General disorders Common: peripheral oedema Sitagliptin with Metformin and Insulin In this 24-week placebo-controlled study of sitagliptin 100 mg once daily as add-on to insulin and metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin in combination with insulin/metformin compared to treatment with placebo in combination with insulin/metformin was 16.2 % and 9.0 %, respectively. Nervous system disorders Uncommon: headache Gastrointestinal disorders Uncommon: dry mouth Metabolism and nutrition disorders Very common: hypo-glycaemia. In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/metformin 50 mg/500 mg or 50 mg/1,000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combina-tion of sitagliptin and metformin compared to patients treated with placebo was 14.0 % and 9.7 %, respectively. The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0 % each) and greater than sitagliptin alone (6.7 %), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions. Additional information on the individual active substances of the fixed dose combination Sitagliptin In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2 % and difference > 1 patient) of that in patients receiv-ing placebo are headache, hypoglycaemia, constipation, and dizziness. In addition to the drug related adverse reactions described above, adverse events (reported regardless of causal relationship to medicinal product) occurring in at least 5 % and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis. Additional adverse events that occurred more fre-quently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity. Across clinical studies, a small increase in white blood cell (WBC) count was observed due to an increase in neutrophils. This observation was seen in most but not all studies. This change in laboratory pa-rameters is not considered to be clinically relevant. No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with sitagliptin treatment. Post-marketing data Sitagliptin During post-marketing experience of Janumet or sitagliptin, one of the active substances of Janumet, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reac-tions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome; pancreatitis. Metformin Nervous system disorders Common: metallic taste Gastrointestinal disorders Very common: gastrointes-tinal symptoms Skin and subcutaneous disorders Very rare: urticaria, erythema, pruritis Metabolism and nutrition disorders Very rare: lactic acidosis, vitamin B12 deficiency Hepatobiliary disorders Very rare: liver function disorders, hepatitis PACKAGE QUANTITIES Janumet 50mg/850mg and 50mg/1000mg film-coated tablets, 56 tablets. POM Date of preparation: Nov 2009 Marketing Authorisation numbers: Janu-met 50mg/850mg film-coated tablets, EU/1/08/455/003. Janumet 50mg/1000mg film-coated tablets, EU/1/08/455/010. Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. © Merck Sharp & Dohme Limited 2009. All rights reserved. API.JANUMET.Nov09.IRL. References: 1. Data on file, MSD. 2. Goldstein BJ, Feinglos MN, Lunceford JK, et al; for the Sitaglip-tin 036 Study Group. Effect of initial combination with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in pa-tients with type 2 diabetes. Diabetes Care. 2007;30:1979–1987. 3. Nauck MA, Meininger G, Sheng D, et al; for the Sitagliptin Study Group 024. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabe-tes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9:194–205. * SU = sulfonylurea; specifically glipizide. Additional prescribing information available on request or from www.medicines.ie
01-1
2-JM
T-20
10-IR
L-29
27-J
Merck Sharp & Dohme Ireland (Human Health) Ltd.Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
30
clinical review
Table 1. x-PErT Ireland Audit results 2006-2010Note: Figures taken from data entered by May 27th 2010
Baseline 6 Months 1 year 2 years
HbA1c % 7.3(n=1003)
6.8(n=282)
7.0(n=164)
7.0(n=36)
Weight kg 89.3(n=1055)
85.2(n=277)
86.1(n=148)
85.8(n=33)
BMI kg/m2 31.9(n=1032)
30.8(n=266)
30.3(n=148)
30.0(n=33)
Total Cholesterol mmol/l 4.3(n=1068)
4.2(n=288)
4.0(n=168)
3.8(n=38)
lDl Cholesterol mmol/l
2.4(n=975)
2.3(n=255)
2.2(n=157)
1.9(n=33)
HDl Cholesterol mmol/l
1.2(n=978)
1.2(n=254)
1.2(n=159)
1.1(n=34)
Triglycerides mmol/l
1.7(n=859)
1.6(n=223)
1.5(n=139)
Not Available
systolic Blood Pressure mmHg
135.4(n=840)
135.7(n=239)
135.2(n=144)
133.5(n=21)
Diastolic Blood PressuremmHg
78.1(n=839)
76.7(n=239)
76.4(n=144)
73.9(n=21)
Empowermentscore
3.8Max score = 5
4.4Max score = 5
4.3Max score = 5
Not Available
“The programme has helped us meet our patients needs in an effective way by really involving them in organized proactive care plans.”
“The patients now relate to the practice nurse on a more personal basis and we feel the condition of diabetes is much better understood and managed overall.”
The X-PERT programme is being successfully led out across Ireland by the community nutrition and dietetic services. Please contact your local community nutrition and dietetic department for further details.
references1.Making Diabetes Count (2006). The Institute of Public Health in Ireland. www.publichealth.ie 2.Diabetes Expert Advisory Group, HsE (2008).3. NICE (2003). Guidance on the use of patient-education models for diabetes – Health Technology Appraisal 60. london, National Institute of Clinical Excellence. 4.Department of Health and Diabetes UK (2005). structured Patient Education in Diabetes – Report from the Patient Education Working Group. london.5.Harkins V (2008). A Practical Guide to Integrated Type 2 Diabetes Care.6.Deakin TA, et al., (2006). Glycaemic Control: The Diabetes X-PERT Programme makes a Difference. Diabetic Medicine 23; 944-954.7. O’Brien yM et al., (2007). A structured patient-education programme for individuals with type 2 diabetes: The X-PERT Programme in Ireland. Proceedings of the Nutrition society Vol 66 p74A8. O’Brien yM et al (2006). XPERT in Ireland–a structured patient education programme for people with type 2 diabetes Diabetic Medicine, 23 (suppl. 4), P446 pg1599. NICE (2006). Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children.
The healthcare cost of looking after people with diabetes is very high – accounting for 5-15% of our health expenditure.
Cialis offers your patients
CIALIS* (TADALAFIL) REPUBLIC OF IRELAND ABBREVIATED PRESCRIBING INFORMATION
Presentation Tablets 2.5mg, 5mg, 10mg, or 20mg of tadalafil. Also contains lactose. Uses Treatment of erectile dysfunction in adult males. Dosage and Administration Adult men: The recommended dose is 10mg orally, taken at least 30 minutes prior to sexual activity. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. Maximum dosing frequency, once per day. 10mg or 20mg tadalafil is not recommended for continuous daily use. In responder patients to an on-demand regimen, who anticipate a frequent use of Cialis (ie, at least twice weekly), a once daily regimen with the lowest doses of Cialis might be considered. The recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. Elderly: Dosage adjustment not required. Impaired renal or hepatic function: In patients with severe renal impairment the maximum recommended dose is 10mg. Once a day dosing of Cialis is not recommended in patients with severe renal impairment. In men with hepatic impairment the recommended dose is 10mg. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. There is limited clinical data on the safety of Cialis in patients with severe hepatic impairment; if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Once a day dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Diabetes: Dosage adjustment not required. Use in children and adolescents: Cialis should not be used in individuals below 18 years of age. Not indicated for use by women. In clinical trials, Cialis demonstrated improvement in patients’ erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing. Contra-indications Known hypersensitivity to any ingredient. Patients using any form of organic nitrates. In men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Patients with myocardial infarction within the last 90 days, patients with unstable angina or angina occurring during sexual intercourse, patients with New York Heart Association class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (<90/50mmHg), or uncontrolled hypertension, patients with a stroke within the last 6 months. Cialis is contra-indicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. Warnings and Special Precautions Prior to any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. It augments the hypotensive effect of nitrates. Tadalafil (2.5mg and 5mg): In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy. Serious cardiovascular events were reported either post-marketing and/or in clinical trials. Although most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors, it is not possible to determine whether these events are related directly to these risk factors, to Cialis, to sexual activity, or to a combination of these or other factors. Visual defects and cases of NAION have been reported in connection with the intake of Cialis and other PDE5 inhibitors. In case of sudden visual defect, patients should be advised to stop taking Cialis and consult a physician immediately. Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, once a day dosing of Cialis is not recommended in patients with severe renal impairment. There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Use with caution in patients who have conditions that might predispose them to priapism, or in patients with anatomical deformation of the penis. Patients who experience erections lasting 4 hours or more should be instructed to seek
medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. It is not known if Cialis is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Cialis should not be administered to patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. In patients who are taking alpha1-blockers, concomitant administration of Cialis may lead to symptomatic hypotension in some patients. The combination of tadalafil and doxazosin is not recommended. Caution should be exercised when prescribing Cialis to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the drugs are combined. The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be informed not to take Cialis with such combinations. Pregnancy and Lactation Not indicated for use by women. There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development. As a precautionary measure, it is preferable to avoid the use of Cialis during pregnancy. Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. Cialis should not be used during breast-feeding. Driving, etc No studies on the effect on the ability to drive and use machines have been performed. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Cialis before driving or operating machinery. Undesirable Effects Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (events not reported in registration trials cannot be estimated from post-marketing spontaneous reports). Very common: Headache. Common: Dizziness, flushing, dyspepsia, nasal congestion, back pain, myalgia. Uncommon: Hypersensitivity reactions, blurred vision, sensations described as eye pain, tachycardia, palpitations, hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), hypertension, abdominal pain, gastro-oesophageal reflux, rash, hyperhidrosis (sweating), chest pain(1). Rare: Stroke(1) (including haemorrhagic events), syncope, transient ischaemic attacks(1), migraine(3), visual field defect, swelling of eyelids, conjunctival hyperaemia, myocardial infarction, urticaria, Stevens-Johnson syndrome(3), exfoliative dermatitis(3), prolonged erections, priapism(3), facial oedema(3), seizures, transient amnesia, NAION(3), retinal vascular occlusion(3), sudden hearing loss(2), unstable angina pectoris(3), ventricular arrhythmia(3), epistaxis, sudden cardiac death(1,3). (1)Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. (2)Sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trial cases with the use of all PDE5 inhibitors, including tadalafil. (3)
Post-marketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials. Adverse reactions reported with tadalafil were transient, and generally mild or moderate. Adverse reaction data are limited in patients >75 years. A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions. For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at http://www.medicines.ie/. Legal Category POM Marketing Authorisation Numbers and Holder EU/1/02/237/001 EU/1/02/237/002 EU/1/02/237/003 EU/1/02/237/004 EU/1/02/237/005 EU/1/02/237/006 EU/1/02/237/007 EU/1/02/237/008 Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands. Date of Preparation or Last Review September 2010 Full Prescribing Information is Available From Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL. Telephone: Basingstoke (01256) 315 000. E-mail: [email protected] or Eli Lilly and Company (Ireland) Limited, Hyde House, 65 Adelaide Road, Dublin 2, Republic of Ireland. Telephone: Dublin (01) 661 4377. E-mail: [email protected] *CIALIS (tadalafil) is a trademark of Eli Lilly and Company. Date of Preparation: September 2010. References: 1. Cialis Summary of Product Characteristics. 2. Dean, J. et al. Psychosocial outcomes and drug attributes affecting treatment choice in men receiving sildenafil citrate and tadalafil for the treatment of erectile dysfunction: Results of a multicenter, randomised, open label, crossover study. J Sex Med, 2006; 3:650-661. IECLS00137
Proven efficacy from 30 minutes up to 36 hours with sexual stimulation1
Greater sexual self-confidence and spontaneity than sildenafil2
A4 Young Couple new API SEPT 2010.indd 1 17/01/2011 17:05
32
clinical review
Feeling down once in a while is normal but some people feel a sadness that just won’t go away. life seems hopeless. Feeling this way, most of the day for two weeks or more is a sign of serious depression.
More than 7% of the population have depression and it is estimated that at any one time, 280,000 people in Ireland have depression. Irish research has shown that it is more common in women, teenagers, the elderly and in single people. It is estimated that one in 10 Irish people will have depression at some point in their lives.
ThE lINkA number of studies have found a higher prevalence of depressive symptoms in people with diabetes1, 2 In controlled studies, the prevalence of depressive symptoms was described to be nearly double in people with diabetes.1, 2 However, some
studies found only small differences between diabetes and non diabetes subjects.3, 4 several studies have demonstrated that depression in people with diabetes is associated with increased co-morbidity and an increased mortality rate. 1-7
Collins et al 20098 carried out a study to identify the prevalence and major determinants of anxiety and depression symptoms in patients with diabetes in Ireland. This was a cross-sectional study of 2049 people with types 1 and 2 diabetes. Anxiety and depression symptoms were assessed with the Hospital Anxiety and Depression scale (HADs). The overall response rate was 71%. Based on the HADs scale, there was evidence of high levels of anxiety and depression symptoms in patients with diabetes; 32% exceeded the HADs cut-off score of ‘mild to severe’ anxiety and 22.4% exceeded the HADs cut-off score of ‘mild to severe’ depression.
rIsk FAcTorsDiabetes complications, smoking, uncertainty about glycaemic control and being an ex-drinker or a heavy drinker were risk factors for both higher anxiety and depression scores in multivariate analysis. Female gender and poor glycaemic control were risks factors associated only with higher anxiety scores. Higher socio-economic status and older age were protective factors for lower anxiety and depression scores. Type of diabetes, insulin use, marital status and models of care were not significant predictors of anxiety and depression scores. This study indicates that the prevalence of anxiety and depression symptoms in patients with diabetes is considerably higher than in general population samples.
A major depressive episode can be persistent and debilitating. Depression may be under diagnosed and undertreated in 50% of cases, and is often unrecognised by both patients and health professionals.9, 10 studies such as the DAWN (Diabetes Attitudes
diabetes and depressionElAINE NEwEll, DIABETEs DEVElOPMENT OFFICER, DIABETEs FEDERATION OF IRElAND
Psychological distress or depression can affect a person’s motivation and ability to cope with self management of diabetes.
33
clinical review
Wishes and Needs) study11 have shown that many nurses and physicians do not recognise depression, anxiety and emotional problems in people with diabetes.11, 12 Health professionals may often be preoccupied with metabolic outcomes11 whereas people with diabetes have to achieve a balance between keeping well and living a normal life.13
Psychological distress or depression can affect a person’s motivation and ability to cope with self management of diabetes, including adhering to prescribed medications, appropriate diet, keeping active and monitoring blood glucose levels.14, 15
Fisher et al (2007)14 suggest that addressing personal and diabetes-related stress by reinforcing coping strategies and problem solving is likely to be more meaningful and effective than treatments specific to depression. Miller (2000)16 described how people with long term conditions respond to a variety of stressors that may impact on their ability to cope. Miller calls these various domains ‘power resources’. These power resources may be weakened by the experience of having a long term condition and through recognising and understanding what these power resources are, the nurse may be able to provide more useful and specific support. supporting a person with diabetes during periods of distress and low mood can be achieved by helping the patient to adopt coping skills and by helping them to recognise and manage stressors.
some of these techniques are borrowed from the cognitive behavioural therapy approach. They do require some skill and practice, but should be within the remit of motivated care providers for people with diabetes.17 screening for depression and diabetes-related distress requires sensitive questioning. A lead into asking about mood might begin with questions about how the person with diabetes feels about his/her diabetes. For example, asking questions such as: How are you finding living with diabetes? Do you think that the way you are feeling affects your self-care (such as healthy eating, monitoring and physical activity)? Are there other aspects of your life that are taking priority at the moment? Once this type of dialogue is established, it may then be appropriate to introduce some specific questions
that may help to identify any depressive illness. For example: During the past few weeks, have you often been bothered by feeling down, depressed or hopeless? During the past month, have you often been bothered by having little interest or pleasure in doing things? A more comprehensive assessment may need to be implemented at this stage. One useful way to help recognise depression is to use a system called FEsTIVAl. This is a list of common symptoms. If five or more of these symptoms are present for more than two weeks, it is likely that a depressive episode is occurring. The symptoms are as follows:
Feeling: depressed, sad, anxious or bored. Energy: tiredness, fatigue, everything seems an effort, slowed movements. sleep: waking during the night or too early in the morning. oversleeping or trouble getting to sleep. Thinking: slow thinking, poor concentration, forgetful or indecisive. Interest: loss of interest in food, work, sex and life generally. Value: reduced sense of self-worth, low self-esteem or guilt. Aches: headaches, chest or other pains or palpitations without a physical basis. live: not wanting to live or suicidal thoughts.
The best management depends on a person-centred approach to care, which enables openness and trust between the health professional and the person with diabetes.
Psychological distress can profoundly impact on diabetes self-management. There are no easy answers about why this is true. The stress of being diagnosed with a chronic condition, dealing with the daily management and never having a ‘day off’ from diabetes and feeling restricted in what you can eat and drink, can make a person with diabetes feel alone or set apart from family and friends who don’t have diabetes. If patients face diabetes complications such as nerve damage or are having trouble keeping their blood sugar levels within range, they may be finding it difficult to control their diabetes and this can make them feel frustrated and sad. For people with diabetes, depression can develop as a result of the lifestyle adjustments they have to make to control their diabetes. Managing diabetes can be stressful and time consuming and the dietary restrictions can make life seem less enjoyable. If a person is feeling depressed and has no energy, they may feel less motivated to eat healthy and take regular physical activity.
TrEATmENTThe outlook for people with diabetes and depression who seek treatment is very promising. The first step in getting help for depression is patients recognising that they may have a problem and discussing their symptoms with their GP or practice nurse. This is not necessarily as easy as it sounds. Depression can be stigmatised negatively and people can feel that they will not be understood and feel alone. Accepting the help of others can be a major hurdle to overcome. As healthcare professionals, we need to be approachable and be responsive to our patients needs.
Attending an Aware support Group offers the opportunity for those with depression to interact with other people in a similar situation. Aware also has a helpline (1890 303 302) that is a listening service for people affected by depression, either personally or as family and friends. Their website address is: www.aware.ie.
sTudy dAy – 11Th mArchTo find out more about diabetes and depression, the Diabetes Federation of Ireland is holding a multidisciplinary study day ‘The Ultimate Diabetes Toolkit to Enhance Cost-effective Management and Reduce Diabetes Related Complications’ in Croke Park March 11th 2011 with guest speaker Richard Holt, Professor in Diabetes & Endocrinology, University of southampton, talking about Diabetes and Depression – Double the Cost? Contact the Diabetes Federation of Ireland on 01-836 3022 or 1850 909 909 for further details.
based on the hAds scale, there was evidence of high levels of anxiety and depression symptoms in patients with diabetes.
34
clinical review
references1. De Groot M., Anderson R., Freeland K.E., Clouse R.E. and lustman P.J.
(2001) Association of depression and diabetes complications: a meta-analysis. Psychometric Medicine 63, 619-630.
2. Black s.A., Markides K.s. and Ray l.A. (2003) Depression predicts increased incidence of averse health outcomes in older Mexican Americans with type 2 diabetes. Diabetes Care 26, 2822-2828.
3. Ciechanowoski P.s. Katon W.J. and Russo J.l. (2000) Depression and diabetes: impact of depressive symptoms on adherence, function and costs. Archive International Medicine 160, 3278-3285.
4. Egede l.E. (2004) Diabetes, major depression and functional disability among Us adults. Diabetes Care 27, 421-428.
5. 5. Egede l.E. (2004) Effects of depression on work loss and disability bed days in individual with diabetes. Diabetes Care 27, 1751-1753.
6. Egede l.E. Nietert P.J. and zheng D. (2005) Depression and all-cause coronary heart disease mortality among adults with and without diabetes. Diabetes Care 28, 1339-1345.
7. zhang X., Norris s.l., Gregg E.W., Cheng y.J., Beckles G. and Kahn H.s. (2005) Depressive symptoms and mortality among patients with and without diabetes. American Journal of Epidemiology 161, 652-660.
8. Collins M.M.; Corcoran P. and. Perry I. J. (2009) Anxiety and depression symptoms in patients with diabetes. Diabetic Medicine 26, 153-161.
9. Anderson R.J., Clouse R.E., Freedland K.E. and lustman P.J. (2001) The prevalence of co morbid depression in adults with diabetes. A meta analysis. Diabetes Care 24(6), 1069 – 1078.
10. Rubin R.R., Ciechanowski P., Egede l.E., lin E.H. and lustman P.J. (2004) Recognizing and treating depression in patients with diabetes. Current Diabetes Reports 4(2), 119-125.
11. Alberti G. (2002) The DAWN (Diabetes Attitudes, Wishes and Needs) study. Practical Diabetes International 19, 22-24.
12. Pouwer F., Beekman A., lubach C. And snoek F. (2005) Nurses’ recognition and registration of depression, anxiety and diabetes-specific emotional problems in outpatients with diabetes mellitus. Patient Education and Counselling 60(2), 235-240.
13. Dunning T. (2009) Care of People with Diabetes. A Manual of Nursing Practice. 3rd edn. Wiley Blackwell, Chichester.
14. Fisher l., skaff M.M., Mullan J.T. et al (2007) Clinical depression vs distress among patients with type 2 diabetes. Not just a question of semantics. Diabetes Care 30, 542-548.
15. Gonzalez J.s., safren s.A. and Cagliero E. (2007) Depression, self-care and medication adherence in type 2 diabetes: relationships across the full range of symptom severity. Diabetes Care 30(9), 2222–2227.
16. Miller J.F. (2000) Coping with Chronic Illness: Overcoming Powerlessness. 3rd edn. FA Davis Company, Philadelphia.
morning session:chair: dr. diarmuid smith
8.30 registration
9.00 welcome and opening remarks
9.15 “The current toolbox of diabetes medications and their appropriate use” A review of older therapies and outline newer treatments with a focus on guidelines and algorithms. Ms. Li Wah Kyaw Tun, Clinical Pharmacist, AMNCH, Tallaght
9.45 “diabetes management and current drug expenditure –in the current climate where is the healthcare professional’s responsibility for cost-effective diabetes management?” Background to diabetes management and the economic impact of diabetes, in particular drug utilisation and expenditure trends in Ireland. Value of diabetes management. Professor Kathleen Bennett, Senior Lecturer, Department of Pharmacology & Therapeutics, St James’s Hospital, Dublin 8
10.30 coffee break
11.00 “Peer support in type 2 diabetes”summary of the results of a study testing Peer support for type 2 diabetes that was carried out in Irish general practices. several issues were highlighted that need to be considered before peer support is introduced widely. Dr Susan Smith, General Practitioner, Inchicore Medical Centre, Dublin 8
11.30 key Note speaker Diabetes and Depression – Double the cost? richard Ig holt, Professor in diabetes & Endocrinology, Faculty of MedicineUniversity of Southampton
12.45 lunch
Afternoon session: upskill your toolkit to enhance everyday management issues
chair: Professor Tomkin
1.45 “hoNk – a rare occurrence or an everyday management issue” Causes, risks and treatment goals Dr. Maeve Durkan, Consultant Physician in Diabetes and Endocrinology,Portiuncula Hospital, Ballinasloe, Co. Galway
2.30 “body Image and intimacy: The role of diabetes” Address negative body image intimacy and the powerful impact of diabetes. Ms. Clare Shaban, Consultant Clinical Psychologist, Bournemouth
3.00 “Engaging the client in their own dietary self management” skill’s to facilitate/ empower change in dietary habits and to encourage weight loss. look at ways to be more cost effective when making healthy choices. Ms. Sally-Ann Mc Laughlin, Senior Community Dietitian, HSE Dublin North East
3.30 closing remarks
multidisciplinary diabetes study day
Friday 11th march 2011hogan mezzanine suite, croke Park, dublin 3
‘The ultimate diabetes toolkit to enhance cost-effective management and reduce diabetes related complications’
Irish Endocrine Society
TREATING THE UNMET NEEDS AT EACH STEP OF DEPRESSION 1-5
73% of Patients achieve
Remission 4
76% of Patients achieve Response 3
Early improvement in moodand daytime functioning 1,2
-2
78% of Patients remain
Relapse-free 5
The f i r s t me l a t one r g i c an t i d ep r e s san tAgomelatineAgoAgoAgoAgoAgogomemelmelmelmelmelaaatine
Valdoxan (agomelatine) abbreviated prescribing information: Please refer to the Summary of Product Characteristics before prescribing. Presentation and composition: Valdoxan 25 mg fi lm-coated tablets. Indication: Treatment of major depressive episodes in adults. Dosage: Adults: The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime. Liver function tests should be performed in all patients at initiation of treatment and then periodically after around six weeks (end of acute phase), after around twelve and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated. Elderly (>65y): Effi cacy has not been clearly demonstrated in the elderly (≥ 65 years). Only limited clinical data is available on the use of Valdoxan in elderly patients ≥ 65 years old with major depressive episodes. Therefore, caution should be exercised when prescribing Valdoxan to these patients. Children and adolescents (<18y): Not recommended. Administration: taken as a single dose at bedtime. Patients with depression should be treated for a suffi cient period of at least 6 months to ensure that they are free of symptoms. Properties: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption. Agomelatine increases noradrenaline and dopamine release specifi cally in the frontal cortex and has no infl uence on the extracellular levels of serotonin. Contraindications: Hypersensitivity to the active substance or to any of the excipients, Hepatic impairment (eg cirrhosis or active liver disease), Concomitant use of potent CYP1A2 inhibitors (e.g. fl uvoxamine, ciprofl oxacin). Pregnancy
and lactation: For Valdoxan, no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing Valdoxan in pregnancy. It is not known whether Valdoxan is excreted into human milk. If treatment with Valdoxan is considered necessary, breastfeeding should be discontinued. Precautions: Valdoxan should not be used in elderly patients with dementia with depressive symptoms as safety and effi cacy has not been established in this group. Valdoxan should be used with caution in patients with a history of mania or hypomania and should be discontinued if a patient develops manic symptoms. Valdoxan contains lactose. The combination of Valdoxan and alcohol is not advisable. Patients with a history of suicide-related events or those exhibiting a signifi cant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. If any patient develops symptoms suggesting hepatic dysfunction liver function tests should be performed. The decision whether to continue the patient on therapy with Valdoxan should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed therapy should be discontinued. Drug Interactions: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fl uvoxamine, ciprofl oxacin) is contraindicated. Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine. While there was no specifi c safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, grepafl oxacine, enoxacine) until more experience has been gained. In vivo, agomelatine does not induce CYP450 isoenzymes. Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro. Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450. Adverse Events: In clinical trials, over 3,900 depressed patients have received Valdoxan. Adverse reactions were usually mild or moderate and occurred within the fi rst two weeks of treatment. The most common adverse reactions were nausea and dizziness. These adverse reactions were usually transient and did not generally lead to cessation of therapy. Adverse reactions are listed below using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), Common: headache, dizziness, somnolence, insomnia, migraine, nausea, diarrhoea, constipation, upper abdominal pain, hyperhidrosis, back pain, fatigue, increases (>3 times the upper limit of the normal range) in ALAT and/or ASAT (i.e. 1.1% on agomelatine 25/50 mg vs. 0.7 % on placebo), anxiety. Uncommon: paraesthesia, blurred vision, eczema. Rare: erythematous rash, hepatitis. Frequency not known: suicidal thoughts or behaviour Overdosage: There is limited experience with agomelatine overdose. During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products. Signs and symptoms of overdose were limited and included drowsiness and epigastralgia. No specifi c antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended. Presentation: Pack of 28 tablets of Valdoxan 25 mg See Summary of Product Characteristics for further details. Legal Category: POM. Marketing Authorisation Numbers and Holders: EU/1/08/499/003 Les Laboratoires Servier, 22 rue Garnier, 92200 Neuilly-sur-Seine, France. Date of Preparation or Last Review: February 2010. Full prescribing information is available from: Servier Laboratories, Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co Dublin. Tel: (01) 6638110, Fax (01) 6638120. Date of preparation of item: February 2010.
1. Kasper L et al. Eur Neuropsychopharmacol. 2008;18(suppl 4), Abstract P.2.c.022. 2. Lemoine P, Guilleminault C, Alvarez E. 2007; J Clin Psychiatry. 2007 ; 68 :1723-32. 3. Kennedy SH, Guilleminault C. Eur Neuropsychopharmacol. 2006;16(suppl 4):S319. Abstract P2.013. 4. Kennedy S, Rizvi S, Fulton K and Rasmussen J. J Clin Psychopharmacol. 2008;28(3):329-333. 5. Goodwin GM, Rouillon F, Emsley R. Eur Neuropsychopharmacol. 2008;17(suppl.4):S361-362. Abstract P2.c.038.
36
in practice
The Irish weather is known for its rain and wind particularly in the winter. To date the weather has taken us by surprise as it is the coldest snap in decades according to the met office. Ferocious weather has an enormous effect on our health,
mood, transport, mobility, down to whether or not most of us get to work or not. Cold weather has a marked effect on determining the quality of a simple blood sample from its journey out of the vein to the laboratory centrifuge.
With particular focus on potassium samples, pseudohyperkalaemia may arise from poor handling, storing and excessively warm or excessively cold weather. This impacts on clinical time and resources initiating repeat blood tests for the patient.
With the advances in computerisation some of us are lucky to be able to access our patient’s results more quickly via email.
The assessment of renal function, with U and E’s (urea and creatinine, sodium, and potassium) will form a significant percentage of them.
“severe hyperkalaemia is a life-threatening emergency as it may cause cardiac arrhythmias, leading to cardiac arrest. With these potentially catastrophic sequelae, urgent investigation and treatment of genuine hyperkalaemia is essential. “(Dr Carabine, 2008)
some of the common causes of hyperkalaemia include renal failure, metabolic acidosis and drugs such as potassium sparing diuretics, angiotensin converting enzyme inhibitors (ACE) and excess potassium therapy.
The practice nurse plays a major role in reducing room for error and avoiding a raised serum potassium that is inaccurate otherwise known as pseudohyperkalaemia.
Pseudohyperkalaemia is described as an artificially raised level of potassium occurring during the collection, storage, or transportation of blood specimens.
Minimising abnormal potassium levels (pseudohyperkalaemia) in cold weather and other conditionsDARINA lANE
30% of blood samples from general practice are reported as abnormal.
37
in practice
Causes include:• Difficult venepuncture• A clenched fist whilst the sample is taken• Cooling of the sample or the sample in excessive heat• A shaken or squirted sample through a needle into the
collection tube.Contamination with anticoagulant from another sample;
therefore, the ‘order of draw’ is important.Deterioration of the specimen due to the length of storage,
hence overnight storage should be avoided.Blood sample collection needs careful thought throughout
the chain of process to get the most accurate result. 30% of blood samples from general practice are reported as abnormal (Johnston and Hawthorne. 1997). The practice nurse needs to be aware that potassium levels are particularly sensitive to temperature.
Temperatures of 25-30°C cause s red cell stimulation and consequently results in a fall in serum potassium. (stuart and smellie 2007) During the summer season average laboratory results have been reported to fall by up to 0.5mmol. (Trull et al)
Higher temperatures in excess of 30°C or storage for long periods may lead to haemolysis of the sample. studies have shown that samples stored at 18°C for up to 16 hours maintain accurate potassium levels. (Masters et al. 1996) Each general practice has its own protocol as to how to deal with abnormal potassium results. In essence, a spurious result where there is any doubt, is a source of unnecessary and significant stress for both the doctor and the patient.
how practice nurses can improve standardsUse the recommended green 21 gauge needle and vacutainer for some samples – use of the black narrower needle carries the risk of hyperkalaemia secondary to damage of the red blood vessels.
Try to avoid using a needle and syringe as haemolysis can occur if syringes are used as the blood is squirted through the needle into the collection tube.
Biochemistry samples should always be taken first before collecting other samples. This is to avoid contamination from other sample bottles with additives, which would otherwise artificially raise potassium levels.
samples should be stored at room temperature.Avoid long storage times. Perhaps consider a policy of no
blood samples in the afternoon therefore avoiding the chance of overnight storage.
Once the samples leave the practice it is difficult to influence the process further. It is always useful to liaise with laboratory staff as a strict protocol has a win-win result for all. liasing with the courier who delivers the samples to the hospital may also be very productive.
summaryIn conclusion, it appears that clear advice and education regarding best practice, drawing, storing, and transporting blood samples is paramount in avoiding spuriously raised potassium results. Always ask yourself the following:• Have I noticed an abnormally raised number of bloods that
need to be repeated unnecessarily?• Have I got a protocol?• Could I improve my technique, blood storing and
transportation of blood samples?I know I can!
referencesJohnston, J.D Hawthorne, s.W. How to minimise fictitious hyperkalaemia in blood samples from general practice. British Medical Journal (1997) 314: p 1200.Masters, P.W., lawson N., Marenah. C.B., Maile, l.J. High ambient temperature: a spurious cause of hypokalaemia British Medical Journal (1996) 312: p. 1652-1653stuart, W., smellie, A. spurious hyperkalaemia. British Medical Journal (2007) 334: p 693-695Trull, A.K., Jackson. C., Walsh, s., Thornton, A., Culank, l.s., McHugh, J. The perennial problem with potassium. Annals of Clinical Biochemistry (2004) 41: p. 47-52
higher temperatures in excess of 30°c or storage for long periods may lead to haemolysis of the sample.
38
bursary
Abstract
backgroundPractice nurses have a key role in chronic disease management. There are no structured programmes in place specifically targeting patients with multimorbidity in Ireland. When programmes are in place the frequency of GP visits, hospital admissions, and acute episodes are reduced and patient satisfaction is increased.
This study aims to explore practice nurses’ perceptions of caring for patients (>65 years) with multimorbidity, in the Irish Primary Care – General Practice setting, with a view to informing practical methods of managing these patients.
The objectives were to:1. Identify existing services (if any) the study participants
provide, within their own practice, specifically for patients (>65years of age) with multimorbidity in this setting,
2. Elicit PN perceptions of caring for the patient with multimorbidity,
3. Identify potential methods of caring for this group of patients at a practice level,
4. Inform future research or initiatives for the management of multimorbidity.
methodsThe sampling frame was practice nurses from one region covered by the Irish Practice Nurses Association. This study used mixed methodologies for data collection. Preliminary data collection (quantitative) used postal questionnaires, gathering information on sample characteristics, and facilitating purposeful sampling to achieve maximum variation in qualitative data collection.
Because of the dearth of literature on the practice nurses’ perspective of managing multimorbidity, the main research design was qualitative using broad precepts of grounded theory. semi-structured interviews allowed an in-depth insight on which to develop recommendations for patient care and service delivery. sample size was determined by data saturation.
resultsThe response rate to the postal questionnaire was 68.9%. Eleven respondents were included in the qualitative analysis. limited resources such as Information Technology and Time were perceived as barriers to multimorbidity management.
Practical methods to improve care such as the establishment of accurate disease registers and practice protocols that address highly correlated comorbidities, as well as the teaching of patient self-management skills, and enhancing practice nurse education were seen as essential. Many elements of case management are already embedded in practice nurses’ roles. Awareness among healthcare providers and policy makers needs to be increased.
conclusionThe primary findings of this study are:• Firstly, a myriad of issues affect multimorbidity management.• secondly, PNs felt that many elements of case management
were already being done in primary care, but not given a title.
• Thirdly, PN education is vital to enable PNs to empower both themselves and patients by teaching the necessary skills for self-management.
• Fourthly, effective communication is key to quality care.• lastly, primary care is already running to full capacity.
Caution must be exercised to ensure the appropriate resources including time and IT are in place before new initiatives are implemented.With such an international and national focus on chronic
disease management comes the opportunity for advancing nursing practice and indeed, for nursing, as a profession, to lead the way in establishing a primary care based health service for patients with multimorbidity.
Winner of the IPNA Educational Bursary 2010
Multimorbidity – the practice nurse perspectiveJane campion
A FORCE AGAINST FRACTURE
Stopping oSteoclaStS before they reach the bone 1, 2
Introducing the first and only licensed RANK
Ligand inhibitor that works throughout the skeleton
to protect women with postmenopausal osteoporosis
from osteoporotic fracture.3
Prolia® (denosumab) Brief Prescribing Information
Amgen (Europe) GmbHDammstrasse 23, CH-6301 Zug, Switzerland.
GlaxoSmithKline,980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.Reference: 1. Prolia® Summary of Product Characteristics, 2010 2. Kostenuik PJ,. Curr Opin
Pharmacol 2005;5:618-625 3. Cummings SR et al N Engl J Med 2009:361;756-765
Please refer to the Summary of Product Characteristics before prescribing PROLIA®. Pharmaceutical Form: Pre-filled syringe with automatic needle guard containing 60 mg of denosumab in 1 ml solution for injection for single use only. Contains sorbitol (E420). Indication: Treatment of osteoporosis in postmenopausal women at increased risk of fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Dosage and Administration: 60 mg PROLIA® administered as a subcutaneous injection once every 6 months. Patients must be supplemented with calcium and vitamin D. No dosage adjustment is required in patients with renal impairment. Insufficient data to recommend use of PROLIA® in children under 18 years of age. Contraindications: Hypocalcaemia or hypersensitivity to the active substance or to any of the product excipients. Special Warnings and Precautions: Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiation of therapy. Monitoring of calcium levels is recommended for patients predisposed to hypocalcaemia. Patients receiving PROLIA® may develop skin infections (predominantly cellulitis) requiring hospitalisation and if symptoms develop then they should contact a health care professional immediately. Osteonecrosis of the jaw (ONJ) has been reported with denosumab or bisphosphonates. ONJ has been reported
rarely with PROLIA® 60 mg every 6 months. A dental examination should be considered prior to treatment with PROLIA® in patients with concomitant risk factors (refer to SmPC). While on treatment, these patients should avoid invasive dental procedures if possible. Good oral hygiene practices should be maintained during treatment with PROLIA®. The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause allergic reactions. Patients with rare hereditary problems of fructose intolerance should not use PROLIA®. Interactions: No interaction studies have been performed with PROLIA®. There are no clinical data on the co-administration of denosumab and hormone replacement therapy (HRT), however the potential for pharmacodynamic interactions would be considered low. Pharmacokinetics and pharmacodynamics of PROLIA® were not altered by previous alendronate therapy. Pregnancy and lactation: There are no adequate data on the use of PROLIA® in pregnant women and it is not recommended for use in these patients. Animal studies have indicated that the absence of receptor activator of nuclear factor κB ligand (RANKL) could interfere with the development of lymph nodes in the foetus and could lead to impairment of dentition and bone growth. A risk/benefit decision should be made in patients who are breast feeding. It is unknown whether denosumab is excreted in human milk.
Animal studies have indicated that the absence of RANKL during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum. No data are available on the effect of PROLIA® on human fertility. Undesirable Effects: In clinical studies the following undesirable effects were observed: Common (≥ 1/100 to < 1/10) included urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash and pain in extremity. Uncommon (≥ 1/1000 to < 1/100): Skin infections requiring hospitalisations were reported in 0.4% vs. 0.1% of postmenopausal women receiving PROLIA® and placebo respectively. Rare (≥ 1/10,000 to < 1/1,000): In the osteoporosis clinical trial program (8710 patients treated ≥ 1 year) ONJ was reported rarely with PROLIA®. Hypocalcaemia (< 1.88 mmols/l) was reported rarely (0.05% of patients) in two phase III trials. In prostate cancer patients receiving androgen deprivation therapy, cataracts were reported more frequently in the PROLIA® patients compared with placebo (4.7% vs. 1.2% respectively). There was no imbalance of cataracts observed in postmenopausal women with osteoporosis or in women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer. In prostate cancer patients receiving androgen deprivation therapy, an imbalance in reports of diverticulitis was observed in PROLIA® patients compared with placebo (1.2% vs. 0% respectively). The
incidence of diverticulitis was comparable between treatment groups in postmenopausal women with osteoporosis or women undergoing aromatase inhibitor therapy for nonmetastatic breast cancer. Please consult the Summary of Product Characteristics for a full description of undesirable effects. Pharmaceutical Precautions: PROLIA® must not be mixed with other medicinal products. Store at 2°C to 8°C (in a refrigerator). PROLIA® may be exposed to room temperature (up to 25°C) for a maximum single period of up to 30 days in its original container. Once removed from the refrigerator PROLIA® must be used within this 30 day period. Do not freeze. Keep in outer carton to protect from light. Legal Category: POM. Presentation and Marketing Authorisation Number: PROLIA® 60 mg: Pack of 1 pre-filled syringe with automatic needle guard; EU/1/10/618/003. Marketing Authorisation Holder: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands. Further information is available from Amgen Limited, 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD. Prolia® is a registered trademark of Amgen Inc. Date of PI preparation: May 2010.
DMB-IRL-AMG-134-2010072010Prolia2769© 2009 Amgen, Zug, Switzerland.All rights reserved.
IE_Prolia_Ad_Medical Independent_273x395_20sep2010.indd 1 20.09.2010 08:39:53
Rememberthis is a SwallowTablet!
his iswwSwallow
T bl t
Convenient to take
20% more calcium than the market leader1
ABBREVIATED PRESCRIBING INFORMATION(Please refer to Summary of Product Characteristics before prescribing)
CALTRATE* 600 mg/400 IU, fi lm-coated tabletPresentation: Each tablet contains 600 mg of calcium (as calcium carbonate) & 10 micrograms of cholecalciferol (equal to 400 IU vitamin D3). Contains sucrose & partially hydrogenated soya bean oil. Indications: Correction of combined vitamin D & calcium defi ciencies in the elderly. As an adjunct to specifi c treatments for osteoporosis, in patients where combined vitamin D & calcium defi ciencies have been diagnosed or those at high risk of defi ciency. Dosage & Administration: Adults & Elderly: One tablet twice a day (morning/evening). Pregnant women One tablet a day. Oral (Swallow with 200mls water). The elderly or patients with known diffi culties in swallowing, may break the tablet into two parts before taking with water. Do not suck or chew. Contraindications: Hypersensitivity to any ingredients including peanut or soya. Patients who now have, or have had renal failure, kidney stones, hypervitaminosis D, hypercalciuria & hypercalcaemia & diseases &/or conditions that lead to hypercalcaemia &/or hypercalciuria. Precautions: In prolonged treatment, check calcaemia & renal function, particularly in the elderly (see interactions). If renal function deteriorates, the dose must be reduced or treatment interrupted. Caution is advised in immobile patients. This product contains vitamin D; further administration of vitamin D or calcium must be medically supervised with regular monitoring of calcaemia & calciuria. Patients with sarcoidosis calcaemia & calciuria must be monitored. Risk of soft tissue calcifi cation must be considered. In severe renal insuffi ciency, vitamin D3 as cholecalciferol is not metabolised normally & other forms of vitamin D3 must be used. Cases of asphyxiation due to tablet choking have been reported. This product contains sucrose; patients with sugar intolerance should not take this medicine. Not intended for use in children & adolescents. Interactions: Thiazide diuretics & systemic corticosteroids (calcium monitoring required). Orlistat, combined ion-exchange resins (cholestyramine) or laxatives (paraffi n oil) can reduce the GI absorption of vitamin D3. Take tetracycline 2 hours before or 4 to 6 hours after taking calcium. Cardiac glycosides (monitor patients regularly with ECG check & calcaemia). Phenytoin or barbiturates (may reduce the activity of vitamin D3). Iron, zinc or strontium preparations, estramustin or thyroid hormones should be spaced at least 2 hours from calcium medicines. Bisphosphonate, sodium fl uoride or fl uoroquinolone administration, Caltrate should be spaced by at least 3 hours from these medicines. Oxalic acid (found in spinach & rhubarb) & phytic acid (found in wholegrain cereals) can inhibit calcium absorption by forming insoluble compounds with calcium ions. Patients must not take calcium containing-products in the two hours after consumption of foods rich in oxalic acid & phytic acid. Pregnancy & lactation: Caltrate may be used during pregnancy & breastfeeding. Daily intake in pregnancy should not exceed 1500mg calcium & 600IU cholecalciferol. Avoid prolonged use as hypercalcaemia can aff ect the developing foetus. Calcium & vitamin D3 pass into breast milk, this should be considered when vitamin D3 is given concomitantly to infants. Side-eff ects: Hypercalcaemia, hypercalciuria, constipation, fl atulence, nausea, abdominal pain, diarrhoea, pruritis, rash & urticaria. Legal Category: P. Pack Size: 90 tablets. PAH: Whitehall Laboratories Ltd T/A Pfi zer Consumer Healthcare, Sandwich, Kent, CT13 9NJ, United Kingdom. PA number: PA172/38/1. Further information is available upon request from Pfi zer Consumer Healthcare Ltd., Citywest, Dublin 24. or look up, www.medicines.ie PCRS Reimbursable. Date of preparation: December 2009. References: 1. MIMS Ireland Dec ‘10, Pg 245.
Jan 11 Ref: Ca 09 108 Med. * Trade Mark.
calcium & vitamin D3
for longer lasting bones
41
abstracts
Assessment of postmenopausal women and significant risk factors for osteoporosis
schnatz PF, marakovits kA,
o’sullivan dmObstet Gynecol Surv 2010
sep; 65 (9): 591-6
The assessment of osteoporosis risk factors can help guide early intervention. The objec-tive of this Us study from the Department of Obstetrics, Reading Hospital and Medical Center, was to analyse numerous potential risk factors to see which were associated with postmenopausal osteoporosis.
Women aged 49 or greater presenting for dual-energy x-ray absorptiometry bone scans were recruited from radiology sites in the Hartford, Connecticut area between January 2007 and March 2009, inclusive. Information was collected regarding primary and secondary risk factors for osteoporosis development, as well as family history and history of pregnancy and breastfeeding.
survey results were subsequently correlated with each woman’s dual-energy x-ray absorptiometry scan results. In a sample of 619 women, history of fracture (odds ratio [OR], 12.49), weight less than 127 pounds (OR, 3.50) and use of anticoagulants (OR, 5.40) increased the chance of developing osteoporosis.
In contrast, multiparity (OR, 0.45) and history of breastfeeding (OR, 0.38) decreased the development of osteoporosis in postmenopausal women.
In women aged 49 to 54, breastfeeding was significantly protective, while low body mass index was most indicative of osteoporosis in women aged 55 to 64. Both previous fracture and low body mass index were associated with osteoporosis in women over the age of 64.
The current results are consistent with other studies suggesting that previous fracture, low body weight and use of anticoagulants increase the risk of osteoporosis. The results also suggest that a history of pregnancy and breastfeeding protects against the development of postmenopausal osteoporosis, especially in women aged 49 to 54.
Women with cardiovascular disease have increased risk of osteoporotic fracture
chen Js, hogan c,
lyubomirsky g, sambrook PNCalcif Tissue Int
4 November 2010
This Australian study from the Kolling Institute of Medical Research, sydney Medical school, investigated whether women with cardiovascular disease (CVD) would have an increased risk of fractures as osteoporosis and CVD share many common risk fac-tors.
From February 2006 to January 2007, 17,033 women aged ≥50 years (mean 71.8, range 50-106) were recruited by 1,248 primary care practitioners and interviewed by trained nurses.
For each woman, 10-year probability of a future major osteoporotic fracture was estimated using the World Health Organisation’s Fracture Risk Assessment Tool (FRAX). The study showed that the 10-year probability of a major osteoporotic fracture was higher for the 6,219 CVD women compared to the 10,814 non-CVD women after adjustment for age, BMI, current smoking and alcohol use (adjusted geometric means 14.3 and 13.8%, respectively; p<0.001).
With regard to high risk of fracture (i.e. 10-year probability ≥ 20 per cent), the adjusted odds ratio for CVD was 1.23 (95 per cent CI 1.13-1.35, p<0.001). However, compared to non-CVD women, CVD women were more likely to report a previous fracture, to have a secondary osteoporosis and to use glucocorticoids.
Among the 4,678 women who were classified as having a high fracture risk, the current use rate of bone-related medications (i.e. any one of bisphosphonates, raloxifene, PTH, vitamin D, calcium or hormone therapy) was 50.2 per cent in the CVD group and 56.9 per cent in the non-CVD group.
Women with CVD were at increased risk of fracture partly due to bone-specific risk factors, such as history of previous fracture, use of glucocorticoids and secondary osteoporosis. This risk is not being treated appropriately by primary health physicians.
focus on: osteoporosis
42
abstracts
implementation of osteoporosis guidelines: a survey of five large fracture liaison services in the netherlands
Jhuntjens km, van geel TA,
blonk mc et al
Osteoporos Int 4 November 20101
The implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at a Fracture liaison service (Fls) was evaluated. Despite one guideline, all Flss differed in the performance of patient selection and prevalence of clinical risk factors (CRFs), indicating the need for more concrete and standardised guidelines.
The aim of this study from the Department of Trauma surgery, Maastricht University Medical Centre, The Netherlands, was to evaluate the implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at Flss in the Netherlands.
Five Flss were contacted to participate in this prospective study. Patients older than 50 years with a recent clinical fracture who were able and willing to participate in fracture risk evaluation were included. Performance was evaluated by criteria for patient recruitment, patient characteristics, nurse time, evaluated CRFs, bone mineral density (BMD) and laboratory testing and results of CRFs and BMD were presented.
Differences between Flss were analysed for performance (by chi-square and student’s t test) and for prevalence of CRFs (by relative risks [RR]).
All Flss had a dedicated nurse spending 0.9 to 1.7 hours per patient. During 39 to 58 months follow-up, 7,199 patients were evaluated (15 to 47 patients/centre/month; mean age, 67 years; 77 per cent women).
Major differences were found between Flss in the performance of patient recruitment, evaluation of CRFs, BMD and laboratory testing, varying between 0 per cent and 100 per cent. The prevalence of CRFs and osteoporosis varied significantly between Flss (RR between 1.7 and 37.0, depending on the risk factor).
All five participating Flss with a dedicated fracture nurse differed in the performance of patient selection, CRFs and in the prevalence of CRFs, indicating the need for more concrete and standardised guidelines to organise evaluation of patients at the time of fracture in daily practice.
Low bone mineral density in rotating-shift workers
Quevedo I, zuniga Am
J Clin Densitom 2010 Oct-Dec;
13 (4): 467-9
shift workers have been reported to have an increased bone resorption. However, no existing evidence indicates lower bone mineral density (BMD) in this group.
The objective of this Chilean study from the Division of Endocrinology, University of Concepcion, was to test the hypothesis that a rotating-shift work schedule is associated with low BMD and osteoporosis.
The authors evaluated 70 postmenopausal nurses from the Naval Hospital in Concepcion. The participants were categorised according to the type of work schedule: 39 had a rotating shift and 31 were daytime workers.
Medical history, a health examination, a questionnaire on health-related behaviors and biochemical determinations, and BMD examination were obtained for all participants.
When comparing the two groups, the rotating-shift workers had lower BMD in the lumbar spine (l1-l4: 0.957 ± 0.15 versus 1.104 ± 0.13; p<0.05) and lower bone density in both femoral neck bones (right: 0.936 ± 0.17 versus 1.06 ± 0.12; p<0.05 and left: 0.956 ± 0.19 versus 1.05 ± 0.12; p<0.05).
Additionally, the T-scores for 10 (25.6 per cent) of the rotating-shift workers indicated osteoporosis at lumbar spine (T-score>-2.5). No evidence of osteoporosis was found for daytime workers.
When comparing the two groups, the rotating-shift workers had a higher prevalence of osteopenia (T-score=-1.0 to – 2.5) than the daytime workers: 46.2 per cent versus 35.5 per cent, respectively.
The authors found significant evidence that rotating-shift workers have lower BMD in the trabecular and cortical bones, thus suggesting that this type of work may be a risk factor for osteoporosis. Due to the fact that this is the first time that this osteoporosis risk factor has been reported, the association needs to be replicated and confirmed in other settings.
focus on: osteoporosis
Help Protect Your Post-Menopausal Patients From OsteoporoticFractures With 5600 IU
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Updated NOF a guidelines recommend 800–1000 IU of vitamin D per day for adults ≥50 years 5
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FOSAVANCE® 70 mg/2800 IU Tablets (70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3)FOSAVANCE® 70 mg/5600 IU Tablets (70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3)ABRIDGED PRODUCT INFORMATION Refer to Summary of Product Characteristics before prescribing.PRESENTATION FOSAVANCE®70 mg/2800 IU Tablets. Capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side, and ‘710’ on the other, containing 70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3). FOSAVANCE® 70 mg/5600 IU Tablets Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other, containing 70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3). USES Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency and for 'Fosavance' 5600 for patients not receiving Vitamin D supplementation. ‘Fosavance’ reduces the risk of vertebral and hip fractures. DOSAGE AND ADMINISTRATION The recommended dosage is one- tablet once weekly. Due to the nature of the disease process in osteoporosis, ‘Fosavance’ is intended for long-term use. Patients must be advised to follow the instructions below: For adequate absorption of alendronate: ‘Fosavance’ must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate. The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation and related reactions:• Swallow ‘Fosavance’ only upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.).• Patients should only swallow FOSAVANCE whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.• Do not lie down until after the first food of the day which should be at least 30 minutes after taking the tablet.• Do not lie down for at least 30 minutes after taking ‘Fosavance’.• Do not take at bedtime or before rising for the day.Patients should receive supplemental calcium if intake from diet is inadequate. Additional supplementation with vitamin D should be considered on an individual basis taking into account vitamin D intake from vitamins and dietary supplements. Equivalence of 2800IU of vitamin D3 weekly in ‘Fosavance’ to daily dosing of vitamin D 400 IU has not been studied. Equivalence of intake of 5600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied. Use in the elderly: No dosage adjustment is necessary. Use in renal impairment: No dosage adjustment is necessary for patients where GFR is greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where GFR is <35 ml/min. Use in children and adolescents: Not recommended. CONTRAINDICATIONS Oesophageal abnormalities and other factors which delay oesophageal emptying, such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to alendronate or to any of the excipients. Hypocalcaemia. PRECAUTIONS Alendronate can cause local irritation of the upper gastro-intestinal mucosa and potentially worsen any underlying disease. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, or ulcers, or with a recent history (within the previous year) of gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty. In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis. Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal strictures, have been reported in patients receiving alendronate. Physicians should be alert to any signs or symptoms of a possible oesophageal reaction, and patients should be instructed to discontinue alendronate and seek medical atten-tion if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain, or new or worsening heartburn. The risk of severe oesophageal adverse reactions appear to be greater in patients who fail to take alendronate properly and/or continue to take alendronate after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient. Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. While no increased risk was observed in extensive clinical trials with alen-dronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticos-teroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease). While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgment of the treating physician should guide the management plan of each patient based on individu-al benefit/risk assessment. Bone, joint and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating. The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate. Stress fractures (also known as insufficiency fractures) of the proximal femoral shaft have been reported in patients treated long-term with alendronic acid (time to onset in the majority of cases ranged from 18 months to 10 years). The fractures occurred after minimal or no trauma and some patients experienced thigh pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures were often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures was also reported. Discontinuation of bisphosphonate therapy in patients with stress fracture is advisable pending evaluation of the patient, based on an individual benefit risk assessment.
Patients should be instructed that if they miss a dose of ‘Fosavance’ , they should take one tablet on the morning after they remember. They should not take two tablets on the same day, but should return to taking one tablet once a week, as originally scheduled on their chosen day. Cause of osteoporosis other than oestrogen deficiency and ageing should be considered. Hypocalcaemia must be corrected before initiating therapy with 'Fosavance'. Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting 'Fosavance'. The content of vitamin D in ‘Fosavance’ is not suitable for correction of vitamin D deficiency. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ‘Fosavance’. Due to the positive effects of alendronate in increas-ing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. Colecalciferol: Vitamin D3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). Urine and serum calcium should be moni-tored in these patients. Patients with malabsorption may not adequately absorb vitamin D3. Excipients: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take ‘Fosavance’.Drug interactions If taken at the same time, it is likely that food, beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product. Since NSAlD use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate. Colecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis. Use in pregnancy and lactation: 'Fosavance' is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women. There are no adequate data from the use of 'Fosavance' in pregnant women. It is not known whether alendronate is excreted into human breast milk. Colecalciferol and some of its active metabolites pass into breast milk. SIDE EFFECTS The following adverse experiences have been reported during clinical studies and/or post-marketing use of alendronate. No new adverse reactions have been identified for ‘Fosavance’. Common (≥ 1.0% and <10%) Gastro-intestinal disorders: Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation. Musculoskeletal and connective tissue: Musculoskeletal (bone, muscle or joint) pain. Nervous system disorder: Headache. Uncom-mon (≥ 0.1% and <1%) Gastro-intestinal disorders: Nausea, melaena, vomiting, gastritis, oesophagitis, oesophageal erosions. Skin and subcutaneous tissue disorders: Rash, pruritus, erythema. Rare (≥ 0.01% and <0.1%) Immune system disorder: Hypersensitivity reactions including urticaria and angioedema. General disorders and administrative site conditions: Transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment. Metabolism and nutrition disorders: Symptomatic hypocalcaemia, often in association with predisposing conditions. Gastro-intestinal disorders: Oesophageal stric-ture, oropharyngeal ulceration, upper gastro-intestinal PUBs (perforation, ulcers, bleeding). Skin and subcutaneous tissue disorders: Rash with photosensitivity. Eye disorders: Uveitis, scleritis, episcleritis. Very rare (<0.1%) Skin and subcutaneous tissue disorders: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Post-marketing experience: The following reactions have been reported (frequency unknown) during post-marketing experience: Nervous system disorders: dizziness, dysgeusia. Ear and labyrinth disorders: vertigo. Skin and subcutaneous tissue disorders: alopecia. Musculoskeletal, connective tissue and bone disorders: Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates. The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis. Osteone-crosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelitis). Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors; joint swelling, stress fractures of the proximal femoral shaft. General disorders and administration site conditions: asthenia, peripheral oedema. Laboratory test findings In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking alendronate 10 mg/day versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to < 8.0 mg/dl (2.0 mmol/l) and serum phosphate to ≤ 2.0 mg/dl (0.65 mmol/l) were similar in both treatment groups. PACKAGE QUANTITIES ‘Fosavance’ 70 mg/2800 IU Tablets 4 tablets.‘Fosavance’ 70 mg/5600 IU Tablets 4 tablets. POM Date of review: November 2009. Marketing Authorisation numbers: ‘Fosavance’ 70 mg/2800 IU Tablets, EU/1/05/310/002. ‘Fosavance’ 70 mg/5600 IU Tablets, EU/1/05/310/007. Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. ® denotes registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A © Merck Sharp & Dohme Limited 2009. All rights reserved. API.FOS. (II/13) Nov 09 Additional prescribing information available on request or from www.medicines.ie References: 1. Data on file, MSD 2. Liberman UA, Hochberg MC, Geusens P, et al. Hip and nonspine fracture risk reductions among antiresorptive agents: evidence from randomised controlled trials. Int J Clin Pract. 2006;60:1394–1400. 3. Cranney A, Guyatt G, Griffith L, et al. IX: Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev. 2002;23:570–578. 4. Papapoulos SE, Quandt SA, Liberman UA, et al. Metaanalysis of the efficacy of alendronate for the prevention of hip fractures in postmenopausal women. Osteoporos Int. 2005;16:468–474. 5. NOF Scientific Statement. National Osteoporosis Foundation’s Up-dated Recommendations for Calcium and Vitamin D3 Intake, October 2008. Available at www.nof.org/prevention/calcium_and_VitaminD.htm. Accessed 9 September 2009. a NOF=National Osteoporosis Foundation.
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
44
abstracts
A team approach: implementing a model of care for preventing osteoporosis-related fractures
giles m, van der kallen J,
Parker v et alOsteoporos Int
3 November 2010
The implementation of a multidisciplinary team-based model of care has led to significant increases in identification of patients with osteoporosis who are at risk of refracture, together with improved treatment uptake and ongoing management.
Osteoporosis-related fractures and consequent hospital admissions are largely preventable; however, little attention has been paid to how to achieve this, in particular, through improved models of care. Presentation to emergency departments (ED) with minimal trauma fracture (MTF) provides opportunity for patients at risk to be identified, referred and managed through a systematic process ensuring prompt intervention and continuing follow-up.
This Australian study from the John Hunter Hospital, Newcastle, was aimed to design and implement a care model for people over 50 years of age, presenting to ED with an MTF.
A multidisciplinary fracture prevention team to identify and capture at-risk patients for referral and management was established. Clinical data revealed the extent of lost opportunities. An electronic flagging system and data acquisition tool were developed and piloted. A referral pathway to detect, manage and follow-up patients was also established which was coordinated by a fracture prevention nurse.
Increased awareness of osteoporosis as a cause of MTF, better identification of at-risk patients across departments and services and the development of a referral protocol has resulted in 100 per cent capture of at-risk patients presented to ED. As a result, there has been a significant increase in patients attending the fracture prevention clinic (p< 0.001) from 11 per cent in 2007 to 29 per cent in 2008 and a significantly reduced time between fracture and when patients were seen in the fracture prevention clinic (p< 0.001).
The authors found that a multipronged systematic team approach to identifying and capturing patients with a high risk of refracture and a dedicated nurse coordinator role have created efficiencies in the detection and management of osteoporosis.
can self-reported height and weight be used to calculate 10-year risk of osteoporotic fracture?
bridges mJ, ruddick s
J Nutr Health Aging 2010 Aug;
14 (8): 611-3
The objectives of this UK study from the Department of Rheumatology, County Durham and Darlington Foundation Trust were: to determine the magnitude of error between self-reported height and weight and measured height and weight; and to measure what affect this has on calculating 10-year probability of osteoporotic fracture using the World Health Organisation’s Fracture Risk Assessment Tool (FRAX).
The data were collected from a nurse-led community osteoporosis clinic and involved 214 post-menopausal women with at least one risk factor for osteoporosis.
Collected data included self-reported and measured height and weight, risk factors for oste-oporosis, demographic details and 10-year probability of hip fracture or any major osteoporotic fracture as measured by FRAX.
It was found that patients over-reported their height by a mean (95 per cent confidence interval) of 2.8 (2.3-3.2) cm and under-reported their weight by a mean of 2.1 (1.3-2.6) kg. The resulting underestimation of body mass index was 1.8 (1.3-2.0) units.
Using self-reported height and weight resulted in a significant over-estimation of 10-year risk of hip fracture and any major osteoporotic fracture when compared to measured height and weight; median 10-year probability of hip fracture 3.75 per cent versus 3.25 per cent (p<0.001), median 10-year probability of any major osteoporotic fracture 15 per cent versus 14 per cent (p<0.001).
When calculating 10-year risk of fracture using the FRAX online assessment tool, measured height and weight should be used instead of self-reported height and weight.
focus on: osteoporosis
Calcium and/or vitamin D deficiency in the elderly can lead to lossof muscle tone and an increase in falls and osteoporotic fractures.1-5
Calcichew-D3 Forte is indicated for the treatment and prevention of calcium and vitamin D deficiency.6
CALCICHEW-D3 FORTE CHEWABLE TABLETS PRESCRIBINGINFORMATION(Please refer to full Summary of Product Characteristics whenprescribing)Presentation: Chewable tablet containing 1250mg calcium carbonate(equivalent to 500mg of elemental calcium) plus 400IU colecalciferol(equivalent to 10 micrograms vitamin D3). Uses: Treatment andprevention of vitamin D/calcium deficiency. Supplementation ofvitamin D and calcium as an adjunct to specific therapy forosteoporosis, in pregnancy, in established vitamin D dependentosteomalacia and in other situations requiring therapeuticsupplementation of malnutrition. Dosage and administration: Oral(suck or chew). Adults and elderly: Two tablets daily. Children: Notintended for use in children. Hepatic impairment: No dose adjustmentrequired. Renal impairment: Should not be used in patients withsevere renal impairment. Contraindications: Diseases and/orconditions resulting in hypercalcaemia and/or hypercalciuria, renalstones, hypervitaminosis D, hypersensitivity to ingredient(s) especiallysoybean oil and peanut. Precautions: Monitor serum calcium andcreatinine levels, particularly in elderly patients on cardiac glycosidesor diuretics and in patients with high tendency to calculus formation.Use with caution in patients with impaired renal function. Take intoaccount risk of soft tissue calcification. Avoid in patients with
phenylketonuria or sugar intolerance. Prescribe with caution inpatients with sarcoidosis. Use with caution in immobilised patients.Additional doses of calcium or vitamin D should only be taken underclose medical supervision. Interactions: Tetracyclines (take 2 hoursbefore, or 4 to 6 hours after Calcichew-D3 Forte), bisphosphonates orsodium fluoride (take 3 hours before Calcichew-D3 Forte), thiazidediuretics, corticosteroids, cardiac glycosides, ion exchange resins(cholestyramine), laxatives (paraffin oil). Calcichew-D3 Forte shouldnot be taken within 2 hours of eating foods high in oxalic acid (e.g.spinach and rhubarb) or phytic acid (e.g. whole cereals). Side effects:Hypercalcaemia, hypercalciuria, constipation, flatulence, nausea,abdominal pain, diarrhoea, pruritus, rash, urticaria. Use in pregnancyand lactation: Can be used in case of calcium and vitamin Ddeficiency. Daily intake in pregnancy should not exceed 1500mgcalcium and 600IU colecalciferol (15 micrograms vitamin D3). Avoidoverdose as permanent hypercalcaemia affects developing foetus.Calcium and vitamin D3 pass into breast milk so consider this whengiving additional vitamin D to the child. Pharmaceuticalprecautions: Do not store above 30°C. Keep container tightly closed.Legal category: Pharmacy product. Product Authorisation No:535/1/3. Product Authorisation holder: Shire Pharmaceuticals Ltd.,Hampshire International Business Park, Chineham, Basingstoke,Hampshire RG24 8EP UK. Distributed in Republic of Ireland by: Cahill
May Roberts, P.O. Box 1090, Chapelizod, Dublin 20, Republic ofIreland. Further information is available on request. Date of revision:July 2007. CALCICHEW is a registered trademark of Shire Pharmaceuticals Ltd inthe Republic of Ireland.
Adverse events should be reported to the PharmacovigilanceUnit at the Irish Medicines Board (IMB)([email protected]). Information about adverseevent reporting can be found on the IMB website(www.imb.ie). Adverse events may also be reported to ShirePharmaceuticals Ltd on +44 1256 894000.
References: 1. Perez-Lopez FR. Maturitas 2007;58: 117-137. 2. Dawson-Hughes B & Bischoff-Ferrari HA. J Bone Miner Res 2007; 22: S2; v59-v63.3. Lin JT & Lane JM. Phys Med Rehabil Clin N Am 2005; 16: 109-128.4. Heaney RP. Endocrinology and Metabolism Clinics 1998; 27(2): 255-265. 5. Hunter DJ & Sambrook PN. Arthritis Res 2000; 2(6): 441-445.6. Calcichew-D3 Forte. Summary of Product Characteristics. July 2007. 7. MIMS May 2010.
Date of preparation: April 2010. Item Code: IRE/CDF/10/0008
Their strength is our forte
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46
product news
Miramel (Pramipexole) 0.088mg, 0.18mg and 0.70mg tablets
Clonmel Healthcare has announced the launch of Miramel (Pramipexole) 0.088mg, 0.18mg & 0.70mg tablets. This product will join our other medicine product listings within the Ethical Prescription Division of Clonmel Healthcare.
Miramel is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease through to the late stages. Miramel is indicated for the symptomatic treatment of moderate to severe idiopathic Restless legs syndrome in dosages up to 0.54mg of base (0.75mg of salt).
Miramel 0.088mg, 0.18mg & 0.70mg tablets are 41% cheaper than the brand leader.
Miramel 0.088mg, 0.18mg & 0.70mg tablets are available on the GMs from 1st January 2011.
GMs codes for Miramel tablets are:Miramel 0.088mg – 33636Miramel 0.18mg – 33637Miramel 0.70mg – 33638 Full prescribing information is available on request or go to
www.clonmel-health.ie .Product is subject to prescription. Please contact Clonmel
Healthcare on 01-6204000 if you require any additional information on Miramel (Pramipexole) 0.088mg, 0.18mg & 0.70mg tablets.
Rivaroxaban significantly reduces risk of stroke in patients with atrial fibrillation
Bayer has announced the results from the pivotal, double-blind Phase III, ROCKET AF trial. In the study, rivaroxaban demonstrated superiority to warfarin in reducing the risk of stroke and non-CNs systemic embolism in patients with atrial fibrillation (AF) who take their medication. Importantly, rates of bleeding were similar to warfarin, and bleeding events most concerning to physicians and patients, including intracranial haemorrhage, critical organ bleed, and bleeding-related death, were significantly lower in the rivaroxaban group. The results were presented as a late-breaker at the American Heart Association scientific sessions 2010 in Chicago, UsA. Commenting on the significance of the study results Prof David Keane, Consultant Cardiologist, st Vincent’s University Hospital, Dublin said: “AF and stroke devastate the lives of thousands of Irish patients and their families every year. Whilst anticoagulation with warfarin is effective in preventing strokes in patients with AF, it has been the standard of care for more than half a century and its use in clinical practice is associated with many limitations. Disappointingly, aspirin has been found to offer only minimal protection from stroke in patients with atrial fibrillation. “Considering the well-known challenges associated with warfarin it is exciting to be able to offer patients an alternative therapy with comparable safety and without an increase in significant bleeding. “The ROCKET AF study has shown that once-daily rivaroxaban promises patients improved protection from stroke, with good safety and added convenience.”
Valdoxan – innovation for the treatment of depression in primary care
The official primary care launch of Valdoxan (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive disorders (MDD) was announced recently.
After several decades of a single, monoaminergic approach to the treatment of depression, Valdoxan’s unique mechanism of antidepressant action represents a novel and totally innovative pharmacological approach to treating MDD – effectively resynchronising the circadian (sleep) rhythms of depressed patients.
speaking at the first of a series of primary care meetings held throughout Ireland focussing on innovation in the treatment of depression to mark the launch of Valdoxan, Professor sidney Kennedy, Professor of Psychiatry, University of Toronto, Canada discussed the products mode of action:
“Valdoxan is the first antidepressant that simultaneously acts as a MT1 and MT2 melatonergic receptors agonist and a 5-HT2C antagonist. As a result, Valdoxan resynchronises circadian rhythms that are profoundly disrupted in depressed patients.”
Discussing the evidence base for Valdoxan, Prof Kennedy detailed both short – and long-term results from a large international clinical development programme of more than 6,000 patients with depression. He said:
“Valdoxan demonstrated superior antidepressant efficacy when compared with placebo, selective serotonin reuptake inhibitors (ssRIs) and serotonin noradrenaline reuptake inhibitors (sNRIs). It has also shown throughout the studies a tolerability and safety comparable to placebo, both in terms of adverse events as well as laboratory parameters or specific tolerability issues, such as sexual function3, body weight, and discontinuation symptoms.”
Fosavance improves vitamin D levels in postmenopausal women with osteoporosis compared to referred care
MsD Ireland announces that new data from FOCUs D presented at the 2010 Annual Meeting of the American society for Bone and Mineral Research (AsBMR) demonstrated that the combination tablet alendronate 70 mg/vitamin D3 5600 IU weekly improved the levels of vitamin D among postmenopausal women with osteoporosis and low vitamin D levels defined as 25-hydroxyvitamin D level <20 ng/ml (50 nmol/l), compared to therapies independently prescribed by their personal physicians, which may have included vitamin D supplementation alongside osteoporosis medicine. After 26 weeks of treatment, the proportion of women with low vitamin D levels, defined as 25-hydroxyvitamin D level <20 ng/ml (50 nmol/l), was significantly lower in patients given the combination tablet alendronate 70 mg/vitamin D3 5600 IU, group compared to those in the Referred Care group (7.8% compared to 31.2%, p<0.001). Data from an extension of the study showed that the same effect on 25-hydroxyvitamin D levels was sustained after 52 weeks of treatment (11.3% compared to 36.9%; p<0.001).
“In postmenopausal women with osteoporosis, vitamin D is critical in helping to protect bones, yet many patients do not receive the necessary amounts as part of their standard care,” said. Dr Tara Coughlan, Consultant Geriatrician AMNCH Tallaght. “Our study found that more than 90 percent of patients with osteoporosis and low vitamin D levels who were treated with the alendronate 70 mg /vitamin D3 5600 IU combination tablet had above the target level of vitamin D compared to 69 percent of those in the Referred Care group.”
www.your
47
product news
Lower protein in infant formula supports growth rate similar to breast milk
Newly published findings indicate that infants fed a lower protein infant formula developed by Pfizer Nutrition gained weight at a similar rate to those who were breastfed, according to a study published online today in the European Journal of Clinical Nutrition. Pfizer Nutrition has always recognized that breast milk is the best source of infant nutrition. The study established that infants fed a new; lower-protein infant formula attained the same growth rate and growth pattern as breastfed infants.
The rate of growth of a child is an important indicator of overall health and reflects a child’s nutritional well-being. The WHO recognizes that nutrition during the first years of life is crucial for life-long health and wellness. Globally, twenty-three million children face nutritional challenges, with at least 20 million children under the age of five estimated to be overweight.
“This study showed that when we fed infants with a formula that contained specially-adjusted levels of protein that more closely matched those found in breast milk, these babies grew at a rate similar to breastfed babies,” said a leading study author Rosario Capeding ,Asian Hospital and Medical Center, Muntinlupa City, Philippines. “As we learn more about the importance of nutrition during early childhood, we recognize there is a critical need to ensure nutrients are received in the most appropriate proportions to support appropriate growth and development
One of the ways in which breast milk and standard infant formulas differ is in their protein composition and concentration. Mature human milk contains 10-12 g/l of protein and is rich in essential amino acids. standard infant formulas typically contain higher levels of protein in order to provide sufficient quantities of essential amino acids. It has been hypothesized that these higher protein concentrations could be one cause of the increased growth velocity seen in some formula-fed infants when compared to growth of infants who are exclusively breastfed. To allow for a reduction in total protein while preserving sufficient content of essential amino acids, the lower protein formula (New formula) used in this study was further enriched with alpha-lactalbumin, a protein that is found in human milk, and supplemented with small amounts of two amino acids, tyrosine and tryptophan.
Clavamel Forte 500mg/125mg film-coated tablets change in pack size
Clonmel Healthcare have announced that the pack size of Clavamel Forte (amoxicillin/clavulanic acid) has changed from 14 to 21 film-coated tablets.
The presentation has also changed from glass bottles to blister packs. The tablets were previously yellowish white to light yellow, oblong tablets debossed with “625” on one side; the new formulation is white to off-white, oval shaped film-coated tablets debossed with ‘AC’ and a score line on one side. The reverse is plain.
If you require any further information, please contact Clonmel Healthcare on 01 6204000.
Iniparib prolongs survival in metastatic triple negative breast cancer
sanofi-aventis and its fully owned subsidiary, BiPar sciences, recently announced that final results from a randomized Phase II clinical trial confirmed that treatment with BsI-201 (iniparib) in combination with gemcitabine/carboplatin results in a significant improvement in overall survival and a high rate of clinical response in women with metastatic triple negative breast cancer (mTNBC). Findings from the study were presented at an oral presentation at the 35th European society for Medical Oncology (EsMO) Congress in Milan, Italy.
Professor John Crown, consultant medical oncologist, st Vincent’s hospital, said: “These promising results suggest the possibility that an effective targeted therapy may soon become available for metastatic triple negative breast cancer. The results of large scale confirmatory trials are very eagerly awaited.”
According to the study results, median overall survival among women who received BsI-201 (iniparib) in combination with the chemotherapy agents gemcitabine and carboplatin was 12.3 months compared with 7.7 months among women who received chemotherapy alone, translating to a 43 percent reduction in the risk of death (HR=0.57). Median progression-free survival in the BsI-201 (iniparib) group was 5.9 months compared to 3.6 months in the chemotherapy group (HR=0.59). In addition, 55.7 percent of patients in the BsI-201 (iniparib) group showed a clinical benefit, defined as a complete or partial response or stable disease of at least six months, compared with 33.9 percent of patients in the chemotherapy group. There was no significant difference in adverse events between the two groups. The most common severe (grade 3 and 4) adverse events included neutropenia, thrombyocytopenia, anemia, fatigue, leukopenia and increases in the enzyme AlT. The study included 123 women with mTNBC.
Teva Pharmaceuticals product discontinuation
Teva Pharmaceuticals Ireland has announced its intention to withdraw the following products from the Irish market:
Aerolin Autohaler CFC-Free 100 micrograms (salbutamol)Expected date for depletion of stock for this product is end of
January 2011Airomir Inhaler 200 dose aerosol (salbutamol) (100 micrograms
per metered dose pressurised inhalation suspension)Expected date for depletion of stock for this product is end of
May 2011The decision to discontinue both products has been taken for
commercial reasons, and is not due to any safety or quality issue, thus allowing pharmacists and patients to continue to dispense or use the stock that they currently have.
The following Teva therapeutic alternatives are available for patients on these products.
salamol Easi-Breathe (salbutamol 100mcg per dose, 200 dose unit)
salamol MDI CFC free (salbutamol 100mcg per dose, 200 dose unit)
should you require any further information regarding these discontinuations, please contact Teva Pharmaceuticals at (042) 9395892
medicines.ie
48
product news
Risontel (Risedronic Acid) 35 mg Once a Week Film-coated Tablets
Clonmel Healthcare has announced the launch of Risontel (Risedronic Acid) 35 mg Once a Week Film-coated tablets. This product will join our other medicine product listings within the Ethical Prescription Division of Clonmel Healthcare.
Risontel is for the treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures and hip fractures. It is also used to treat osteoporosis in men at high risk of fractures.
Risontel (Risedronic Acid) 35 mg Once a Week Film-coated Tablets are 28% cheaper than the brand leader. Risontel 35mg Once a Week Film-coated tablets are available on the GMs from 1st January 2011.
The GMs code for Risontel 35mg Once a Week Film-coated Tablets is – 50703:
Full prescribing information is available on request or go to www.clonmel-health.ie .
Product is subject to prescription. Please contact Clonmel Healthcare on 01-6204000 if you require any additional information on Risontel (Risedronic Acid) 35 mg Once a Week Film-coated Tablets.
www.yourmedicines.ie
Qlaira is first combined oral contraceptive approved to treat heavy menstrual bleeding
New data show that Qlaira (oestradiol valerate/dienogest) is the first oral contraceptive with proven efficacy in significant, rapid and sustained reductions in menstrual blood loss in women who suffer from heavy menstrual bleeding.
The clinical data were presented at the recent 13th World Congress of Obstetrics, Gynecology and Infertility.
Qlaira is the first in a new class of oral contraception to deliver oestradiol combined with the progestogen, dienogest.
It was launched as an oral contraceptive in Ireland in 2009 and, in October 2010, received approval for the additional indication ‘Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception’.
Ebixa Oral Solution – name change
The Alzheimer’s medication Ebixa Oral Drops is to undergo a change of name which will be effective from January 2011. The current name “Ebixa 10mg/g Oral Drops, solution” is changing at the request of the European Medicines Agency (EMA) to more accurately reflect the actual dosing of the Ebixa oral solution pump device. The new name will, from January 20011, be “Ebixa 5mg/pump, Oral solution”. From January 2011 the Ebixa oral solution bottles will express the volume of Ebixa solution in mls. The volume will be expressed as 50ml and 100ml and this will replace the current quantity listed on the packs which is expressed in weight i.e 50g and 100g. Existing stocks of the current named product will be exhausted prior to supply of the “Ebixa 5mg/pump, Oral solution” – 50ml & 100ml bottles.
Ebixa 10mg Tablets – New lactose Free tablet – consequential change of tablet colour
The tablet formulation of Ebixa will also be changed to a lactose free tablet. As a consequence of this the excipients have changed and the colour of the tablet which is ‘yellow’ in colour. It is expected that stock of the yellow tablet will be available from approximately February 2011. Existing stocks of the white tablet will be exhausted prior to the supply of the yellow tablet.
Overall, the above changes to the tablets and oral solution do not affect the dosing of the Ebixa range of medications.
Full dose range of Blopress (candesartan cilexetil) remains available
Following Astra-zeneca’s recent announcement confirming the withdrawal of candesartan 2mg, Takeda would like to reassure healthcare professionals that the full dose range of Blopress (candesartan cilexetil), including Blopress 2mg, remains available in Ireland. Blopress is indicated for the treatment of essential hypertension and chronic heart failure in patients with an lVEF < 40%.* Blopress is now the only candesartan treatment available as a 2mg tablet (pack of 7 or 28) and a 32mg tablet (pack of 28).
In addition, Blopress Plus (candesartan cilexetil/hydrochlorothiazide), indicated for the treatment of essential hypertension, is the only fixed dose combination available in the following doses of candesartan/hydrochlorothiazide: 8mg/12.5mg, 32mg/12.5mg and 32mg/25mg (all packs of 28).
Please refer to www.medicines.ie for the summary of Product Characteristics (smPC) for both Blopress and Blopress Plus.
* Blopress is indicated for the treatment of chronic heart failure in patients with an lVEF < 40% as an add-on to ACE inhibitors or when ACE inhibitors are not tolerated.
49
crossword
Name:
Address:
Email:
Congratulations to the winner of last month’s crossword, Melanie Carey, 18 Jigginstown Park, Naas, Co Kildare.
Please send your answers to the Editor, Nursing in General Practice, GreenCross Publishing, 7 Adelaide Court, Adeliade Road, Dublin 2. Closing date for entries: 4th March 2011.Winner will receive v50. Please note: the winners’ cheques will be sent out within 45 days.
Caltrate is a trademark. PA 172/38/1. Full prescribing information available from Wyeth Consumer Healthcare, Plaza 254, Ballycoolin, Dublin 15 or from www.medicines.ie
Across5 Egg production centre (5)6 Nicotinic acid found in California,
Cinciannati etc. (6)8 Part of a foot but not of a leg! (4)9 severe conjunctivitis contracted from ham
actor (8)10 Aerial on insect's head? (7)12 There's no place like it! (4)13 Anoble look? (4)15 Ah! Harpo confused the king of Egypt (7)17 Bone breakage is far cuter rearranged (8)20 Mail distribution in Peru (4)21 surge forward to energise a battery? (6)22 Heavenly body with a tail (5)
dowN1 The front of the eyeball can sound cornier
(6)2 The crate misapplied for a drainage tube
(8)3 sac found in juicy steak (4)4 Hasty in spots? (4)6 Falls between U.s.A. and Canada! (7)7 In Memoriam, in short! (2,3)11 The god of the sea is a heavenly body! (7)12 light for miner or motorist? (8)14 A planet but not a heavenly body (5)16 Mr. Dumpty (6)18 City in a bottleneck? (4)19 Engrave in a quiet church (4)
ANswErs To lAsT moNTh’s crosswordACROss: 6 patella 7 bones 9 aida 10 sedative 11 tomtit 13 rout 15 whoa 16 inhale 18 omnivore 21 peer 22 ascot 23 insects DOWN: 1 mania 2 melanoma 3 plus 4 port 5 nervous 8 a ditch 12 tailor 13 relapsed 14 chemist 17 meath 19 iron 20 etna
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