Breast implant safety
The safety profile of breast implants continues to elicit controversy and debate. Catherine Reilly investigates
Covid-19 has presented Irish prisons with significant challenges in protecting the health of inmates, reports
Emily Clarke Gifford
Public and private distress
The ‘two-tier system’ is often blamed unfairly for issues that arise in the delivery of healthcare, writes Dr
Lack of ‘managerial accountability’ highlighted by SIAC
The existing “lack of managerial accountability” and “conflict between corporate and clinical management” in the health service needs to be addressed as part of reform measures, the Sláintecare Implementation Advisory Council (SIAC) has warned.
At its March meeting, the SIAC held a detailed discussion about the implementation of the planned new regional health areas (RHAs). A number of contributors emphasised the “need to ensure proper clinical governance”.
“Existing gaps in governance, including the lack of managerial accountability and the need to tackle the challenge of conflict between corporate and clinical management with respect to resource allocation and maintaining safe care were raised,” according
to minutes of the 30 March meeting, seen by the Medical Independent (MI)
SIAC Chair Dr Tom Keane said the points raised “highlighted the need for a detailed discussion of clinical governance at SIAC and to develop an understanding of what the Sláintecare objectives are for clinical governance”.
During the meeting, SIAC members divided “into three breakout rooms” to discuss aspects of the RHAs.
One group discussed “governance and safe care” and the minutes noted there “was a discussion at the outset around clearly defining whether governance referred to clinical and/or corporate governance and the need to articulate that more clearly”.
“The need to clearly define roles and responsibilities across the health service and its various entities was emphasised,”
Roll-out of cancer information system hampered by delays
The Covid-19 pandemic has delayed the roll-out of the national cancer information system (NCIS) by a number of months, while the impact of the cyberattack on implementation is still being assessed, the Medical Independent (MI) can report.
The NCIS is a clinical information system which will be used in the nine designated cancer centres and 17 other hospitals to support the care of oncology and haemato-oncology patients.
At a meeting of the executive management team of the National Cancer Control Programme (NCCP) in January, the minutes of which were seen by MI through Freedom of Information law, it was stated that the Covid-19 surge at the time would “impact on the roll-out with potential delays” of three-tofour months.
At the beginning of the year, St James’s Hospital and Beaumont Hospital in Dublin were planning to ‘go live’ with the system in the first quarter of 2021.
However, a NCCP spokesperson told MI that completion of the installation of the NCIS in St James’s and Beaumont is now expected by year-end.
“The response to Covid-19 did have and continues to have an impact on the implementation projects in individual sites, with projects that were planned for 2020/2021 delayed,” the spokesperson stated.
according to the minutes.
“The question of national consistency, and retaining that in a regionalisation model, was also discussed. Points were also raised regarding the interface of governance and safe care with delivery of a high-quality care and how regionalisation could facilitate the integration of acute and community services.”
SIAC members also “noted the need for an evidence and data-based dimension for safe care to be included to facilitate decision-making”.
There was a discussion on the issue of “culture” in regard to accountability and patient safety and “the need to move from a challenging to a constructive culture”.
At its meeting in December, SIAC members strongly disagreed with Minister for Health Stephen Donnelly’s view that progressing the new RHAs
should be postponed as a result of the pandemic.
In July 2019, the Government approved the geographies of six new RHAs.
“A programme of work for rolling out the regions was developed pre-Covid in early 2020, but
Implementation of the system has been completed in St Luke’s Hospital, Rathgar; University Hospital Galway; and Mayo University Hospital.
Roll-out to the remaining hospitals will proceed throughout 2022/2023.
In relation to the cyberattack, the NCCP spokesperson stated: “The cyberattack continues to have an impact on many hospital services and projects including the NCIS.”
“The NCIS suffered no loss of data or functionality. As the impacts of the cyberattack abate, the roll-out timelines for the NCIS will be reassessed, with every effort being made to retain the roll-out sequence.”
No system-specific changes are envisaged at this stage, but recommendations and measures resulting from the cyberattack response will be applied to the NCIS, this newspaper was told.
The development of the NCIS was led by the NCCP in response to the requirement identified by cancer care services.
The system is to be used where medical oncology and haemato-oncology patients are receiving systemic anti-cancer therapy.
Access to the patient’s cancer treatment record will be available through the NCIS. This will ensure that all relevant healthcare providers have access to the patient’s data in an appropriate and timely manner.
The NCIS has a number of key functionalities, which will be used by various healthcare professionals in areas including: Prescribing; electronic medication administration records; support for aseptic compounding; multidisciplinary team meetings; documentation; and reporting.
this was understandably delayed as a result of the pandemic,” a Department of Health spokesperson told MI
“The development of the RHA business case recommenced earlier this year and is being coordinated by the Department.”
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Surgical trainees take part in the RCSI’s recent Surgical Bootcamp, learning the technical and non-technical skills they will need as surgeons.
Ireland’s new licensed fast-release, 3 mg melatonin drug
Melatonin is available on prescription in Ireland and we are now introducing Melatonin Pharma Nord, a high-quality medical drug that only contains pure melatonin without any unnecessary additives. The fast-release formula enables the melatonin content to deliver a swift and reliable effect.
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Each tablet of Melatonin Pharma Nord contains 3 milligrams of high-quality, pharmaceutical-grade melatonin.
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Prescribing Information – Ireland
For full prescribing information refer to the Summary of Product Characteristics.
1. What Melatonin Pharma Nord is and what it is used for Melatonin Pharma Nord contains the active substance melatonin. Melatonin Pharma Nord can be used for treatment of jet-lag in adults. Jet-lag can be recognized by sleep disturbances, daytime tiredness, fatigue, mild mental impairment, irritability and digestive system disturbances experienced after flying.
How Melatonin Pharma Nord works Melatonin is a hormone produced by the body that synchronizes the body’s biological day-and-night rhythm. The biological rhythm can be disturbed by travelling across time zones. This is known as a jet-lag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Melatonin Pharma Nord can help restore the normal day-and-night rhythm and reduce the symptoms. You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
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Do not take Melatonin Pharma Nord if you are allergic to melatonin or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonin Pharma Nord • if you have epilepsy. Melatonin may increase seizure frequency in patients with epilepsy if you have an autoimmune disease (where the body is ‘attacked’ by its own immune system) if you have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood if you suffer from significantly impaired liver function or kidney function if you smoke. Smoking may reduce the effect of Melatonin Pharma Nord as components of tobacco smoke can increase the breakdown of melatonin by the liver.
Children and adolescents
Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy are unknown.
Other medicines and Melatonin Pharma Nord
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Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin.
Psoralens (used for the treatment of skin disorders e.g. psoriasis), as psoralens may increase the effect of melatonin.
Cimetidine (used for the treatment of stomach problems such as ulcers), as cimetidine may increase the effect of melatonin. Estrogens (used in contraceptives or hormone replacement preparations), as estrogens may increase the effect of melatonin.
Quinolones (used in the treatment of bacterial infections), as quinolones may increase the effect of melatonin.
Rifampicin (used in the treatment of bacterial infections), as rifampicin may decrease the effect of melatonin.
Carbamazepine (used in the treatment of epilepsy), as carbamazepine may decrease the effect of melatonin.
Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, e.g. midazolam, temazepam, and zaleplon, zolpidem, zopiclone), as melatonin may enhance the sedative effect of such medicines, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion).
Melatonin Pharma Nord with food and alcohol
• This medicine should not be taken with food (see Section 3).
As alcohol can impair sleep and potentially worsen certain symptoms of jet-lag (e.g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed while taking this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Melatonin Pharma Nord is not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are a woman of childbearing potential you have to use contraception.
Melatonin Pharma Nord is not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed infant or child cannot be excluded.
Melatonin Pharma Nord is not recommended in women and men planning to have a baby as there is insufficient information on the effects of melatonin on female and male fertility.
Driving and using machines
Melatonin Pharma Nord may cause drowsiness and may decrease alertness for several hours after intake. Therefore, this medicine should not be taken prior to driving or using machines.
3. How to take Melatonin Pharma Nord
Always take this medicine exactly as described in the spc or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults and elderly is 1 tablet daily for a maximum of 5 days. When the effect of Melatonin Pharma Nord is inadequate, 2 tablets can be taken simultaneously. The first dose should be taken on arrival at destination at your usual bed-time. Intake on the following days should also be at your usual bed-time. Tablet(s) should not be taken before 20:00 hr or after 04:00 hr. Tablets should be swallowed whole with water or
other liquid (e.g. milk, fruit juice). Food should not be consumed 2 hours before or 2 hours after intake of Melatonin Pharma Nord.
Melatonin Pharma Nord 3 mg may be taken for a maximum of 16 treatment periods per year.
If you take more Melatonin Pharma Nord than you should
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The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.
If you forget to take Melatonin Pharma Nord
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If you stop taking Melatonin Pharma Nord
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following serious side effects stop taking this medicine and contact your doctor immediately:
Uncommon side effects (may affect up to 1 in 100 people)
• Chest pain.
Rare side effects (may affect up to 1 in 1.000 people)
• Reduced number of white blood cells in the blood. Reduced number of blood platelets, which increases the risk of bleeding or bruising. Disorientation.
Visual impairment, including blurred vision. Feeling your heartbeat (‘pounding chest’).
• Blood (red blood cells) in the urine.
Not known (frequency cannot be estimated from available data)
Severe allergic reaction resulting in swelling of the tongue or lining of the mouth.
Non-serious side effects
If you experience any of the following non-serious side effects contact your doctor or pharmacist:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Irritability, nervousness, restlessness, abnormal dreams, anxiety.
• High blood pressure. Abdominal pain, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea.
• Itching, rash, dry skin.
Excretion of glucose in the urine, excess protein in the urine.
• Weight increase.
Rare side effects (may affect up to 1 in 1,000 people)
• High levels of certain fat molecules (triglycerides) in the blood.
Altered mood, aggression, increased sex drive. Memory impairment, restless legs syndrome, ‘pins and needles’ sensation.
• Vomiting, wind, excess saliva, bad breath, inflammation of the stomach lining.
• Arthritis, muscle spasms. Passing large volumes of urine. Prolonged erection that might be painful, inflammation of the prostate gland.
Abnormal levels of electrolytes in the blood.
Not known (frequency cannot be estimated from available data)
• High blood glucose level.
Flow of milk from the breasts (also in men).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. Reporting forms and information can be found at: https://www.hpra.ie/.
6. Contents of the pack and other information
What Melatonin Pharma Nord contains
The active substance is melatonin.
Each tablet contains 3 mg melatonin. The other ingredients are: magnesium stearate, colloid silica anhydrous, maltodextrin, microcrystalline cellulose, carmellose sodium. Film coating: hypromellose.
What Melatonin Pharma Nord looks like and contents of the pack
Round, biconvex, clear-coated, white to off-white tablet.
Size 7.5 mm.
Blister pack containing 30 film-coated tablets. Marketing Authorisation Holder and Manufacturer
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DK-6500 Vojens Denmark
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IMO makes claims for hospital inspections
The IMO has filed “a number of anonymous” complaints with the Workplace Relations Commission (WRC) seeking inspections of hospitals allegedly breaching working time law.
The complaints from NCHDs relate to breaches of the maximum 48-hour week in sites nationally, Industrial Relations Officer at the IMO, Mr Paul Maier, told the Medical Independent Mr Maier did not wish to disclose the names of hospitals to be inspected, but they included hospitals in all seven Hospital Groups.
HSE notes ‘differing views’ on private hospitals agreement
The HSE has noted that “differing views” may exist between it, the Department of Health (DoH), and the Department of Public Expenditure and Reform (DPER), regarding the “appropriate value/effectiveness metrics” in its pandemic capacity arrangement with private hospitals.
with regard to appropriate value/effectiveness metrics in the arrangement and that careful, balanced interpretation of data will be necessary. HSE affirm that they are happy to provide all available data.”
A HSE spokesperson said the safety net arrangement has been updated and utilised during the recent cyberattack.
The HSE’s ability to provide governance of NCHD working hours “doesn’t seem to be effective and we say that with resignation”, he added.
Mr Maier said the Organisation was mainly pursuing inspections rather than adjudication claims, as the issue was systemic.
“[NCHDs] don’t believe they are individually unique in their claim. They are raising the issue not because they feel they want to be compensated or feel individually wronged, but because they feel the system as a whole is wrong. The inspections are a way to ask for a review of the system of work.”
However, Mr Maier did not rule out the submission of adjudication claims, which the union previously identified as a
strategy to force reform on NCHD working hours.
“For the time being, we will continue to file inspection claims for additional sites as they arise.”
If teams in sites are facing particularly egregious breaches of working time law, “we may have that cohort file for adjudication as a group.”
Mr Maier urged healthcare management to engage on the issue.
Compliance with working time law will entail “fundamental change” in the health service, including restructuring services, making consultant posts more attractive, and ensuring NCHD training is less impacted by service provision.
In January 2021 the HSE came to an agreement with private hospitals to provide additional capacity for any further ‘surges’ in Covid-19 cases. The “safety net arrangement” is in place for one year.
Discussions regarding the “value for money” of this arrangement took place between the Executive, DoH and DPER officials at the April meeting of the health budget oversight group.
According to the minutes, DPER said that “outstanding data are likely held by VHI and should be available (potential constraints due to commercial sensitivity are noted)”.
“HSE note that differing views may exist between DoH/HSE and DPER
The HSE “has been provided with significant additional funding to support access to care in 2021, in addition to work under the safety net arrangement”.
“This [funding] will be targeted at delivering additional public sector activity and purchasing capacity in the private sector under procured arrangements. The National Treatment Purchase Fund is also continuing to target funding at purchasing care for patients who are on waiting lists.”
Following termination of the original private hospitals agreement in June 2020, the Government mandated the HSE to seek to agree with the private hospitals a new arrangement for additional capacity.
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THE MEDICAL INDEPENDENT | 12 AUGUST 2021 3 News
Dr Steevens Hospital
Unravelling the risks of breast implants
While breast implants have been used for decades in aesthetic and reconstructive surgical procedures, their safety profile continues to elicit controversy and debate. Catherine Reilly reports
Breast augmentation is “a hugely benefiting procedure” for some women, Mr Cormac Joyce, a plastic surgeon at the Avoca Clinic in Co Wicklow, told the Medical Independent (MI)
Currently in full-time private cosmetic practice, Mr Joyce said he performs about 400 breast augmentation surgeries annually. He is on the Medical Council’s specialist register for plastic, reconstructive, and aesthetic surgery and is a member of the Irish Association of Plastic Surgeons (IAPS).
The motivations of patients include wanting a larger breast size, or changes to the appearance of asymmetrical and tuberous breasts. Some women may feel very self-conscious about their breasts and avoid using changing rooms and other activities, he outlined.
“It is a hugely benefiting procedure for some. It is hard to imagine that just two balls of silicone can do that to somebody, but there you go.”
In the public system, implants and/or autologous techniques are used for breast reconstruction following mastectomy.
Notably, the deep inferior epigastric perforator (DIEP) flap procedure – considered the ‘gold standard’ in autologous breast reconstruction for suitable patients – is not available publicly in most parts of the country.
According to the Irish Cancer Society, “many women affected by breast cancer reconstruction issues in Ireland face significant and complex challenges in accessing reconstructive procedures.”
Internationally, about 75 per cent of implant-based procedures are for cosmetic purposes.
In Ireland, a longstanding concern of the IAPS is use of the title ‘cosmetic surgeon’ by doctors not on the specialist register for plastic, reconstructive and aesthetic surgery.
(The IAPS was contacted for comment on issues in this article, but no-one was available by press time. MI also submitted questions about sponsorship of IAPS meetings by medical device companies and the marketing material of some members).
According to Mr Joyce, “[Cosmetic surgery] is an unregulated industry, that is the scary thing about it.”
He said at his clinic every Monday he sees patients who have been operated on by ‘cosmetic surgeons’. “In some cases, the mistakes can be fixed, other times they can’t. It is a murky world in cosmetic surgery, particularly in Ireland, because of the lack of
regulation.” Some patients also present after procedures overseas.
Mr Joyce said he has examined patients with “poorly done” breast augmentations, sometimes involving certain types of implants “like polyurethane implants, which are very, very difficult to remove because they become embedded in the breast tissue”.
“Patients are saying they wanted a certain ‘look’ and they didn’t get it. Their implants are sitting very low, or the patients may have needed a lift where in fact an implant was put in. I have had patients coming in looking for a breast reduction when they have gone to other clinics and they were offered an implant.
“When all you have is a hammer, everything becomes a nail, and these surgeons have not gone through vigorous training processes, so they are unable to offer patients the correct procedure.”
At the Avoca Clinic, cosmetic breast surgeries are marketed as standalone procedures, but also as part of a ‘Mommy Makeover’ (eg, breast and abdominal procedures on the same day). Having multiple procedures at once “will not only save you money and healing time, you will only need a one-night stay”, according to the clinic’s website.
Asked about the ethics of this marketing, Mr Joyce maintained it was offering a choice to those interested in multiple procedures. “We don’t upsell it. We don’t say ‘look, you need your breasts done as well’.”
Demand for cosmetic surgery in Ireland has increased during the Covid-19 pandemic due to travel restrictions and people accruing extra savings, according to Mr Joyce.
He said breast augmentation is “the
number one cosmetic surgery procedure worldwide and it is always going to be increasing in prevalence”.
This projection remains to be seen, however.
The IAPS website describes breast implants as amongst “the most used and most highly studied implantable medical devices in the world”. It cites the commonest problems associated with breast implants as capsular contracture, implant displacement, and implant rupture.
on the market (see panel).
Following the PIP scandal, breast implant safety has seldom strayed far from the spotlight, as determined by the emergence of two further concerns: A recently recognised condition called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare, but serious type of T-cell lymphoma; and separately, ‘breast implant illness’ (BII), a constellation of symptoms potentially associated with implants. BII remains a contentious issue within medicine and between some doctors and patients.
Prior to BIA-ALCL’s recognition by the World Health Organisation in 2016, it had been a ‘hot topic’ within plastic surgery for several years. The first case report was in 1997. In 2011, the US Food and Drug Administration (FDA) cited a possible link between breast implants and ALCL and stated it was aware of about 60 case reports worldwide.
In late 2014, at an IAPS breast symposium held in Dublin, keynote speaker from Canada, Dr Elizabeth Hall-Findlay, stated she would not use “aggressively textured” implants due to a rare, but serious risk of ALCL. However, many surgeons regarded this as a dramatic and unnecessary step.
In late 2018, Allergan suspended sales of its textured breast implants and tissue expanders and withdrew remaining supply in European markets. At the time, the company’s communication with its urgent field safety notice said the suspension stemmed from the expiration of the CE mark for these products.
While this was factually true, the issue arose from concerns relating to BIA-ALCL expressed by France’s regulatory authorities.
Subsequently, in July 2019, Allergan announced a “voluntary worldwide recall” of its Biocell textured breast implants and tissue expanders. The company took this action “as a precaution” following notification of recently updated global safety information from the FDA concerning “the uncommon incidence” of BIA-ALCL.
The published literature “indicates that breast implants are thought to be safe in general, but can have rare, serious side-effects”.
In 2010, the Poly Implant Prothese (PIP) scandal exposed an archaic and flawed regulatory framework for medical devices on the EU market. PIP fraudulently used industrial grade silicone in its breast implants, which went undetected for years. A new EU medical devices regulation has come into application this year and aims to instigate significant improvements to regulation of medical devices
Internationally, most but not all cases of BIA-ALCL have been associated with Allergan textured implants, according to a HSE serious incident management team (SIMT) report.
In Ireland to date, “less than five” reports of BIA-ALCL have been received by the Health Products Regulatory Authority (HPRA).
As of July 2020, some 345 confirmed cases of BIA-ALCL had been reported by EU countries and the UK. Of the confirmed cases with available information about the implant’s surface (ie, 295), 279 (94.5 per cent) were reported to be linked to textured implants at the time of diagnosis.
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 4
The issue of BIA-ALCL has had a huge impact on how we consent patients
Mr Cormac Joyce
BIA-ALCL presents, on average, eight years post implant insertion, although the range is one to 20-plus years, according to the HSE SIMT report.
The condition usually presents with relatively sudden swelling around the implant, typically unilateral, but may be bilateral, or the development of a new lump around the capsule or breast.
Generally, treatment is en-bloc surgical excision of the implant and its surrounding tissues (capsulectomy). Patients have an excellent prognosis when identified and treated early.
Initially thought to be “extremely rare”, more recent reports had identified “a much higher incidence in textured implants, particularly macro-textured implants”, noted the HSE report.
“It appears that the more textured the implant the higher the risk, with the Allergan Biocell type being reported as having at least six times the risk of some other textured implants, especially those less textured. Reports from the Australia and New Zealand registry suggest this risk is at least as high as 1:3,300 in Allergan (previously Inamed/ McGhan) Biocell implants.
“In September 2020 a single site study by Nelson et al, revised the estimated the overall incidence of BIA-ALCL at 1.79 per 1,000 patients (one-in-559) with textured implants and 1.15 per 1,000 textured implants (one-in 871), with a median time to diagnosis of 10.3 years (range, 6.4-to-15.5 years.).” All 11 of the BIA-ALCL confirmed cases in the Nelson study involved exposure to Allergan/Inamed/ McGhan Biocell implants.
According to the HSE report, sales data indicated that up to 29,000 Allergan/Inamed/ McGhan Biocell implants had been sold in Ireland. The Executive estimated the total patient population with implants/tissue expanders as between 17,943 and 31,372, including those who had procedures in private hospitals and abroad.
As of early 2020, the HSE had issued letters to 2,711 people identified through public hospital data as receiving Allergan Biocell implants, while letters had been sent to 2,184 people who had other implants. The correspondence provided information on BIA-ALCL symptoms and advised that implant removal was not recommended for asymptomatic patients. Advisories were sent to clinicians in late 2019.
The lack of an Irish breast implant registry
Medical Devices Regulation aims to protect patient safety
The Health Products Regulatory Authority (HPRA) “does not have access” to a complete listing of all CE-marked breast implants and tissue expanders available across Europe and Ireland, a spokesperson confirmed.
Within the European regulatory framework for medical devices, national competent authorities (such as the HPRA) act as a market surveillance authority, but do not approve or certify medical devices for sale in the EU.
For class III devices such as breast implants, the conformity of the device is assessed and verified by a notified body, which will issue a CE certificate following a positive outcome of their assessment.
The EU Medical Devices Regulation (MDR) aims to enhance safety, quality and transparency in regard to medical devices on the European market.
The MDR’s date of application was 26 May 2021 and many aspects are fully applicable, according to the HPRA.
Breast implants and tissue expanders will have to be certified under the MDR before the expiry of their certificate or before 2024 for continued market access.
“The MDR introduces the obligation for increased traceability requirements, which will be visible on the European Commission developed database, EUDAMED,” outlined the HPRA spokesperson.
“The development of the EUDAMED database has been delayed and is expected to become applicable from May 2022…. When functional, EUDAMED will improve transparency and access to information regarding medical devices
available on the EU market.”
The MDR has further defined and developed the requirements for the continued surveillance of medical devices on the market by competent authorities.
“The MDR places more specific obligations on regulatory authorities and expands the range of market surveillance activities which can be conducted both at national and European level. This includes increased assessment of regulatory compliance of devices, increased provisions for sampling and testing of devices and greater legal powers to address noncompliant products.”
The regulation also requires that each device must bear a unique identifier.
Furthermore, under the MDR, all implantable and class III devices, other than custom made or investigational devices, require a summary of safety and clinical performance (SSCP) to be prepared by the manufacturer. This document will be made available to the public/user via EUDAMED.
The SSCP must include specific device information, including a summary of the clinical evaluation and any relevant information on postmarket clinical follow-up, including post-market clinical studies.
The MDR requires that sponsors of all clinical investigations prepare a summary of the clinical investigation report, which must be available to the public via EUDAMED within one year of the end of a study.
In addition, manufacturers of class IIa, IIb, and III devices are required to prepare a periodic safety update report for each device.
has hindered incident management following the Allergan recall. The establishment of a registry is a key objective of a new BIA-ALCL expert advisory group.
Meanwhile, much about BIA-ALCL remains unknown.
In March 2021, the European Commission’s scientific committee on health, environmental and emerging risks (SCHEER) concluded there was “a moderate weight of evidence for a causal relationship between textured breast implants and ALCL”. However, estimates of incidence had significant limitations related to the “frequent use of ad hoc reporting of cases compared with systematic reporting, and the use of sales data provided by manufacturers”.
Furthermore, the pathogenic mechanisms of the induction of BIA-ALCL were “not well understood”.
In September 2020, the FDA issued labelling recommendations for implants to “better ensure certain information is received and understood by patients”.
A boxed warning should be part of physician and patient labelling materials, stating BIA-ALCL risk; that breast implants have been “associated with systemic symptoms”; and they are not considered lifetime devices, among other points.
The issue of BIA-ALCL has “had a huge impact on how we consent patients”, according to Ms Ruth Waters, President of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). As it is a malignancy associated with implants, the issue requires “a long and serious conversation”, she told MI “In some ways it unbalances your conversation… because there are lots of risks associated with any surgery, and with implants in particular, that we need to discuss because they are common risks, whereas ALCL is a very rare risk, but a very serious one if you get it.”
In the UK the estimated risk of BIA-ALCL, based on the reported confirmed cases, is one per 20,000 implants sold (using data for all types of breast implants including breast tissue expanders known to be sold in the UK). It is an imperfect method of estimating risk, but the best means available at present, noted the BAPRAS President.
To offer perspective, Ms Waters said she often quotes the lifetime risk of breast cancer on account of being female, which is currently one-in-seven women in the UK.
With more recognition among clinicians than previously, Ms Waters is hopeful patients will receive timely diagnosis where cases arise. She indicated a need for greater public awareness. “One of the interesting and slightly worrying things I find is, when women are coming to me requesting breast implants, none of them had heard of it.”
Back in Ireland, Mr Joyce also noted people requesting augmentation surgery are unaware of BIA-ALCL, despite being generally well-researched. He said the matter is always discussed at consultation.
“Most of the cases of ALCL have been linked back to Allergan implants, which are now off the market,” he commented.
At consultation, Mr Joyce said he quotes from UK estimates, as well as those made
in other countries (eg, one case per 86,000 implants, which has been reported by researchers in Australia/New Zealand in regard to Mentor Siltex textured implants).
“You give all the facts and figures to patients and let them decide if they want to go for textured or smooth,” said Mr Joyce, who added that he informs patients about uncertainties regarding estimates.
“Personally, I think there is more morbidity associated with the smooth implant compared to a textured implant, even taking on board the ALCL.”
He cited a “very high risk of capsular contracture” if a smooth implant is placed on top of the muscle, which is the positional preference of many patients.
Breast implant illness
In 2018, Ms Elaine Fields Anthonsen started an Irish online support group for people who consider their breast implants have caused illhealth. There are approximately 300 members in the group. Ms Fields Anthonsen said she is aware of a very small number who have received a diagnosis of BIA-ALCL.
She contended that many surgeons are “not worried about [BIA-ALCL], because they feel the numbers are so low. But at the end of the day, no number should be too low to not take something seriously.”
Most women in the support group, including Ms Fields Anthonsen, state that they have been affected by BII.
According to the HPRA, some individuals and health researchers have used the term ‘breast implant illness’ to refer to a range of symptoms in association with breast implants. The symptoms described have included joint pain, rashes, memory loss, and ‘brain fog’, among others. “These symptoms and what causes them are not well understood at this time,” stated the Authority.
The HPRA has received 45 reports – relating to 32 people - which may potentially relate to BII. Nineteen reports have come from manufacturers and 26 from the public.
“There is ongoing research to try to understand these symptoms and their origin. The reports which the HPRA have received relate to a range of breast implant products and manufacturers.”
In 2005 Ms Fields Anthonsen, now 47, had a breast augmentation in the private Clane Hospital, which involved PIP implants.
Subsequently, she was informed by the hospital about potential rupture risk. An explant was covered by Clane in 2013, but Ms Fields Anthonsen was required to pay for replacement implants. “They didn’t discuss what type of implants they were putting in, they just said it was the best one on the market.”
The replacement devices were textured Allergan implants.
Approximately six months after the procedure, Ms Fields Anthonsen began to experience a range of symptoms, including darting pains and itchiness in her breast area and bouts of tiredness. An active runner, her energy levels significantly declined.
She said a mammography did not provide any evidence of rupture, while various medical tests were inconclusive. Her health continued to deteriorate. “I would say I was in bed for two years, where I couldn’t walk to the toilet alone, couldn’t speak, think of words, brain fog…,” said Ms Fields An-
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 5 Feature News
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Ms Ruth Waters
thonsen, who is a mother of three.
In late 2018 she was on the Facebook page of a chronic fatigue support group and “somebody put up on the group, ‘does anyone have breast implants? If you do, look into something called breast implant illness.’”
Ms Fields Anthonsen began researching the issue and saw 40 different symptoms listed on the page of a US support group. “I literally had every single symptom. I said ‘that is it – that has to be it’.”
The advice from support groups was she should seek removal of the implants with the capsules intact – an enbloc capsulectomy. This procedure is indicated for treatment of BIA-ALCL, but surgical associations say there is no scientific data that supports the need for en-bloc capsulectomy in the absence of malignancy. Nevertheless,
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internationally, some surgeons are heavily promoting enbloc procedures for BII. Other surgeons may consider it on a case by case basis.
“I couldn’t find a supporting doctor in Ireland whatsoever,” said Ms Fields Anthonsen. She said one surgeon informed her “if I go ahead with the surgery, I am going to look like a saggy mass of nothing… and that all of this is a craze on social media”.
The surgeon informed her en-bloc capsulectomy could be dangerous surgery and was not required.
After numerous enquiries, Ms Fields Anthonsen opted to go to a surgeon in private practice in Birmingham. The procedure was conducted in March 2019, and in its immediate aftermath, she said she felt significantly improved, but acknowledged this may not be everyone’s experience.
She now reports feeling well, although when she picks up infections, many of the symptoms return, “which is quite scary”.
According to Ms Fields Anthonsen, the Irish support group is a valuable forum for women to discuss their symptoms, implants, surgeries, and progress.
Some women had Allergan implants on the public system following treatment for breast cancer, they are reporting having BII, and are not able to access explant publicly.
One woman in the group, who did not have symptoms associated with BII or BIA-ALCL, had her implants removed privately as she was extremely concerned about developing lymphoma or otherwise becoming ill. Ms Fields Anthonsen considered that the woman made the correct decision, but agreed it was important to seek appropriate medical counsel and investigations. Some women do have concerns about breast appearance following explant.
There is an online global list of surgeons who are considered more sympathetic to BII and to requests for en-bloc capsulectomy. One surgeon in the Republic of Ireland is on the list (the surgeon declined to speak with MI and therefore the veracity of the listing cannot be confirmed).
Ms Fields Anthonsen told this newspaper another surgeon contacted her trying to get onto the list. “I had a conversation on the phone and spoke to him about breast implant illness and he still wouldn’t admit it was ‘a thing’, but he was willing to do the surgery.”
BII in UK
Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia1
familial hypercholesterolaemia. Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended.
Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with predisposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where coadministration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients. Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30 ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60 ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates. Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20 mg. As with other HMG-CoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5xULN) a confirmatory test should be carried out within 5-7 days. If the repeat test confirms a baseline CK >5xULN, treatment should not be started. Patients with pre-disposing factors for myopathy/rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled coadministration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3×ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is ≥3xULN. The reporting rate for serious events is higher at the 40mg dose. In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other HMG-CoA reductase inhibitors, rosuvastatin
should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 to 6.9 mmol/l, BMI >30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, nonproductive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be reintroduced seven days after the last dose of fusidic acid.
In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Pregnancy, Breastfeeding and Fertility: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Interactions: Contraindicated combinations: Ciclosporin. Not-recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, erythromycin, Oral contraceptive/hormone replacement therapy. When coadministering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40 mg daily dose of rosuvastatin taken without interacting medicinal products. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common (≥1/100 to <1/10): diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon (≥1/1,000 to <1/100): decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare (≥1/10,000 to <1/1,000): thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare (<1/10,000): polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated
Asked about the body of opinion on BII within British plastic surgery, Ms Waters at BAPRAS said: “I think it has got to the point where no-one is dismissive of it anymore. We don’t know everything about everything, and if people have breast implants and they feel unwell, and then they have the implants removed and they feel better, you would have to think something was going on there. I don’t think it’s just psychological….” In her experience, BII presentations are not common, but also not unusual and have increased
Nevertheless, Ms Waters noted that “the problem with breast implant illness is it is a very diverse range of symptoms and so it is difficult to put your finger on it. I definitely think if somebody feels their implants are making them unwell, then you can say to them… there is a lot of evidence now that there are women who feel that way and have their implants removed, and at least half of them feel better afterwards.”
However, where a patient says they have BII and want their implants removed, “I would certainly not say, ‘yes let us do it, because that will make you better’, because you can’t say that either.”
Asked about en-bloc capsulectomy for BII patients, Ms Waters said she would not advise a patient that this type of surgery can be guaranteed.
She said women reporting BII can be assessed for explant including en-bloc capsulectomy. Women who may be good candidates for en-bloc capsulectomy are those with very dense capsular contracture; conversely, where the implanted breasts feel soft and normal, she would not recommend an en-bloc procedure for BII due to potential damage in attempting this form of capsule removal.
In her own practice, patients who do not have capsular contracture, but have their implants removed for BII symptoms “still seem to feel better even when the capsule is not removed”.
She confirmed BII is always discussed at the first consultation for implant surgery and it is on the consent form.
Mr Joyce at the Avoca Clinic also said BII is discussed with his patients, although it is not on his consent form.
“It is very wishy washy in terms of the symptomology. The international classification of diseases does not even designate it as an actual disease…. It is an unknown quantity.” According to the surgeon, he has not had patients seeking explant for systemic symptoms they associate with their implants.
“It is very much American-driven. It is making its way to these shores, a bit like everything over time.”
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 6 20 mg /10 mg Rosuvastatin + Ezetimibe 10 mg /10 mg Rosuvastatin + Ezetimibe 40 mg /10 mg Rosuvastatin + Ezetimibe
of rosuvastatin and ezetimibe
doses* Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: firstname.lastname@example.org Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com Reference: 1. Suvezen Summary of Product Characteristics * LDL-C: Low-density lipoprotein Cholesterol ** Suvezen is available in 3 doses in Ireland. Suvezen 10mg/10mg, 20mg/10mg and 40mg/10mg: Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe. MAT-IE-2001867 (v1.0) – December 2020 Prescribing Information: Suvezen (rosuvastatin/ ezetimibe) film-coated tablets Please refer to the Summary of Product Characteristics (SPC) for full prescribing details. Presentations: Suvezen 10mg/10mg, 20mg/10mg and 40mg/10mg: Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe. Indication: Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous
complicated by rupture), myalgia, myopathy/ rhabdomyolysis, oedema, asthenia. Legal Category: POM. Marketing Authorisation Numbers: 10mg/10mg: PA0540/193/001; 20mg/10mg: PA0540/193/002; 40mg/10mg: PA0540/193/003. Marketing Authorisation Holder: Sanofi-Aventis Ireland Ltd. T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com Tel.: (01) 4035600. Date of Preparation: December 2019.
tendon disorders (sometimes
11738_Suvezen_AD_10X4_DEC20_01.indd 1 19/01/2021 17:00
Continued from p5 ▸
Ms Elaine Fields Anthonsen
When a DPP-4 inhibitor is needed
Simplicity. Reinforced . for a
BROAD RANGE of adults with type 2 diabetes (T2D)
UNIQUE CONVENIENCE through always one dose, once daily 1 5mg once daily
Demonstrated CV AND KIDNEY SAFETY PROFILE 2,3
PROVEN EFFICACY VS PLACEBO for adults with T2D 1,4
1. TRAJENTA® (linagliptin) Summary of Product Characteristics. Available at: https://www.medicines.ie/medicines/trajenta-5-mg- lm-coated-tablets-34014/
2. Rosenstock J, et al. JAMA. 2019;321:69–79
3. Rosenstock J, et al. Cardiovasc Diabetol. 2018;17:39
4. McGill JB, et al. Diabetes Care. 2013;36:237–44
Prescribing Information (Ireland) TRAJENTA® (Linagliptin)
Film-coated tablets containing 5 mg linagliptin. Indication: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment; combination therapy in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control. Dose and Administration: 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia. Renal impairment: no dose adjustment required. Hepatic impairment: pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking. Elderly: no dose adjustment is necessary based on age.
Paediatric population: the safety and efﬁcacy of linagliptin in children and adolescents has not yet been established. No data are available. Take the tablets with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as possible but a double dose should not be taken on the same day. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin; a dose reduction of the sulphonylurea or insulin may be considered. Acute pancreatitis has been observed in patients taking
linagliptin. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is conﬁrmed, Trajenta should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Bullous pemphigoid has been observed in patients taking Linagliptin. If bullous pemphigoid is suspected, Trajenta should be discontinued. Interactions: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. It is not an inducer of CYP isozymes. Linagliptin is a P-glycoprotein substrate and inhibits P-glycoprotein mediated transport of digoxin with low potency. Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-glycoprotein substrates. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, warfarin, digoxin or oral contraceptives (please refer to Summary of Product Characteristics for information on clinical data). Fertility, pregnancy and lactation: Avoid use during pregnancy. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the beneﬁt of breast-feeding for the child and the beneﬁt of therapy for the woman. No studies on the effect on human fertility have been conducted for linagliptin. Undesirable effects: Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trials and from post-
marketing experience. 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) or very rare (<1/10,000). Adverse reactions with linagliptin 5 mg daily as monotherapy: Common: lipase increased. Uncommon: nasopharyngitis; hypersensitivity; cough; rash; amylase increased. Rare: pancreatitis; angioedema; urticaria; bullous pemphigoid. Adverse reaction with linagliptin in combination with metformin plus sulphonylurea: Very common: hypoglycaemia. Adverse reaction with linagliptin in combination with insulin: Uncommon: constipation. Prescribers should consult the Summary of Product Characteristics for further information on side effects. Pack sizes: 28 tablets. Legal category: POM. MA number: EU/1/11/707/003. Marketing
Authorisation Holder: Boehringer Ingelheim International GmbH, D-55216 Ingelheim am Rhein, Germany. Prescribers should consult the Summary of Product Characteristics for full prescribing information. Additional information is available on request from Boehringer Ingelheim Ireland Ltd, The Crescent Building, Northwood, Santry, Dublin 9. Prepared in December 2019.
Adverse events should be reported.
Reporting forms and information can be found at https://www.hpra.ie/homepage/about-us/reportan-issue. Adverse events should also be reported to Boehringer-Ingelheim Drug Safety on 01 2913960, Fax: +44 1344 742661, or by e-mail: PV_local_UK_Ireland@boehringer-ingelheim.com
PC-IE-101116 V1 Date of preparation: February 2021 This advertisement is intended for health care professionals practicing in Ireland only
HUG4838 Trajenta Med Ind 370x255 - IRE v2.indd 1 15/02/2021 15:10
Donegal could be ‘first of many’ bespoke SATUs
The opening of a new sexual assault treatment unit (SATU) in Letterkenny, Co Donegal last year will “hopefully” be the “first of many” bespoke SATUs in the country, this newspaper has been told.
In late June, the SATU national service published its 2020 annual report which showed that the six SATUs provided care to 734 people, a decrease from 2019 when 943 patients attended.
“As well as capturing the metrics that we always report on, this year’s report also focuses on the specific impact that the Covid-19 pandemic had on our services,” Dr Maeve Eogan, National Clinical Director of the SATU service and Consultant Obstetrician and Gynaecologist at the Rotunda Hospital, Dublin, told the
Medical Independent (MI)
Dr Eogan noted the report’s section on the new Donegal SATU, which will be “hopefully the first of many bespoke SATUs”.
In 2020, the “first purpose-built SATU in the Republic of Ireland” was opened “after 11 years of being temporarily facilitated in the NoWDOC premises in Letterkenny”.
“We would like to take this opportunity to acknowledge and thank NoWDOC management and staff in their support for the SATU service,” noted the annual report.
In terms of the recent impact of the cyberattack, Dr Eogan told MI that SATU clinical care “was not affected”.
She added that the SATU service collects anonymous details on attendances, including information on age, gender, and type of incident. “While this database was not compromised by the cyber hack, it has been unavail-
Continued increase in numbers receiving Suboxone
There was a further increase in the number of patients being administered buprenorphine/ naloxone (Suboxone) in the first third of this year, according to figures provided by the HSE to this newspaper.
A spokesperson for the Executive told the Medical Independent (MI) that 441 patients were in receipt of Suboxone in January.
The figure continued to increase in February and March, with 492 receiving Suboxone in April. These figures include patients registered in prisons.
The trend is in line with the increase in patients receiving Suboxone throughout the Covid-19 pandemic. In January, MI reported that 407 patients were in receipt of Suboxone in November 2020 compared to 376 in September 2020.
In 2015, the opioid substitution implementation group recommended a phased increase in access to buprenorphine products, subject to legislation being introduced and funding made available. New regulations were introduced in November 2017 to provide access to certain buprenorphine-based medicinal products in the opioid substitution treatment system on the same statutory basis as methadone.
The HSE’s spokesperson said the continuing roll-out of the Suboxone programme had not been impacted by the pandemic.
Dr Tony Holohan, Chief Medical Officer, Department of Health, following the announcement that walk-in vaccination centres were opening across the country and anyone over 16 could register for a Covid-19 vaccine.
“The HSE is satisfied that those who need access to the Suboxone programme are able to do so,” said the spokesperson.
At the end of April, 10,975 patients were receiving methadone, which compared to 10,969 in January this year.
Separately, earlier this month the National Drug and Alcohol Survey 2019/20 was published by the Health Research Board.
It found a reduction in the use of cannabis and a significant decrease in the instances of cannabis use disorder recorded when compared to the 2014/15 survey.
Overall, the use of illegal drugs has remained at a similar level to that recorded in the 2014/15 survey; however, an increase was seen in the use of cocaine and ecstasy.
Meanwhile, a recent cross-section observational study on the seroprevalence of antibodies to Covid-19 in patients receiving opiate agonist treatment (OAT), conducted by the HSE National Drug Treatment Centre (NDTC), noted the possibility of a protective effect of OAT medications on development of the disease.
None of the approximately 565 attendees at the NDTC presented with serious illness indicative of Covid-19 throughout the three waves of the pandemic, nor were any deaths due to Covid-19 reported.
The study was published in the Irish Journal of Medical Science.
able to us since 14 May, so we do not have up-to-date statistics for that period of time,” said Dr Eogan.
“Work is ongoing to get it back up and running, and clearly data can be inputted retrospectively, but we miss having access to that in terms of monitoring activity levels and ensuring our service is fit for purpose.”
The annual report found that while there was a 22 per cent reduction in attendances compared with 2019, it was “significant to note that sexual violence unfortunately did not disappear”.
“We have summarised some of the salient metrics. What is most notable is that there was a sustained demand for the service throughout the year.... These metrics confirm the multifactorial nature of sexual violence, with prevention undoubtedly requiring a ‘whole of society’ approach,” according to the report.
Over 3,700 medical assessments in first half of 2021
There were 3,782 medical assessments carried out in the first half of 2021 to determine a person’s continued eligibility for illness benefit, according to figures provided to the Medical Independent (MI) by the Department of Social Protection (DSP).
“In the same period, 47 medical assessments, which had been initiated in 2020, were carried out to determine a person’s continued eligibility for disability allowance,” the DSP spokesperson said.
“Due to Covid restrictions, there have been no disability allowance control medical reviews initiated and no disability allowance payments ceased in the period from January 2021 to date.”
The DSP said that during the first half of this year, a total of 185 illness benefit recipients were found to be no longer entitled to payment following a medical assessment.
In January, MI reported that
there was a small decrease in the number of medical assessments for illness benefit carried out by the DSP last year compared to 2019.
There were 8,885 medical assessments conducted in 2019 and 8,732 in 2020 to determine a person’s continued eligibility for illness benefit.
Last year saw a significant increase in the number of assessments conducted for disability allowance. In 2019, some 1,099 medical assessments were carried out to determine a person’s continued eligibility for disability allowance, while there were 2,882 similar assessments in 2020.
“The increase… resulted mainly from further medical evidence that was provided by customers in response to a review of their entitlement,” the DSP spokesperson told MI in January.
During 2019 and 2020 combined, a total of 256 disability allowance recipients were found to be no longer entitled to payment following a medical assessment and had their payment stopped.
8 THE MEDICAL INDEPENDENT | 12 AUGUST 2021 News
We have to continue to drive up vaccination rates as high as possible. The higher we go the better the protection we have and the sooner we’ll be able to ease more of the economic and social restrictions that still remain in place.”
Enhanced surveillance and expanded public health capacity would enable earlier identification and management of AMR [antimicrobial resistance] threats, as well as inform investment decisions by the Department of Health and the HSE.”
Dr Máirín Ryan, Deputy CEO, HIQA, on new research by the Authority, which found that AMR to eight bacteria cost the health sevice an additional €12 million in extra hospital bed days in 2019.
In 2020, we treated approximately 550 people and less than 100 of those in the wider community setting. We have to rethink how we can reach our target of treating 1,500 people per year to eliminate hepatitis C by 2030.”
Prof Jack Lambert, Consultant in Infectious Diseases and Genitourinary Medicine, Mater Misericordiae University Hospital, Dublin, speaking on World Hepatitis Day (28 July).
Prescribing Information: Please read the Summary of Product Characteristics (SPC) before prescribing. Presentation: Prolonged-release tablet, containing mirabegron 25mg/50mg. Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Posology and method of administration: The recommended dose is 50 mg once daily. A lower dose of 25mg is recommended for specific patient populations (renal and hepatic impairment) as well as in specific patient populations in combination with strong CYP3A inhibitors such as itraconazole, ketoconazole, ritonavir and clarithromycin.
Renal impairment: End stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis): Not recommended. Severe renal impairment (GFR 15 to 29 mL/min/1.73 m2): Reduce dose to 25 mg. Severe renal impairment and concomitant strong CYP3A inhibitors: Not recommended. Moderate renal impairment (GFR 30 to 59 mL/min/1.73 m2): 50 mg. Moderate renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Mild renal impairment (GFR 60 to 89 mL/min/1.73 m2): 50 mg. Mild renal impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. Hepatic impairment: Severe hepatic impairment (Child-Pugh Class C): Not recommended. Moderate hepatic impairment (Child-Pugh B): Reduce dose to 25 mg. Moderate hepatic impairment and concomitant strong CYP3A inhibitors: Not recommended. Mild hepatic impairment (Child-Pugh A): 50 mg. Mild hepatic impairment and concomitant strong CYP3A inhibitors: Reduce dose to 25 mg. The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed. It may be taken with or without food Contraindications: Hypersensitivity to the active substance or to any of the excipients (see the SPC for a list of excipients). Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg. Special warnings and precautions for use: Renal impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) and, therefore, it is not recommended for use in this patient population. Data are limited in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); based on a pharmacokinetic study a dose reduction to 25 mg is recommended in this population. This medicinal product is not recommended for use in patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors. Hepatic impairment: Betmiga has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, it is not recommended for use in this patient population. This medicinal product is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B) concomitantly receiving
strong CYP3A inhibitors. Hypertension: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with mirabegron, especially in hypertensive patients. Data are limited in patients with stage 2 hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg). Patients with congenital or acquired QT prolongation: Betmiga, at therapeutic doses, has not demonstrated clinically relevant QT prolongation in clinical studies. However, since patients with a known history of QT prolongation or patients who are taking medicinal products known to prolong the QT interval were not included in these studies, the effects of mirabegron in these patients is unknown. Caution should be exercised when administering mirabegron in these patients. Patients with bladder outlet obstruction and patients taking antimuscarinic medicinal products for OAB: Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medicinal products for the treatment of OAB has been reported in postmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in patients treated with Betmiga; however, Betmiga should be administered with caution to patients with clinically significant BOO. Betmiga should also be administered with caution to patients taking antimuscarinic medicinal products for the treatment of OAB. Interactions: Pharmacokinetic interactions: Mirabegron is a substrate for CYP3A4, CYP2D6, butyrylcholinesterase, uridine diphosphoglucuronosyltransferases (UGT), the efflux transporter P-glycoprotein (P-gp) and the influx organic cation transporters (OCT) OCT1, OCT2, and OCT3. Pharmacokinetic interactions involving the potential for other medicinal products to affect mirabegron exposures: Increases in mirabegron exposure due to drug-drug interactions may be associated with increases in pulse rate. Strong CYP3A inhibitors See Posology and administration above for dose adjustments recommended during concomitant use of strong CYP3A inhibitors in patients with renal or hepatic impairment. Mirabegron exposure (AUC) was increased 1.8-fold in the presence of the strong inhibitor of CYP3A/P-gp ketoconazole. CYP2D6 inhibitors: No dose adjustment is needed for mirabegron when administered with CYP2D6 inhibitors (or in patients who are CYP2D6 poor metabolisers). Inducers: Inducers of CYP3A (such as rifampicin) or P-gp may decrease the plasma concentrations of mirabegron. No dose adjustment of mirabegron is required as this effect is not expected to be clinically relevant. Pharmacokinetic interactions involving the potential for mirabegron to affect exposures to other medicinal products: Inhibition of CYP2D6: Moderate and time dependent inhibition of CYP2D6 by mirabegron may result in clinically relevant drug interactions. CYP2D6 activity recovers within 15 days after discontinuation of mirabegron. Caution is advised if mirabegron is co-administered with medicinal
products metabolized by CYP2D6 with a narrow therapeutic index such as thioridazine, Type 1C antiarrhythmics (e.g.flecainide, propafenone) and tricyclic antidepressants (e.g., imipramine, desipramine). Caution is also advised if mirabegron is co-administered with CYP2D6 substrates that are individually dose titrated. Inhibition of P-gp: Mirabegron is a weak inhibitor of P-gp. For patients who are initiating a combination of Betmiga and digoxin, the lowest dose for digoxin should be prescribed initially. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. The potential for inhibition of P-gp by mirabegron should be considered when Betmiga is combined with sensitive P-gp substrates e.g. dabigatran. Fertility, pregnancy and lactation: The effect of mirabegron on human fertility has not been established. Betmiga is not recommended during pregnancy and in women of child-bearing potential not using contraception. Mirabegron should not be administered during breast feeding. Refer to SPC for full guidance. Driving and use of machines: Betmiga has no or negligible influence on the ability to drive and use machines. Undesirable effects: Summary of the Safety Profile: the safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days). In the three 12-week phase 3 double blind, placebo controlled studies, 88% of the patients completed treatment with this medicinal product, and 4% of the patients discontinued due to adverse events. Most adverse reactions were mild to moderate in severity. The most common adverse reactions reported for patients treated with Betmiga 50 mg during the three 12-week phase 3 double blind, placebo controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving Betmiga 50 mg.
Tachycardia led to discontinuation in 0.1% patients receiving Betmiga 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Betmiga 50 mg.
Urinary tract infections led to discontinuation in none of the patients receiving Betmiga 50 mg. Serious adverse reactions included atrial fibrillation (0.2%). Adverse reactions observed during the 1-year (long term) active controlled (muscarinic antagonist) study were similar in type and severity to those observed in the three 12-week phase 3 double blind, placebo controlled studies. The following adverse reactions were observed with mirabegron in the three 12-week phase 3 double blind, placebo controlled studies. The frequency of adverse reactions is defined as follows: 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); not known (cannot be established from the available data) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse events
are grouped by MedDRA system organ class. Infections and infestations: Common: urinary tract infection Uncommon: vaginal infection, cystitis Psychiatric disorders: Not known: Insomnia*, confusional state* Nervous system disorders: Common: headache* dizziness* Eye disorders: Rare: eyelid oedema Cardiac disorders:
Common: tachycardia Uncommon: palpitation, atrial fibrillation Vascular disorders:
Very rare: Hypertensive crisis* Gastrointestinal disorders: Common: nausea*, constipation*, diarrhoea* Uncommon: dyspepsia, gastritis Rare: lip oedema Skin and subcutaneous tissue disorders: Uncommon: urticaria, rash, rash macular, rash papular, pruritus Rare: leukocytoclastic vasculitis, purpura, angioedema* Musculoskeletal and connective tissue disorders: Uncommon: joint swelling Renal and urinary disorders: Rare: urinary retention* Reproductive system and breast disorders: Uncommon: vulvovaginal pruritus Investigations Uncommon: blood pressure increased, GGT increased, AST increased, ALT increased (*observed during post-marketing experience) Reporting of suspected adverse reactions: see below. Legal category: POM (S1B) Marketing Authorisation number: EU/1/12/809/003 25mg EU/1/12/809/010 50mg. Marketing
Authorisation holder: Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, The Netherlands. Further information is available from: Astellas Pharma Co., Ltd, 5 Waterside, Citywest Business Campus, Dublin 24. Phone: +3531 467 1555. Summary of Product Characteristics with full prescribing information available upon request. Job number: BET_2019_0002_IE Date of preparation of API: 27 May 2019.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
HPRA Pharmacovigilance Astellas Pharma Co. Ltd
Earlsfort Terrace, IRL - Dublin 2 Tel: + 353 1 467 1555
Tel: +353 1 6764971 E-mail: Irishdrugsafety@astellas.com
Fax: +353 1 6762517
Website: www.hpra.ie E-mail: email@example.com.
Date of preparation: June 2019 References: 1. Freeman R, et al. Current Medical Research and Opinion 2017. https://doi.org/10.1080/03007995.2017.1419170. Approval code: BET_2019_0005_IE
His 14th walk in the park since the day he started BETMIGA1
10988_Betmiga_PARK_A4_MAY19_01.indd 1 10/07/2019 16:40
Prison healthcare in a pandemic
The Covid-19 crisis has presented Irish prisons with significant additional challenges in protecting the physical and mental health of prisoners. Emily Clarke Gifford reports
According to a recent report by the Irish Penal Reform Trust (IPRT), Irish prisons and Covid-19: One year on, there were over 4,200 people in custody at the start of the pandemic.
It said the Irish Prison Service (IPS), prison staff and prisoners were to be commended for working together to keep the number of Covid-19 cases in Irish prisons low to date. However, the report underlined that the pandemic “has had a devastating impact on people in prison”.
Dr John Devlin, Clinical Director at the IPS, said that “prisons are very vulnerable” in terms of the current crisis. However, he said Irish prisons had been “fortunate” in managing to keep out Covid-19 during the first and second waves of the pandemic.
no Covid-19-related deaths among prisoners or staff and no referrals to hospital.
Dr Devlin said the IPS meets weekly with the HSE to review all measures in place to mitigate the spread of Covid-19.
In the case of an outbreak, a management team implements an emergency response plan that establishes an outbreak control team immediately.
Dr Devlin explained that “we have a whole template of measures” involving 30-to-40 actions to limit the impact of an outbreak.
Outbreak control meetings are held daily to evaluate the measures in place and determine what additional steps may need to be implemented.
To prevent these outbreaks, health checks have been carried out on everyone entering prisons. Additionally, restrictions were put in place for visitations and the number of face-to-face groups were reduced in line with national restrictions.
“These are the kinds of measures that you had to [take] to reduce your big con-
ity in the vaccine roll-out.
He said: “In our view, there’s only one solution at the end of the day and that’s that staff and prisoners need to be vaccinated at the earliest opportunity.”
The vaccination roll-out began in March with the most at-risk groups. This was determined based on age and significant underlying conditions in prisoners.
As of 29 July, over 5,195 vaccines had been administered to prisoners, with a number of prisons completing the first and second doses of an mRNA vaccine, according to Dr Devlin.
The IPS initiated a communications programme to address any concerns relating to vaccine hesitancy.
Dr Devlin told MI the median average vaccine acceptance rate was 93 per cent.
“We’re very anxious that we complete that as soon as we can, because it is a vulnerable setting and at the end of the day, when we get high levels of vaccinations, that will stop Covid in its tracks and we’re very much in favour of that.”
20 per cent during the pandemic.
Addictions in Irish prisons mainly involve alcohol, benzodiazepines, cannabis, opiates and “more recently agents called the novel psychoactive substances”, outlined Dr Devlin.
Speaking to the Medical Independent (MI), Dr Devlin said the biggest healthcare challenges in prisons related to mental health, addiction, and lifestyle issues. In addition to these problems, “we’ve always had a challenge in relation to making sure our prisons are free of tuberculosis (TB).” (See panel on page 12).
Irish prisons have had significantly smaller Covid-19 outbreaks in comparison to some other countries.
Dr Devlin said there were “massive explosive outbreaks” in several jurisdictions, but this had not occurred in Irish prisons.
Covid-19 has been “hugely challenging” to many prisons worldwide, with hundreds of cases and a number of deaths in different jurisdictions.
“Thankfully we haven’t seen that. We know from experience in other countries what can happen. I think we’ve been fairly reasonably successful in terms of controlling Covid so far.”
As of late July, there had been 11 Covid-19 outbreaks in Irish prisons. Some outbreaks involved six or seven people including staff members, Dr Devlin said.
The most recent outbreak, at time of writing, occurred in Loughan House, Co Cavan. Dr Devlin said there was one positive case in a prisoner in this incident.
Across all Irish prisons, there had been
tacts between individuals,” said Dr Devlin.
“It was inevitable that sometime Covid would appear by virtue of the fact that it’s so prevalent in the community.”
Commenting on an outbreak in May at Mountjoy Prison, Dublin, Dr Devlin said “we were fortunate that we detected it quite early”.
Cocooning measures were put in place in April 2020 to protect the most vulnerable of the prison population. Dr Devlin explained that people aged over-70 consorted, worked, and trained together while being kept away from the general prison population.
People with pre-existing health conditions also followed the same cocooning regime. According to the IPRT, 52 per cent of Ireland’s female prison population were cocooning due to their chronic health needs.
All cocooned prisoners were offered an FFP2 mask to help provide protection from SARS-CoV-2.
Cocooning officially ceased in June 2020, but prisoners could maintain this regime if they wished.
According to Dr Devlin, since December, the IPS had made submissions to the national public health emergency team, HSE and Department of Health in relation to making prisoners and prison staff a prior-
Dr Devlin explained that a “significant percentage” of the prison population may have health challenges before they enter prison. These conditions can relate to homelessness, smoking and drug use. As a result, these prisoners “have a tendency to get chronic diseases more frequently than the general population”.
Infectious diseases other than Covid-19 also present issues for prison healthcare, particularly blood-borne viruses including hepatitis C, hepatitis B and human immunodeficiency virus (HIV).
“Those would be the ongoing challenges; certainly Covid has just added an extra layer onto that,” said Dr Devlin.
The impact of the pandemic on hospitals was felt in prisons as there were a limited number of outpatient appointments available.
To address the health needs of prisoners, a “blended model of treatment” was introduced. This involved video and telephone consults with some face-toface consults for those deemed to be urgent or a priority.
Not only was this beneficial for delivering general healthcare, but also to “maintain a level of service for addictions services and also for mental health services”, Dr Devlin noted.
However, he said the number of addiction counselling sessions reduced by up to
According to Dr Emma Regan, Head of Psychological Services at the IPS, a mental health protocol is implemented during outbreaks.
This includes using iPads to communicate with people who are at risk; manned telephones for psychological first aid; care packages with activities for those in isolation; and daily contact between prison officers and prisoners to check on any concerns they may have and to offer support.
The IPRT’s report outlined that isolation and loneliness during the pandemic had severely impacted the mental health and wellbeing of people in prison. For some, Covid-19 isolation requirements “have felt like solitary confinement or additional punishment”, it noted.
Dr Regan told MI “the biggest challenge we face in the psychology service has been the impact of Covid and increased isolation on people’s mental health”.
She explained that isolation does not mean being “locked up in a cell for a prolonged period” of time. It relates to not having family visits, not seeing members of the community, and not having access to usual prison services for a long duration.
According to the IPRT report, “people in prison have experienced severely reduced contact with families, lack of purposeful activity, limited access to education/work/training and long hours spent in cells.”
Dr Regan explained that the inability to access regular services or see family impacts on prisoners’ routines, which are “really important in terms of managing people’s mental health”.
She said: “There’s no doubt that people felt more trapped, and more hopeless and helpless, isolated, [because] of having nothing to look forward to when they
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 10
News Feature Continued on p12 ▸
Dr John Devlin
To address the health needs of prisoners, a ‘blended model of treatment’ was introduced
Dr Emma Regan
TREATING ALLERGIC SYMPTOMS IS CHILD’S PLAY WITH1,2†
10mg Available in 2 formulations: Oral Solution and Orodispersible Tablets*
†*Easy administration - orodispersible tablet is to be placed in the mouth where it disperses rapidly in saliva OR dispersed in
A non-sedating antihistamine indicated for the symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 – 11 years with a body weight of at least 20kg1,2
Drynol 10 mg orodispersible tablets and 2.5mg/ml oral solution (bilastine) Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. Presentation: Orodispersible tablets (ODT): round, slightly biconvex white tablets containing 10 mg bilastine. Oral Solution (OS): clear, colourless, slightly viscous aqueous solution. Uses: Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in children aged 6 to 11 years with a body weight of at least 20 kg. Dosage: Oral administration. Children aged 6 to 11 years with a body weight of at least 20 kg. ODT: Take 1 tablet once daily. OS: Take 4 ml of oral solution once daily. ODT and OS: Take one hour before or two hours after food or fruit juice. Children under 6 years: no information. In adults and adolescents (over 12 years of age) the administration of Drynol 20 mg tablets is appropriate. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Avoid
co-administration with P-glycoprotein inhibitors in patients with moderate or severe renal impairment. Do not use in children under 6 years of age. Interactions: No interaction data available for children. Consider interactions as for adults: food, grapefruit juice, ketoconazole, erythromycin, diltiazem; medicinal products that are substrates or inhibitors of P-gp, such as cyclosporine. Pregnancy and Lactation: Avoid use during pregnancy. Side Effects: Common: rhinitis, headache, allergic conjunctivitis, abdominal pain/upper abdominal pain. Uncommon: dizziness, loss of consciousness, eye irritation, diarrhoea, nausea, lip swelling, eczema, urticaria, fatigue. Frequency not known: palpitations, tachycardia, hypersensitivity reactions, and vomiting. Pack Sizes: ODT: 30 orodispersible tablets. OS: One bottle containing 120 ml oral solution. Legal Category: POM. Product
Authorisation Numbers: PA 865/18/02 and PA 865/18/03.
Product Authorisation Holder: Menarini International Operations Luxembourg S.A, 1 Avenue de la Gare, L-1611
Luxembourg. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC. Date of Preparation: July 2019
References: 1. Drynol 10mg orodispersible tablet Summary of Product Characteristics, last updated March 2019. 2. Drynol 2.5mg/ml oral solution Summary of Product Characteristics, last updated March 2019
Date of Item: January 2021. IR-DRY-01-2021
CM MY CY CMY K
were in custody.”
Prisoners’ mental health deteriorates when they are required to spend increased time in their cells and have a lack of interaction with their families.
This leads to feelings of “hopelessness, anxiety, depression, and potentially more of a risk to self”, said Dr Regan.
“Their sense of wanting to look well and to have a reason to shower and to shave, and to get up in the morning, just reduces. I think that for most people, our sense of pride in ourselves almost deteriorates.”
The less people engage in personal care, the more it impacts on their self-esteem, self-worth and motivation to do regular things that generate wellbeing.
Dr Regan said this is the same for both prisoners and the general public. However, the confinements of prison can exacerbate feelings of isolation.
“We’re all human in or outside custody and that lack of engagement with other people has meant that people’s standards dropped and that impacts on all of our mental health.”
A number of measures have been put in place to help protect the wellbeing of prisoners, including fortnightly newsletters.
The newsletter was first circulated at the beginning of the pandemic to communicate with prisoners about Covid-19 in the general community. It contains information on mental healthcare within the confinements of a prison cell.
Dr Devlin said from an early stage “we were conscious of the fact that we need to really communicate well with people who are in custody”.
In-cell TVs have been in prisons for almost 20 years. Dr Regan said while there is no formal research, “there was a reduction in self-harm and suicide” when the TVs were first introduced.
The TV channels have regular films as well as mindfulness programmes. A podcast, The Two Norries, is also available. The podcast has been “important” to the psychological services as it is by two men who were previously in prison and had a successful recovery, offering some hope to prisoners.
Dr Regan noted “there’s real legitimacy in that because the two men that are doing interviews have been through the prison system, so I think that’s been a really important piece for us”.
The IPRT suggests that the IPS introduce in-cell tablets as part of e-learning developments to give prisoners more access to education.
Last year, 1,300 referrals were made to the prison’s psychological services. Dr Regan said there is usually one-third of the prison population on the waiting list.
The waiting period to see a psychologist is based on the length of time the prisoner is on the list, combined with their estimated release date to ensure they are seen before they are released.
However, in cases of self-harm, suicide or challenging behaviours such as personality disorders, this is highlighted by the multidisciplinary teams. The prisoner is then reviewed and prioritised, Dr Regan explained.
One of the psychologists sought to
TB in prisons – the need for early diagnosis
Increased testing for TB in prisons was recommended in a recently published paper titled, ‘The largest prison outbreak of TB in Western Europe investigated using whole-genome sequencing.’
The study was carried out by Trinity College Dublin (TCD), the Irish Mycobacteria Reference Laboratory (IMRL), St James’s Hospital, Dublin, and the Department of Public Health (HSE East).
The paper describes an outbreak of TB in an Irish prison in 2011, leading to 34 people contracting TB from a single case.
In addition to the confirmed TB cases, the study found that half (50 per cent) of the prison staff who were close contacts of the case developed latent TB due to the exposure.
Latent TB is an asymptomatic, noninfectious form of TB that can develop into an active form of TB at a later date.
The report details how whole genome sequencing allowed the investigators to track the course of transmission and link TB cases from as recent as 2019 to an outbreak in 2011.
Prof Tom Rogers, Clinical Microbiology, TCD, and formerly Clinical Director,
measure the levels of depression and anxiety in people who had been in isolation due to an outbreak. From those who responded, 83 per cent scored within the clinical range (or borderline) for depression and 96 per cent scored within the clinical range for anxiety, Dr Regan said.
She noted that all prisoners can contact the Samaritans mental health service through a direct link with the prison. Last year, phone calls to the Samaritans went from an average of 4,000 to 12,000 calls.
As referenced in the IPRT report, poor mental health is experienced disproportionately among both male and female prisoners.
Dr Regan explained that female prisoners’ “pathways to offending tend to be more closely associated with deprivation, trauma, addiction, mental health, and social marginalisation”.
Although men also have these experiences, “for women there tends to be more layers of that because they may be more vulnerable.”
She added, “this inevitably leads to more significant, or vulnerability to, mental health difficulties and personality disorder difficulties, which we then end up seeing in prison.”
Additionally, factors such as motherhood can lead to women feeling “distress, guilt, anxiety [and] depression”.
In the UK, it was found that only 5 per cent of female prisoners’ children were cared for at home when the mother went to prison. However, most children continued to be cared for at home when the father was imprisoned, noted Dr Regan.
Female prisoners tend to experience more isolation as they get fewer visitations from their partners, she added.
Dr Regan said that “the restricted access
IMRL, St James’s Hospital, said: “This report demonstrates the power of whole genome sequencing to enhance epidemiological investigations of TB outbreaks over prolonged periods of time. The IMRL has created a national database of TB genomes which will facilitate future public health investigations of TB in Ireland.”
Dr Marcus Butler, Vice-President of the Irish Thoracic Society, said the study supports the “need for improving early TB diagnosis and care in the Irish prison system”.
Improving TB care in Irish prisons can be done through a three-step approach: Establishing a TB information and testing service in prisons; establishing a latent TB clinic at St James’s Hospital; and appointing a national TB lead to oversee this work as part of an integrated national TB control service.
Dr Butler said the national control service should include TB screening for high-risk groups; an investment in contact tracing and TB surveillance; and an education and awareness programme for both the public and healthcare professionals.
that we’ve had to people in custody has exacerbated [their mental health wellbeing] as well”.
She said the psychology service’s waiting lists were completely suspended last year from mid-March until July 2020. This meant that all planned individual therapy engagement was put on hold.
Prisoners were instead provided with emergency first aid by a telephone helpline. In July 2020, the services resumed under a blended model of treatment.
Last year, there was a reduction of 60 per cent in the group programmes.
In September 2020, group programmes recommenced but they soon became “entirely restricted” when level five restrictions were reintroduced. There had been no group sessions thus far in 2021.
Explaining the importance of group therapy, Dr Regan said “it’s one of the most effective ways of working with people, particularly around their mental health and criminogenic needs in prison because [witnessing the] challenge of [other] group members is really important and can be really effective”.
When the psychological teams do not have access to prisoners through individual and group work, it means they are not being assessed.
“It is highly likely that people have left prison at this stage, who were not seen for either an assessment of their mental health or an assessment of their criminogenic needs,” she said.
Once prisoners are released into the community, the IPS psychological services do not have contact with them. Therefore the “opportunity” for further intervention is lost.
Going forward, there is an emphasis on ensuring adequate mental health and ad-
diction services in Irish prisons.
In 2020, a report from the Council of Europe’s anti-torture committee was critical of the care afforded to vulnerable prisoners in Ireland, notably those with a mental illness.
Dr Devlin told MI that a Government taskforce on mental health and addiction met for the first time recently. This taskforce will tackle the challenges of mental welfare in prisons while looking at how the IPS can work better with the HSE.
He said this will help to “unlock some of the additional services that we need”.
There are a small number of prisoners who are very vulnerable and need to be admitted to the Central Mental Hospital. The taskforce will look at how this type of care can be developed for such prisoners and will try to increase the capacity for people who need urgent care, Dr Devlin explained.
“That will set the scene for us in relation to going forward, aware of not just mental health, but our general health needs.”
In August 2018, the terms of reference for a review of prison healthcare were agreed between the Department of Justice, Department of Health and IPS. The health needs assessment for Irish prisons has been delayed to ensure the report reflects the “current situation” of Covid-19 in prisons, according to the IPS.
The report, due to be finalised in June, required clarification in light of the pandemic. It is currently being completed and will go to the relevant departments and IPS for consideration.
The IPRT noted that “many community organisations are reporting poor mental health among clients coming out of prison during the pandemic”.
Dr Regan explained that it has been “difficult in terms of channelling people into community services”.
She explained that the time of release is when people are most at risk of reoffending. When they have proper access to community services, they will be more successful in recovery.
“But if we’re not able to assess and find out what people’s needs are, we’re not able to refer into the community and get those reference services available to us,” she continued.
Delays in accessing prisoners and providing risk assessments causes delays in their parole board reports.
Dr Regan would like to see community-based services return in prisons as they are “really important in terms of people’s mental health and wellbeing” and help them leave prison safely.
“What we really need is to make sure that the community services [that were originally in prisons] are back in prisons, meeting with people and preparing them for release and developing relationships with them, so that they can transition out of prison and into those community services.”
Dr Regan said that horticulture and animal therapy are some of the outdoor activities that can be implemented in prisons to promote wellbeing.
She explained that developing a relationship with animals and being able to support and care for something, such as plants, helps prisoners with their compassion and is “really important for people who are in prison, particularly for a long time”.
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 12 News Feature
Continued from p10 ▸
Vimovo® is indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.1
In randomised controlled studies, Vimovo treatment provided significant improvement in WOMAC pain2, WOMAC function2, and PGA-scores2, compared to placebo3. The PGA questionnaire asked patients “Considering the way your arthritis affects you, how well are you doing today?„ and the WOMAC pain and function included items such as walking on a flat surface, climbing stairs and going shopping.
duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient. Dosage and method of administration: Adults: Oral use. Swallowed whole (not split, chewed or crushed) with water. Recommended to take at least 30 minutes prior to food intake. One tablet twice daily. Use lowest effective dose for shortest duration possible. Patients not treated with NSAID previously, or when 1000mg/day of naproxen is not considered appropriate, alternative therapeutic treatment with lower strength of naproxen or of other NSAIDS as non-fixed combination should be utilised. Review at regular intervals and discontinue if no benefit or if worsening. Not intended for relief of acute pain conditions. Flares of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis may be treated. Renal / Hepatic impairment: Use cautiously in mild to moderate renal/hepatic impairment and monitor closely. Consider reduction in total daily naproxen dose. Elderly (>65 years): older people are at risk of serious consequences of adverse reactions. Paediatric population: Safety and efficacy not established in 0 to 18 years.
Contra-indications: Hypersensitivity to ingredients, history of asthma, urticaria or allergic-type reactions induced by administration of acetylsalicylic acid or other NSAIDs, third trimester of pregnancy, severe heart failure, severe renal impairment, active peptic ulceration, gastrointestinal (GI) bleeding, cerebrovascular bleeding or other bleeding disorders, must not be used concomitantly with atazanavir and nelfinavir. Special Warnings and precautions: Avoid concomitant NSAIDs use. Can be used with low dose acetylsalicylic acid. Undesirable effects may be minimized by using lowest effective dose for the shortest duration necessary. Assess at meaningful intervals to prevent over-treatment. Risk-factors to develop NSAID related GI complications include high age, concomitant use of anticoagulants, corticosteroids, other NSAIDs including low-dose acetylsalicylic acid, debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers and upper GI bleeding. In Inducible porphyries and systemic lupus erythematosus and mixed connective tissue disease use only after rigorous benefit-risk ratio. Patients on long-term treatment should be kept under regular surveillance. Contains very low levels of methyl and propyl parahydroxybenzoate. Elderly: Naproxen: Older people have an increased frequency of adverse reactions especially GI bleeding, and perforation, which may be fatal. Gastrointestinal effects: Naproxen: GI bleeding, ulceration or perforation, which can be fatal with or without warning symptoms or a previous history of serious GI events. Risk is higher with increasing NSAID doses, patients with history of ulcers and in older people. Start with low dose and consider combination therapy with protective agents. Caution in patients receiving NSAIDs with concomitant medications which could increase risk of ulceration or bleeding. Withdraw treatment if GI bleeding or ulceration. Caution in patients with a history of GI disease. Esomeprazole: In the presence of any alarm symptom and when gastric ulcer is suspected, malignancy should be excluded. Dyspepsia could still occur. May lead to increased risk of GI infections. May reduce absorption of vitamin B12 due to hypo- or achlorhydria. Cardivascular and cerebrovascular effects: Naproxen: Appropriate monitoring and advice for patients with history of hypertension and/or mild to moderate congestive heart failure. The use of coxibs and some NSAIDs may be associated with a small increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with naproxen after careful consideration. Consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events. Renal effects: Naproxen: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Patients at greatest risk of this are those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics, angiotensin converting enzyme (ACE) inhibitors, or angiotensin II receptor antagonists and older people. Use with great caution in patients with impaired renal function and monitoring of serum creatinine and/or creatinine clearance is advised. Contraindicated in patients with baseline creatinine clearance less than 30 ml/min. Assess renal function before and during therapy in patients with compromised renal blood flow. Hepatic effects: Borderline elevations of liver tests may occur, due to hypersensitivity rather than toxicity. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes have been reported. Hepatorenal syndrome: Use of NASAIDs may be associated with acute renal failure in patients with hepato-cirrhosis. These patients frequently also have concomitant coagulopathy related to inadequate synthesis of clotting factors. Antiplatelet effects associated with naproxen could further increase risk of severe bleeding. Haematological effects: Naproxen: Careful observation when administered to patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis. Increased risk of bleeding if given to patients with high risk of bleeding and those on full anti-coagulation therapy. Naproxen decreases platelet aggregation and prolongs bleeding time. If active and clinically significant bleeding from any source occurs, withdraw treatment. Eye effects: Naproxen: recommend ophthalmic examination if any change or disturbance in vision occurs. Dermatological effects: Naproxen: Discontinue at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Esomeprazole: associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE). If lesions occurs and if accompanied by arthralgia, seek medical help promptly and consider stopping treatment. SCLE after previous treatment with a PPI may increase the risk of SCLE with other PPIs. Anaphylactic (anaphylactoid) reactions: Naproxen: anaphylactic (anaphylactoid) reactions may occur in patients with and without a history of hypersensitivity or exposure to acetylsalicylic acid, other NSAIDs or naproxen-containing products. They may also occur in individuals with a history of angio-oedema, bronchospastic reactivity, rhinitis and nasal polyps. Pre-existing asthma: Naproxen: Use with caution and should not be administered to patients with aspirin-sensitive asthma. Inflammation: Naproxen: may reduce fever and other signs of inflammation thereby diminishing their utility as diagnostic signs. Female fertility: not recommended in women attempting to conceive. Combination with other medicinal products: Must not be used with atazanavir. Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment, the potential for interactions with drugs metabolised through CYP2C19 should be considered. Concomitant use with clopidogrel should be discouraged. Hypomagnesaemia: Severe hypomagnesaemia has been reported in patients treated with Proton Pump Inhibitors (PPIs). Consider measuring magnesium levels before starting PPI treatment and periodically during treatment in patients expected to be on prolonged treatment or those on concomitant digoxin or drugs that may cause hypomagnesaemia. Bone fracture: PPIs, if used in high doses and over long durations (>1 year), may increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence of other recognised risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and have an adequate intake of vitamin D and calcium. Interference with laboratory tests: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, treatment should be stopped for at least 5 days before CgA measurements. Interactions: Antiretroviral agents: Concomitant use of atazanavir and nelfinavir with esomeprazole is not recommended and concomitant administration with Vimovo is contraindicated. Concomitant use with precaution: Other analgesics including cyclooxygenase-2 selective inhibitors: Concomitant use with other NSAIDs except for low-dose acetylsalicylic acid (≤ 325 mg/day), is not recommended. Acetylsalicylic acid: Can be administered with low dose acetylsalicylic acid (≤ 325 mg/day). In clinical trials, Vimovo in combination with low-dose acetylsalicylic acid did not have increased occurrence of gastric ulcers. However, concurrent use may still increase risk of serious adverse events. Clinical pharmacodynamic data suggests concomitant naproxen usage for more than one day consecutively may inhibit the effect of low-dose acetylsalicylic acid on platelet activity and this inhibition may persist for up to several days after stopping naproxen. Clinical relevance of this interaction is not known. Tacrolimus: A reinforced monitoring of tacrolimus concentrations as well as renal function should be performed and dose of tacrolimus adjusted if needed. Ciclosporin: caution when coadministered because of increased risk of nephrotoxicity. Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazides in some patients. Observe patient closely for signs of renal failure as well as to assure diuretic efficacy. SSRIs: Concomitant use of NSAIDs, including COX-2 selective inhibitors, and SSRIs increases the risk of GI bleeding. Corticosteroids: Increased risk of GI bleeding when combined with NSADIs including COX-2 selective inhibitors. Caution when NSAIDS are concomitantly administered with corticosteroids. ACE-inhibitors/Angiotensin II receptor antagonists: caution when combined with NSAIDs in patients who are older, volume-depleted, or with renal impaired renal function as NSAID may diminish antihypertensive effect and increase risk of renal impairment associated with ACE-inhibitor or angiotensin II receptor antagonists. Digoxin: NSAIDs may increase plasma cardiac glycoside levels when co-administered with cardiac glycosides such as digoxin. Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Observe carefully for lithium toxicity. Methotrexate: esomeprazole and naproxen could enhance the toxicity of methotrexate. Caution when administered concomitantly with methotrexate. In high-dose methotrexate administration a temporary withdrawal of Vimovo is recommended. Sulphonylureas, Hydantoins: Naproxen is highly bound to plasma albumin; thus a theoretical potential for interaction with other albumin-bound drugs (sulphonylureas, hydantoins). When coadministered patients should be observed for adjustment of dose. Clopidogrel: Concomitant use should be discouraged due to inconsistent data on clinical implications of a PK/PD interaction of esomeprazole in terms of major cardiovascular events reported from observational and clinical studies. Anti-coagulants and thrombocyte aggregation inhibitors: NSAIDs may enhance the effects of oral anti-coagulants, heparins and thrombocyte aggregation inhibitors. Close monitoring when initiating and ending treatment with warfarin or other coumarine derivatives. Beta receptor-blockers: Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers. Probenecid: Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. Drugs with gastric pH-dependent absorption: gastric acid suppression during treatment with esomeprazole, and other PPIs might decrease or increase the absorption of drugs with a gastric pH dependent absorption. The absorption of drugs such as ketoconazole, itraconazole, posaconazole and erlotinib can decrease while the absorption of drugs such as digoxin can increase. Concomitant use with posaconazole and erlotinib should be avoided. Other Information Concerning Drug Interactions: Studies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant interaction. Concomitant administration of cholestyramine can delay absorption of naproxen. In healthy volunteers, concomitant administration esomeprazole resulted in an increase in area under the plasma concentration-time curve and prolonged elimination half-life but no significant increase in peak plasma levels of cisapride. Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin and quinidine. Esomeprazole inhibits CYP2C19, the major esomeprazole metabolising enzyme. Esomeprazole is also metabolised by CYP3A4. Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John‘s Wort) may lead to decreased esomeprazole serum levels. Omeprazole and esomeprazole act as inhibitors of CYP2C19. Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking quinolones may have an increased risk of developing convulsions. Drug/Laboratory Test Interaction: Naproxen may decrease platelet aggregation and prolong bleeding time. Naproxen may result in increased urinary values for 17-ketogenic steroids. Suggested therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used. Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA). Pregnancy and lactation: In women attempting to conceive or in first and second trimester, do not give unless potential benefit to patient outweighs risk to foetus. Duration of treatment should be as short as possible. Contraindicated during third trimester. Should not be used during breastfeeding. Effects on driving and using machinery: minor influence on the ability to drive and use machines; based on that some of the adverse effects (e.g. dizziness) reported following the use may reduce the ability to react.
Undesirable effects: Reported fromVimovo clinicaltrials: Very common (≥1/10): dyspepsia. Common (≥1/100 to <1/10): dizziness, headache, taste disturbance, hypertension, abdominal pain, constipation, diarrhea, esophagitis, flatulence, gastric/duodenal ulcers, gastritis, nausea, vomiting, skin rashes, arthralgia, oedema. Other important undesirable effects: paraesthesia, syncope, arrhythmia, GI bleeding, stomatitis, urticaria, (Uncommon (≥ 1/1,000 to < 1/100), diverticulitis, hypersensitivity reactions, myocardial infarction, tachycardia, rectal bleeding, renal failure, (Rare (≥ 1/10,000 to < 1/1,000). Naproxen: adverse experiences reported during trial and through postmarketing reports: Common (≥1/100 to <1/10): diverticulitis, depression, insomnia, dizziness, drowsiness, headache, lightheadedness, vertigo, visual disturbances, tinnitus, hearing disturbances, palpitations, dyspnea, dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation, heartburn, pepticulcers, stomatitis, pruritus, ecchymoses, purpura, skin rashes, fatigue, oedema, sweating, thirst. Other important undesirable effects: sepsis, agranulocytosis, eosinophilia, granulocytopenia, Pancytopenia, thrombocytopenia, anaphylactic reaction, anaphylactoid reactions, hypersensitivity reactions, coma, convulsions, optic neuritis, paresthesia, syncope, corneal opacity, papilloedema, arrhythmia, myocardial infarction, tachycardia, eosinophilic pneumonitis, pneumonia, respiratory depression, gastric/duodenal ulcers, gastrointestinal bleeding and/or perforation, pancreatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn‘s disease), rectal bleeding, cholestasis, hepatitis, jaundice, liver failure, exanthema, urticaria, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme, systemic lupus erythematosus, pseudoporphyria, nephrotic syndrome, renal failure, renal papillary necrosis, tubular necrosis, Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000). Esomeprazole: adverse drug reactions identified or suspected in clinical trial for enteri-coated esomeprazole and/or post marketing. None were found to be dose-related: Common (≥1/100 to <1/10): headache, abdominal pain, diarrhea, flatulence, nausea/vomiting, constipation, fundic gland polyps (benign). Other important undesirable effects: paraesthesia, pruritus, urticaria, fracture of the hip, wrist or spine (Uncommon (≥ 1/1,000 to < 1/100). leukopenia, thrombocytopenia, hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock, depression, paraesthesia, syncope, arrhythmia, gastrointestinal bleeding, stomatitis, pruritus, urticaria, (Rare (≥ 1/10,000 to < 1/1,000)). agranulocytosis, pancytopenia agranulocytosis, pancytopenia, hepatic failure, hepatic encephalopathy in patients with pre-existing liver disease, erythema multiforme, Interstitial nephritis, (Very rare (< 1/10,000)). Overdose: Effects of overdose expected to reflect the effects of naproxen overdose. Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. GI bleeding can occur. Hypertension, acute renal failure, respiratory depression, and
VIMOVO 500mg/20mg modified-release tablets (naproxen and esomeprazole) Refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: Modified-release tablet (oval, biconvex, yellow, marked 500/20 in black ink) containing enteric-coated naproxen (500 mg) and film-coated esomeprazole (20 mg). Indication: In adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or
by symptomatic and supportive care following a NSAID overdose, particularly with respect to GI effects
renal damage. Hemodialysis
naproxen because of the high degree of protein binding. Emesis
activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful. Esomeprazole is not readily dialyzable. There are no specific antidotes for naproxen or esomeprazole. Legal classification: POM. Marketing Authorisation number, pack sizes: PA 1019/024/001, 60 packs. Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden. Date of preparation: August 2020. M-VMO-IE-08-20-0001. References: 1. Vimovo Summary of Product Characteristics. 2. Bellamy N. WOMAC: a 20-year experiential review of a patient-centered self-reported health status questionnaire. The Journal of Rheumatology. 2002;29(12):2473-2476. 3. Hochberg MC, Fort JG, Svensson O et al. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin. 2011;27(6):1243-1253. M-VMO-IE-10-20-0004 – October 2020 Combined to reflect their potential
coma may occur, but rare. Anaphylactoid reactions have been
few patients have experienced convulsions. It is not known what dose of the drug would be life-threatening. The symptoms in connection with esomeprazole overdose are transient. Patients should be managed
does not decrease the plasma concentration of
Inside health research from outer space
Bette Browne looks at the benefits that are being accrued from health research in space
The International Space Station (ISS), the brightest object in the night sky over Ireland during these summer months, is a unique laboratory for groundbreaking health research and innovation.
Take the NeuroArm, the world’s first robot that is as dexterous as the human hand, but even more precise and tremor-free and can perform surgeries inside an MRI machine that would otherwise be impossible.
This device was developed by Canadian technology and research aboard the ISS in 2008 and has since been used to treat 70 patients who were otherwise inoperable.
Then there is the Image-guided Autonomous Robot (IGAR), a digital innovation that is expected to increase access to critical surgical techniques to fight breast cancer.
Another breakthrough was Modus V, a robotic digital microscope that helps in the treatment of patients with a range of brain and spine conditions, which is being used in 30 hospitals across North America.
use space to study our bones, heart, blood vessels and brain. Their experiments have produced findings that can help people suffering from cardiovascular disorders, type 2 diabetes, osteoporosis, and balance problems. Living in weightless conditions changes the human body in many ways.
“Canada’s main focus is on health research,” Ms Isabelle Tremblay, Director, Astronauts, Life Sciences and Space Medicine at the Canadian Space Agency (CSA), told the Medical Independent (MI) in a telephone interview.
The CSA is one-of-five international space agencies participating in innovative work aboard the modular ISS as it orbits the planet. The others are NASA (United States), Roscosmos State Corporation for Space Activities (Russia), JAXA (Japan Aerospace Exploration Agency), and the ESA (European Space Agency) of which Ireland is a member. The ISS, now 21 years old, will operate until at least 2024 and discussions are underway to extend that to 2028.
The Americans, Russians, and Europeans contribute most of the funding, but Japan and Canada are also key members. Canada is proud of its contribution.
“Although we have a small share allocation (on the ISS), Canada punches above its weight,” said Ms Tremblay.
Space is continually improving our understanding of medical conditions on Earth, she told MI. “Canadian scientists
“The effects observed in astronauts are similar to accelerated aging and health problems caused by a sedentary lifestyle. Studying the human body in space for six months gives us data that would take 10 to 20 years to gather on Earth. All the knowledge is applicable here on Earth to better understand the effects of inactivity and what we can do efficiently to stay healthy.”
NASA also publicises the benefits of research aboard the space station, where astronauts have conducted nearly 3,000 scientific experiments over the last 20 years.
“The International Space Station is a unique laboratory for performing investigations that affect human health both in space and on Earth,” the US agency says on its website. “During its time in orbit, the space station has enabled research that is providing a better understanding of many aspects of human health including aging, trauma, disease and environmental impacts.”
The results of its research have provided new ways to mitigate bone loss, insights into bacterial behaviour, and innovative wound-healing techniques. “Advances in telemedicine, disease models, psychological stress response systems, nutrition, and cell behaviour are just a few more examples of the benefits that have been gained from applying studies in orbit to human health back on Earth.”
It cites insights into a range of diseases and conditions including Alzheimer’s disease, Parkinson’s disease, cancer, asthma, and heart disease. “Microgravity research has provided new insights to scientists studying these diseases. Without the interference of Earth’s gravity, Alzheimer’s researchers have studied protein clusters that can cause neurodegenerative diseases.
“Cancer researchers studied the growth of endothelial cells on the space station. Endothelial cells help supply blood in the body, and tumors need that blood to form. Space station-grown cells grow better than those on Earth and can help test new cancer treatments.”
Protein crystal growth experiments conducted aboard the space station have provided insights into numerous diseases, from cancer to gum disease, NASA says.
“One of the most promising results of
these station experiments has come from the study of a protein associated with Duchenne muscular dystrophy (DMD). A treatment for DMD based on this research is in clinical trials.”
Research from NASA’s landmark ‘twins study’ was published in 2019 in the journal Science . The study brought 10 research teams together to observe what physiological, molecular, and cognitive changes could happen to a human from exposure to spaceflight hazards. This was accomplished by comparing retired US astronaut Scott Kelly while he was in space, to his identical twin brother, retired astronaut Mark Kelly who remained on Earth. Because identical twins share the same genetic makeup, twin studies provide a way for scientists to explore how health is impacted by the environment. Scott provided a test case to measure in space, and Mark provided a baseline test case to compare those measurements on Earth.
“Findings from the twins study may be used to develop new treatments and preventative measures for stress-related health risks on Earth.” For example, NASA said telomere research may improve efforts to mitigate the effects of aging and disease.
“The proteomic research could have implications for research on traumatic brain injury. Research in astronauts could give new insights into how changes in the body are related to risk factors for diseases. These are just a few of many ways spaceflight research can help humankind.”
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 14
Ms Isabelle Tremblay
Continued on p16 ▸
Studying the human body in space for six months gives us data that would take 10 to 20 years to gather on Earth
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics (SmPC) for how to report adverse reactions.Xarelto 2.5 mg/ 10 mg / 15 mg / 20 mg film-coated tablets and 1mg/ml granules for oral suspension (Rivaroxaban). Presentation: 2.5mg/10mg/15mg/20mg rivaroxaban tablet (contains lactose) & 1mg/ml granules for oral suspension. Indication(s): 2.5mg, Xarelto, coadministered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Xarelto is co-administered with acetylsalicylic acid (ASA) in prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 10mg Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults (see W&P for haemodynamically unstable PE patients). 15mg/20mg Prevention of stroke & systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors such as congestive heart failure, hypertension, age ≥ 75, diabetes mellitus, prior stroke or transient ischaemic attack (SPAF).Treatment of DVT & PE, & prevention of recurrent DVT & PE in adults (see W&P for haemodynamically unstable PE patients). Paediatrics: 1mg/ml – Treatment of VTE and prevention of VTE recurrence in term neonates, infants & toddlers, children, & adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment. Treatment of VTE & prevention of VTE recurrence in children & adolescents aged less than 18 years & weighing from 30kg to 50kg (for 15mg) / above 50kg (for 20mg) after at least 5 days of initial parenteral anticoagulation treatment. Posology & method of administration: 2.5mg – Oral b.d. dose; patients should also take a daily dose of 75 – 100mg ASA or a daily dose of 75 – 100mg ASA in addition to either a daily dose of 75mg clopidogrel or a standard daily dose of ticlopidine. Start Xarelto as soon as possible after stabilisation, including revascularisation for ACS; at the earliest 24 hours after admission & at discontinuation of parenteral anticoagulation. If dose is missed take next dose, do not double the dose. For CAD/PAD the recommended dose is 2.5 mg b.d. Patients taking Xarelto 2.5 mg b.d. should also take a daily dose of 75 – 100 mg ASA. Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk of thrombotic events versus the bleeding risks. In patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of this treatment should be evaluated depending on the type of event or procedure and antiplatelet regimen. Dual antiplatelet therapy has not been studied in combination with Xarelto 2.5 mg b.d. in patients with CAD/PAD 10mg – hip or knee replacement surgery: Oral o.d. dose; initial dose taken 6 to 10 hours after surgery provided haemostasis established. DVT & PE: When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg o.d. In patients in whom the risk of recurrent DVT or PE is considered high, such as those with complicated comorbidities, or who have developed recurrent DVT or PE on extended prevention with Xarelto 10 mg o.d., a dose of Xarelto 20 mg o.d. should be considered. 15mg/20mg – Take with food SPAF. 20 mg orally o.d. DVT & PE: 15 mg b.d. for 3 weeks followed by 20 mg o.d. for continued treatment & prevention of recurrent DVT & PE. Children & adolescents – calculate dose based on body weight: body weight <30kg refer to the SmPC for Xarelto 1mg/ml granules for oral suspension; body weight 30-50kg take 15mg o.d.; body weight >50kg take 20mg o.d. Monitor child’s weight & review regularly. All strengths - Refer to SmPC for full information on duration of therapy & converting to/from Vitamin K antagonists (VKA) or parenteral anticoagulants. Special populations: Patients undergoing cardioversion: Xarelto 15mg/20mg can be initiated or continued in patients who may require cardioversion. Patients with non-valvular atrial fibrillation who undergo PCI (percutaneous coronary intervention) with stent placement: There is limited experience of a reduced dose of 15 mg Xarelto once daily (or 10 mg Xarelto once daily for patients with moderate renal impairment [creatinine clearance 30 – 49 ml/min]) in addition to a P2Y12 inhibitor for a maximum of 12 months in patients with non-valvular atrial fibrillation who require oral anticoagulation & undergo PCI with stent placement. Renal impairment: mild (creatinine clearance 50-80 ml/min) – no dose adjustment; 2.5mg /10mg - moderate (creatinine clearance 30-49 ml/min)– no dose adjustment. 15mg/20mg – adults with moderate (creatinine clearance 30-49 ml/min) & severe (creatinine clearance 15-29ml/min) - SPAF: reduce dose to 15mg o.d., DVT & PE: 15 mg b.d. for 3 weeks, thereafter 20mg o.d. Consider reduction from 20mg to 15mg o.d. if patient’s bleeding risk outweighs risk for recurrent DVT & PE; children & adolescents - Due to no clinical data available in children 1 year or older with moderate or severe renal impairment (glomerular filtration rate < 50 mL/ min/1.73 m2) or in children younger than 1 year with serum creatinine results above 97.5th percentile - Xarelto is not recommended. All strengths – Severe impairment: limited data indicate rivaroxaban concentrations are significantly increased, use with caution. Creatinine clearance <15 ml/min - not recommended. Hepatic impairment:
Contraindicated in patients with coagulopathy & clinically relevant bleeding risk including cirrhotic patients with Child Pugh B & C Paediatrics: Only for treatment of VTE & prevention of VTE recurrence. Contra-indications:
Hypersensitivity to active substance or any excipient; active clinically significant bleeding; lesion or condition considered to confer a significant risk for major bleeding (refer to SmPC); concomitant treatment with any other anticoagulants except under specific circumstances of switching anticoagulant therapy or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter; hepatic disease associated with coagulopathy & clinically relevant bleeding risk including cirrhotic patients with Child Pugh B & C; pregnancy & breast feeding. 2.5mg - concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or transient ischaemic attack; concomitant treatment of CAD/PAD with ASA in patients with previous haemorrhagic or lacunar stroke, or any stroke within a month. Warnings & precautions (W&P): Clinical surveillance in line with anticoagulant practice is recommended throughout the treatment period. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine, if clinically indicated rivaroxaban levels can be measured by calibrated quantitative anti-Factor Xa tests. Discontinue if severe haemorrhage occurs. Increasing age may increase haemorrhagic risk. Xarelto should be discontinued at the first appearance of a severe skin rash, or any other sign of hypersensitivity in conjunction with mucosal lesions. Not recommended: In patients with severe renal impairment (creatinine clearance <15 ml/min); in patients with an increased bleeding risk (refer to SmPC); in patients with prosthetic heart valves; for patients with a history of thrombosis diagnosed with antiphospholipid syndrome; Xarelto should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR); 1mg/ml oral suspension - sodium benzoate may increase jaundice in new-born infants (up to 4 weeks old). Not recommended: in children less than 6 months of age who at birth had <37 weeks of gestation, a body weight of <2.6 kg, or had <10 days of oral feeding; Use with caution: in patients treated concomitantly with medicines affecting haemostasis; when neuraxial anaesthesia or spinal/epidural puncture is employed; in patients at risk of ulcerative gastrointestinal disease (prophylactic treatment may be considered); in children with cerebral vein & sinus thrombosis who have a CNS infection.
2.5mg treatment in combination with antiplatelet agents other than ASA & clopidogrel/ ticlopidine; in patients ≥75 years of age or with lower body weight (<60kg); in CAD patients with severe symptomatic heart failure. Patients on treatment with Xarelto & ASA should only receive concomitant treatment with NSAIDs if the benefit outweighs the bleeding risk.
2.5mg/10mg in patients with moderate renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations 10mg/15mg/20mg in haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy; 15mg/20mg in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations. Interactions: Not recommended: In patients receiving concomitant systemic treatment with strong concurrent CYP3A4- & P-gp-inhibitors, i.e. azole antimycotics such as ketoconazole, itraconazole, voriconazole & posaconazole or HIV protease inhibitors like ritonavir; in patients treated concomitantly on dronedarone as clinically relevant increased rivaroxaban plasma concentrations are observed. Use with caution: In patients concomitantly receiving NSAIDs, ASA or platelet aggregation inhibitors due to the increased bleeding risk; patients concomitantly receiving SSRIs/SNRIs due to a possible increased bleeding risk. Concomitant use of strong CYP3A4 inducers should be avoided unless patient is closely observed for signs & symptoms of thrombosis. Fertility, Pregnancy and Lactation: Pregnancy: Xarelto is contraindicated during pregnancy. Breastfeeding: Xarelto is contraindicated during breast-feeding; a decision must be made to discontinue breast-feeding or discontinue/abstain from therapy. Fertility: No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility. In a study on male and female fertility in rats, no effects were seen. Effects on ability to drive & use machines: syncope (uncommon) & dizziness (common) were reported. Patients experiencing these effects should not drive or use machines. Undesirable effects: Common: anaemia, dizziness, headache (in children: very common), eye haemorrhage, hypotension, haematoma, epistaxis (in children: very common),haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting (in children: very common),increase in transaminases, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage (menorrhagia very common in women < 55 years treated for DVT, PE or prevention of recurrence, common in female adolescents after menarche), renal impairment, fever (in children: very common),peripheral oedema, decreased general strength and energy, postprocedural haemorrhage, contusion, wound secretion. Uncommon: thrombocytosis, thrombocytopenia (in children: Common), allergic reaction, dermatitis allergic, angioedema, allergic oedema, cerebral and intracranial haemorrhage, syncope, tachycardia (in children: Common), dry mouth, hepatic impairment, urticaria, hemarthrosis, feeling unwell, increases in: bilirubin (in children: Common), blood alkaline phosphate, GGT, LDH, lipase, amylase. Rare: jaundice, bilirubin conjugated increased (in children: uncommon), cholestasis, hepatitis (including hepatocellular injury), muscle haemorrhage, localised oedema, vascular pseudoaneurysm (uncommon in prevention therapy in ACS following percutaneous coronary intervention). Very Rare: Anaphylactic reactions including anaphylactic shock, Stevens-Johnson syndrome/ toxic epidermal necrolysis, DRESS syndrome. Frequency not known: compartment syndrome secondary to a bleeding, renal failure/ acute renal failure secondary to a bleeding. Classification of supply: Prescription only Medicine. Marketing Authorisation Holder: Bayer AG, 51368 Leverkusen, Germany. MA numbers: EU/1/08/472/001-051. Further information available from: Bayer limited, The Atrium, Blackthorn Road, Dublin 18, Ireland. Tel: 01 2163300. For more details please refer full SmPC on medicines.ie Date of Preparation: 06/2021
Protection for babies* to grandparents1
• Now Xarelto can also take care of the most vulnerable patients from babies to cancer patients and older people1
• Tried and tested with > 82 million Xarelto patients across a breadth of indications2
1. Bayer AG. Xarelto® (rivaroxaban) SmPC. https://www.ema.europa.eu/en/documents/productinformation/xarelto-eparproduct-information_en.pdf.
2. Bayer estimate based on caluculations on IQVIA data (source used: IQVIA MIDAS Database Quarterly Sales Q4 2020). *Term neonates
* GUIDELINEINWITHCHILDREN VTE NEW LICENCE
Tissue chips have also been tested. Tissue chips are roughly USB drive-size devices that contain human cells in a 3D matrix, representing functions of an organ. They help scientists to test how those cells respond to stresses, drugs, and genetic changes.
The Tissue Chips in Space initiative aims to use these devices in microgravity to better understand and improve human health and disease treatment on Earth.
Chips simulating lung, kidney, brain, and intestine behaviour have been sent to the space station by a branch of the US National Institutes of Health.
Many of the changes in the body caused by microgravity resemble the effects of diseases associated with aging on Earth but occur much faster in space. This means scientists may be able to use tissue chips in space to model changes that might take months or years to happen on Earth, according to NASA.
Protein crystals grown on Earth are affected by gravity, which may alter the way the molecules align on the crystal, but researchers have discovered that growing crystals aboard the space station allows for slower growth and higher quality crystals. This high-quality crystallisation allows scientists to identify the structures of disease-causing proteins to develop new medications and treatments, according to NASA.
June was a particularly busy month for research work aboard the ISS. On 5 June, Flight Engineer Thomas Pesquet of the ESA installed the Molecular Muscle Experiment-2 in the space station’s Columbus laboratory module. “MME-2 will test a series of drugs to see if they can improve health in space possibly leading to new therapeutic targets for examination on Earth,” stated NASA.
On 7 June, NASA astronaut Megan McArthur installed a new research device known as the ADSEP-2, or Advanced Space Experiment Processor-2, which will support observations of biological or physical samples. On the same day, fellow astronaut Shane Kimbrough put in place sample packs for an experiment to observe how bacteria is affected by microgravity and investigate ways to counteract any potential harmful changes. NASA suggests that results could also have a positive influence for oral health.
The ESA also describes the ISS as humankind’s laboratory in space. “Its unique microgravity environment enables researchers to study phenomena and carry out experiments that would not be possible on Earth,” according to the ESA’s website. “Scientific discoveries made are applied widely from health to metallurgy, while the increased knowledge we gain about our solar system helps build a deeper understanding of Earth and life itself.”
ESA’s human spaceflight research coordinator Jennifer Ngo-Anh explains the benefits of research aboard the ISS. “We typically run three types of experiments, research that cannot be done on Earth, research to understand and improve astronaut health and research that exploits the
unique aspect of sending perfectly healthy and fit humans into a new and stressful environment,” she told the ESA website.
This work has included research into endothelial cells that line blood vessels. It is helping understand how and why they contract and expand, and why they have reduced functionality in old age on Earth. Scientists are also exploring whether new blood vessels can be grown in space by exploiting weightlessness.
Meanwhile, in November, the ESA announced that Irish tech companies were using space technologies to help remotely monitor the health of patients with Covid-19.
The ESA-backed projects involve monitoring technologies, which were to be trialed in Ireland and other ESA member states.
An early trial at Beaumont Hospital, Dublin, demonstrated that the system deployed could identify patients at risk of suffering respiratory failure 12 hours earlier than normally possible.
Keeping an astronaut healthy from a distance is the flight surgeon’s task on Earth. Small, easy-to-use machines are required for diagnosis, but also for research into human health. “Great strides have been made over the last two decades in ultra-
six months,” Ms Tremblay emphasised. “We need to know that before we send people to Mars and how it’s going to affect their health over two years. We are involved in an initiative called Health Beyond or Deep Space Healthcare. That’s where major medical developments can be expected.”
Much of this evaluation of astronauts’ health and wellbeing will be done on a planned Lunar Gateway, a small space station that will be built over the course of this decade and will serve as a multi-purpose outpost orbiting the Moon.
Last year, four of the five space agencies working on the ISS reached agreement to back the Lunar Gateway. The CSA, ESA, and JAXA announced plans to participate in the NASA-led Lunar Gateway project.
However, Roscosmos said that the project was too “US-centric” and in January 2021, it announced it would not be participating. However, two months later, the Russian space agency signed an agreement with the Chinese National Space Administration to build what they called an International Scientific Lunar Station –a base on or around the Moon.
Canada has been laying the foundations for its participation in Mars missions and focusing on the health aspects of such exploration.
According to an expert group report on
longer periods than ever before. Limited communication and speed-of-light delays will greatly reduce the role of mission control in helping the expedition succeed. Aborting a mission to return early, for example in the case of system failure or crew illness, will be impossible.”
The report stressed that “different approaches to complex medical operations in space and the functionality of spacecraft themselves” must be validated prior to the first Mars exploration mission.
“The practice of clinical medicine on Earth also happens to be evolving to become a more patient-centric and point-ofcare model, similar to what is envisaged for the care of deep-space astronauts. Thus, this new autonomous model could potentially be evaluated by health-practitioners working in northern communities on Earth and by geriatric patients being remotely monitored at home.”
It seems that everything translates back to enhancing healthcare on Earth. “Absolutely,” Ms Tremblay responded. “When we tackle a very challenging problem like space exploration it’s a powerful driver of innovation and we can apply that on Earth. If we look at deep space healthcare, we can see how we can also drive innovation in that area, working with partners, and that has the potential to transform the way our healthcare systems work and how we provide healthcare here on Earth.
“What inspired me to work on space exploration is that power to project us into the future and to have those advanced technologies that will transform our lives here on Earth. So, for me, space exploration has a key role in advancing our societies and our technologies when we work together. The ISS is a powerful example of that collaboration.”
sound machines, heart-rate monitors, thermometers as well as in operating and sending the data to medical professionals many thousands of kilometres away,” according to the ESA.
Such advances help remote communities in very practical ways, Ms Tremblay told MI. “In Canada, we want to generate benefits and improve equity, especially for communities in the north of Canada. Remote presence robotic technologies provide the sense that physicians are present, enabling them to provide real-time clinical services at a distance.
“In Mars missions, a signal will take 20 minutes to go there and 20 minutes to come back so if there is an emergency, astronauts need to be able to make the decisions that matter in the short-term. So we need to improve their autonomy when it comes to health and improve systems that will allow us to monitor their health to prevent issues arising. Empowering people to take care of their health in space is very similar to what we need [to achieve] on Earth.”
Indeed, Ms Tremblay believed that major medical innovations and benefits may emerge from research during deep space missions. The health impact of a sixmonth stint on the ISS will be far different to several years on Mars.
“We don’t know [health effects] beyond
the Potential Canadian Healthcare and Biomedical Roles for Deep-Space Human Spaceflight, published in 2018, “Medical processes during past flights have been Earth-centric, as the overall health of astronauts and cosmonauts has been supervised by a medical team on the ground. Expected and routine disorders could be diagnosed and treated by onboard crew medical officers.
“For more complicated issues or medical contingencies that could not be readily resolved in space, a flight surgeon has managed the medical situation from the ground until the ill crewmember could be returned to Earth for further treatment. This stabilisation and transportation was possible with abundant real-time voice communication between the medical team on Earth and the onboard crew, as well as with the electronic transmission of health data.”
However, while this concept has worked well, it won’t be realistic once astronauts venture beyond Earth’s orbit.
“A round-trip journey to Mars takes almost three years. During that time, the expedition crew and spacecraft must operate with little or no resupply of air, water, food, medical supplies or spare parts. Astronauts will endure the harmful effects of weightlessness and space radiation for
It is also an example of the kind of collaboration that has worked well during the Covid-19 pandemic, believed Ms Tremblay. “We’ve just lived through a major pandemic and all the countries worked together and shared information so we had a vaccine very quickly. Scientists worked together internationally to solve the problem. We’ve been doing this in space for over 20 years on the ISS. When the world works together, we can solve the most challenging problems.
“Space is a unique environment to study health from a new perspective and accelerate research on medical and other issues so we can stay healthy and age healthily. We’re living longer and therefore many people get diseases – cancers of course are a big issue. So on the ISS and other platforms, eventually we will be able to do more research like that – more breakthrough research on these issues.”
While such possibilities are tantalising, space exploration is an expensive business and funding will be critical, Ms Tremblay emphasised. She cited space tourism as a vehicle that could help finance missions and research.
“There are so many ways in which the ISS is being used for health research now, but the capacity to do this research is limited. If we can reduce the cost of access to space by generating revenue from space tourism, for example, we can make more potential breakthroughs because health is always a big focus.”
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 16 News Feature
Continued from p14 ▸
Space is a unique environment to study health from a new perspective and accelerate research on medical and other issues so we can stay healthy and age healthily
DR PETER LACHMAN
A SAFE approach to awareness and safety in hospitals
As the fourth round of the Situation Awareness for Everyone (SAFE) collaborative is launched, Dr Peter Lachman discusses the methodology of the programme and how it complements the Irish National Early Warning System
The HSE National Deteriorating Patient Improvement Programme (DPIP), supported by the Office of Nursing and Midwifery Services Director (ONMSD), has generously funded the most recently graduated cohort of 13 adult and maternity frontline teams who undertook the Situation Awareness for Everyone (SAFE) programme.
The RCPI is delighted to announce a further funding partnership with DPIP and ONMSD to cover the 202122 SAFE course fee for up to 13 teams with recruitment underway.
The World Health Organisation’s Global Patient Safety Action Plan 2021–2030 sets out a vision of a world in which no one is harmed in healthcare, and every patient receives safe and respectful care, every time, everywhere. The recent Irish National Adverse Events (INAES) study reported that the level of harm in the Irish health system is unchanged from the previous report, despite some progress in many areas, particularly in the decrease in hospital-acquired infections.
Across the Irish healthcare system, there is evidence of a strong commitment to improving the quality of care, seen in the many and various improvement initiatives being undertaken by frontline teams and at group, organisation and system level. Improving quality and safety is the responsibility of all who work in healthcare, and healthcare providers need to know how to deliver safe care based on the science of patient safety.
The RCPI is committed to providing tailored education and training to empower those working in healthcare to achieve real and sustained improvements and better outcomes for patients and staff.
The SAFE quality improvement (QI) collaborative offered by RCPI to frontline clinical staff is one such training programme. SAFE brings multidisciplinary teams together with expert faculty, patient representatives and peers to explore patient safety risks and potential harms in a clinical system; and develop and implement bespoke patient safety interventions using QI methods to enhance safe and person-centred care, which are core values of the HSE framework for improving quality.
An updated version of the Irish National Early Warning System (INEWS) was published by the DPIP in 2020. The updated guidelines see a move towards an anticipatory approach to the management of clinically deteriorating patients. An anticipatory approach to care acknowledges the vulnerability of patients with ‘no’ or ‘low’ INEWS scores. It involves proactive management of risk to enable the earlier recognition of the potential for deterioration using clinical judgement, situation awareness and an appropriate tiered response model. To facilitate the sharing of information, the use of safety huddles and other communication tools to enhance patient safety is strongly advocated.
The importance of creating an environment of psychological safety where healthcare professionals feel comfortable seeking help and advice from one another and from senior colleagues cannot be underestimated and is a key feature of the SAFE programme. In the current climate, facing both a global pandemic and a HSE cyberattack, the importance of effective communication and the need for an environment of psychological safety for staff has come to the fore and has to be a priority for us all.
Dr Geraldine Shaw, Nursing and Midwifery Services Director, Office of the Nursing and Midwifery Services Director
The SAFE Intervention
Patient safety is a complex process and needs to incorporate many different theories and methodologies. The SAFE programme empowers teams to proactively manage safety in their clinical teams and settings.
The SAFE programme has a strong theoretical basis and aims to address the challenges of working in a complex adaptive system. It is strongly based on work in Cincinnati Children’s Hospital Medical Centre, US, and the latest theories in patient safety. Learning is borrowed from other high reliability industries with a focus on investment in teamwork and the development of proactive safe systems with a strong foundation in psychological safety.
SAFE was developed by a team at the Royal College of Paediatrics and Child Health, led by this author and funded by the Health Foundation. The programme was introduced in over 50 hospitals, with paediatric teams. In Ireland, the programme was tested and introduced on 20 children’s and neonatal wards across the country with demonstrable improvements in how teams worked together. In Cork University Hospital, there were decreased transfers to the ICU which also reflected the data from hospitals in the UK.
ty and infrastructure frequently fall short of ideal, can be frustrating. It is easy to become preoccupied by failure. The SAFE programme provided us with a firm foundation in the science of patient safety acknowledging how it can be difficult to feel safe in complex systems, but focusing on safety being the ability to sustain required operations under expected and unexpected conditions (with ‘unexpected events’ being very common in the work we do.). The programme emphasised the role of anticipation in preventing harm.
Armed with this knowledge, we introduced a multidisciplinary, interdepartmental safety huddle. The aim was to improve safety by facilitating communication within and between hospital teams. This has proven to be popular and effective even more so when we had to adapt to unexpected challenges including building works, Covid surges and the recent HSE cyber hack. This initiative has enhanced our understanding of situational awareness, emphasising the importance of enabling all staff to recognise elements of their environment that may affect patient care, and supporting them to respond or escalate appropriately in order to mitigate risk.
Dr Maeve Eogan, Consultant in Obstetrics and Gynaecology, Rotunda Hospital
Another participant on the SAFE Programme was Dr Julie Lucey, Consultant Paediatrician with a special interest in Infectious Diseases, University Hospital Waterford
What’s the point of Situation Awareness for Everyone? In the case of a busy paediatric department, the whole idea is to reduce risk and reduce harm to patients.
The success of the safety huddle in Cork University Hospital has resulted in CUH leading an application and successfully obtaining funding from Research Collaborative in Quality and Patient Safety (HRB/HSE/RCPI) for a study known as PROTECT (Proficiency-based simulation training for safety huddle performance). The PROTECT research team consists of national/international leaders in patent safety, communication and healthcare simulation. The study is currently underway.
Dr Dorothy Breen, Consultant in Intensive Care and Clinical Lead for Quality, Cork University Hospital
The SAFE programme aims to develop safer clinical systems which will have an impact on safety, person-centred care and ultimately on the cost of healthcare itself.
The Covid-19 pandemic demonstrated the lack of preparedness in clinical systems. It also demonstrated the need to pay attention to healthcare worker physical and mental wellbeing. The SAFE programme addresses these deficiencies by attending to both the psychological and physical safety of staff and the people for whom they care.
Four people from obstetrics and midwifery at the Rotunda Hospital were delighted to get involved with the SAFE programme. Optimising patient safety is a key priority for everyone in healthcare, especially in obstetrics and midwifery where the consequences of unsafe systems can be devastating for patients and staff alike.
Working in a hospital built in the 1750s, where capaci -
On the opening day, the course director alluded to Hudson’s safety culture ladder of five levels; pathological, reactive, calculative, proactive, and generative. Like most other teams in the room that day, we placed our organisation in the ‘reactive’ category, where safety becomes a priority after an accident. What would we have to do to move into a culture where we could say ‘Safety is how we do business here’.
We were given our task of introducing a daily huddle on our ward to highlight safety concerns on that given day.
We perceive the huddle as a positive move towards delivery of quality care to our young patients. Two years on, it is embedded in our day-to-day ward activity. Nursing staff believe that their concerns are being heard in a timely manner. It has promoted better communication and goodwill among staff in general. We are also more cognisant of our patients’ and parents’ opinions through regular surveying of our inpatients and their families.
A crucial element of the programme is that it has clinical, person-centred and financial benefits. There will be a return on investment that will have long-term positive implications for the health of people in Ireland.
The outcomes that teams have seen include reduction of avoidable error and harm to the acutely unwell, improvement of communication between all involved in an individual’s care, and improvement in the working culture for healthcare staff providing care.
Applications are now open for a September 2021 start. To apply for the programme or for further information, please see the dedicated SAFE webpage (www.rcpi.ie/news/releases/situation-awareness-for-everyone-safe-collaborative/) or contact the RCPI QI Department at firstname.lastname@example.org
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 18
An anticipatory approach to care acknowledges the vulnerability of patients with ‘no’ or ‘low’ INEWS scores
Lead of the Quality Improvement Faculty, RCPI, and former CEO of the International Society for Quality in Healthcare
Brintellix is indicated for the treatment of major depressive episodes in adults1
Brintellix® (vortioxetine) film-coated tablets
Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10, 15 or 20mg vortioxetine. Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. May be increased to a maximum 20mg daily or reduced to 5mg if necessary. After symptoms resolve, treatment recommended for at least 6 months. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily. Children (7-11 years): Not recommended. Adolescents (12-17 years): Not recommended in major depressive disorder; efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment; subpopulations are vulnerable and data on the use of Brintellix are limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with nonselective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide).
Fertility, pregnancy and lactation: Limited data; should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Animal studies showed reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Potential risk of postpartum haemorrhage following exposure to an SSRI or SNRI within the month prior to birth. Excreted into human milk, risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed. Please refer to SPC for more detail.
Warnings & Precautions: Closely supervise patients, especially those at high risk for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Brintellix tablets contain sodium (<1mmol/tablet).
Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver. Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines; St John’s wort; products which may lower the seizure threshold, e.g. antidepressants, neuroleptics, mefloquine or bupropion. Lower dose may be considered if strong CYP2D6 inhibitor is added to treatment depending on patient response, these effects may be greater in patients who are poor metabolisers of CYP2D6. Dose adjustment may be considered if a broad cytochrome P450 inducer is added to treatment. Reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines:
No or negligible influence, dizziness has been reported; use caution at the start of treatment or when the dose is changed. Adverse events: Most common adverse reaction is nausea, usually mild or moderate, transient and occurs within first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients): nausea. Common (≥1/100 to <1/10): abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100): flushing, night sweats. Rare (≥1/10,000 to <1/1,000): mydriasis (which may lead to acute narrow- angle glaucoma). Not known: anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: 20mg dose was associated with increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Paediatrics: Higher incidences reported in adolescents for abdominal pain-related events and suicidal ideation. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: November 2020. Reference: IE-BRIN-0254. Brintellix® is a Registered Trade Mark.
Job number: IE-BRIN-0262
Date of preparation: March 2021
Reference: 1. Brintellix Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com
depression to feel, think and do better1
For high risk patient eligibility*
Repatha® (evolocumab) Brief Prescribing Information
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Repatha.
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Repatha. Pharmaceutical Form: Pre-filled pen (SureClick®) containing 140 mg of evolocumab in 1 mL solution for injection.
containing 140 mg of evolocumab in 1 mL solution for injection.
indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDLC goals with the maximum tolerated dose of a statin or; alone or in combination with other lipidlowering therapies in patients who are statin-intolerant, or for whom a is contraindicated.
Repatha is indicated in adults and adolescents aged 12 years and with homozygous familial hypercholesterolaemia in combination other lipid-lowering therapies.
cardiovascular atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or; alone or in combination with lipid-lowering therapies in patients who are statin-intolerant, or whom a statin is contraindicated.
effects on LDL-C, cardiovascular events and populations studied section 5.1 of the SmPC.
subcutaneous injection into the abdomen, thigh or upper arm region.
Indication: Hypercholesterolaemia and mixed dyslipidaemia: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDLC goals with the maximum tolerated dose of a statin or; alone or in combination with other lipidlowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia: Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease: Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or; alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1 of the SmPC. Dosage and Administration: Repatha is for subcutaneous injection into the abdomen, thigh or upper arm region. Repatha is intended for patient self-administration after proper training. Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome,
proper training. Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome,
hypothyroidism) should be excluded. Primary hypercholesterolaemia and mixed dyslipidaemia in adults: The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent. The safety and efficacy of Repatha in children aged less than 18 years has not been established. Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over: The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule. The safety and efficacy of Repatha in children aged less than 12 years has not been established. Established atherosclerotic cardiovascular disease in adults: The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special Warnings and Precautions: Traceability: Clearly record the name and batch number of administered product to improve traceability of biological products. Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDLC reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha should be used with caution in patients with severe hepatic impairment. Dry natural rubber: The needle cover of the glass pre-filled pen (SureClick®) is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions. Interactions: No interaction studies have been performed.
Fertility, pregnancy and lactation: There are no or limited amount of data
from the use of Repatha in pregnant women. It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/ infants cannot be excluded. No data on the effect of evolocumab on human fertility are available. Undesirable Effects: Adverse reactions reported in pivotal, controlled clinical studies and from spontaneous reporting: common (≥ 1/100 to < 1/10) influenza, nasopharyngitis, upper respiratory tract infection, hypersensitivity, rash, headache, nausea, back pain, arthralgia, myalgia, injection site reactions; rare (≥1/10,000 to <1/1,000) angioedema. Please consult the SmPC for a full description of undesirable effects. Pharmaceutical Precautions: Store in a refrigerator (2°C – 8°C). Do not freeze. Store the pre-filled pen (SureClick®) in the original carton in order to protect from light. If removed from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month. Legal Category: POM. Presentation, Basic Costs and Marketing Authorisation Number: Repatha pre-filled pen (SureClick®) 140 mg/1mL: Pack of 2 pre-filled pens. EU/1/15/1016/003. Price in Republic of Ireland is available on request. Marketing Authorisation
Holder: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands. Further information is available from Amgen Ireland Limited, 21 Northwood Court, Santry, Dublin D09 TX31. Repatha is a registered trademark of Amgen Inc. Date of PI preparation: March 2021 (Ref: IE-REP-0321-00002).
Adverse reactions/events should be reported to the Health Products Regulatory Authority (HPRA) using the available methods via www.hpra.ie. Adverse reactions/events should also be reported to Amgen Limited on +44 (0)1223 436441 or Freephone 1800 535 160.
Amgen Ireland Northwood Court Dublin 9, Ireland
Managed Access Protocol – Repatha Repatha
When statins plus ezetimibe are not enough, add Repatha® to lower LDL-C and reduce CV risk1
Amgen Ireland 21 Northwood Court Santry, Dublin 9, Ireland © 2021 Amgen Inc. All rights reserved. IE-REP-0421-00005. Date of preparation: May 2021
* Managed Access Protocol – Repatha®
(evolocumab) Amgen – Summary of Product Characteristics. https://www.medicines.ie/medicines/repatha-sureclick-33565/smpc
Physical and mental health of vulnerable groups must be protected
In this issue of the Medical Independent, we have published a feature on Covid-19 in Irish prisons. Speaking to this newspaper, Dr John Devlin, Clinical Director at the Irish Prison Service (IPS), said the Service has been “reasonably successful” in terms of controlling Covid to date. As of late July, there had been 11 outbreaks in Irish prisons.
As is made clear in the feature, Covid-19 does not just threaten the physical health of people in prisons. A recent report from the Irish Penal Reform Trust (IPRT), Irish Prisons and Covid-19: One Year On, highlighted how isolation and loneliness during the pandemic had severely impacted the mental health and wellbeing of this population. During outbreaks, a mental health protocol is implemented, including using iPads to communicate with people who are at risk; manned telephones for psychological first aid; and care packages with activities for those in isolation.
It is hoped, as with society at large, the vaccination programme will herald better days ahead. At the end of July, over 5,195 vaccines had been administered to prisoners, with a number of prisons completing the first and second doses of an mRNA vaccine.
The prison population is but one of the vulnerable groups impacted by the pandemic. Of these, Travellers remain the highest at-risk cohort. Over a 14-month period, there were 5,226 Covid-19 notifications among Travellers. At 169 per 1,000, this represented three times the rate among the general population (50 per 1,000). Also, 4.5 per cent of Travellers were hospitalised, compared to 0.5 per cent of the general population.
Recently, the HSE National Social Inclusion Office and the Department of Housing, Local Government and Heritage published The Report on the National Traveller Covid-19 Accommodation Preparedness Checklist. The report outlined the actions and outcomes of a collaborative initiative to strengthen Covid-19 preparedness and infection prevention and control in Traveller accommodation.
Also, like the prison population, the mental health of the Traveller community has been deeply affected by the pandemic. In an opening statement to the Oireachtas mental health sub-committee on 13 July, Pavee Point’s Ms Geraldine McDonnell said Covid-19 “came at a time when our mental health was already at a crisis point”. Travellers have a six times higher suicide rate than the general population, and it accounts for about 11 per cent of all Traveller deaths.
The IPRT and Pavee Point have been calling for the publication of national reports into prisoner and Traveller health, respectively. The health needs assessment for Irish prisons has been delayed to ensure the report reflects the “current situation” of Covid-19 in prisons, according to the IPS. The report, due to be finalised in June, is currently being completed and will go to the Department of Health, Department of Justice and IPS for consideration.
And a national Traveller health action plan, the consultations for which took place in 2018, is still being reviewed by the Department of Health. It is of utmost importance these documents are published as soon as possible to point the way forward for the healthcare requirements of these two groups during the pandemic and beyond.
REACTION TO DR GABRIELLE COLLERAN'S COLUMN, 'OPPORTUNITY OFFERED IN CONSULTANT CONTRACT NEGOTIATIONS NEEDS TO BE GRASPED', 22 JULY
"Excellent article by @GColleranMD." Seána Ó Rodaigh, @seanaorodaigh, 17 July
"'Trained to heal, but appointed to ration' — that was the line that hit home for me. What consultants we have are operating with one hand tied behind their backs due to lack of resources. This has to change." Tim White, @timwhite_ie, 17 July
"Excellent Gabrielle. Hope decision-makers in @roinnslainte @merrionstreet and @HSELive are ready for negotiations. Patients and HCWs need staffing issues resolved." Jackie O’Connell, @JackieMeath, 17 July
"I agree completely, but I would make the point that the unfilled consultant posts and waiting lists have been a long-term problem [since] well before Covid." Rory O'Hanlon, @ohanloncmr, 17 July
"I’ve been posting about this issue of proposed Sláintecare consultant contracts recently. Gabrielle Colleran hits the nail on the head as to why consultants are leaving Ireland in droves, they are trained to heal but appointed to ration. It has to change, @roinnslainte." David Scott, @davescottsings, 17 July
"Excellent opinion piece from Gabrielle Colleran on addressing the issues with the proposed new consultant contract." Dr Declan Keane, @bergerie0709, 16 July
"The Dept and HSE must bear in mind the impact their current approach will have in enticing medical graduates into hospital medicine in the first place. In my view and experience, it will be seriously damaging." Donal De Golfer Esq, @DonalDeGolfer, 16 July
“'Our doctors go to other countries, and because their services are functioning better than ours, it’s very difficult for them to decide to come home to Ireland to make the very difficult choices of who gets that one bed when you have four who need it.'”
Dr Toby Gilbert, @DrTobyGilbert, 16 July
REACTION TO OUR NEWS STORY, 'OVER HALF OF NEW DRUGS BUDGET ALREADY COMMITTED', 8 JULY
"This comes as no surprise — budget for new innovative therapies always lags. Approval for reimbursement does not mean a drug can be prescribed. The people who suffer are among the most vulnerable. The battle to access transformative lifesaving therapies never ends..." Rare Diseases IE, @RareDiseasesIE, 9 July
REACTION TO OUR NEWS STORY, 'UNDERLYING CULTURE OF HOMOPHOBIA IN HOSPITALS', 8 JULY
"Visibility, role models, pushing to change the culture in healthcare to reflect our wonderfully diverse society. Not just for #PrideMonth."
Dr Suzanne Crowe, @itsthatgirlsuzi, 8 July
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THE MEDICAL INDEPENDENT | 12 AUGUST 2021 21 Letters to: The Editor, The Medical Independent, Greencross Publishing Ltd, Top Floor, 111 Rathmines Road Lr, Dublin 6 or email firstname.lastname@example.org
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Editorial PAUL MULHOLLAND
Public and private distress
The ‘two-tier system’ is often blamed unfairly for issues that arise in the delivery of healthcare
said quietly “Don’t rush out”.
stopped at the next appointment.
DR CHRISTINE O’MALLEY
more by Dr Christine
O’Malley at www.mindo.ie
I’ve been lucky during Covid. None of my friends or family needed hospital care for the virus, or for any other reason. That’s changed. The healthcare conversations have started again.
A relative had chest pain going into her arm and went off in an ambulance. Because of Covid, her husband couldn’t go with her. In the emergency department she was triaged and a cardiac event was ruled out. Happy? No! She spent a miserable night sitting in a chair, cold and sleepless. Meanwhile, he was worrying that she hadn’t been seen, when actually she was waiting for results.
A first-time mother planned a home birth. She didn’t want Covid rules to stop her husband from being with her and the baby. But baby came feet first, so she had to have a caesarean section. Mother and child are both well. Isn’t that great! No. She was not happy – the nurses left her to change the baby herself. If only she’d been in a private hospital came the cry! They were surprised to hear that “private” doesn’t necessarily mean extra nursing. I find the “two-tier” system often gets blamed unfairly.
Hospitals are hard on patients. Years ago, after urgent eye surgery, the doctors suggested I was fit for early discharge. I didn’t feel ready, but I said nothing, until a nurse
The hospital team have to focus on tests to exclude a heart attack, making sure mother and baby are healthy, checking that my eye healed post-op. But a miserably cold night isn’t good for anyone’s heart. A new mum may need the reassurance of help with her baby. In my case, one more night made a big difference.
Twice recently, I’ve had to tell friends: “Please stop being so nice to your doctors.” Yes, doctors are very busy. Yes, they have to reduce contact with patients because of Covid. But they still want to hear your problems.
One friend attends a number of consultants privately. Due to Covid, it’s all on the phone. The doctors couldn’t see he had aged years in a few months. He presumed his distressing symptoms were inevitable, didn’t want to trouble his doctors. Then it emerged his problems vanish on Difene. “Take the bloody stuff,” I said. No, he replied, his doctors warned him it was very risky. I told him to book an appointment and explain how wretched life had become. When we next met, he looked years younger. His doctor said exactly what I said: “Take the bloody stuff! Life is for living.”
The other person wanted a recommendation for a private clinic. Following life-saving surgery some years ago, a public clinic monitors her blood tests and checks her medication. Due to Covid, of course she meets no-one. The doctors just want the blood tests, they didn’t even ask how she feels. If they did, maybe she’d have mentioned her symptoms. “Make a list,” I said, “Doctors hate lists, so make it short.” Later I went Googling and saw her complaints were all recognised side-effects of the tablet. It was
Long before Covid, I’ve had healthcare conversations, sometimes with near strangers.
There was the consultant in a public clinic who said he would call security if the patient didn’t leave. I don’t really know what happened, but over the years, I’ve learned that anger from patients or families is usually a front for anxiety or fear. This man was terrified he had cancer. Furthermore, a friend of his had similar problems and was being treated for advanced cancer. The friend had health insurance and he didn’t. It took a long time to explain that his care was entirely appropriate, nothing to do with the “two tier-system”.
A man said he was thinking of making a complaint to the Medical Council. Why? The nurses were wonderful during his wife’s cruel illness and inevitable death, in a private hospital. However, the consultant caused her needless distress in her dying days, by persisting with futile treatments.
As we talked over the truly difficult and tragic choices involved, because of their young family, I realised he thought the consultant didn’t care. Why? Because the husband was left waiting for hours for the consultant to arrive from the public hospital. That happened twice. Trust in the doctor was lost and now he doubted the treatment.
These people are all smart, educated, articulate. Some are health professionals. The discussions are rarely simple, rarely brief. It takes a long time for the important details to emerge. I hope I helped a little and I think I did. Maybe these conversations are my contribution to healthcare. Maybe they are my penance.
Unlocking doctors’ dress codes
Formal attire promoted the greatest patient confidence and trust. The item that triggered the most dramatic loss of confidence was the nose ring, while wearing a formal shirt and trousers was the minimum required to inspire a reasonable amount of confidence by patients in their physicians.
comfort is an individual’s prerogative to express themselves. So says bioethicist Mary Catherine Beach, MD, MPH, a Professor of Medicine at Johns Hopkins University School of Medicine, in the context of the acceptability of visible tattoos on doctors.
Dress codes in medicine have long been considered important. Hippocrates advised doctors to be “clean in person” and “well dressed”. Mind you, he also recommended that they be plump and that they cover themselves with “sweet-smelling unguents”.
Covid-19 has moved the goalposts significantly in the sartorial stakes: Not seeing a patient in person has led to a relaxation in the usual ground rules. Patients, too, have gone with the flow – with some appearing on screen in various stages of undress.
Scrubs have become ubiquitous in hospitals. Usually the acceptable garb for surgeons, anaesthetists and emergency physicians, the need for all doctors to change in and out of PPE on an ongoing basis has seen scrubs become the norm on wards too.
Traditionally, how we dress has been about creating a good first impression and projecting the more professional, conservative image often associated with medicine.
A 2002 Australian study of 12 male general physicians and 1,680 patients in a teaching hospital took place over a seven-month period. The 12 doctors sequentially removed, changed or added one piece of clothing during this time.
Firstly, they shed their white coat, then took off their ties, before changing from formal trousers to jeans. The next sequence involved wearing Hawaiian shirts, followed by highlighting their hair before finally donning a nose ring.
But that was then. Ties are now considered an infection hazard, while many hospitals have ditched the traditional white coat for staff and students.
In a 2015 review of patient preferences for doctors’ attire carried out by researchers at the University of Michigan, three key themes emerged that suggest important variations in what patients may prefer their doctors to wear.
First, studies involving older patients or those from Europe or Asia all reported higher satisfaction when physicians wore formal attire.
Second, in emergency, surgical or intensive care settings, scrubs were not only preferred by patients, but also more often equated with professionalism. This makes sense, as in these more “hands-on”, procedure-oriented settings, formal suits, shirts and ties clearly seem out of place.
Finally, in doctors’ offices and outpatient clinics, scrubs were viewed unfavourably and often resulted in negative impressions.
The same researchers carried out a 2018 study in which just over half of the 4,062 patients surveyed in the clinics and hospitals of 10 major medical centres said that what physicians wear is important to them – and more than one-third said that what a doctor wears influences their satisfaction with their care.
The obvious question then is: Should we cater to others’ –patients’ or colleagues’ – unconscious biases? It seems that what we wear to work is evidence to many of our training and (perhaps questionably) our clinical competency.
However, balanced against potential patient bias or dis-
Tattoos with offensive words or symbols are inappropriate and piercings that are an expression of a religious, ethnic, or cultural tradition should be respected, she says. The pendulum is swinging toward greater acceptance, Beach notes. “As things become more normative, they become less distracting.”
In a sign of the times, a 2018 US study into doctors’ appearance found the presence of visible body art seems to have no discernible impact on what patients think of their doctor’s professionalism or competence. US researchers quizzed nearly 1,000 emergency care adult patients in an urban trauma centre in Pennsylvania about their doctors’ appearance after they had had a consultation.
Patients were specifically asked what they thought of their physician’s competence, professionalism, caring attitude, approachability, trustworthiness, and reliability. The patients were told the survey aimed to find out how the centre could better provide courteous and competent medical care, with the aim of improving their experience, rather than what they thought of doctors with visible tattoos and piercings.
Interestingly patients rated all the studied qualities highly more than 75 per cent of the time, irrespective of whether or not they were treated by a doctor wearing visible body art.
Clearly, the times they are a changing. It’s too early to conclude how virtual consults will change attitudes to physician dress and body art; but it seems unlikely to reverse a definite trend towards a general relaxation in the “how we look” code.
Opinion THE MEDICAL INDEPENDENT | 12 AUGUST 2021 22
Covid-19 has moved the goalposts significantly
DR MUIRIS HOUSTON Read more by Dr Muiris Houston at www.mindo.ie @muirishouston
Significantly improves exercise duration and reduces angina frequency1
Abbreviated Prescribing Information: Ranexa (ranolazine). Please consult the Summary of Product Characteristics (SPC) for full prescribing information. Presentation: Prolonged-release tablets containing 375 mg, 500 mg or 750 mg of ranolazine. 750 mg tablet contains E102 and lactose. Use: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). Dosage and administration: Oral administration. Patients should be instructed to list their medication to their health care professional at each visit. Adults: Initial dose is 375 mg twice daily. After 2-4 weeks, dose should be titrated to 500 mg twice daily and, according to patient’s response, further titrated to 750 mg twice daily. Concomitant treatment with moderate CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended. Renal impairment: Careful dose titration is recommended in mild to moderate renal impairment, and contraindicated in severe renal impairment. Hepatic impairment: Careful dose titration is recommended in mild hepatic impairment, and contraindicated in moderate to severe hepatic impairment. Elderly: Dose titration in the elderly should be exercised with caution. Low weight: Dose titration in patients with low weight should be exercised with caution. Congestive Heart Failure (CHF): Dose titration in moderate to severe CHF should be exercised with caution. Paediatric patients: No data in children below the age of 18 years. Ranexa tablets should be swallowed whole and not crushed, broken or chewed. They may be taken with or without food. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Severe renal impairment. Moderate or severe hepatic impairment. Concomitant administration of potent CYP3A4 inhibitors. Concomitant administration of Class Ia or Class III antiarrhythmics other than amiodarone. Warnings and Precautions: Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected. QT prolongation: Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval. Interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Renal impairment: Check renal function at regular intervals during treatment. Interactions: CYP3A4 inhibitors: Increase plasma concentrations of ranolazine. Combining ranolazine with potent CYP3A4 inhibitors is contraindicated. CYP3A4 inducers: Avoid initiation with Ranexa during administration of CYP3A4 inducers. CYP2D6 inhibitors: May increase plasma concentrations of ranolazine. Effect of ranolazine on other medicinal products: Dosage adjustment of sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range may be required. Lower doses of CYP2D6 substrates may be required. Caution with CYP2B6 substrates. Monitor digoxin levels following initiation and termination of Ranexa. Limit dose of simvastatin to 20mg once daily in patients taking Ranexa. Limit dose of atorvastatin and consider clinical monitoring in patients taking Ranexa. Monitor blood levels of tacrolimus when coadministering with Ranexa and adjust tacrolimus dose accordingly. Also recommended for other CYP3A4 substrates with a narrow therapeutic range. Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin increased in subjects with type 2 diabetes mellitus when co-administered with Ranexa. The exposure of other OCT2 substrates may also be affected. Theoretical risk that concomitant treatment with drugs known to prolong the QTc interval may increase the possible risk of ventricular arrhythmias. Pregnancy and lactation: Ranexa should not be used during pregnancy unless clearly necessary. Ranexa should not be used during breast-feeding. Effect on fertility unknown. Side-effects: Generally mild to moderate in severity and often develop within the first 2 weeks of treatment. Common (1-10%): dizziness, headache, constipation, vomiting, nausea, asthenia. Uncommon (0.1–1%): anorexia, decreased appetite, dehydration, anxiety, insomnia, confusional state, hallucination, lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paraesthesia, blurred vision, visual disturbance, diplopia, vertigo, tinnitus, hot flush, hypotension, dyspnoea, cough, epistaxis, abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort, pruritus, hyperhydrosis, pain in extremity, muscle cramp, joint swelling, muscular weakness, dysuria, haematuria, chromaturia, fatigue, peripheral oedema, increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight. In a long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients. Rare (0.1-0.01%): hyponatremia, disorientation, amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia, impaired hearing, peripheral coldness, orthostatic hypotension, throat tightness, pancreatitis, erosive duodenitis, oral hypoaesthesia, angioedema, allergic dermatitis, urticaria, cold sweat, rash, acute renal failure, urinary retention, erectile dysfunction, elevated levels of hepatic enzyme. Not known: myoclonus. Increased incidence of congestive heart failure and transient ischaemic attacks seen in patients with history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention and treated within 2 weeks with ranolazine (1000 mg twice daily [dose not approved in Europe]) in a placebo-controlled post-PCI trial. Elderly, renal impairment and low weight: In general, adverse events occurred more frequently among elderly patients and patients with renal impairment. Adverse events in patients with low body weight were similar to those of patients with higher weight. Please consult the SPC for further information.Pack size: 60 tablets. Legal category: POM. Marketing authorisation numbers: EU/1/08/462/001, 003, 005 Marketing Authorisation holder: Menarini International Operations Luxembourg S.A. Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd, 2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SPC. Last updated: October 2020
Date of item: November 2020. IR-RAN-12-2020
References: 1. Chaitman, B.R., et al. JAMA, 2004; 291(3): p. 309-16.
Challenging formula companies
For too many years, formula companies formed strong alliances with healthcare professionals and institutions
May marked the 40th anniversary of the World Health Organisation (WHO) Code of Marketing of Breastmilk Substitutes. This Code was developed by the WHO/UNICEF to address unethical advertising practices by large formula companies that adversely affect breastfeeding rates globally.
The Code is a model document, and it is up to each country to enact it into law. Many countries, including Ireland, have failed to implement the Code substantially. Despite this, the Code is the desired standard for every individual and institution. In an ideal world, the Code would no longer be necessary. Unethical marketing of baby milk substitutes would have ceased with an increase in breastfeeding rates. This is not the case. The Code is still relevant today as this $70 billion per year commercial milk formula industry continues to find loopholes that circumvent the recommendations.
One of these recommendations is that “healthcare providers, hospitals, and medical facilities should not promote, advertise, or distribute breastmilk substitutes that may undermine attempts to encourage breastfeeding”. So, it was apt that a motion passed at the 2021 ICGP AGM in May stated that the College would cease to accept sponsorship and advertising revenue from commercial formula companies. In doing this, the ICGP has followed in the path of the BMJ, a global healthcare knowledge provider that publishes over 70 medical journals and the Royal College of Pediatrics and Child Health. The decision to disentangle from commercial formula companies resulted in an almost €350,000 deficit in revenue for the BMJ Another positive development for Irish mothers and children is the publication of A Position Paper on Breast-
MULTIPLE CHOICE QUESTIONS
feeding by the Faculty of Paediatrics, the Faculty of Public Health and the Institute of Obstetricians and Gynaecologists, Royal College of Physicians. This paper aims to highlight the health benefits of breastfeeding and propose actions to improve breastfeeding rates in Ireland, which are currently the lowest in Europe.
Many of the recommendations contained in this paper are self-explanatory: Increased community resources for maternal and child health, including public access to International Board-Certified Lactation Consultants; improved education for health professionals including GPs; implementation of existing breastfeeding policies; and yet again, the protection of mothers and babies from the influence of industry as per the WHO Code.
Many people are aware of the unethical practices of formula companies, but may think that the 1970s Nestle boycott ‘fixed’ the problem. Some marketing methods have changed, such as not allowing company sales personnel direct access to mothers. But when complying with one recommendation, commercial formula companies have consistently devised new ways of reaching customers. The development of ‘follow-on milk’, ‘good night milk’, ‘anti-reflux milk’ and ‘anti-colic milk’ are examples of unnecessary products manufactured solely to circumvent the Code and entice new customers.
Many mothers choose not to breastfeed, making infant formula a necessary product. But their decision is often not well-informed. They believe that formula milk is equal or superior to breastmilk. Formula feeding is entrenched in our society, partly due to the relentless marketing of breastmilk substitutes. Mothers who choose formula deserve scientific, factual, and non-promotional information about
A. Typically presents as groin pain.
B. Is caused by the acetabulum impinging on the neck of the femur.
C. Pain is relieved by hip flexion and internal rotation.
D. Treatment of choice is a one-month course of an NSAID
E. Will require surgery in about 5 per cent of cases.
For the effective treatment of scabies with permethrin dermal cream (Lyclear)
A. Treat the whole body.
B. Warn patients not to wash their hands for at least eight hours after application of the cream.
C. Advise patients to have a hot bath before applying the cream.
D. Repeat the treatment weekly as long as the patient continues to itch.
E. Advise the patient to change and hot wash all bedding.
Well-recognised presenting symptoms of lung cancer include
A. Unilateral arm swelling.
E. Hypercalcaemic symptoms.
A. Is defined, in the elderly, as voiding over 33 per cent of the total urine volume at night.
B. Affects men more often than women.
C. Causes include diabetes mellitus.
D. Is helped by fluid restriction for one-to-two hours before bed.
E. In bladder outflow obstruction, may be completely relieved by turp.
With normal development by 15 months a child should be able to
A. Ask for the potty.
B. Pick up an ordinary cup and drink from it.
C. Take off shoes.
D. Join two-to-three words together to make a sentence.
E. Imitate parent in domestic work.
infant feeding. They need to know that the WHO recommends that infants be exclusively breastfed for six months and continue breastfeeding with complementary foods until two years and beyond.
Mothers need to understand that this recommendation applies regardless of where they live – Ireland, New York, or Bangladesh. They need to know that this is the best practice whether their baby has reflux or colic, is hungry, sleepy, or awake all night. They need to be aware that all infant formula is standardised and not to believe what they read on the packet.
As health professionals, we can keep parents informed, but only if we possess the necessary knowledge, skills, and attitudes. We can open our eyes to Code violations and pressurise the Government to implement the Code to create a more level playing pitch for families.
We need to do this even though Ireland has a substantial share in the commercial milk industry. We need to practise total sequestration from commercial entities to avoid conflicts of interest and remain uninfluenced. For too many years, formula companies formed strong alliances with healthcare professionals and institutions, which has served them well.
Breastfeeding is a public health imperative. It protects babies from infections, allergies, and diabetes, and mothers from ovarian and breast carcinoma. It reduces social inequality and is better for the environment. There is not one single scientific study (to the best of my knowledge) that indicates that breastfeeding is harmful. The international Code has been described as the most significant international consumer protection standard of modern time. It is past time that Ireland implemented it in full.
E. TRUE. ‘Domestic mimicry’.
D. FALSE. 21-to-24 months for this.
C. TRUE. By 18 months old will also take off socks, gloves.
B. TRUE. Also will feed self.
A. FALSE. 18 months for this.
E. FALSE. Has far less of an effect in improving nocturia than on other parameters of prostate symptoms score.
D. FALSE. Restrict fluids for three-to-four hours before bed.
C. TRUE. And bladder outflow obstruction or detrusor overactivity, etc.
B. FALSE. Affects men and women with equal frequency.
A. FALSE. This is nocturnal polyuria.
E. TRUE. Bony metastases or tumour-derived factors may cause hypercalcaemia with symptoms of pain, dyspepsia, thirst, fatigue, and anorexia.
D. TRUE. From laryngeal nerve palsy.
C. TRUE. Worry if patient is over 40 years of age, a smoker or an ex-smoker.
A. TRUE. Or distended neck veins or chest wall veins, from obstruction of the superior vena cava.
E. FALSE. The mites do not live off the body.
D. FALSE. Allergic reaction responsible for the itch takes about two weeks to subside after treatment.
C. FALSE. No preparation necessary before application.
B. TRUE. Whole application must not be washed off for 8-to-12 hours, but patient may forget and wash hands.
A. TRUE. Single application, easy to apply, nonirritant.
E. FALSE. Surgery is almost never needed.
D. FALSE. Steroid/local anaesthetic injection is often diagnostic and therapeutic.
C. FALSE. This is the case in iliopsoas bursitis.
B. FALSE. This is ‘impingement’ presenting in sportspersons with pain at extremes of hip movement.
A. FALSE. There is localised pain when direct pressure is applied to the greater trochanter.
B. FALSE.Though this is a frequent complication of chemotherapy, anorexia, and opiate use.
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 24
Opinion Read more by Dr Lucia Gannon at www.mindo.ie
DR LUCIA GANNON
THERESA LOWRY-LEHNEN, RGN, GPN, RNP, PhD National PRO of the Irish General Practice Nurses Educational Association, Clinical Nurse Specialist, and Associate Lecturer at Institute of Technology Carlow
Irritable bowel syndrome in focus
An overview of the latest diagnostic guidelines and treatment approaches to one of the most common gastrointestinal conditions
Irritable bowel syndrome (IBS) is a common, chronic gastrointestinal (GI) disorder characterised by symptoms of abdominal pain and disturbances in bowel habits in the absence of known organic pathology. The condition affects between 5 and 10 per cent of healthy individuals at any one time and in most people runs a relapsing and remitting course. IBS is recognised as a multifactorial disorder, with GI dysmotility, inflammation, visceral hypersensitivity and altered intestinal microbiota contributing to symptomatology.1 Symptoms of IBS include loose, frequent stools, constipation, bloating, and abdominal pain and cramps. Patients may notice symptoms following the intake of specific foods or that symptoms, such as stool consistency or pain location, change over time. Patients may also present with headache, lethargy, nausea, bladder symptoms or faecal incontinence.1,2,9
The condition typically occurs before the age of 45 years and is more common in people aged 20-to-30 years. 5 IBS appears to become less common with age and does not affect life expectancy or lead to other serious diseases. IBS affects both men and women, but the condition occurs more frequently in women. Women tend to have more frequent and severe IBS symptoms during menses and menopausal women have fewer symptoms than women who are still menstruating.10 Women more commonly report symptoms of abdominal pain and constipation, while men more commonly report diarrhoea. Men, however, are much less likely than women to report signs of IBS. 2,4
The causes and pathophysiology of IBS are complex and remain poorly understood. Theories include combinations of gut-brain axis problems, gut motility disorders, pain sensitivity, infections including small intestinal bacterial overgrowth, neurotransmitters, genetic factors, and food sensitivity. Onset may be triggered by an intestinal infection or stressful life event. It is thought that a number of factors may contribute to development of the disorder. Genetic predisposition and environmental interactions, such as familial susceptibility and psychosocial stressors, have been implicated in the multifactorial
pathogenesis of IBS.1 Diet and stress have been proposed as contributing factors to this heterogeneous disorder. Because stress has been identified as a mechanism in the development of IBS, the major components of the stress response system, the autonomic nervous system (ANS) and the hypothalamic-pituitary-adrenal (HPA) axis, have been the subject of numerous investigations of IBS.1
IBS is commonly associated with other functional, somatoform and mental disorders. In over 20 per cent of cases, there is an overlap of IBS with functional GI disorders of the upper GI system, particularly functional dyspepsia and gastro-oesophageal reflux disease (GORD), and of the lower GI system, such as diarrhoea, incontinence, pelvic floor dyssynergia, and constipation. Psychiatric comorbidities are present in approximately 50 per cent of IBS patients and include depressive symptoms, anxiety and eating disorders.10
A strong association between GI infections and the development of IBS has been established. Around one in nine patients exposed to infectious enteritis may develop IBS, at a rate four times higher than non-exposed individuals. The greatest risk is associated with protozoal and bacterial infections, with viral infections having a lower risk of development of IBS. The severity of acute gastroenteritis increases the risk of developing IBS, but symptoms
usually decrease over time.10 In IBS, the epithelial barrier, gut microbiota, food antigens, and bile acids give rise to abnormal responses in the main regulators of sensorial and motor functions, such as the hypothalamus-pituitary-adrenal axis, the immune system, the brain-gut axis and the enteric nervous system.10
Classification criteria and diagnosis
IBS has been categorised as a functional bowel disorder, ie, it is not associated with any structural or biochemical abnormalities in the GI tract. No specific laboratory or imaging tests can diagnose IBS. The Rome criteria (See Table 1) are used to diagnose IBS when the presence of organic disease such as inflammatory bowel disease (IBD), colon cancer, and Coeliac disease have been excluded.1,2 The Rome III classification diagnostic criteria served as the symptom-based, diagnostic criteria for IBS since their release in 2006 and subtyped IBS patients based on predominant stool pattern: Constipation (IBS-C), diarrhoea (IBS-D), mixed (IBS-M) or unsubtyped (IBS-U). Rome III classified the disorder by symptom onset greater than six months and recurrence of at least three days per month during the last three months. Diagnostic criteria required abdominal discomfort or pain to be associated with two or more of the following: Improvement with defecation, onset associated with change in the form of stool, or onset associated with a change in the frequency of stool.
Rome III Rome IV
In early 2016 the Rome Foundation released Rome IV, an updated classification system for conceptualising and diagnosing functional GI disorders.1 The Rome IV definition of IBS maintains symptom chronicity greater than six months and current activity present within the prior three months, however, symptom frequency has been changed to at least one day per week from at least three days per month. Pain related to bowel movements is required, rather than just improving with bowel movements, because, in some cases, pain can worsen after bowel movements. The ‘onset’ of abdominal pain has been eliminated from the association of pain with changes in stool. Rome IV also updated the subtyping of IBS patients (IBS-C, IBS-D, IBS-M and IBS-U), in that stool type is based on days with abnormal bowel movements, as opposed to bowel movements on all days. The term ‘discomfort’ was eliminated from the criteria because it is non-specific and has different meanings in different languages. Rome IV retains the Bristol Stool Form Scale as a useful tool to categorise bowel habit.1,10 The Rome IV process also redefined IBS as a disorder of gut-brain interaction, in recognition of the complex interplay of biological, psychological, and social factors underpinning the condition.11
In the absence of any biomarker being available for IBS, the condition is diagnosed using a positive approach, based on the clinical history. To make an accurate diagnosis of IBS, it is generally recommended to incorporate Rome IV criteria along with the patient history including dietary questions, physical examination including abdominal and anorectal examination, laboratory tests such as full blood count, C-reactive protein or erythrocyte sedimentation rate (ESR), possible Coeliac disease serology, and when indicated a colonoscopy and/or upper GI endoscopy and other tests. An abdominal x-ray can be considered to rule out faecal loading if constipation is the predominant symptom. When Rome IV criteria are present and alarm features are absent, only a limited number of laboratory tests are recommended without the need to perform invasive investigations.10 Patients may have IBS-type symptoms for many years without presenting to medical care, often self-managing their symptoms with-
Gastroenterology Clinical THE MEDICAL INDEPENDENT | 12 AUGUST 2021 25
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Psychiatric comorbidities are present in approximately 50 per cent of IBS patients and include depressive symptoms, anxiety and eating disorders
description Abdominal discomfort or pain Abdominal pain Symptom association Improvement with defecation Related to defecation (two or more) Onset associated with change Associated with a change in in the form of stool in the form of stool Onset associated with a change in Associated with a change in the frequency of stool the frequency of stool
onset greater than six months Symptom activity during the last six months Symptom frequency at least three days per month Symptom
Tool to categorise bowel habit Bristol Stool Form Scale Bristol Stool Form Scale Symptom onset greater than six months Symptom activity during the last three months Symptom frequency at least one day per week Table 1: Rome criteria1 for IBS classification
Predominant stool pattern Stool type based on bowel movements
type based on days with of IBS subtype: IBS-C, IBS-D, on all days
bowel movements IBS-M, IBS-U
Continued from p25 ▸
out medical input, and some may never consult. Nevertheless, lower GI symptoms frequently prompt people to present to primary care, accounting for approximately one-in-12 of all consultations.11 Functional GI disorders, such as IBS, are by far the most common diagnosis, but symptoms can be difficult to assess and the possibility of colorectal cancer or IBD may create diagnostic uncertainty for clinicians, and anxiety for patients.11
GPs are usually the first point of contact and provide the diagnosis and medical care for most people with IBS. Management guidelines encourage GPs to make a positive diagnosis of IBS, based on symptoms, in the absence of alarm symptoms or signs that warrant referral to exclude colorectal cancer or abnormalities on simple investigations. However, persistent abdominal bloating or distension in female patients should prompt consideration of CA-125 and pelvic ultrasound to exclude ovarian cancer.11 It is important to question patients about dietary and medication changes, life stressors and support networks, as part of the diagnostic assessment. Alternative diagnoses that should be considered when patients present with IBS symptomatology include Coeliac disease, microscopic colitis (MC), IBD including Crohn’s disease and ulcerative colitis, bile acid malabsorption, colorectal cancer, and dyssynergic defecation. 3
Once a diagnosis of IBS has been made, the GP should endeavour to follow-up with the patient within the next two months to ensure symptoms are not getting progressively worse, which may be indicative of a more sinister underlying disease process.11
BSG guidelines on the management of IBS (July, 2021)
The newly published (July, 2021) British Society of Gastroenterology (BSG) guidelines on the management of IBS (available at https://gut.bmj.com/content/70/7/1214) state: “This more restrictive nature of the Rome IV criteria calls into question whether they should be used to diagnose IBS in clinical practice, and a more pragmatic definition of the symptoms that constitute IBS may be preferred. The National Institute for Health and Care Excellence (NICE) guideline for the management of IBS in primary care recommends a broader, more pragmatic, definition of IBS, focusing on abdominal pain or discomfort associated with altered stool frequency or stool form for at least 6 months, in the absence of alarm symptoms or signs, and acknowledging that coexistent bloating, lethargy, nausea, backache or bladder symptoms are common.”11
Furthermore, the 2021 BSG guidelines with regard to the diagnosis of IBS in primary care state: “The Rome diagnostic criteria are based on specific symptoms of a defined duration and frequency, which have been derived predominantly from secondary care patients and are rarely used in primary care. Their applicability to clinical practice has been challenged as unnecessarily restrictive and only a minority of people diagnosed with IBS in primary care fullfill them.
“This restrictive diagnostic approach to IBS may be unhelpful and overly complicated in this setting, where fundamentals of clinical management are common across all these functional gastrointestinal disorders. Applying rigid criteria potentially leaves many patients with troublesome impactful symptoms without a clear diagnosis, increasing uncertainty and leading to issues with providing appropriate advice and management options. The NICE guideline definition of IBS is therefore preferable.”11
The new BSG 2021 guidelines also point out: “The fall in prevalence in IBS that results from the changes made in moving from the Rome III to Rome IV criteria is noteworthy, reflecting the more restrictive nature of the latter. This has important clinical implications because, although as intended, the criteria are now more specific for diagnosing IBS, up to 50 per cent of patients who believe they have IBS will no longer meet criteria for the condition. Instead, they will be diagnosed as having another functional bowel disorder, such as functional diarrhoea, functional constipation or functional abdominal bloating or distension.
“Moreover, there may be an impact on treatment trials in IBS, and the interpretation of results, because patient populations recruited using the Rome IV criteria will differ from those recruited using Rome III, and may have more severe symptoms and higher degrees of psychological comorbidity Moving from Rome III to Rome IV IBS may therefore reduce the likelihood of novel pharmacological therapies demonstrating efficacy in future randomised controlled trials (RCTs), due to the spectrum of symptom severity, or may mean that trials need to be considerably larger, and therefore more expensive to conduct, to show a beneficial effect.”
There is no known permanent ‘cure’ for IBS. Treatment is focused on symptom control, in order to improve quality-of-life. There is no definitive treatment for the management of the condition and a combination of lifestyle and dietary advice and use of pharmacological therapies is often required. Pharmacological management including laxatives, antidiarrhoeals and certain antispasmodics is centred on treatments that alleviate symptoms of IBS, but which are not specifically authorised for IBS itself. Education and reassurance is an important aspect of patient care and treatment, explaining the natural history of the disease and providing reassurance that it is a benign condition. It is important to build up a good rapport with the patient, including them in the decision-making process and ensuring their
reputable online information or peer support, reassurance, advice and management options. There should be a realistic discussion concerning the limitations of all available treatments for IBS to manage expectations. It is important to stress that cure is unlikely, but substantial improvement in symptoms, social functioning and quality-of-life is achievable.11
voice and concerns are heard as well as validating their symptoms. Management of IBS involves an integrated approach and treatment options include establishment of an effective patient-provider relationship, education, reassurance, nutritional interventions, pharmacological and psychological therapy. 2,5,9,10 Key skills, in relation to chronic disorders such as IBS in general practice, are for the GP/clinician to make a positive diagnosis, provide a simple explanation of the pathophysiology underlying the symptoms, clarify the patient’s main concerns and manage current symptoms in the wider context of the patient’s life. The clinician-patient relationship, continuity of care, empathy, including acknowledgement of the impact of symptoms on daily life, a shared understanding of IBS and shared decision-making can assist in providing appropriate education, signposting to
The choice of pharmacological therapy depends on the nature and severity of IBS symptoms. Many drug treatment options for IBS are available over-the-counter (OTC). Antispasmodics are among the most frequently used OTC treatments for IBS and can be broadly divided into antimuscarinics and smooth muscle relaxants. Antimuscarinics, including dicycloverine, propantheline, otilonium bromide and hyoscine butylbromide, reduce intestinal motility, whereas alverine and mebeverine are direct-acting intestinal smooth muscle relaxants.11 Butylscopolamine, due to its ability to antagonise the binding of acetylcholine to the muscarinic receptor at the neuromuscular junction, leads to smooth muscle relaxation, however, due to antimuscarinic adverse effects such as constipation, it should not be used in patients with IBS-C.10 Mebeverine, a spasmolytic without atropine-like side-effects, has high efficacy for abdominal pain and reduction in daily defecation frequency, as well as an improvement in well-being, with good tolerability with minor complications. Peppermint oil inhibits smooth muscle contraction through calcium channel blockade and has been proven to reduce IBS symptoms, being a safe and effective treatment. Antispasmodics are thought to improve symptoms of abdominal pain and have been shown to provide short-term relief of symptoms. 5,10 Osmotic laxatives such as polyethylene glycol are often recommended to improve constipation for those with IBS-C, however, they have not been shown to improve abdominal pain or bloating. Stimulant laxatives may also be used. Lactulose is not recommended, as it increases gas production, causes bloating and can exacerbate symptoms. 2 Patients who have not responded to laxatives
Clinical Gastroenterology THE MEDICAL INDEPENDENT | 12 AUGUST 2021 26
Continued on p28 ▸
Figure 1: Algorithm for the diagnosis of IBS. BSFS, Bristol Stool Form Scale; IBS-C, IBS with predominant constipation; IBS-D, IBS with predominant diarrhoea; IBS-M, IBS with predominant irregular bowel habits (mixed C/D)10
IBS has been categorised as a functional bowel disorder, ie, it is not associated with any structural or biochemical abnormalities in the GI tract
FILL IN THE BLANKS THIS SEPTEMBER
from the different classes and who have constipation for at least 12 months can be treated with linaclotide, however, caution must be taken due to its predisposition to fluid and electrolyte imbalance. Linaclotide is contraindicated in GI obstruction inflammatory disease. 5
Loperamide hydrochloride is the first-line choice of anti-motility drug for relief of diarrhoea due to its action on opioid receptors in the GI tract, and because it does not readily cross the blood brain barrier. It inhibits peristalsis, prolongs gut transit and reduces faecal volume. As constipation is an adverse effect, it should be used with caution for patients with IBS-M. Patients with IBS should be advised how to adjust their dose of laxative or anti-motility drug according to stool consistency with the aim of achieving a soft, well-formed stool. 2,5
A low-dose tricyclic antidepressant (TCA), such as amitriptyline hydrochloride (unlicensed indication) can be used for abdominal pain or discomfort as a second-line option in patients who have not responded to antispasmodics, anti-motility medications or laxatives. They should be commenced at a low dose, eg, 10mg amitriptyline once a day and titrated slowly to a maximum of 30-50mg once a day.11 An SSRI may be considered in those who do not respond to a tricyclic antidepressant. As with tricyclic antidepressants, they can be initiated in primary or secondary care, but careful explanation as to the rationale for their use is required, and patients should be counselled about their side-effect profile. 5,9,11
Psychological interventions can be offered to patients who have no relief of IBS symptoms after 12 months of drug treatments. There is good evidence that psychological treatments directed against IBS symptoms, especially cognitive behavioural therapy (CBT) and hypnotherapy, are helpful for many patients’ symptoms, but unfortunately these are not always readily accessible. 5,11
Diet and lifestyle changes are important for effective self-management of IBS. First-line dietary advice should be offered to all patients with IBS. Patients should be encouraged to increase physical activity, with recommended guidelines of 30 minutes at least five days a week and advised to eat regularly without missing or leaving long gaps between meals. Dietary advice should also include limiting fresh fruit consumption to no more than three portions per day. The fibre intake of patients with IBS should be reviewed. If an increase in dietary fibre is required, soluble fibre, such as ispaghula husk, or foods high in soluble fibre, such as oats, are recommended. Intake of insoluble fibre such as bran and resistant starch should be discouraged as they may exacerbate symptoms. Fluid intake, mainly water, should be increased to at least eight cups per day and the consumption of caffeine, alcohol and carbonated drinks reduced/avoided. Artificial sweetener sorbitol should be avoided in patients with diarrhoea. Where probiotics are being used, continue for at least four weeks while monitoring the effect. 5,9,11
A growing focus of clinical research has been to improve IBS symptomatology through dietary modifications.6 Over 80 per cent of individuals with IBS report food-related symptoms, especially to fermentable carbohydrates and fats.11 Food ingestion can contribute to the generation of symptoms through stimulation of chemoreceptors, mechanoreceptors, by osmotic actions, altered secretion, activation of motor reflexes, and colonic fermentation. Dietary intolerance in IBS patients has been attributed to gluten, wheat, lactose, fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) as well as fructose malabsorption. FODMAPs are short chain carbohydrates found in a variety of fruits, vegetables, dairy products, artificial sweeteners, and wheat that are poorly absorbed in the small intestine and subsequently fermented by bacteria in the distal small and proximal large intestine.11 This is a normal phenomenon, common to everyone. The resultant production of gas potentially results in bloating and flatulence. Although FODMAPs can produce certain digestive discomfort in some people, they do not cause intestinal inflammation and can also help avoid it, because
Vitamin D supplements ineffective treatment for painful IBS symptoms
Vitamin D supplements are not an effective treatment for easing painful symptoms of IBS, a new study from the University of Sheffield reveals.
Scientists from the University’s Department of Oncology and Metabolism – in conjunction with health supplement company, BetterYou –carried out trials on participants who suffer with the chronic condition to assess whether vitamin D reduced the severity of their symptoms, and whether it could improve their quality-of-life.
Results of the study – published in the European Journal of Nutrition – found that despite an improvement in vitamin D status in the participants in response to a vitamin D3 oral spray supplementation over a 12 week trial, there was no difference to their IBS symptom severity over this period, nor a reported change in the participants’ quality-of-life.
Carried out in collaboration with Sheffield Teaching Hospitals NHS Foundation Trust, the study also identified that although vitamin D supplements do not ease symptoms of IBS, a vitamin D deficiency is widespread amongst the IBS population, potentially leading to an increased risk of suffering from fractures and osteoporosis in the long-term.
Co-author of the study Dr Liz Williams, a Senior Lecturer in Human Nutrition at the University of Sheffield, said: “There has been interest from researchers and from patient groups in the potential of high dose vitamin D to alleviate symptoms of IBS, but there haven’t been many properly controlled trials in this area. What our research shows is that supplementing vitamin D at a safe dose did not reduce the severity of IBS symptoms.
“It is worth noting, however, that the vitamin D supplementation did correct deficiencies in those people who were found to have poor vitamin D status, and this is important for other aspects, such as bone and muscle health.”
Lead-author Professor of Human Nutrition
they produce beneficial alterations in the intestinal flora that contribute to maintaining the good health of the colon. FODMAPs are not the cause of IBS nor other functional GI disorders, but rather a person develops symptoms when the underlying bowel response is exaggerated or abnormal.7 A low FODMAP diet is recommended as a second-line diet for IBS, under the guidance of a trained dietitian.11 Exclusion diets have been used in patients with IBS, for instance with wheat and dairy, although conflicting results have been reported.1 Food elimination diets based on IgG antibodies are not recommended in patients with IBS.11
Parallel to the focus on dietary modifications are efforts to alter the intestinal microbiota. Undigested food is used by intestinal microbes (GI microbiota) upon entering the intestine, and microbiota play a major role in GI processes and overall health. 8 The faecal microbiome of patients with IBS may differ significantly from that of healthy individuals. The theory that this might, in part, be involved in pathophysiology has led to interest in whether probiotics can be used to alter the microbiome.11 Numerous
and Health at Newcastle University and Honorary Fellow at the University of Sheffield, Bernard Corfe, said: “For some people living with severe IBS, low vitamin D levels may be attributable to changes in diet and lifestyle. Some may feel due to the severity of their symptoms that they limit their outdoor activities due to the anxiety their symptoms can cause, or alter their diet to avoid certain foods triggering their symptoms.
“Unfortunately all of these coping mechanisms can be detrimental to overall health and wellbeing and reduce exposure to valuable sources of vitamin D.
“Given that vitamin D is essential for overall health and wellbeing, it is still important people with IBS get tested and treated and seek dietary advice so it does not impact on their long-term health.”
The research team at Sheffield were the first to suggest a possible link between people living with IBS and low vitamin D levels in 2012, and have since followed the issue closely. This new study is the largest, and most definitive study to date showing clearly that vitamin D supplementation does not ease severe IBS symptoms.
Although little is known about why and how the debilitating condition develops, and there is currently no cure for IBS, further research is trying to identify better ways to support and manage people living with the chronic condition.
Prof Corfe added: “There is a range of management strategies that people living with IBS can seek help with from their GP, but because of the heterogeneity of the syndrome, managing IBS can be trial and error for each individual patient.
“As it is estimated that between 5 and 15 per cent of the population could be living with IBS – some undiagnosed due to the anxiety and embarrassment their symptoms can cause – it is vitally important we continue with research to find new ways to diagnose, treat, and understand the impact of IBS on the population.”
studies have investigated the utility of probiotics in IBS, in efforts to manipulate the intestinal microbiota and improve symptomatology. 8 Although there are some inconsistencies in different studies, there is sufficient evidence to suggest their efficacy in reducing IBS symptoms, such as bloating, abdominal pain and flatulence.10
Novel drugs that have been tested successfully in chronic idiopathic constipation, including elobixibat and mizagliflozin, a sodium-glucose cotransporter-1 inhibitor, are likely to undergo testing in IBS-C.11 Plecanatide, a peptide guanylate cyclase C receptor agonist is a promising therapeutic option and an efficacious second-line drug for IBS-C in secondary care. In a phase 3 clinical trial it led to a significant reduction of IBS symptoms, however, diarrhoea is a common side-effect. Although the drug is licensed for IBS with constipation in the US, it is not yet
Clinical Gastroenterology THE MEDICAL INDEPENDENT | 12 AUGUST 2021 28
Continued from p26 ▸ Continued on p30 ▸
Abbreviated Prescribing Information
Consult the Summary of Product Characteristics for full information. Additional information is available on request.
Idacio (adalimumab) 40 mg
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See below for how to report adverse reactions.
Idacio 40 mg solution for injection in pre-filled syringe
Idacio 40 mg solution for injection in pre-filled pen
Idacio 40 mg solution for injection in vial for paediatric use
Presentation and method of administration: Each single dose 0.8 ml pre-filled syringe, 0.8 ml pre-filled pen or 0.8 ml vial contains 40 mg of adalimumab for subcutaneous injection.
Indications and Dosage: Please refer to SmPC for full information. Idacio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Idacio is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio. Patients treated with Idacio should be given a patient alert card. After proper training in injection technique, patients may self-inject with Idacio if their physician determines that it is appropriate and with medical follow-up as necessary. During treatment with Idacio, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised. Rheumatoid arthritis (RA), adults: In combination with methotrexate (MTX) for moderate to severe, active RA with inadequate response to disease-modifying antirheumatic drugs (DMARDs) including MTX. In combination with MTX for severe, active and progressive RA when not previously treated with MTX. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Reduces rate of progression of joint damage on X-ray and improves physical function, in combination with MTX. Dosage:40 mg single dose every other week (EOW). Concomitant MTX should be continued. In monotherapy, patients may require 40 mg every week or 80 mg EOW if they experience a decrease in clinical response. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Consider need for dose interruption, e.g. before surgery or if serious infection occurs. Reintroduction after 70 days or longer of discontinuation gave same magnitudes of clinical response and similar safety profile as before dose interruption. Polyarticular juvenile idiopathic arthritis (pJIA), paediatrics 2 years and above: In combination with MTX for active pJIA with inadequate response to one or more DMARDs. Can be given as monotherapy if intolerance to or when continued treatment with MTX is inappropriate. Dosage: 10 kg to < 30 kg 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Enthesitis-related arthritis (ERA), paediatrics 6 years and above: For active ERA with inadequate response to or intolerance to conventional therapy. Dosage: 15 kg to < 30 kg: 20 mg single dose EOW. If ≥ 30 kg: 40 mg single dose EOW. Ankylosing spondylitis (AS), adults: For severe active AS with inadequate response to conventional therapy. Dosage: adults: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), adults: For severe nr-axSpA with objective signs of inflammation (elevated CRP and/or MRI), and an inadequate response to or intolerance to nonsteroidal anti-inflammatory drugs. Dosage: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Psoriatic arthritis (PsA), adults: For active and progressive PsA with inadequate response to DMARDs. Reduces rate of progression of peripheral joint damage on X-ray in polyarticular symmetrical subtypes of the disease and improves physical function. Dosage: 40 mg single dose EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Psoriasis, adults: For moderate to severe chronic plaque psoriasis in candidates for systemic therapy.
Dosage: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment beyond 16 weeks should be reconsidered if no clinical response in that time (refer to SmPC).
Paediatric Plaque Psoriasis, 4 years and above: For severe chronic plaque psoriasis with inadequate response to or if topical therapy and phototherapies are inappropriate. Dosage: 15 kg to < 30 kg: 20 mg dose initially followed by 20 mg EOW starting one week after initial dose. If ≥ 30 kg: 40 mg dose initially followed by 40 mg EOW starting one week after initial dose. Treatment beyond 16 weeks should be reconsidered if no clinical response in that time.
IDACIO® is an adalimumab biosimilar, which is approved for the same indications as the biologic reference product, including the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.1, 2 Patients prescribed IDACIO can access KabiCare, a web-based resource developed with a holistic approach to patient support.
IDACIO® is an adalimumab biosimilar, which is approved for use in the same conditions as thebiologic reference product, including the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.1, 2 Patients prescribed IDACIO can access KabiCare, a web-based resource developed with a holistic approach to patient support.
The indications for IDACIO include the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adults who have had inadequate response to conventional therapies or who are intolerant to or have contraindications to such therapies.1 Before prescribing IDACIO please consult the Summary of Product Characteristics. Patients prescribed IDACIO should receive a patient alert card. For more information about IDACIO and KabiCare, please contact your local Fresenius Kabi representative.
The indications for IDACIO include the treatment of moderately to severely active Crohn’s disease and ulcerative colitis in adults who have had inadequate response to conventional therapies or who are intolerant to or have contraindications to such therapies.1 Before prescribing IDACIO please consult the Summary of Product Characteristics. Patients prescribed IDACIO should receive a patient alert card. For more information about IDACIO and KabiCare, please contact your local Fresenius Kabi representative.
1. IDACIO Summary of Product Characteristics. Fresenius Kabi Ltd.
1. IDACIO 40mg solution for injection in pre-filled syringe and pre-filled pen. Summary of Product Characteristics. Fresenius Kabi Deutschland GmbH.
Fresenius Kabi Ireland
Fresenius Kabi Ireland
Unit 3B Fingal Bay Business Park, Balbriggan, Co.Dublin, Ireland
Unit 3B Fingal Bay Business Park, Balbriggan, Co.Dublin, Ireland
T: +353 (0)1 8413030
T: +353 (0)1 8413030
F: +353 (0)1 8496949 www.fresenius-kabi.ie
F: +353 (0)1 8496949 www.fresenius-kabi.ie
Date of preparation: July 2020
Date of preparation: July 2020
2. Humira 40mg solution for injection in pre-filled syringe and pre-filled pen. Summary of Product Characteristics. AbbVie Deutschland GmbH & Co. KG. KabiCare is funded and developed by Fresenius Kabi. IDACIO and KabiCare are registered trademarks of Fresenius Kabi.
2. Humira Summary of Product Characteristics. Abbvie Ltd. KabiCare is funded and developed by Fresenius Kabi. IDACIO and KabiCare are registered trademarks of Fresenius Kabi.
Hidradenitis suppurativa (HS), adults and adolescents from 12 years and above: For active moderate to severe HS (acne inversa) with inadequate response to conventional systemic HS therapy. Dosage: HS, adults: 160 mg dose initially at Day 1, followed by 80 mg two weeks later at Day 15. Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg EOW.HS, adolescents 12 years and above ≥ 30 kg: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. If there is inadequate response to 40 mg EOW, an increase in dosage to 40 mg every week or 80 mg EOW may be considered. Antibiotics may be continued if necessary. Concomitant topical antiseptic wash on HS lesions is recommended to be used on a daily basis. Treatment beyond 12 weeks should be reconsidered if no improvement in that time. Reintroduction of Idacio after treatment interruption as appropriate. Evaluate periodically the benefit and risk of continued longterm treatment. Crohn’s disease (CD), adults: For moderately to severely active CD with no response despite a full and adequate course of, intolerance to or contraindication for a corticosteroid and/or an immunosuppressant therapy. Dosage: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW. During maintenance, corticosteroids may be tapered in accordance with clinical guidelines. If decrease in clinical response, can increase dosage to 40 mg every week or 80 mg EOW. Patients with no response by Week 4 may benefit from continued maintenance therapy to Week 12. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Paediatric Crohn’s disease (CD), 6 years and above: For moderately to severely active CD with inadequate response to, intolerance to or contraindication for conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator. Dosage: < 40 kg: Induction: 40 mg dose at Week 0, followed by 20 mg at Week 2. For a more rapid response: 80 mg at Week 0, followed by 40 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 20 mg dose EOW from week 4. If insufficient response, consider an increase in dosing frequency to 20 mg every week. If ≥ 40 kg: Induction: 80 mg dose at Week 0, followed by 40 mg at Week 2. For a more rapid response: 160 mg dose at Week 0, followed by 80 mg at Week 2; risk of adverse events higher during rapid induction. Maintenance: 40 mg dose EOW from week 4. If insufficient response, consider an increase in dosage to 40 mg every week or 80 mg EOW. Treatment beyond 12 weeks should be reconsidered if no clinical response in that time. Ulcerative colitis (UC), adults: For moderately to severely active UC with inadequate response to, intolerance to or contraindication for conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA). Dosage: Induction: 160 mg dose at Week 0, followed by 80 mg at Week 2. Maintenance: 40 mg dose EOW. During maintenance, corticosteroids may be tapered in accordance with clinical guidelines. If insufficient response, consider an increase in dosage to 40 mg every week or 80 mg EOW. Treatment beyond 8 weeks should not be continued if no clinical response in that time. Uveitis, adults: For non-infectious intermediate, posterior and panuveitis with inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Dosage: 80 mg initial dose at Week 0, followed by 40 mg EOW from Week 1. Treatment can be initiated in combination with corticosteroids and/or with other nonbiologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Idacio. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Paediatric Uveitis, 2 years and above: For chronic non-infectious anterior uveitis with inadequate response to or intolerance to conventional therapy, or in whom conventional therapy is inappropriate. Dosage: < 30 kg: 20 mg dose EOW in combination with MTX. Optional 40 mg (for patients < 30 kg) or 80 mg (for patients ≥ 30 kg) loading dose one week prior to start of maintenance therapy. No clinical data in use of loading dose < 6 years of age (see SmPC). If ≥ 30 kg: 40 mg dose EOW in combination with MTX. Evaluate on a yearly basis the benefit and risk of continued long-term treatment. Idacio may be available in other strengths and/or presentations depending on the individual treatment needs. Contraindications: Hypersensitivity to the active substance or to any excipients (see SmPC); Active tuberculosis (TB) or other severe infections such as sepsis and opportunistic infections; Moderate to severe heart failure (NYHA class III/IV). Warnings and precautions: Clearly record the name and batch number of administered product to improve traceability of biological products. Infections: Patients taking TNF-antagonists are more susceptible to serious infections.
Impaired lung function may increase the risk for developing infections. Monitor for infections, including TB, before, during and for at least 4 months after treatment. Treatment with Idacio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Idacio should be considered prior to initiating therapy. Evaluate new infections during treatment and monitor closely. Stop treatment if new serious infection or sepsis and treat appropriately. Exercise caution in patients with a history of recurring infections or who are predisposed to infections, including the use of concomitant immunosuppressive medications. Serious infections: Serious infections, including those associated with hospitalisation or death, were reported in patients receiving treatment. TB: Consult SmPC for details. Reactivation and new onset TB, both pulmonary and extrapulmonary (disseminated), were reported. Screen all patients before therapy initiation for active or inactive (latent) TB. Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients. If latent TB is suspected, consult physician with appropriate expertise and follow local treatment recommendations for prophylaxis prior to initiation of Idacio. Despite prophylaxis, TB reactivation has occurred on adalimumab. If active TB is diagnosed, do not initiate Idacio treatment. Other opportunistic infections: Opportunistic infections were observed in patients receiving adalimumab. Stop treatment in patients with signs and symptoms of such infections. Consult with physician with appropriate expertise for diagnosis and administration of empiric antifungal therapy in these patients. Hepatitis B reactivation: Reactivation of HBV has occurred in chronic carriers (surface antigen positive). Patients should be tested for HBV infection before initiating treatment. HBV carriers should consult a specialist physician and be closely monitored for reactivation of HBV infection throughout therapy and for several months following termination of treatment. If reactivation occurs, stop treatment and initiate appropriate antiviral and supportive treatment. Neurological events: Caution in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders. Discontinuation of treatment should be considered if any of these disorders develop. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to initiation of treatment and regularly during treatment, to assess for pre-existing or developing central demyelinating disorders. Allergic reactions: Reports of serious allergic reactions including anaphylaxis received. For serious allergic or anaphylactic reaction, stop Idacio immediately and initiate appropriate therapy. Malignancies and lymphoproliferative disorders: A possible risk has been reported of malignancy, including lymphomas and leukaemia, in all patients, including paediatric patients, treated with Tumour Necrosis Factor (TNF) antagonists. Examine all patients, especially those with a medical history of extensive immunosuppressant or PUVA treatment, for non-melanoma skin cancer prior to and during treatment; caution in COPD patients, and in patients with increased risk for malignancy due to heavy smoking. Consider the potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab (hepatosplenic T-cell lymphoma has occurred). Risk of hepatosplenic T-cell lymphoma cannot be excluded. Caution in patients with a history of malignancy. Risk of developing dysplasia or colon cancer is unknown. Patients with UC with increased risk of dysplasia or colon carcinoma, or history of dysplasia or colon carcinoma, to be screened for dysplasia before treatment and throughout disease course. Haematological reactions: Adverse events of the haematological system reported with adalimumab. Patients should seek immediate medical attention if signs and symptoms of blood dyscrasias develop while on treatment. Vaccinations: Patients may receive concurrent vaccinations, except for live vaccines. Bring paediatric patients up to date with all immunisations prior to initiating Idacio treatment. Congestive heart failure: See contraindications. Caution is advised with mild heart failure (NYHA class I/II). Discontinue treatment if new or worsening symptoms of congestive heart failure. Autoimmune processes: Autoimmune antibodies may form with Idacio. Stop treatment if development of a lupus-like syndrome with positive antibodies against double-stranded DNA. Surgery: Consider the long half-life of Idacio for planned surgical procedures. Monitor closely for infections. Elderly patients: Serious infections were higher in patients over 65 years of age, some of which had a fatal outcome. Consider risk of infections in these patients. Interactions: Antibody formation was lower when adalimumab
Job code: BIO/IDACIO/011.20
Job code: BIO/IDACIO/013.20
Additional information is available on request
Additional information is available on request
was given together with MTX in comparison with use as monotherapy. Combination of Idacio with other biologic DMARDs (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended. Fertility, pregnancy and lactation: Idacio should only be used during pregnancy if clearly needed. Women of childbearing age should consider the use of adequate contraception and continue its use for at least 5 months after the last treatment. No administration of live vaccines (e.g. BCG) to infants exposed to Idacio in utero for 5 months following mother’s last Idacio treatment during pregnancy. Idacio can be used during breast-feeding. Adverse Reactions: Very common ≥ 1/10: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), leukopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, elevated liver enzymes, rash (including exfoliative rash), musculoskeletal pain, injection site reaction (including injection site erythema). Common ≥ 1/100 to < 1/10: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections, skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm, leucocytosis, thrombocytopenia, hypersensitivity, allergies (including seasonal allergy), hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration, mood alterations (including depression), anxiety, insomnia, paraesthesias (including hypoesthesia), migraine, nerve root compression, visual impairment, conjunctivitis, blepharitis, eye swelling, vertigo, tachycardia, hypertension, flushing, haematoma, asthma, dyspnoea, cough, GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome, worsening or new onset of psoriasis (including palmoplantar pustular psoriasis), urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia, pruritus, muscle spasms (including blood creatine phosphokinase increased), renal impairment, haematuria, chest pain, oedema, pyrexia, coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased, impaired healing. Serious, including fatal, adverse reactions have been reported including infections/ sepsis, TB, opportunistic infections, allergic reactions (including anaphylaxis), HBV reactivation and malignancies (including leukaemia, lymphoma and hepatosplenic T-cell lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and StevensJohnson syndrome. Other less common and rarely reported adverse reactions are listed in the SmPC. Legal Category: POM. Marketing Authorisation Holder: Fresenius Kabi Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe, Germany.
Marketing authorisation numbers: EU/1/19/1356/001, EU/1/19/1356/002, EU/1/19/1356/003
Package size and cost: UK / ROI - Idacio 40mg/0.8ml vial x 1: £316.93 / €309.31, Idacio 40mg/0.8ml pre-filled syringe x 2: £633.86 / €618.63, Idacio 40mg/0.8ml pre-filled pen x 2: £633.86 / €618.63 Further information: available from Fresenius Kabi Ltd., Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT. Tel +44 (0)1928 533 533 Date of preparation of PI: April 2020 001/API/IDACIO/FKUK-IRL
Adverse events should be reported. Reporting forms and information can be found at: yellowcard.mhra.gov.uk www.hpra.ie/homepage/about-us/report-an-issue Adverse events should also be reported to Fresenius Kabi Ltd. Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT Tel +44 (0)1928 533 533
available for this indication in many countries.10,11 Tenapanor, an inhibitor of the GI sodium/hydrogen exchanger NHE3 and an efficacious second-line drug for IBS with constipation in secondary care, is another novel agent. It increases intestinal fluid volume and transit, leading to an improvement of constipation, bloating and pain. Again, diarrhoea is a frequent side-effect and although the drug is licensed for IBS with constipation in the US, it is also not yet available for this indication in many countries.10,11 Tegaserod, a 5-Hydroxytryptamine 4 receptor agonist, is also an efficacious second-line drug for IBS with constipation in secondary care, but is unavailable outside the US and diarrhoea is a common side-effect.11 Colesevelam, a bile acid sequestrant, has been evaluated
in patients with IBS-D. Clinical trials demonstrated that colesevelam increases the delivery of bile acids to stools, improving stool consistency, and increases hepatic bile acid synthesis, avoiding steatorrhoea in IBS-D patients.10
The highly selective 5-HT4 agonist minesapride has been studied in two phase 2 dose-ranging RCTs in patients with IBS-C. A dose of 40mg once a day was superior to placebo, in terms of improvements in number of bowel movements per week, abdominal pain and global symptoms. The drug was well-tolerated, with diarrhoea the most common side effect, and there were no cardiovascular adverse events.11
Other novel approaches include drugs that act on cannabinoid receptors, which are expressed in the GI tract and may also modulate pain expression.11
Although faecal microbiota transplantation (FMT) was thought to be a potential therapeutic option, current ev-
Author: Eamonn Brady MPSI, owner of Whelehans Pharmacy in Mullingar
idence suggests there is no improvement in global IBS symptoms after FMT.10
Efforts in identifying the different pathophysiological mechanisms involved in symptom generation have allowed the development of new symptom-based and target edtherapies. New insights and ongoing research into trials of novel treatments, including pharmacological, dietary and behavioural therapies, device-based treatments and FMT will hopefully bring a better quality-of-life to patients with IBS, as they contribute to a new understanding of this common syndrome.
1. Weaver K, Melkus G, Henderson A. (2017). Irritable bowel syndrome: A review. American Journal of Nursing: June 2017 - Volume 117 - Issue 6 - p 48-55 doi: 10.1097/01.NAJ.0000520253.57459.01. www.ncbi. nlm.nih.gov/pmc/articles/PMC5453305/
2. Callachand N. (2020). Irritable bowel syndrome in focus. Medical Independent. Published August 6 2020. Available at: www. medicalindependent.ie/irritable-bowel-syndrome-ibs-in-focus/
3. Lacy B, Mearin F, Chang L, Chey W, Lembo A, Simren M, Spiller R. (2016). Bowel disorders. Gastroenterology. 2016; 150:1393–1407. doi: 10.1053/j.gastro.2016.02.031
4. Healthline (2021). Everything you want to know about IBS. Available at: www.healthline.com/health/irritable-bowel-syndrome
5. BNF British National Formulary (2020). Edition 80. September 2020 – March 2021. British Medical Association/Royal Pharmaceutical Society, London
6. Chey W. (2016). Food: The main course to wellness and illness in patients with irritable bowel syndrome. American Journal of Gastroenterology. 2016;111:366-371. doi: 10.1038/ajg.2016.12
7. Mullin G, Shepherd S, Chander R, Ireton-Jones C, Matarese L. (2014). Irritable bowel syndrome: Contemporary nutrition management strategies. Journal of Parenteral and Enteral Nutrition. 2014;38:781–799. doi: 10.1177/0148607114545329
8. Barbara G, Feinle-Bisset C, Ghoshal U, Santos J, Vanner S, Vergnolle N, Quigley E. (2016). The intestinal microenvironment and functional gastrointestinal disorders. Gastroenterology. 2016;150:1305–1318. doi: 10.1053/j.gastro.2016.02.028
9. NHS (2021). Irritable Bowel Syndrome. National Health Service, UK. Available at: www.nhs.uk/conditions/irritable-bowel-syndrome-ibs/
10. Ferreira A, Garrido M, Castro-Poças F. (2020). Irritable Bowel Syndrome: News from an Old Disorder. GE Port J Gastroenterol 2020; 27:255–268
11. BSG (2021). British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. British Medical Journal. Volume 70, Issue 7. Available at: https://gut.bmj.com/ content/70/7/1214
Clinical Gastroenterology THE MEDICAL INDEPENDENT | 12 AUGUST 2021 30 Continued from p28 ▸ Successful completion of this module will earn you 1.5 CPD credits A B C doctorCPD.ie Visit www.medilearning.ie/doctorcpd.ie Free CPD – now accessible on android, iPhone and tablet Latest module
module will focus on certain aspects of analgesia, including distinguishing different types of pain, particularly chronic pain.
Chronic pain control –
Other novel approaches include drugs that act on cannabinoid receptors, which are expressed in the GI tract and may also modulate pain expression
MS SARAH O’CONNOR, CEO, Asthma Society of Ireland
Supporting asthma patients during the pandemic
In late February 2020, the Asthma Society of Ireland’s team realised that an outbreak of Covid-19 was a very likely event in Ireland and we began to plan accordingly. We used initial Community Foundation funding to buy laptops to move our operations online, we adapted the working of our asthma adviceline so that all telephone calls could be managed remotely and we assessed which programmes would need to be paused in the event of the pandemic outbreak. On one hand, this makes us sound prescient and forward-thinking, but on the other hand, we had no idea what we were about to face.
Our Covid-19 response team – advocacy and awareness response
We established a Covid-19 response team, comprising of our Advocacy and Research Manager, Advocacy Officer, CEO, Communications team, and our Medical Advisory board, and our staff triaging and managing calls, who all worked tirelessly to ensure we had accurate information, advice and recommendations in relation to asthma and Covid-19 on our website and social media. In the initial weeks from March until July 2020, we created updates of our Covid-19 FAQ, getting input and approval from our clinical advisors and the HSE National Respiratory Clinical Programme. When the scale of the challenge became clear, we realised we couldn’t afford to rely on our one-to-one services and we focused on how to scale up our patient supports to help us in answering the incredible volume of queries and very real anxieties from patients and their carers. Where visits to our website had stood at over 410,000 in 2019, we had in excess of that figure visiting www.asthma.ie in the six weeks from the initial pandemic outbreak alone. With each iterative wave of concern from patients, we proactively responded with medical guidance, advice and support through our own channels, digital media and traditional media. With each of these waves, we listened to patients and advocated to the Minister for Health, Department of Health, HSE, and Respiratory Clinical Programme for what patients needed.
Our flagship patient support service, our asthma ad -
viceline service (1800 44 54 64), truly came into its own during the pandemic. It is hard to convey the scale of the challenge here. Twenty years in existence, our specialist respiratory nursing team delivering this service have built up extraordinary expertise in supporting and educating patients over the telephone. In order to maximise the impact of the nurse appointment, our team operated a triage system for months, ensuring that the patients most in need of advice, support, and guidance had access to the nurse. All other patients were supported by members of our patient services team, providing advice approved by the National Clinical Programme signposting to HSE materials and supports, and offering guidance and reassurance as required.
New service – WhatsApp nurse support
In May 2020, in conjunction with an Asthma Awareness Week theme focused on supporting asthma patients through the pandemic, we launched a new Sláintecare-funded service – a nurse WhatsApp support messaging service. Staffed by a respiratory specialist nurse team, it offered support, guidance and advice for patients. With 610 users from May to December 2020, the service involved 5,064 patient chats with the nurse. Some were quick queries and others long, extended conversations about asthma management. Healthcare professionals can refer patients to this service and using it could not be simpler – patients send a message on WhatsApp to 086 059 0132 with their question, or concern and the nurse responds to support them with advice, best practice asthma management, videos or links – depending on what they need.
While the Asthma Society was reactive in the initial weeks after the pandemic outbreak, by May 2020 we were in listening mode and our 2,400 respondent strong survey helped us to listen to patients and give them the supports they needed. We created a whole host of specially designed Covid-19 supports tailored to their needs:
An Asthma Self-Management masterclass,
Covid-19 asthma and COPD management leaflets,
A Protecting the Cocooners pack, webpage and video guidance programme,
A Back to School/Back to Normal awareness programme to support children returning to school or people returning to work,
Ordinarily, the Asthma Society has one full-time receptionist taking adviceline calls; this increased from March until June 2020 to five full-time staff triaging and managing calls and scheduling nurse appointments. In 2020, the triage team managed 6,816 incoming/outgoing support calls to the adviceline. We provided 4,416 nurse appointments across the asthma and COPD adviceline, a 148 per cent increase from 2019. Despite a focus on Covid-19 related queries, asthma action plans were discussed in 88 per cent of adviceline nurse appointments – helping patients to understand the need for improved asthma control and providing a key intervention recognised internationally to prevent asthma deaths.
A series of respiratory supports including wellness, patient education webinars, and awareness building (in conjunction with other respiratory charities, with the support of Bank of Ireland),
A Winter Wellness campaign,
Videos and leaflets to support patient sub-groups particularly impacted by Covid-19 outbreaks – like members of the Traveller community and the Roma community,
Asthma and Covid-19 patient packs, through Careplus pharmacies.
The Covid-19 legacy
Over 16 months in, we are left trying to understand the collective trauma of the pandemic – for all of us in Ireland. For those of us in the Asthma Society, that trauma is very real. Our fundraising has been seriously impacted and we have not been able to retain our full team as a result. There has been no improvement into 2021 and we are challenged with continuing our work. The Society cannot continue to provide its services without a substantial upturn in funding and fundraising – we may have to lose services in advocacy, awareness, research, and patient supports. This is a very serious realisation for us and for our patients – and all while our latest research launched during Asthma Awareness Week 2021, which shows that one-in-four patients avoided an emergency department visit when they needed it for fear of contracting Covid-19. We have never been more needed and we have never been less able to continue to meet the needs of patients.
By 2030, we want to end asthma deaths in Ireland, but we need our work and services to survive to accomplish that goal. We need your help to do that – as healthcare professionals who can create meaningful asthma interventions with patients, boosting their asthma management skills, but also as Asthma Society donors. Please go to www.asthma.ie to become a healthcare professional member of the Society and to donate on a monthly basis.
Clinical Respiratory Medicine THE MEDICAL INDEPENDENT | 12 AUGUST 2021 31
Despite a focus on Covid-19 related queries, asthma action plans were discussed in 88 per cent of adviceline nurse appointments
SPORTS QUIZ WIN €50 12 August 2021
Q1 Who are the new 2021 Ulster Football champions?
Q2 How many medals did Team Ireland win at the Olympics in Tokyo?
Q3 The Premier League will kick off this weekend. Name the three promoted teams for this upcoming season?
Q4 Formula One held its first sprint qualifying race recently. What track was it staged on?
Q5 Name the Irish golfer who won his first PGA tournament last month?
Q6 Who are the new NBA Finals champions for 2021?
12 August 2021
Q1 What year did Ireland first qualify to appear in the European (Euro) football championship? A: 1988
Q2 Denmark won the 1992 Euro championship, but didn’t originally qualify for the tournament. Which nation was expelled, thus allowing the Danes appear? A: Yugoslavia
Q3 Where will the 2024 Euro championship be staged? A: Germany
Q4 What year was the first Euro championship held? A: 1960
Q5 Which two nations have won the Euro championship on three occasions? A: Spain and Germany/West Germany
Q6 Who is the all-time leading goal scorer in the Euro championship? A: Cristiano Ronaldo
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 32 Post your answers to: Mindo Quizzes, The Medical Independent, Greencross Publishing Ltd, Top Floor, 111 Rathmines Road Lr, Dublin 6. Closing date for entries is 25 August 2021 Solution to Crossword Competition
The winner of the 8 July 2021 Sporting Quiz Competition is Dr Kathleen Murtagh, Co Kilkenny The winner of the 8 July 2021 Crossword is Dr Eamonn Kenny, Dublin 8
Answers to Sports Quiz Competition Solution to Sudoku B E H A V E E E R E O R E M E M B E R H E R R O E L A R E S O R T R O A D L O R I G T F O R T Y N O M I N E E E M N N M A N A G E R A G E N T C S A C X A S T E P S H R I M P C I O U A O A K T O M O R R O W R L N N E L I T T L E 1 7 5 6 4 2 8 9 3 2 3 9 5 7 8 6 1 4 8 6 4 9 1 3 7 2 5 3 2 6 4 5 7 1 8 9 5 1 8 2 3 9 4 6 7 4 9 7 8 6 1 3 5 2 7 5 3 1 9 6 2 4 8 6 4 2 3 8 5 9 7 1 9 8 1 7 2 4 5 3 6 1 3 4 5 9 7 8 4 7 4 1 2 4 6 5 2 9 3 1 5 6 2 5 SUDOKU SCRIBBLE BOX 8 JULY 2021 ANSWERS, SOLUTIONS, AND WINNERS WIN €50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Across 1 - Of considerable size (11) 9 - Elector (5) 10 - Space or interval (3) 11 - Firearm (5) 12 - Absolute (5) 13 - Usually (8) 16 - Person who maintains machines (8) 18 - Violent atmospheric disturbance (5) 21 - Eg spaghetti (5) 22 - Frozen water (3) 23 - Record on tape (5) 24 - Absorbing; intriguing (11) Down 2 - Identifying outfit (7) 3 - More than two (7) 4 - Real (6) 5 - Conditions (5) 6 - Debate in a heated manner (5) 7 - Joint business (11) 8 - Fitting (11) 14 - Where you go to catch a flight (7) 15 - Official sitting (7) 17 - Sewing instrument (6) 19 - Eg Pacific or Atlantic (5) 20 - Film (5) ACROSS 1 Of considerable size (11) 9 Elector (5) 10 Space or interval (3) 11 Firearm (5) 12 Absolute (5) 13 Usually (8) 16 Person who maintains machines (8) 18 Violent atmospheric disturbance (5) 21 Eg, spaghetti (5) 22 Frozen water (3) 23 Record on tape (5) 24 Absorbing; intriguing (11) DOWN 2 Identifying outfit (7) 3 More than two (7) 4 Real (6) 5 Conditions (5) 6 Debate in a heated manner (5) 7 Joint business (11) 8 Fitting (11) 14 Where you go to catch a flight (7) 15 Official sitting (7) 17 Sewing instrument (6) 19 Eg, Pacific or Atlantic (5) 20 Film (5)
For all that matters in medicine AVAILABLE IN PRINT AND DIGITAL
Ford’s Puma will please both Jekyll and Hyde
If you’re facing a situation where practicality or family needs have steered you in the direction of a crossover SUV – but you don’t want to go too ‘sensible’ – fear not as Ford is here.
In the new Puma ST, you can pootle around suburbia being Dr Jekyll to your heart’s content, comfortable in the knowledge that at a moment’s notice, you can drink the elixir, push that Sport button and release Mr Hyde.
While testing this car, I kept comparing it to the fantastic Ford Fiesta ST I tested for the Medical Independent two years ago; but that was the wrong thing to do. You can’t look at the Puma ST through the same lens as you do a hot hatchback. The Fiesta ST handles like it’s on rails, whereas the Puma ST has a little bit more body roll in the bends. The Fiesta ST is trying to break your spine whenever it drives over a pothole, whereas the Puma ST takes them in its stride. So trust me and don’t compare this car to a hot hatchback because it’s not; it’s a hot crossover and that’s a different animal.
The Puma ST comes with a 1.5 litre EcoBoost (turbocharged) 200hp petrol engine with a six-speed manual gearbox getting a respectable 6.0l/100km. It’s a frontwheel drive car, but there wasn’t a whisper of understeer while driving it. The test car came with a mechanical limited slip differential to help in the bends.
This car is the first Ford performance SUV in Europe to feature a bespoke chassis, which is 40 per cent stiffer than the Fiesta ST to counter the higher centre of gravity. It also boasts force vectoring springs to support the Puma ST’s agility. The turbocharged 1.5 litre engine gets the Puma ST from 0-100km/h in 6.7 seconds. In order to deal with the power upgrades, the ST’s steering respons -
es are 25 per cent faster and its brakes are 17 per cent larger than the standard Puma. I found second gear in this car to be a complete antichrist, so beware of it because it takes off like a bullet.
According to Ford’s Performance Manager for Europe, Stefan Muenzinger: “We believe that we have the best-handling small SUV in its segment. It really does feel connected and has the true ST feel. It is a joy to drive.”
The Puma ST offers a number of modes: Normal, Eco, Sport, and Track, each of which does exactly what you’d imagine. The Track mode also has launch control, to shoot you off the line at Mondello.
Of course the styling has been upgraded from the average Puma, with more pronounced wheel arches, a Ford Performance-embossed splitter integrated into the front bumper, a large rear roof spoiler and a diffus -
er incorporated into the rear bumper. There are also the signature ST upper and lower grilles, which Ford claim are designed to deliver increased engine cooling capability. There are a number of special colours available for the Puma ST, like Mean Green and Fantastic Red, not to mention that there’s a gloss black finish for the roof, grille surrounds, side spears, door mirror caps, and rear roof spoiler as standard.
The interior is also festooned with ST bling, like the big heated Recaro racing seats, covered with grippy Miko dinamica material, Ford performance skid plates, a flat-bottomed leather steering wheel and an ST gear knob. One of the cherries atop this wonderful, dual personality, automobile is the nightclub standard sound system they’ve shoehorned into it. Audiophiles amongst you will know that Bang and Olufsen are some of the best in the business, whether you’re playing Beethoven or Biggie Smalls.
As for family positive perks, the Puma ST offers a gigantic uncompromised loadspace of 456 litres, thanks in part to the MegaBox, which Ford claim will comfortably accommodate two golf bags in an upright position.
According to Mr Muenzinger: “Real driving enthusiasts aren’t going to settle for less excitement just because life demands a more ‘sensible’ car, so our number one priority was that the Puma ST had to be as exhilarating and capable as every ST model, without sacrificing any of Puma’s practicality.”
The entry price for the normal Puma is €26,069, while the ST starts at €41,813. It’s a practical, fun car that will serve all your Dr Jekyll and Mr Hyde needs and wants. From trips to the beach with the kids to a barnstorming burn around Mondello Park.
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 Life Motoring
MORGAN FLANAGAN CREAGH
Read more at www.mindo.ie @MorganFlanaganC
One of the cherries atop this wonderful, dual personality, automobile is the nightclub standard sound system they’ve shoehorned into it
Ford Puma ST
1.5 litre Ford EcoBoost 200PS petrol
Six speed manual FWD
0-100km/h in 6.7 seconds
CO2 emissions: 134g/km (NEDC ) Band B2
Colour: Grey Matter
Reg no: 211 D 20077
STANDARD FEATURES INCLUDE:
19” magnetite machined alloy wheels
Unique ST elements to front and rear body styling kit including Ford performance embossed splitter
Fixed LED signature headlamps
Black painted contrast roof
Dual chrome exhaust
Red brake callipers
ST logo projection (from door mirrors)
Selectable driver modes – normal/Eco /sport/track
Engine sound enhancer
Front parking sensors
Ford keyfree system (keyless entry)
ST flat bottomed steering wheel with metal grey stitching Recaro sport seats with ST logo finished in partial leather and Miko Dinamica
Heated steering wheel
Front heated seats
Unique ST gear shift knob
ST scuff plates
ST front and rear mats
Alloy sports pedals
ADDITIONAL OPTIONS ON THIS MODEL
ST performance pack: Mechanical limited slip differential (LSD), launch control, performance shift light, and shift indicator - €1,172
Driver assistance pack: AEB by Radar/camera, BLIS with CTA and active braking, intelligent adaptive cruise control with evasive steering with manual transmission, Stop and go include traffic jam assist (automatic only), active park assist, front parking sensors, rear view camera - €1,456
Entry price for new Ford Puma ST from €41,813
Entry price for Ford Puma from €26,069
(prices exclude delivery and related charges)
THE MEDICAL INDEPENDENT | 12 AUGUST 2021 35
College of Anaesthesiologists of Ireland Annual Congress 2021
Life Gallery THE MEDICAL INDEPENDENT | 12 AUGUST 2021 36
Pictured L-R: Prof George Shorten, President Elect, College of Anaesthesiologists of Ireland (CAI); Dr Brian Kinirons, outgoing President, CAI; and Dr Niamh Hayes
Dr Carrie Murphy; Mr Martin McCormack, CEO, CAI; Dr Niamh Hayes; and Prof Ellen O’Sullivan
Dr Catalin-Iulian Efrimescu and Dr Karthik Srinivasan, President, Irish Society of Regional Anaesthesia
Dr Sinead Harte and Prof Ellen O’Sullivan
Dr Deirdre McCoy
Pictured at the book launch of Safety As We Watch Anaesthesia In Ireland 1847-1998 is co-author Dr Declan Warde
Dr Anil Kumar Patel and Dr David Moore
Pictured at the book launch of Safety As We Watch Anaesthesia In Ireland 1847-1998 were Prof George Shorten; Dr Declan Warde; and Mr Martin McCormack Dr Anil Kumar Patel and Dr Hari Gopal Dr Therese O’Connor
Photos: David Coleman/Bobby Studio
ABBOTT ANNOUNCES R&D INVESTMENT IN CLONMEL FOR CONTINUED DEVELOPMENT OF CARDIOVASCULAR DEVICES
Global healthcare company Abbott has announced further investment in its cardiovascular Research and Development Centre based at its vascular devices site in Clonmel, Co Tipperary.
According to the company: “Abbott is the world leader in drug-eluting stents. Both R&D and manufacturing of Abbott’s new vascular technologies to treat complex heart disease take place at its Clonmel site. The Irish R&D team spent three years developing the company’s market-leading stent, XIENCE Sierra, which is being used worldwide in patients who, because of the nature of their disease, might not previously have been suitable for minimally invasive surgery. Abbott’s manufacturing plant in Clonmel manufactures its XIENCE family of stents, including XIENCE Sierra, for global use.”
The continued major investment programme in its R&D centre in Clonmel, supported by the Irish Government through IDA Ireland, comes as Abbott celebrates 75 years in Ireland this year. Over the next three years, Abbott will invest €37.8 million in an R&D programme focusing on the discovery, innovation, and development of a number of projects, including next generation drug-eluting stents, as well as coronary and endovascular balloon technologies.
Tánaiste and Minister for Enterprise, Trade and Employment Leo Varadkar said: “Abbott was one of the first US companies to establish operations in Ireland and is one of our largest med-tech employers, with six manufacturing sites and three corporate services operations throughout the country. This announcement reflects Abbott’s ongoing commitment to Ireland. It is also a tribute to the management and staff of Abbott’s vascular division in Clonmel, who have played a pivotal role in the global success of Abbott’s XIENCE Sierra stent. I congratulate the Irish and global teams on this investment.”
Ms Deirdre Mullins, Site Director, Abbott in Clonmel, said: “Our market leading XIENCE stents were developed in Clonmel and this announcement places us at the vanguard of Abbott’s global research efforts in cardiovascular treatments. We are very
proud that the life changing technologies we design and manufacture in Clonmel are saving lives in Ireland and across the world.”
CEO of IDA Ireland Mr Martin Shanahan added: “Abbott has demonstrated real commitment to its Irish operations in its 75 years here, investing and expanding its operations and growing jobs across its manufacturing and shared services sites, employing over 4,000 people in Ireland. The economic and jobs benefit of Abbott’s longevity here is substantial. I congratulate the Irish and global teams on this investment and wish Abbott continued success in its operations here.”
Over 90,000 Irish people have heart disease and it is one of the most common causes of hospitalisation in people aged over 65. Dr Colm Hanratty, Consultant Cardiologist at Mater Private Network Dublin, commented: “Drug eluting stents revolutionised the treatment of cardiovascular disease. But we are starting to see more complex cases. As people get older, the arteries narrow, they be-
76 PER CENT OF 18-TO-34-YEAR-OLDS WOULD TAKE VACCINE
The international research-based biopharmaceutical industry has urged younger people to get vaccinated for Covid-19 to slow the transmission of the disease and protect the population.
Research carried out by Ipsos MRBI for the Irish Pharmaceutical Healthcare Association (IPHA), shows that 76 per cent of people aged between 18 and 34 said they would take a vaccine for the disease. That figure excludes those who have already been vaccinated for Covid-19. In June, the same figure was 78 per cent and, in April and May, it was 77 per cent.
Overall, 89 per cent of people either intend to get vaccinated for Covid-19 or have already received a vaccine for the disease, according to the research released in late July. That figure has remained steady in recent months.
Just 6 per cent overall said they will refuse a Covid-19 vaccine and 4 per cent were unsure.
Among the 6 per cent of people overall who said they will not take a vaccine, it was highest among 25-to34-year-olds, at 12 per cent. While 4 per cent said they were unsure about taking
a Covid-19 vaccine, it was highest among 18-to-24year-olds, at 15 per cent.
Mr Bernard Mallee, Director of Communications and Advocacy at IPHA, said: “The rising prevalence of the highly transmissible Delta variant means more of the population needs to be protected to move us closer to overall community protection. Our data shows very significant public appetite to get vaccinated for Covid-19. People aged between 18 and 34 are slightly more hesitant about getting vaccinated for the disease. We urge them to get vaccinated because that way we can maximise protection in the population. At the same time, the industry urges continued adherence to public health advice.
“Vaccines makers are continuing to surge global production of Covid-19 vaccines, investing in their own sites and forming hundreds of partnerships and collaborations with other suitable manufacturing sites. At the same time, our industry is working hard to generate responses for variants of concern as the fight against Covid-19 continues.”
TRAINING FOR GPS AS NEW INTRAUTERINE BALL LAUNCHED FOR IRISH WOMEN
duction has helped align pharmacy regulation in Ireland with how healthcare settings, more generally, are regulated,” stated Mr Niall Byrne, Registrar and Chief Officer of the PSI.
“Internationally, regulatory standards, and the monitoring of performance against standards, are recognised for their effectiveness in driving improvements in quality and safety in healthcare and in supporting good governance and strong leadership across healthcare settings.”
The PSI’s operational standards cover a range of areas including infection prevention and control, patient and staff safety, as well as continuity planning to help ensure the ongoing provision of pharmacy and medicine services. As part of its initial monitoring of the standards, the regulator conducted over 40 visits to pharmacists.
flect very well on the commitment and professionalism of community pharmacists and of their pharmacy teams. As regulator, we believe it is very important to highlight good practices as part of how we assure the public that they can trust the quality of healthcare services and advice available through their local pharmacy.”
According to the PSI’s overview report, these initial visits also highlighted areas that required further improvement. For example, there was some evidence that not all pharmacists were benefiting from appropriate rest breaks during their working day.
Dr Colm Hanratty
come twisted and there is a build-up of plaque. Abbott’s XIENCE Sierra stent is a feat of engineering that means we can treat previously untreatable patients.”
Dr Diarmuid Meagher, Director of Research and Development at Abbott, said the engineering team worked closely with Dr Hanratty and the global interventional cardiology community to understand the challenges that were impacting successful cardiovascular interventions.
“We adapted the XIENCE design to develop a stent for older and more complex patients which was smaller, more flexible and physically stronger. Its sophisticated navigation makes it easier to manoeuvre through challenged arteries and obstacles and it’s now being used in 90 countries around the world.”
Consilient Health is inviting GPs to attend a series of training sessions online and in person conducted by women’s health expert Dr Deirdre Lundy. The sessions will take place in September ahead of the launch of the next generation IUD, an Intrauterine Ball (IUB).
The sessions, which will be online (2 September) and in person in Dublin (9 and 13 September), Galway (16 September) and Cork (23 September), will discuss the launch of IUB Ballerine.
Dr Deirdre Lundy
Space is limited. To secure your place at these meetings, contact Ms Hazel Travers at firstname.lastname@example.org
PSI PUBLISHES OVERVIEW REPORT ON COVID-19 OPERATIONAL STANDARDS FOR PHARMACIES
The Pharmaceutical Society of Ireland (PSI) has published its first overview report on the implementation of the Covid-19 Operational Standards for Pharmacies, which were introduced last year on a ‘use and learn’ basis. The standards provide guidance to those in leadership and governance positions in pharmacies on how to best
ensure safe services and environments for patients, public and staff during the pandemic. The report highlights a range of good practices found in pharmacies as well as noting some areas requiring improvement.
“We are encouraged by the positive response of community pharmacies to the standards. Their intro-
Mr Byrne commented: “While this is a small number of community pharmacies, we learned a lot from our engagement with pharmacists and their wider pharmacy teams, gaining valuable insights into how the standards are working in practice. Our monitoring visits allowed us to see the many good practices and innovative measures that pharmacy teams have put in place to protect their patients, communities and staff, while continuing to deliver essential healthcare services, despite the ongoing risks and challenges presented by Covid-19.
“These good practices re-
The PSI was also concerned that, due to the necessary measures implemented to reduce the spread of Covid-19 in pharmacies, patients may not always be receiving the appropriate level of counselling on t heir medicines.
“These are three important areas of patient safety and wellbeing, which both pharmacies and the regulator need to focus on into the future,” said Mr Byrne.
“We will be doing further monitoring over the coming months to learn more about good practices in use and to encourage wider adoption of the standards. Our learnings will inform the further development of our monitoring and judgement framework. This will assist us in carrying out ongoing assessments of performance against the standards once the ‘use and learn’ period has concluded at the end of 2021.”
FIRST TRAINEE IN PHARMACEUTICAL MEDICINE COMPLETES TRAINING IN PFIZER
The first trainee in pharmaceutical medicine in Ireland, Dr Sean Gardiner, has formally completed his training and received his certificate of completion of specialist training from the RCPI.
Ireland is the only EU country to recognise pharmaceutical medicine as a medical specialty. Pfizer was the first organisation to be accredited as a training site in Ireland for doctors and the first to recruit a trainee.
The Association of Pharmaceutical Physicians (APPI) in Ireland have worked over many years to achieve recognition of the specialty and to develop an agreed curriculum and training programme with the Institute of Medicine
in the RCPI. Chair of the APPI Dr Anthony Chan welcomed Dr Gardiner’s graduation as a major milestone in pharmaceutical medicine in Ireland.
Dr Mary Teeling, National Specialty Training Director for Pharmaceutical Medicine, said: “I would like to take this opportunity to congratulate Sean on the completion of the training programme and his recognition as a Specialist in Pharmaceutical Medicine. This is testament to the hard work completed by Sean and his trainer Dr Alistair McBride, Deputy Medical Director, Pfizer Healthcare Ireland. Continuous training is so important especially in the medical field where new innovations and developments are happening rapidly.”
Product Focus RXDX THE MEDICAL INDEPENDENT | 12 AUGUST 2021 37
GP REQUIRED – EAST CORK
Up to 6 sessions per week with days negotiable. Flexible, friendly, computerised practice that aims to keep patient safety and to provide a caring and supportive work environment at its core. Working with three other doctors, two practice nurses, three administration staff. 15-minute appointments. 30 minutes from Cork City. No house calls/nursing homes/admin.
There would be an OOH commitment of approximately two evenings per month and four weekends per year.
Please contact Dr Mark Buckley email@example.com or 086 025 6001
GP POSITION AVAILABLE
GP position available with a view to partnership in Killybegs, south-west Donegal.
The practice is fully computerised, with a well-established GMS and private patient base. It is supported by excellent nursing and administrative staff. Attractive remuneration for the suitable candidate.
Please contact: firstname.lastname@example.org
GP required in the Ashe Street Clinic in the heart of Tralee, Co Kerry, on a part-time basis to join our expanding team of three GPs and a GP registrar. Long-term position available in a friendly, progressive and dynamic urban practice. We are fully computerised with a practice manager, practice nurses, phlebotomist, and members of SouthDoc Co-Operative. Excellent T&Cs.
Please apply with a CV or contact us for further information: email@example.com
GP required to join practice in Dundalk, Co Louth with a view to succession. Mixed GMS/private.
Student teaching attachment RCSI.
Very little on-call (large group rota). Socrates software. Email CV to firstname.lastname@example.org
(Full-time/Sessions also available)
Riverwest Medical, Foynes, Co Limerick are looking for a GP to join our practice. We are a two GP practice and we are supported by an excellent nursing and administration team.
We are fully computerised and our appointments are 15 minutes. We have an excellent package, paid professional indemnity, and there is no out-of-hours commitment.
Starting date is negotiable and we can accommodate a future start date for those in a current role.
Please contact us at email@example.com or call Eileen on 087 296 6970 to arrange a meeting.
See our website on www.riverwest.ie
Unique opportunity to live and work in the bustling and scenic town of Tralee.
Part-time GP required to work 4 to 6 sessions (flexible) per week in a friendly, flexible, well organised, training practice at Fairies Cross Medical Centre, Tralee.
Excellent rate of pay.
Please apply with CV or contact for further information if required to firstname.lastname@example.org
Unique opportunity for GP to live and work in beautiful Kinsale, Co Cork.
We are a 6 doctor practice, GP training, academic, affiliated to University College Cork. We have multiple GP specialities and enjoy working in a stimulating supportive team.
Must be MICGP or MRCGP qualified/equivalent on specialist register. Required to work 8 sessions per week, excellent rate of pay, accommodation is available in Kinsale town if required.
Please reply to Marie Lovell practice manager with any queries, 087 927 3228 or by email email@example.com
ASSISTANT GP LOCUM REQUIRED
• Location: Inishowen Medical Clonmany and Buncrana (mixed urban and rural practice).
• Work: 8-9 sessions per week as part of a multi-doctor team.
• No out-of-hours requirements.
• Practice fully computerised (HPM) and practice offering a very generous pay package.
Should you be interested please either send your CV to Inishowenmedical@gmail.com or alternatively call 074 936 1800 and ask for Marie McGowan
Part-time two days per week plus optional extra sessions. Drummartin Clinic blends both conventional and functional medicine and uses advanced cutting-edge therapies, which are otherwise only available in the US and mainland EU.
Our patients are mostly people suffering from ‘difficult-to-treat’ conditions such as CFS, IBS, fibromyalgia, PMS, severe hormonal imbalances, allergies, and autoimmune disorders.
The Clinic team is small (currently five people) and we work closely together. We value humour and there is also a big ‘feel-good’ factor when we see our patients ‘getting their lives back’.
The role will include phlebotomy and administration of intravenous treatments. You will work as part of a team with Kathryn our senior nurse and Dr Magovern and will be well-mentored and supported clinically. Remuneration €27-30 per hour.
You will be an experienced nurse with a high degree of personal initiative: A team-player who is a good listener, enjoys professional development, and is empathetic and humorous.
To apply please email your CV to firstname.lastname@example.org with ‘NURSE’ in the subject line
Classifieds & Recruitment THE MEDICAL INDEPENDENT | 12 AUGUST 2021 38
PRACTICE NURSE REQUIRED
Friendly group practice in South West Dublin seeking to recruit a permanent part-time practice nurse to join our team. Experience in practice nursing is desirable, but not essential. Suitable candidates from various nursing backgrounds will be considered. Job training offered, to build necessary skill set, if required.
Hours: Mon-Fri, 15-19 hours per week. Afternoons initially. Flexible schedule.
Salary: Dependent upon experience. Please contact email@example.com or Tel 01 626 0562 for further information
PRACTICE NURSE REQUIRED
Practice nurse required for North Dublin City practice. Experience helpful, but not essential for right candidate. Duties include, but not limited to, phlebotomy, ECG, vaccines, smears tests, and managing smear recall system, stock ordering, chronic disease management. Hours flexible. Salary negotiable.
Please email cv to firstname.lastname@example.org
PRACTICE NURSE REQUIRED
Practice nurse required two days a week – Southside Cork City practice. Apply to: email@example.com
Saturday 11th September 2021
This event will be a live streamed webinar. Topics include practical demonstrations, such as interpretation of ECG results and spinal examinations. Other topics cover referral pathways, adolescent back pain, cardiology updates, and more. Speakers include Dr David Burke, Prof Jonathan Lyne, Dr Rory O’Hanlon, Mr Seamus Morris, and Mr Marcus Timlin amongst others. Register via the GP events section on our website. CME Accreditation applied for
THE MEDICAL INDEPENDENT | 12 AUGUST 2021
To advertise, email Louis at firstname.lastname@example.org
ARE YOU LOOKING FOR GP COVER? LOCUM, LONG-TERM OR PARTNERSHIP GET IN TOUCH WITH MATCHMEDICS TODAY TO FIND YOUR NEXT HIRE! CALL GRAHAM ON 087 758 4592 Email: email@example.com
Free, independent CPD for doctors, nurses and pharmacists… all under
EVENT BEACON HOSPITAL CARDIOLOGY AND SPINAL GP STUDY MORNING
If you have anything you would like to share, please email: firstname.lastname@example.org
A round-up of news and oddities from left field by
Dr Doug Witherspoon
The naked truth about medical care in the ancient Olympic Games
As you read this, the slightly strange and crowd-free Olympic Games are drawing to a close. Of course, the medical assistance offered to all of the athletes is now world class, with the best sports medicine specialists and top-line monitoring and treatment equipment, as well as a dizzying array of physiotherapists, nutritionists, nurses, and so on.
However, if you were an Olympian in some of the early
Games, the medical care was a little more, shall we say, rough and ready.
For a start – literally – ancient Greek Olympians competed in the nude. Casual nudity was a fundamental part of Greek culture, although according to historians, the Persians and Egyptians were somewhat puzzled by this practice. However, in ancient Greece, exhibitionism and vanity were par for the course and it was thought that only 'savages' were afraid to show their naked bodies. It is
E xper t assessment and treatment for patient s with medical and surgical conditions.
Patients will be seen by appointment only. Call in advance for screening, triage and appointment time.
a matter of debate, but some historians say the nudity was a tribute to the Greek god Zeus, as the competitors wanted to display their muscular physiques as an homage. One can only imagine the hazards of competing naked in events such as running, jumping, wrestling, etc. They also held races where the athletes had to race each other carrying flaming torches. Not for the faint-hearted naked competitor.
Speaking of the events, some survive to this day, such as boxing, discus throw, pentathlon, while others have fallen by the wayside, such as chariot racing and 'plankation', a primitive form of martial art combining wrestling and boxing. Healthcare for these athletes of old took some strange twists and turns. According to historians, medical teams were in situ from the Athens Games in 1896, with doctors carried in carts behind the marathon runners to treat runners with difficulties.
For the 1900 Games in Paris, huts were provided for doctors to shelter from the July sun, whilst they waited to treat any swimmers. However, much to the chagrin of the organisers, there were freak rainstorms, so the doctors found things got a bit cramped as people used the huts to shelter from the pounding rain. This was also the first Olympics to feature ambulances.
On to the 1904 Games and the odd tale of the winner of the gold medal for the marathon, Thomas Hicks, a brass worker from the US. There are photos online showing Hicks being basically carried by two men, as the punishing race took its toll. To revive him, it was decided by his team to administer 'therapy' in the form of hot water baths, egg whites, brandy, and two one-60th grains of sulphate of strychnine administered in two doses. Hicks literally fell over the finishing line, which was lucky for him – any more 'help' from his team probably would have finished him off. Incidentally, the only water available to the runners of that race was at the 12-mile mark.
Of course, any athlete today using strychnine as a stimulant would be disqualified immediately and the next Games in 1908 in London were the first to see anti-doping measures introduced. These were also the first Games where a doctor's sign-off was required to declare an athlete fit to compete. However, the doctors were not provided with any special equipment to enforce this – they simply had to walk up and down the line of competitors to visually establish who looked 'juiced'. Hydration was also finally on the organisers' radar, albeit in the form of hot Oxo (one of the sponsors of a stall at the event), cold Oxo mixed with soda, raisins, bananas, and milk.
Proper Olympics medical care as we know it really began to evolve at the 1932 Olympics in Los Angeles, where a dedicated pop-up hospital was provided for the first time and the first ever Olympic Village was introduced, introducing a new aura of professionalism to the Games. The medical care was provided free of charge to the athletes in the Village; however, for the 18 athletes whose injuries were beyond the on-site scope of treatment, they had to pay a pretty penny for treatment in an LA hospital. Some things never change.
The above just scratches the surface of the evolution of Olympic medical care and it's well worth taking a deeper dive into this area of historical sports medicine.
The Dorsal View THE MEDICAL INDEPENDENT | 12 AUGUST 2021 40
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