One can ask legitimate scientific questions about the Covid-19 vaccines and potential side-effects without being an ‘anti-vaxxer’, writes
Terry MaguireCLINICAL CONTENT
Brush-up on your knowledge on Wound Care, Infant Pain, and Testicular Cancer
IP speaks with the head of the Practitioner Health Matters Programme about helping pharmacists with emotional or substance abuse problems
medicine. The additive e ect of concomitantly administered products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be considered. Pregnancy and lactation: Not recommended. Side e ects: pruritus, rash, urticaria, angioedema, anaphylactic reaction, oral mucosal blistering, abdominal pain, diarrhoea, nausea, vomiting, dyspnoea, exacerbation of asthma.TR 2006/1/1. TR Holder: Kwizda Pharma GmbH, E ngergasse 21, A-1160 Vienna, Austria. IRE BRO
02 NEWS National and international news in the world of pharmacy and healthcare
12 HELPING HANDS We speak with the head of the Practitioner Health Matters Programme about the supports available for pharmacists
14 SMOKE WITHOUT FIRE?
Dr Des Cox writes that e-cigarettes are not the harmless option they are made out to be
18 GUT FEELINGS
Oonagh O'Hagan
MPSI outlines her road to recovery from IBS and the compound that helped improve her symptoms
20 FINTAN MOORE Codeine addiction and pharmacyhopping require creative thinking and solutions
23 TERRY MAGUIRE
It's possible to ask legitimate questions about Covid vaccine side-effects without being
26 DR DES CORRIGAN
A review of the findings in a HSE report on the residual contents of syringes returned to needle exchange facilities
30 MEN'S HEALTH
An overview of the diagnosis, treatment and management of testicular cancer, as well as the need for early detection and treatment
40 WOUND CARE
A clinical overview of wound care, including choosing the right dressing and the need for proper nutrition
46 MOTORING Paddy Comyn reviews the Polestar 2, his favourite electric vehicle and his chosen car of the year
Editor Pat Kelly, pat@greenx.ie
Creative Director Laura Kenny, laura@greenx.ie
Administration Manager
Daiva Maciunaite, daiva@greenx.ie
Managing Director Graham Cooke, graham@greenx.ie
GreenCross Publishing was established in 2007. Publisher and Managing Director: Graham Cooke, graham@greenx.ie
© Copyright GreenCross Publishing Ltd 2022.
36 INFANT PAIN Treating pain in infants poses its own particular problems, not least in terms of communication with the patient
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The views expressed in Irish Pharmacist are not necessarily those of the publishers, editor or editorial advisory board. While the publishers, editor and editorial advisory board have taken every care with regard to accuracy of editorial and advertisement contributions, they cannot be held responsible for any errors or omissions contained.
A new study has found that the number of ePharmacy users will reach 1 billion globally by 2027, increasing from 795 million in 2022, a growth of 28 per cent. The research identified this increase as the culmination of surging adoption resulting from the Covid-19 pandemic, where consumers were unable to leave their homes and turned to receiving medication through ePharmacies. Growth will continue, as vendors focus on retaining and expanding their customer bases by refining the efficiency and simplicity that ePharmacy provides, according to the study.
The research predicts that consumers will continue to utilise ePharmacies as they realise the benefits they provide them, including affordability of medication, and a wider range of choice compared to bricksand-mortar pharmacies.
Furthermore, the report predicts that ePharmacy growth will be sustained by
simplifying the online process. This can be achieved through more widespread acceptance of ePrescriptions, eliminating paper copies of prescriptions.
The research anticipates that ePharmacy services will continue to be predominantly utilised for OTC medication. OTC transactions will reach 8.9 billion globally in 2027, accounting for 64 per cent of total global transaction value. This is compared to 5 billion prescription transactions globally in the same year. Prescription digitisation will lag behind due to consumer concerns around delivery accuracy, timing and missed deliveries, say the study authors. In order to allay these concerns and offset the abundance of illegitimate ePharmacies, real-time tracking and stronger regulations for ePharmacies should be priorities to secure future growth, they added.
The study was carried out by Juniper Research and is available at www.juniperresearch.com/press releases/epharmacy-users-to-reach1bn-globally-by-22.
Knowledge and skills recommended for pharmacists to practise cancer care are defined in new guidance from the International Pharmaceutical Federation (FIP) published recently. Such knowledge is not limited to the biology of cancer and cancer medicines, but includes public health strategies, non-pharmacological support, and communication. In addition to providing pharmacists with a comprehensive list of knowledge and skills, the new resource, ‘Knowledge and skills reference guide for professional development in cancer care’, aims to highlight key considerations for educators in the area of cancer to support pharmacists’ professional development.
“The global burden of cancer is increasing and requires a more robust response from healthcare systems worldwide. The World Health Organisation
has passed a resolution for cancer prevention and control, in the context of an integrated approach, to encourage countries to set goals, collect data and improve outcomes. By supporting pharmacists to develop, upskill and refresh knowledge in cancer care, FIP is empowering pharmacists to facilitate these goals,” said Dr Dalia Bajis, FIP lead for provision and partnerships and editor of the guidance document, which has been reviewed by a group of experts and contributed to by the European Society of Clinical Pharmacy.
The new guidance is intended as a companion to ‘Cancer care — A handbook for pharmacists’, also published by FIP recently. This resource covers all aspects of cancer care for pharmacists, from prevention and screening, through treatment and management, to
complications and end-of-life care. It, too, has been developed by an international expert advisory group and with the collaboration of the International Society of Oncology Pharmacy Practitioners. Dr Evelyn Handel, the Society’s president, writes in a foreword that oncology is an area where change is at its most rapid and that pharmacists are well poised to significantly implement many of the new treatments, technologies and research in cancer care.
“This handbook and its accompanying knowledge and skills guide cover a lot of ground and provide a comprehensive foundation. . . I am excited for the impact [FIP’s Practice Transformation Programme on Non-Communicable Diseases] and accompanying resources will have on elevating the quality and consistency of oncology pharmacy practice globally,” Dr Handel commented.
paracetamol/caffeine
DUAL ACTIVE FORMULA PROVIDES 30% MORE POWERFUL PAIN RELIEF THAN STANDARD PARACETAMOL1
GENTLE ON THE STOMACH AND NON-DROWSY**
SOLUBLE RELIEF FOR TOUGH PAIN, INCLUDING HEADACHES, PERIOD PAIN AND DENTAL PAIN
*compared to standard paracetamol. **when used as directed/always read the label before use.
Reference: 1. Laska EM et al. JAMA 1984; 251(13): 1711-1718.
Product Information: Please consult the summary of product characteristics for full product information. Panadol Extra 500mg/65mg Soluble Effervescent Tablets, paracetamol 500mg, caffeine 65mg. Indications: Relief of mild to moderate pain including rheumatism, neuralgia, musculoskeletal disorders, headache, symptoms of colds and flu, fever, toothache and menstrual pain. Dosage: Adults and children 16 years and over: 2 tablets up to 4 times a day. Do not exceed 8 tablets in 24 hours. You may need a lower dose if you are underweight (<50kg), malnourished, dehydrated or if you have alcohol problems. Children aged 12-15 years: 1 tablet up to 4 times a day. Do not exceed 4 tablets in 24 hours. Do not give to children under 12 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol, caffeine or any ingredients. Precautions: Avoid concurrent use with other paracetamol-containing products. Diagnosed liver of kidney impairment. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels or chronic alcoholism or sepsis. Avoid excessive caffeine intake. Caution in those with hereditary sugar intolerance or on a low sodium diet. Should not be used in pregnancy or lactation without medical advice. Caution, due to paracetamol, if administered with flucloxacillin due to increased risk of high anion gap metabolic acidosis. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur or if symptoms persist for longer than 3 days, consult your doctor. Side effects: See SPC for full details. All very rare: Thrombocytopenia, hypersensitivity reactions including anaphylaxis and skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Frequency unknown: Nervousness, dizziness. When combined with dietary caffeine intake, higher doses of caffeine may increase potential for caffeine related adverse events such as insomnia, restlessness, anxiety, irritability, headaches, GI disturbances and palpitations. Overdose: Immediate medical advice should be sought in the event of an overdose, even if symptoms of overdose are not present. Legal Category: Supply
Researchers at the Health Innovation Via Engineering (HIVE) Laboratory, University of Galway, will use state-of-the-art medical device technology, including remote sensors and artificial intelligence software, as part of a suite of interventions to deliver nextgeneration chronic disease management in the community.
Modern medicine has meant that people are living longer and correspondingly there has been an increase in chronic diseases such as diabetes and hypertension, and therefore new approaches are needed to deliver this care efficiently and effectively, as was evidenced during Covid public health restrictions.
The Home Health project combines video consultations with remote physiological monitoring, including blood pressure, weight, and blood sugar, to deliver more useful virtual care.
It aims, through supporting and adding to existing healthcare provision, to improve the management of patient care for the 165 residents on Clare Island and make the island a beacon for the delivery of digital health solutions.
Its multi-stakeholder engagement will ensure a sustainable and scalable solution is created though the Health Service Executive living lab framework, said the researchers.
Dr Noreen Curtis, GP in Clare Island, said: “I am very excited with the Home Health project and anticipate that improving virtual care will augment the current services and improve overall care for the patients here."
Project Principal Investigator and CÚRAM-Funded Investigator Prof Derek O’Keeffe said: “Digital health is the future of medicine and data empowers the patient and allows them and their clinicians to make better medical decisions.”
The Home Health project will also investigate the development of a dynamic medical appointments architecture, whereby patients are scheduled to be reviewed based on clinical need rather than the traditional static calendar appointments. In addition, the project will evaluate novel health promotion interventions, drone delivery of medications, and robotic triage simulation.
To overcome the digital divide, a central part of the project is the development of
Experiential Learning) is now seeking expressions of interest from pharmacists in community and hospital pharmacy settings who would like to facilitate an experiential learning placement for a 4th-year pharmacy student in 2023. These placements will run from 28 August to 15 December 2023.
Experiential learning placements are a key part of the integrated pharmacy masters (M.Pharm). In their 4th year, students can undertake placements in both patient-facing (ie, community and hospital pharmacy) and non-patient-facing settings
(including in the pharmaceutical industry and in role-emerging practice).
Pharmacists who have previously facilitated APPEL placements have found the experience enjoyable and rewarding. In surveys, 90 per cent of pharmacists said they would recommend facilitating a placement to other pharmacists. The advantages of facilitating an APPEL placement include:
Continuing Professional Development — APPEL Trainer Training can contribute to pharmacists’ CPD, as can the experience of facilitating a placement.
Development of your talent pipeline —
a new private 5G network on the island to enable monitoring of data.
Brian Jordan, Head of Innovation and Industry Solutions, Cisco Ireland, said: “There is a transformative opportunity to map virtual care digital technology to the entire patient care continuum. Bridging the capabilities of AI, connectivity, the world of IOT -enabled medical devices and cybersecurity will enable this.”
Commenting on the significance of the project, CÚRAM Director Prof Abhay Pandit said: “This project is one of the largest industry collaborations our centre has supported to date. It is an excellent example of the impact that collaborations between CÚRAM and industry can have on local communities and society at wide.”
As well as CÚRAM and Cisco, the project has multiple stakeholders, including the island community, HSE and the Western Development Commission. Public Patient Involvement (PPI) is a central theme of the HOME HEALTH project, having the island community involved in all aspects of the project planning, development and implementation.
many students will look to start their career in the organisations or practice settings where they undertook their placements.
Engagement — participating in the APPEL programme provides you with the opportunity to increase awareness of your pharmacy/organisation. APPEL training and events provide fantastic networking opportunities.
The deadline to confirm your interest in offering placements is 11 November 2022. You can do this by visiting: https:// forms.gle/asBEd93CwDvm72gJ6. For further information, email ops@appel.ie.
PRESCRIBING INFORMATION (PI)
SKYRIZI®▼ (risankizumab) 75 mg solution for injection in pre-filled syringe; Skyrizi 150 mg solution for injection in pre-filled pen and Skyrizi 150 mg solution for injection in prefilled syringe. Refer to Summary of Product Characteristics (SmPC) for full information before prescribing. PRESENTATION: Skyrizi 150 mg solution for injection in pre-filled pen/syringe: each prefilled pen/syringe contains 150 mg risankizumab in 1 mL solution. Skyrizi 75 mg solution for injection in pre-filled syringe: each pre-filled syringe contains 75 mg risankizumab in 0.83 ml mL solution. INDICATION: For treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. DOSAGE AND ADMINISTRATION: Intended for use under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis. Dosage: The recommended dose of Skyrizi is 150 mg by subcutaneous injection at weeks 0, 4, and every 12 weeks thereafter. Two 75mg pre-filled syringes should be injected for the full 150 mg dose. Consider discontinuation of treatment in patients showing no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special Populations: Elderly: No dose adjustment required. Renal or hepatic impairment: No dose adjustment required. Paediatric Population: No data available. Overweight patients: No dose adjustment required. CONTRAINDICATIONS: Hypersensitivity to any of the active substances or excipients. Clinically important active infections (e.g. active tuberculosis). SPECIAL WARNINGS AND PRECAUTIONS: See SmPC for full details. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Skyrizi may increase the risk of infections. In patients with a chronic infection or history of recurrent infections, or known risk factors for infection, Skyrizi should be used with caution. Treatment with Skyrizi should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients should be evaluated for tuberculosis infection prior to initiating treatment. Anti-TB therapy should be considered prior to initiating Skyrizi in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Completion of all appropriate immunisations should be considered prior to initiating therapy. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with Skyrizi. Patients treated with Skyrizi should not receive live vaccines during treatment and for at least 21 weeks after treatment. If a serious hypersensivity reaction occurs, administration of Skyrizi should be discontinued immediately and appropriate therapy initiated. Excipients with known effect (75 mg solution for injection only): Skyrizi contains 68.0 mg sorbitol and less than 1 mmol sodium (23 mg) per 150 mg dose. INTERACTIONS: The safety and efficacy of Skyrizi in combination with immunosuppressants, including
biologics or phototherapy have not been evaluated. PREGNANCY AND LACTATION: Women of Childbearing potential: An effective method of contraception during treatment and for at least 21 weeks after treatment should be used. Pregnancy: Limited data available. It is preferable to avoid the use of Skyrizi during pregnancy as a precautionary measure. Lactation: It is not known whether Skyrizi is excreted in breast milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from Skyrizi therapy, taking into account the benefit of breastfeeding to the child and the benefit of Skyrizi therapy to the woman. Fertility: The effect of Skyrizi on human fertility has not been evaluated. ADVERSE REACTIONS: See SmPC for full details on adverse reactions. Very common adverse reactions (≥1/10): Upper respiratory infections. Common adverse reactions (≥1/100 to <1/10): Tinea infections, headache, pruritus, fatigue and injection site reactions.
▼ 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 via HPRA Pharmacovigilance; Website: www.hpra.ie. Suspected adverse events should also be reported to AbbVie Limited on 01-4287900.
LEGAL CLASSIFICATION: POM (S1A). MARKETING AUTHORISATION NUMBERS/PRESENTATIONS:
Skyrizi 75 mg solution for injection in pre-filled syringe (Pack of 2 pre-filled syringes): EU/1/19/1361/001; Skyrizi 150 mg solution for injection in pre-filled pen: EU/1/19/1361/002; Skyrizi 150 mg solution for injection in pre-filled syringe: EU/1/19/1361/003. Not all presentations may be marketed. Further information is available from: AbbVie Ltd., 14 Riverwalk, Citywest Business Campus, Dublin 24. DATE OF REVISION: May 2021 PI/1361/003
HRQoL, Health-Related Quality of Life; PASI, Psoriasis Area Severity Index.
REFERENCES:
When it comes to your patients’ psoriasis treatment goals
There has been a significant decline in problem opioid use among those aged 15to-34 between 2015 and 2019, according to a Health Research Board (HRB) study published recently. Levels of use in the 35-to-64 age group have remained stable. In total, there were an estimated 19,875 problem opioid users aged 15-to-64 living in Ireland in 2019 – almost seven problem opioid users in every 1,000 people.
Opioids, which include heroin, methadone and codeine, are addictive, sedating, narcotic drugs. While some of these drugs have valid medical purposes, their misuse as ‘street drugs’ can lead to many health and social issues.
The typical problem opioid user in Ireland today is male (seven-in-10 of the total), aged between 35 and 64 (seven-in-10 of the total), and lives in Dublin. Dublin counts for by far the highest numbers of
problem opioid users in the country, with almost 13 per 1,000 inhabitants — which is three times the prevalence in the rest of Ireland (nearly four problem opioid users per 1,000 people).
Commenting on the report’s finding about a decline in younger people using opioids, lead author Dr Michael Hanrahan, commissioned by the HRB to conduct this research at University College Cork, said: “The decline in opioid use among young people is a positive development and could be attributed to the negative image of heroin among young people or the provision of prompt treatment that can break a cycle whereby heroin users introduce the drug to others, or a combination of these factors. This finding should also be viewed in light of recent data in the HRB’s National Drug and Alcohol Survey, which found that the use of
stimulant-type drugs such as cocaine and ecstasy has increased among younger age groups since 2014.”
The HRB commissions this type of research on behalf of the Department of Health in line with the current Government strategy ‘Reducing Harm, Supporting Recovery: A health-led response to drug and alcohol use in Ireland 2017-2025’, which Government says aims to develop sound and comprehensive evidenceinformed policies and actions.
HRB Chief Executive Dr Mairead O’Driscoll concluded: “Drug policy can only be effective if we have an accurate picture of the level and nature of drug use within the population. The HRB supports studies like these to enable policy-makers to observe trends, evaluate the effectiveness of interventions and predict where action may be needed in the future.”
Researchers at Queen’s University Belfast have designed a new bandage treatment, known as a scaffold, to treat diabetic foot ulcers (DFUs), which is cost-effective while improving patient outcomes. Produced by 3D bioprinting, the scaffolds slowly release antibiotics over a four-week period to effectively treat the wound.
Diabetes, a life-long condition that causes a person's blood sugar level to become too high, is among the top-10 causes of deaths worldwide.
DFU is a serious complication of diabetes, affecting approximately 25 per cent of diabetic patients. When identified, over 50 per cent are already infected and over 70 per cent of cases result in lower-limb amputation.
The treatment strategy required for the effective healing of DFU is a complex process that requires several combined therapeutic approaches. As a result, there is a significant clinical and economic
burden associated in treating DFU. These treatments are often unsuccessful, which leads to lower-limb amputation.
This new research demonstrates outcomes with significant implications for patient quality of life, as well as decreasing the costs and clinical burden in treating DFU.
Recent research has focused on drugloaded scaffolds to treat DFU. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound-healing.
The research, published in Springer Link, was presented by Prof Dimitrios Lamprou, Professor of Biofabrication and Advanced Manufacturing at Queen's School of Pharmacy and corresponding author, at the Controlled Release Society (CRS) Workshop, Italy, on 7-9 October.
“These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke
infection and delay the healing process,” he commented.
“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound.”
Lead author Ms Katie Glover from the Queen’s School of Pharmacy added: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound. This provides a low-cost alternative to current DFU treatments, which could revolutionise DFU treatment, improving patient outcomes while reducing the economic burden caused by rapidly-increasing patient demand as the number of people with diabetes continues to increase every year.”
*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
*Ryaltris™ is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis1
Ryaltris™ 25 mcg/actuation
Any interactions expected to reflect interaction between in combination.
Please consult the Summary
Mometasone Furoate: Cooutweighs the be monitored. benefit to mother prescribing in lactating
Uncommon: dizziness, nausea, fatigue. Rare: blurred vision, dry oropharyngeal laceration. Frequency hypersensitivity (including cataracts, glaucoma,
One delivered to 25 mcg mometasone olopatadine. White, homogeneous In adults and adolescents severe nasal symptoms associated For nasal use actuations in each nostril required. Children under
Hypersensitivity
Presence of untreated localised simplex. Recent nasal surgery have been reported. Not using Ryaltris™ over several possible changes in the of epistaxis have been reported. topical corticosteroid use.
blurred vision or other visual as central serous chorioretinopathy corticosteroids. Hypersensitivity
Immunosuppression: use tuberculous infections bacterial infections, systemic systemic effects of corticosteroids adrenal suppression, growth and more rarely, a range hyperactivity, sleep disorders, Hypercorticism and adrenal dosages or in susceptible
Increased risk of signs
dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system
systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following administration of Ryaltris™ in clinical studies. Caution in patients operating machinery or driving a motor vehicle. Avoid concurrent use with alcohol or other central nervous system (CNS) depressants. Increased risk of antihistamine adverse effects with concomitant use of olopatadine or other antihistaminic drugs administered via nasal, ocular or oral route. Paediatric population: It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. Contains 0.02 mg benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or
hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Hypercorticism and adrenal suppression may appear at higher than recommended dosages or in susceptible individuals at recommended dosages - discontinue slowly. Increased risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis possible with concomitant use with other inhaled corticosteroids. Careful monitoring needed for acute adrenal insufficiency in response to stress in patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids. In patients with asthma or other conditions requiring long term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of symptoms. Somnolence has been reported following
on request from A. Menarini
2nd Floor, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.
Date of Preparation:
IR-RYL-11-2022 May 2022
HPA axis possible with monitoring needed for previously treated for prolonged topical corticosteroids. In systemic corticosteroid treatment, cause a severe exacerbation administration of Ryaltris™ driving a motor vehicle. Avoid (CNS) depressants. Increased use of olopatadine or other route. Paediatric population: prolonged treatment with benzalkonium chloride in
Support for pharmacists to provide services to people with chronic respiratory diseases — namely asthma and chronic obstructive pulmonary disease — is now available in the form of two new resources published by the International Pharmaceutical Federation (FIP) recently. These are:
Chronic respiratory diseases — A handbook for pharmacists; and
Knowledge and skills reference guide for professional development in chronic respiratory diseases.
The handbook, authored by an international group of experts (including representatives from the International Primary Care Respiratory Group and the European Society of Clinical Pharmacy) and brought together by FIP, includes chapters on prevention and control of chronic respiratory diseases, screening, interprofessional working, non-pharmacological management, pharmacological management (including medicines optimisation), and palliative care.
The new publication also presents metrics for services for chronic respiratory diseases, and barriers to the implementation of these
services, and explores both the ethical considerations in disease management and the practice-based research related to this area. The reference guide accompanying the handbook defines the knowledge and skills that pharmacists need to acquire to provide services for chronic respiratory diseases.
“Chronic respiratory diseases impose significant health and economic burdens on individuals, healthcare systems and society overall. As healthcare delivery undergoes a paradigm shift towards a people-centred care
approach to optimising therapy and health outcomes, pharmacists are well-positioned to play a unique and complementary role in an interprofessional collaborative care model to manage chronic respiratory diseases,” said Mr Gonçalo Sousa Pinto, FIP lead for practice development and transformation and editor of the handbook.
In a foreword to the handbook, Ms Siân Williams and Prof Ee Ming Khoo, CEO and President, respectively, of the International Primary Care Respiratory Group, write: “In many countries, particularly in low- and middle-income countries, the only interaction the public has with healthcare is with their pharmacist, and this may include life-saving interventions such as management of acute attacks of chronic respiratory disease and treating tobacco dependence. So it is in everyone’s interest that this interaction is of high quality. . . We urge pharmacists to consider how they can improve their community’s respiratory health, and enhance their engagement, so that we can all live in a world where everyone is breathing and feeling well through universal access to the right care.”
The International Pharmaceutical Federation (FIP) has recently published a new Statement of Policy on continuing professional development (CPD). FIP says it recognises that pharmacists acquiring, developing and maintaining professional competence throughout their careers is a fundamental and ethical requirement, and the statement sets out FIP’s commitments to help them achieve this.
The statement replaces an earlier statement published in 2002. Whereas the 2002 statement defined CPD and continuing education, and made a number of general recommendations, the latest statement greatly expands on this. It contains a number of recommendations specifically for government agencies and policymakers, for FIP member organisations and
national pharmaceutical associations, for CPD providers, for employers and for pharmacists themselves.
It establishes a framework through which obligations set out in other quality assurance-related FIP guidance — including its Statement of Policy on quality assurance of education, its code of ethics for pharmacists, its reference guide on good pharmacy practice and its statement on good pharmacy education practice — can be met.
In the statement, the Federation sets out a number of commitments whereby it agrees to develop strategies which, among others: (i) Highlight the importance of CPD and how it ensures a competent workforce;
(ii) develop indicators to measure the implementation of the workforce element
of FIP Development Goal 9 (CPD strategies); (iii) promote international co-operation to close education and training gaps; and (iv) advocate the development of programmes to support return to work after career breaks or sector changes.
“As pharmacists’ roles continue to expand, it is essential that they commit to lifelong learning and that they maintain and develop competence relevant to current and future levels of professional practice,” said Prof Rula Darwish, chair of FIP’s CPD Policy Committee. She added: “As well as demonstrating pharmacists’ commitment, participation in CPD enhances the profession’s reputation and, ultimately, improves patient care. FIP’s new CPD statement provides a foundation upon which this can be built.”
Researchers at Lero, the Science Foundation Ireland Research Centre for Software, are playing a vital role in a €5.9m Europeanwide innovation project developing patientoriented healthcare management for millions of older patients.
Researchers based at University College Dublin and Dublin City University (DCU) will co-design, test and prepare to deploy an innovative, cost-effective, patient-centred holistic health management system, known as GERONE, funded by the European Union’s Horizon 2020 research and innovation programme.
DCU’s Prof Regina Connolly said the five-year project aims to improve quality of life — defined as wellbeing on three levels, global health status, physical functioning, and social functioning — for older patients with cancer and other diseases, while reducing the overall costs of care.
“An ageing population has resulted in
growing numbers of complex multimorbid chronic patients who require medical support. Therefore, modern medicine requires a novel, patient-centred attitude for more effective treatment options, lower costs and better decision-making.
“The goal is for specific recommendations to implement the proposed patient-centred intervention, which will be rolled-out in Ireland on the completion of the programme,” she added.
DCU’s Prof Anthony Staines said the standard of care is patient-centred integrated care, and GERONTE will provide invaluable information on how to do this and make it work.
“We need to learn how to bring in and change care pathways, and how to use technology to support these pathways of care for patients with complex needs,” he added.
The GERONTE multimorbid patient-
centred system to be co-designed with patients, informal caregivers and health professionals proposes the following:
Co-ordination of management by a patient-tailored, interdisciplinary health professional consortium (HPC), including hospital and home-based professionals, with a case manager.
Timely registration of symptoms and patient-reported outcomes at home through a web-based app for the anticipation of avoidable adverse events.
Proposal of self-management guidelines according to intrinsic capacity evaluation by geriatricians for patient-driven improvement of independent living.
A structured collection of data from electronic health records into a dashboard made available to a HPC, patients and caregivers, thanks to its capacity to securely interoperate with all electronic health records, including software managing medical data.
Transformation of pharmaceutical education, which includes expansion of the number of pharmaceutical education institutions globally and a large shift to online learning, is one of several major current trends in pharmacy identified by the International Pharmaceutical Federation (FIP) Board of Pharmaceutical Practice. The findings are presented in the board’s ‘Trend analysis report amid the Covid-19 pandemic, 2021–2022’, which was published recently.
The report contains directions identified by each of FIP’s sections, covering academic pharmacy, clinical biology, health and medicines information, community pharmacy, hospital pharmacy, industrial pharmacy, military and emergency pharmacy, and social and administrative pharmacy. For example, FIP’s Community Pharmacy Section reports that the role and
recognition of community pharmacy as a readily-accessible healthcare resource and trusted information centre is increasing.
It also reports that a previously identified trend of integration of the sector within large healthcare corporations appears to have halted during the pandemic. Another trend described in the report is increased government funding for pharmaceutical research (particularly pandemic-related), highlighted by FIP’s Academic Pharmacy Section. However, the section also warns of reduced funding for chronic diseases as a negative consequence.
The changes identified have been classed into six major trend groupings as follows:
Transformation in pharmaceutical education;
Expanding scope of practice;
Pandemic and natural disaster preparation;
Cultural and environmental concerns;
Increased investment in data systems and automation; and
Economic and distribution concerns.
“FIP’s most valuable asset is its people: The network of pharmaceutical healthcare experts it brings together. Through their commitment and practice, they combine knowledge and adaptability so our profession can navigate the challenges of the present and future, to better serve our communities and healthcare systems. This report, offering insight into each sector of pharmacy practice, can be used as a strategic tool in planning for the developments ahead that will impact on how we work as the world emerges from the Covid-19 pandemic,” said Mr Daragh Connolly, chair, FIP Board of Pharmaceutical Practice.
ABBREVIATED PRESCRIBING INFORMATION
Product Name: Brupro for Children 100mg/5ml Oral Suspension & Brupro for Children Six Plus 200mg/5ml oral suspension.
Composition: Each 5 ml of oral suspension contains 100 mg or 200 mg ibuprofen respectively.
Description: White or almost white suspension, homogeneous after agitation
Indication(s): 100 mg/5 ml: Reduction of fever and relief of mild to moderate pain, such as cold and flu symptoms, teething pain, headache, sprains and strains and to ease the pain of sore throats and earache. For short term use only. 200 mg/5 ml: For the short-term symptomatic treatment of mild to moderate pain. For the short-term symptomatic treatment of fever.
Dosage: Infants aged 3-6 months who weigh more than 5kg. Do not dose more frequently than at 6 hourly intervals and do not exceed the recommended dose. For infants aged 3-5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist and no later than 3 days in children aged from 6 months and in adolescents. Recommended time interval is 3 times in 24 hours: 100 mg/5 ml: 3-12 months (5-9 kg bodyweight): 2.5 ml; 1 to 3 years (10-16 kg): 5 ml; 4 to 6 years (17-20 kg): 7.5 ml; 7 to 9 years (21-30 kg): 10 ml (two 5ml spoonfuls); 10 to 12 years (31-40 kg): 15 ml (three 5ml spoonfuls). 200 mg/5 ml: Not for use in children under 6 years of age or under 20 kg body weight. 6-9 years (20-29 kg): 5ml (200 mg); 10-12 years (30-40 kg): 7.5ml (300 mg).
Renal insufficiency: No dose reduction in mild to moderate impairment. Hepatic insufficiency: No dose reduction in mild to moderate impairment.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. In patients: - who have previously shown hypersensitivity (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory (NSAID) medicinal products; with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy; - with active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); - with cerebrovascular or other active bleeding; - with severe hepatic failure or severe renal failure; - with severe heart failure; -with unclarified blood-formation disturbances; -with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). During the last trimester of pregnancy. Warnings and Precautions for Use: Refer to the SPC for detailed warnings. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms and patients should report any unusual symptoms especially any GI bleeding. Elderly: Have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Are at increased risk of the consequences of adverse reactions. Caution in: Systemic lupus erythematosus as well as those with mixed connective tissue disease, due to increased risk of aseptic meningitis; Congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria); Gastrointestinal disorders and chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease). Consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) and also for patients requiring concomitant low dose acetylsalicylic acid, or other drugs likely to increase gastrointestinal risk; A history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy; Renal impairment as renal function may further deteriorate; Hepatic dysfunction; Dehydration; Directly after major surgery; Hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk for them of allergic reactions occurring. These may be present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria; In patients who have already reacted allergically to other substances, as an increased risk of hypersensitivity reactions occurring also exists for them on use of this product; Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. Dermatological effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported. Discontinue Brupro for Children at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. Symptoms of underlying infections and fever can be masked which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. Monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen. Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. It is advisable to avoid use of ibuprofen in case of varicella. Cardiovascular and cerebrovascular effects: Ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Low dose ibuprofen (e.g. ≤ 1200 mg/day) is suggested not to be associated with a small increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided and consider carefully if long term treatment is needed. Other notes: Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. Discontinue treatment immediately and seek medical attention. Ibuprofen may temporarily inhibit the blood-platelet function (thrombocyte aggregation). Monitor patients with coagulation disturbances carefully. Check liver values, kidney function and blood count in prolonged treatment. Be aware of diagnosis of medication overuse headache (MOH), suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Alcohol may increase adverse effects that concern the gastrointestinal tract or the central nervous system. Renal: Habitual use of analgesics, especially the combination of different analgesic drug substances, can lead to lasting renal lesions with the risk of renal failure (analgesic nephropathy). There is a risk of renal impairment in dehydrated children. Contains sorbitol and propylene glycol. Interactions: Refer to the SPC for detailed information on the interactions. Avoid in combination with: Other NSAIDs including cyclooxygenase-2 selective inhibitors; Acetylsalicylic acid; Antihypertensives, (ACE inhibitors, beta-receptor blocking medicines and angiotensin-II antagonists) and diuretics; Cardiac glycosides: e.g. digoxin; Lithium; Potassium sparing diuretics; Phenytoin; Methotrexate; Tacrolimus; Ciclosporin; Corticosteroids; Anti-coagulants; Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs); Mifepristone; Sulphonylureas; Zidovudine; Probenecid and sulfinpyrazone; Baclofen; Ritonavir; Aminoglycosides; Quinolone antibiotics; Cholestyramine; Captopril; CYP2C9 inhibitors: e.g. voriconazole and fluconazole.
Pregnancy and Lactation: Pregnancy: During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Contraindicated during the third trimester of pregnancy. Breast-feeding: Ibuprofen and its metabolites can pass in low concentrations into the breast milk. No harmful effects to infants are known to date, so for short-term treatment with the recommended dose for pain and fever interruption of breast feeding would not generally be necessary. Fertility: There is some evidence that substances which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.
Ability to Drive and Use Machinery: For short-term use this medicinal product, has no or negligible influence on the ability to drive and use machines.
Undesirable Effects: Gastro-intestinal: abdominal pain, nausea and dyspepsia, diarrhoea, flatulence, constipation, heartburn, vomiting and slight gastrointestinal blood losses that may cause anaemia in exceptional cases. Refer to the SPC for other undesirable effects. Marketing Authorisation Holder: Rowa Pharmaceuticals Ltd., Bantry, Co. Cork.
Marketing Authorisation Number: PA0074/067/004-005 Further information and SPC are available from: Rowex Ltd., Bantry, Co. Cork. Freephone: 1800 304 400 Fax: 027 50417
E-mail: rowex@rowa-pharma.ie. Legal Category: Not subject to medical prescription. Date of Preparation: March 2021
Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie) or by emailing Rowex pv@rowa-pharma.ie
Supply status: Supply through pharmacies only
Date of Preparation: 07-22
The head of the Practitioner Health Matters Programme speaks with IP about the trends in its latest annual report
The number of healthcare professionals presenting with stress, anxiety, and burnout has increased by more than one-third, according to the Practitioner Health Matters Programme (PHMP) Annual Report 2021.
The data shows a 36 per cent year-on-year increase in new presentations and a more than doubling of presentations since 2015. Some of the top-line findings include:
106 new presentations to PHMP in 2021 –increased from 78 in 2020.
Issues relating to anxiety, depression, substance use, and burnout feature predominantly in those presenting.
83 per cent of those presenting are doctors, followed by pharmacists (10 per cent), dentists (4 per cent) and students (3 per cent).
Since the PHMP service began in 2015, the programme has supported 454 patients with circa 2,000 consultations.
Dr Íde Delargy, Medical Director, PHMP, spoke with Irish Pharmacist (IP) about the particular challenges being faced by the pharmacy profession. In particular, she was asked about the stress placed on pharmacists during Covid-19, as pharmacies were required to stay open even from the outset of the pandemic, when there was great uncertainty as to the true nature of the virus and its threat to human life.
“Pharmacists really were right at the front line during the whole of Covid, not just in the early stages, but they were vital in the vaccination stage as well,” she said. “They really played a stellar role in combating Covid but of course that takes its toll on individuals, people who may have felt personally anxious about their own health, as well as trying to contribute to the national effort. This is combined with trying to keep their pharmacy open, trying to keep their staff safe — all of those demands were enormous for pharmacists; they were
particularly badly affected by all of this.”
However, Dr Delargy also commented on the overall rates of emotional and psychological issues within the profession. “Despite all this, the overall numbers for pharmacists [presenting to PHMP] is still relatively low,” she told IP. “We recognise the challenges that pharmacists have been under, but we also recognise that there are no doubt many people out there who could have difficulties, and of course we are happy to see them and help them to get through their difficulties.
“So we are trying to get that message out — we know there are others out there who for the moment haven’t come forward to get some support, help and advice, and we would really encourage those people to come forward.”
Dr Delargy has noted in the past that there is a tendency for healthcare professionals to self-diagnose and self-prescribe, and she
has previously emphasised the importance of doctors having their own GP, for example. This advice is transferrable to pharmacists, she pointed out. “It’s almost a professional requirement really that you would have your own medical advisor and seek out that advice when you have difficulties, and that you don’t resort to the self-management and self-medication route, which can lead to a more serious scenario, particularly for some vulnerable individuals,” she commented.
“It’s important to recognise that as professionals, we are no different to anybody else — we are still human beings, we still face the same day-to-day challenges of any person, but married with that are huge responsibilities, because we are there to take care of other people.
“It’s not a source of shame or vulnerability to come forward to us and say, ‘I’m struggling and need a little help’. That can be through your GP, if you are comfortable enough to speak with
them about these matters.”
However, she also acknowledged that there are often perceived barriers to healthcare professionals in asking for such help. “They often feel that they cannot speak to their local GP about such things,” Dr Delargy told IP. “There are lots of reasons for that and we need to combat that, and that’s where our confidential service comes in, that’s where we can deal with issues in a low-threshold but confidential way that can make it more acceptable for somebody with a problem to come forward.”
Pharmacists have faced their own particular issues in recent years, such as fee cuts, increased bureaucratic and administrative workloads, issues around remuneration for services, and staffing and locum issues, and Dr Delargy was asked whether these issues were voiced in their presentations to the PHMP. “These issues are all contributors to a sense of being overwhelmed, of anxiety and stress,” she replied. “Financial pressure, work demands, increasing responsibility, and so on — they are all contributing factors, and I acknowledge that. But it’s never just one thing that people come forward with. They may come into the room and say it’s one particular thing, but usually when we go through the assessment and pare-back the layers, we find it’s usually a combination of things that have come together and broken the person and taken them to a place where they are at the limit of what they can cope with.
“They then need help to de-escalate the situation and reposition their way of thinking and their way of coping,” she continued. “We can help these pharmacists — it can take time, but that’s what we can do with the service we offer.”
The number of new presentations in a calendar year has now more than doubled in the five-year period from 2015 to 2021, according to the figures.
Of those presenting, the predominant issues include anxiety, depression, substance use issues and burnout, with others also citing stress, feelings of being overwhelmed, sleep problems and moral distress.
According to the PHMP, healthcare professionals rarely present with a single issue, but rather a wide range of conditions and concerns. Three out of four new
presentations are aged between 26-to-49 years, with 57 per cent female.
The PHMP continues to support 79 practitioners while they continue to work, 19 practitioners who have returned to work after a period of time off, and eight practitioners who are no longer working but continue to attend.
In response to the growing demand for the programme, the PHMP has introduced two additional services in 2021, including psychoeducation programmes for practitioners suffering from stress and anxiety, and group intervention programmes.
Since the PHMP began in 2015, it has supported 454 patients from the healthcare profession, with almost 2,000 consultations recorded over this period.
Writing in the Annual Report, Dr Delargy explained: “This year, we recorded the biggest increase in new presentations since the PHMP service began, which can be attributed in part to the continued impact of Covid-19 on our healthcare system.
“As a society, we stood behind our healthcare professionals, many of whom worked on the front-line for much of the pandemic. But... whether stress is caused by the uncertainty of the pandemic or the mental and physical strain of a relentless workload, the lasting legacy of Covid-19 will be felt by our doctors, dentists, and pharmacists for a considerable time to come.
“We are seeing more and more clinicians attending the PHMP service with symptoms associated with burnout, anxiety, and depression. Many of these symptoms are leading individuals to misuse substances, whether alcohol, drugs, or both. Others talk about having reached a breaking point where they can no longer see a future in their careers and have no other option but to leave the profession. In the most severe cases, some admitted to suicidal thoughts.
“Happily, however, with the right support and intervention, there can be positive outcomes. Of those we have treated, 92 per cent have continued working when sufficiently recovered having successfully accessed the necessary time, care and support needed to address what are often very complex needs.
"Most importantly, they do so in a strictly
confidential manner with the full support of the relevant professional councils.
“A challenge for us today is ensuring that all doctors, dentists, and pharmacists are aware of our service and how to access the programme before they ever reach crisis point,” she concluded. “While, as practitioners ourselves, we understand the complexities of why a healthcare professional may be reluctant to admit they have a problem, the more public awareness we can create of the supports that are available, the more likely we are to be able to intervene before a problem becomes critical.”
Of those who have presented over this time, more than three-quarters are doctors (79 per cent) followed by pharmacists (10 per cent), dentists (9 per cent) and other (2 per cent).
The majority are aged between 26 and 49 years (74 per cent), and most are female (54 per cent). Of the 358 doctors who have presented, 45 per cent were NCHDs, 29 per cent were GPs and GP trainees, and 23 per cent were consultants.
Prof Frank Murray, Chairperson of PHMP, also commented: “We are only beginning to see the damage caused to the mental health and well-being of doctors, dentists, and pharmacists from Covid-related pressures on the healthcare system and those at its coalface.
“The confidential nature of the PHMP, as well as its independence, goes a long way to providing reassurances to healthcare professionals who need help but for whom normal healthcare pathways may be difficult to engage with.
“Enabling the majority of healthcare professionals who engage with PHMP to return to practice successfully is testament to the quality of care provided by this important service.”
The PHMP was launched in 2015 and provides a confidential service to doctors, dentists and pharmacists who may be experiencing stress, burnout, mental health, or substance use issues. This important service acknowledges that practitioners can often find it difficult to access appropriate and confidential medical help, particularly when it relates to their own health and wellbeing.
For more information, or to make contact with the service, see www.practitionerhealth.ie. l
We now know that e-cigarettes are a gateway to tobacco smoking and due to their growing popularity among young people, risk harming the health of a new generation. It has taken some time to evaluate and build clinical evidence around e-cigarettes — relatively new products, largely owned and marketed by the tobacco industry. But we now can say that children and young adults in particular need to be protected from these products.
Based on current evidence, the packaging, advertising and marketing of e-cigarettes should be restricted in the same way that tobacco products are and only tobacco-flavoured products should be available in Ireland — something which has been successfully implemented in Finland, Hungary and Estonia, with no documented rise in overall smoking rates. This would allow ex-smokers continued access to tobacco-flavoured e-cigarettes and curb their use in adolescents and young adults. A systematic review on the topic found that adolescents who have ever used e-cigarettes are between three and five times more likely to start smoking compared with adolescents who have never used e-cigarettes.
Much has been made of their potential benefits as a tool to help people to stop smoking, but the evidence increasingly does not support this claim.
Current evidence does not support the use of e-cigarettes as a stop-smoking tool. There remain significant concerns regarding their long-term safety, and they have now been proven to be a gateway to tobacco smoking for adolescents. Healthcare professionals should promote safe and effective stop-smoking methods such as varenicline and nicotine replacement therapy (NRT) above unproven methods such as e-cigarettes.
These gateway products now pose a
significant risk that Ireland will fail to achieve its targets under Tobacco Free Ireland, launched in 2013 to reduce the prevalence of tobacco smoking to 5 per cent by 2025. Almost 10 years later, according to the most recent Healthy Ireland survey (2021), 18 per cent of the Irish adult population still smokes. Despite tobacco smoking rates gradually declining over time, this figure has increased by 1 per cent since 2020. So, not only are we currently far off the target of 5 per cent, our progress with helping people to quit smoking has stalled. We need to adopt a more ambitious approach to tobacco control in Ireland. While e-cigarettes have emerged as a tool to support smokers to quit and reduce the risks of harmful tobacco use, little is known about their long-term health effects and recent studies have found significant evidence of people using e-cigarettes together with tobacco.
Several reviews have been published comparing e-cigarettes with other tobacco cessation therapies. The reviews found very low evidence supporting the use of e-cigarettes as a quitting tool (‘Efficacy of electronic cigarettes for
smoking cessation: A systematic review and meta-analysis’, AmericanJournalofHealth Promotion, 2020) and identified an increased risk of relapse to tobacco smoking among e-cigarette users (‘Risk of smoking relapse with the use of electronic cigarettes: A systematic review with meta-analysis of longitudinal studies’, Tobacco Prevention & Cessation, 2021).
A Health Research Board (HRB) review and analysis, published in 2020, concluded that e-cigarettes were no more effective than approved and regulated NRTs (‘Electronic cigarettes and smoking cessation: An evidence review’).
In contrast to the HRB report, a Cochrane review published in 2021 found that there is moderate-certainty evidence that e-cigarettes increase quit rates compared with NRT (‘Electronic cigarettes for smoking cessation (Review)’).
The different conclusions reached by the HRB, and the Cochrane review, are due to several factors. Firstly, the HRB used a more robust form of meta-analysis and included a greater number of studies, thus presenting a fuller picture of the evidence for clinicians. Also, the HRB were independent of the primary studies in the systematic review. This was not the case in the Cochrane review.
In January, Ireland’s first national stop smoking guideline was published, with no recommendation in relation to e-cigarettes as a stop-smoking tool due to insufficient evidence and substantial uncertainties with these products. At present, there is not enough evidence to support the use of e-cigarettes as a smoking cessation tool.
What about the harm reduction argument? Is it better for smokers who have attempted
*To verify contact: verify@perrigo.com. Based on IQVIA sales data.
Nytol One-A-Night 50 mg Tablets contains diphenhydramine hydrochloride. A symptomatic aid to the relief of temporary sleep disturbance in adults. Adults: One tablet to be taken 20 minutes before going to bed, or as directed by a physician. Do not exceed the maximum dose of one tablet in 24 hours. Elderly patients or patients with liver or kidney problems should consult their doctor before taking this medicine. Children under 18 years: Should not be used. The product should not be taken for more than 7 days without consulting a doctor. Contraindications: hypersensitivity to the active substance or to any of the excipients, stenosing peptic ulcer, pyloroduodenal obstruction, phaeochromocytoma, known acquired or congenital QT interval prolongation, known risk factors for QT interval prolongation. Special warnings and precautions: Seek medical advice during pregnancy/lactation or patients with renal and hepatic impairment. Use with caution in patients with myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis, COPD. Patients should be advised to promptly report any cardiac symptoms. Tolerance and / or dependence may develop with continuous use. Do not take for more than 7 consecutive nights without consulting a doctor. Should not be used in patients currently receiving MAO inhibitors (MAOI) or patients who have received treatment with MAOIs within the last two weeks. Use in the elderly should be avoided. Avoid concomitant use of alcohol or other antihistamine-containing preparations. Do not drive or operate machines. Cases of abuse and dependence were reported in adolescents or young adults for recreational use and/or in patients with psychiatric disorders and/or history of abuse disorders. Contains lactose. Interactions: May potentiate effects of; alcohol, CNS depressants, MAO inhibitors, anticholinergic drugs (e.g. atropine, tricyclic antidepressants), metoprolol and venlafaxine, CYP2D6 inhibitors, Class Ia and Class III anti-arrhythmics. Side effects: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness, thrombocytopenia, hypersensitivity reactions, confusion, paradoxical excitation, convulsions, headache, paraesthesia, dyskinesias, blurred vision, tachycardia, palpitations, thickening of bronchial secretions, dry mouth, gastrointestinal disturbance, muscle twitching, urinary difficulty, urinary retention, fatigue. Legal category: Supply through pharmacy only. [P] PA1186/016/001 MAH: Chefaro Ireland DAC. The Sharp Building. Hogan Place. Dublin 2. Ireland. Additional information available on request. Revision date: 06/2021. SPC: https://www.medicines.ie/medicines/nytol-one-a-night-50-mg-tablets-34889/spc IRE NYT 2021
and failed numerous quit attempts to switch to e-cigarettes? Research studies examining the harms and benefits of e-cigarettes have identified negative cardiovascular and respiratory effects.
Studies have found that e-cigarettes increase the long-term risk for coronary events (‘Cardiovascular effects of electronic cigarettes: A systematic review and metaanalysis’, European Journal of Preventative Cardiology, 2019).
The European Commission Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) report, in 2021, concluded that the risk of long-term systematic effects on the cardiovascular system is moderate.
Although there is little evidence of the risk of increasing the risk of cancer with e-cigarettes, there is mounting evidence that they have negative health effects on the respiratory system (‘E-cigarettes and respiratory health: The latest evidence’, The Journal of Physiology, 2020). For example, some found that adolescent e-cigarette users were at a higher risk of having asthma compared with non-users (‘Association between e-cigarettes and asthma in adolescents: A systematic review and meta-analysis’, American Journal of Preventative Medicine, 2022).
Some studies have reported a decrease in disease burden in adults with asthma or chronic obstructive pulmonary disease, (‘Overview of electronic nicotine delivery systems: A systematic review, AmericanJournal of Preventative Medicine, 2017), which does indicate that e-cigarettes are less harmful than tobacco products in severe cases. Pro-vaping lobbyists often cite the statistic that e-cigarettes are 95 per cent safer than tobacco products. However, the statement was derived from the opinions of 12 physicians (some of who had links to the e-cigarette industry) back in 2014, when we knew little about the harmful effects of e-cigarettes. Public Health England went on to mistakenly endorse this factoid in 2015 and it has now become the calling card for many provaping campaigners.
While it is important to acknowledge that e-cigarettes are less harmful than tobacco products, they are not harmless and the public needs to be aware of this fact. E-cigarettes contain varying combinations
and concentrations of compounds and flavours which are being vaporised at different temperatures via different devices, with unknown long-term effects.
A number of international bodies, including the World Health Organisation (WHO) and international respiratory societies, have all concluded that e-cigarettes should not be recommended as a safe and effective smoking cessation tool. As healthcare professionals, we should be recommending tried and trusted therapies to our patients as a first-line quitting tool until we learn more about the long-term effects of e-cigarettes.
of age, the committee recommended a ban on the sale of all flavours except tobacco flavours, the introduction of plain packaging, and the prohibition of all forms of advertising for e-cigarettes. These measures are undoubtedly geared towards addressing the problem of e-cigarettes and adolescent use.
The findings from the European Schools Project on Alcohol and other Drugs (ESPAD) reported a 50 per cent rise in e-cigarette use in adolescents aged 16-to-17 years, since the previous study in 2015. Nearly four-in-10 (39 per cent) adolescents have tried them and one-infive (18 per cent) were found to be current users. The recently-published ASH UK survey on vaping in adolescents found that the percentage of 11- to 17-year-olds surveyed who ever tried an e-cigarette rose from 11.2 per cent in 2021 to 15.7 per cent in 2022. Worryingly, this rise in e-cigarette use coincided with a significant rise in the use of disposable vape products among adolescents. The report found a seven-fold increase in the use of disposable vapes in this age group between 2020 and 2022. Almost half of the adolescents surveyed who reported seeing e-cigarettes being promoted saw them on TikTok. This is a targeted marketing strategy to initiate adolescents and young adults to e-cigarette products. The tactics are straight out of the ‘Big Tobacco’ playbook and it is no surprise to learn that most of the major tobacco manufacturers have invested heavily in e-cigarette companies over recent years.
The other major problem with switching from tobacco products to e-cigarettes is that as many as 40 per cent of e-cigarette users continue to smoke, which negates any benefits that smokers would get from switching to e-cigarettes, putting the nail in the harm reduction argument for e-cigarettes. For e-cigarettes to be a viable option in the harm reduction strategy, they would have to demonstrate that they are safe products which help people quit smoking and are regulated by the HPRA.
Recently, the Oireachtas Health Committee published its report on the Public Health (Tobacco and Inhaled Nicotine Products) Bill. In addition to recommending a ban on the sale of e-cigarettes to children under 18 years
New Zealand is about to bring into law the most ambitious tobacco control legislation to date and Ireland should follow suit. The three-pronged 'tobacco endgame' strategy involves banning the sale of tobacco products to anyone born after 2009, decreasing the nicotine content in tobacco products, and reducing the number of retail premises that can sell tobacco products. Recent modelling data from New Zealand demonstrates that once the legislation passes in law later this year as planned, tobacco prevalence will fall below 5 per cent by 2025. There is substantial evidence that increasing the legal age on the sale of tobacco to 21 alone will result in decreased smoking rates in adolescents and young adults and the RCPI policy group on tobacco will continue to advocate for this important policy change. l
As healthcare professionals, we should be recommending tried and trusted therapies to our patients as a first-line quitting tool until we learn more about the long-term effects of e-cigarettes
Product Information: Please consult the Summary of Product Characteristics for full product information. Nexium Control 20 mg gastro resistant tablets and hard capsules (esomeprazole). Indications: The short term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults. Dosage: The recommended dose is 20 mg esomeprazole (one tablet or capsule) per day. Tablets or capsules may need to be taken for 2-3 consecutive days to achieve symptom improvement. Maximum treatment duration: up to 2 weeks. Contraindications: Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients. Esomeprazole must not be used concomitantly with nelfinavir. Precautions: Refer to doctor if patient has: Jaundice or severe liver disease, unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded as treatment with esomeprazole may alleviate symptoms and delay diagnosis, gastric ulcer or gastrointestinal surgery, continuous treatment of indigestion or heartburn for 4 or more weeks, or is over 55 years old with new or recently changed symptoms. Not suitable for long term use. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium di cile Consult doctor prior to have an endoscopy or urea breath test. Co administration with atazanavir is not recommended. Interactions with medicinal products metabolised through CYP2C19 should be considered. The use of esomeprazole with clopidogrel should be discouraged. Patients should not take another PPI or H2 antagonist concomitantly. PPI are associated with very infrequent cases of SCLE. If lesions occur, especially in sunexposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly. Side e ects: Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/ vomiting, fundic gland polyps (benign). Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritus, rash urticaria. For rare, very rare and other side e ects please refer to the SPC for full information. Legal category: Supply through pharmacy only. Product licence number: EU/1/13/860/001; EU/1/13/860/002; EU/1/13/860/003; EU/1/13/860/004 and EU/1/13/860/005. MAH: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, County Waterford, Ireland. Additional information is available upon request. Text prepared: June 2022. Contains esomeprazole. Always read the label/leaflet.
or
Treating the symptoms of irritable bowel syndrome (IBS) has been a clinical conundrum for many years, as the condition affects different individuals in a variety of ways. The explosion in research into gut microbiota in recent years has led to a number of innovations, and most recently, there has been a significant addition to the armament of pharmacists treating their patients for IBS.
To coincide with World Microbiome Day in June, it was announced that Symprove Ireland, a brand new distribution company in Ireland, will offer a new lease of life to IBS sufferers in the form of Symprove, a product with unique efficacy and potential indications for other conditions, including Parkinson’s disease. Symprove has been scientifically demonstrated to improve the amount of ‘good’ bacteria in the gut microbiome to support it, effectively rebalancing the microbiome. This has led to an improvement in the symptoms of bowel conditions such as IBS, and a study published recently in the InternationalJournal of Pharmaceutics also showed that Symprove altered the composition of the gut microbiome in Parkinson’s disease patients. Further studies are ongoing to elucidate the benefits of Symprove for these patients and explore the extent to which Symprove can help to improve the quality of life for patients with diseases other than IBS, with the results expected to be released later this year.
Meaghers Pharmacy Group was the first stockist of Symprove in 2014 and now Meaghers owner and Managing Director, Ms Oonagh
O’Hagan MPSI, has launched Symprove Ireland, a brand new distribution company that will make it available to Irish patients through their trusted pharmacist and health food stores.
Speaking with Irish Pharmacist (IP), Ms O’Hagan explained that the product has been helping to change the lives of IBS patients in the UK for a number of years. Herself an IBS sufferer, Ms O’Hagan explained that the dramatic improvements she experienced with Symprove
inspired her to set up the company. She also saw first-hand how the product was changing the lives of her IBS patients in Meaghers Pharmacies, with demand for the product rising exponentially.
“It really has been a journey of discovery,” Ms O’Hagan told IP. “I suffered with the symptoms of IBS for years and it would flare-up if I was stressed, or if there was exam pressure, for example, with a lot of bloating, cramps and significant pains, as well as alternating constipation and diarrhoea, it was very debilitating and it got so bad that I had numerous surgeries to remove recurrent piles as a result of my symptoms but with little effect.” She explained that after discussing her condition with her gastroenterologist, she subsequently began to study evidence, emerging initially from the US, to show a strong link between IBS and the gut microbiome. “I tried every probiotic product that was on the market at the time, and none of them worked.” She also pointed out that restrictive elimination diets designed to alleviate the symptoms of IBS can leave the sufferer with a diet that is so bland and that does not provide sufficient nutrition.
She eventually discovered and researched Symprove, which was developed in the UK, and a subsequent study by a team of gastroenterologists in University College London showed that Symprove was the only gut supplement out of seven other comparators to contain bacteria that survived the acidic environment of the stomach, allowing it to arrive and thrive in the gut. “Within six weeks, I was like a new woman — no symptoms whatsoever, and for the first time in my life, I didn’t need to take medication for cramps or laxatives to have a normal bowel motion,” she continued.
SKIN
Ms O’Hagan then developed a partnership
with the UK manufacturer to allow Meaghers pharmacies to stock Symprove, and “it has completely changed the lives of many of our patients with IBS,” she said. “As the product has grown and developed, what we find is that people who have IBS and may have other coexisting conditions, who are taking the product, have reported symptom improvement in those other conditions. A good example of this is with skin conditions,” she continued. “People with IBS may also have psoriasis or rosacea — they report symptom improvement and because the conditions are so visible, the improvements are so obvious.”
There are currently three ongoing studies examining the effects of Symprove specifically on Parkinson’s patients, which are being conducted in King’s College London and Sheffield Hallam University. Symprove’s efficacy has peaked the interest of top neurologists for its potential to improve a range of other conditions. Results from the Parkinson’s trials are expected by year-end 2022, she explained, and it is a super-exciting area of research undertaken by some of the world’s leading neurologists.
“We have set up a distribution company called Symprove Ireland to help get the message out there,” she concluded. “We are selecting committed partners who are passionate about gut health and can articulate this message with the clinical evidence. We will train our partners to the level of information that we have ourselves in Meaghers, because we have been involved with Symprove for nearly 10 years. We are also working to educate other healthcare professionals — many gastroenterologists are already aware of this product from discussions with their UK and Irish peers, and from the clinical trials.
“We are committed to making a lasting difference on more people’s health and wellbeing through education on the importance of good gut health. I am a firm believer that good gut health supports your overall health.”
To find out more about Symprove Ireland, please contact accounts@smyproveireland.ie l
A clinically-proven product is set to change the lives of IBS patients in Ireland. The owner and MD of Meaghers Pharmacy Group, Oonagh O’Hagan MPSI, speaks with IP about its benefits for IBS and other conditionsMs Oonagh O’Hagan MPSI
The recent Prime Time episode broadcast on RTÉ dealing with the topic of codeine overuse made for uncomfortable viewing at times from a pharmacist point of view. As professional healthcare providers, we don’t want to end up in the situation where we are facilitating the supply of codeine-containing products to people with an addiction problem, but the current guidelines are not a serious barrier to such people if they’re willing and able to travel to multiple pharmacies. For instance, the lady who was interviewed for the programme who used to bring period products to the counter when buying codeine products had worked out a solid strategy. As long as she didn’t hit the same pharmacy too often in a short space of time, then she could plausibly answer all relevant questions, and the sale would seem like a reasonable course of action.
Trying to help people who are dependent on codeine to the extent that they’re touring pharmacies is no mean feat, and anybody purporting to have easy answers probably doesn’t fully understand the problem. If all the relevant OTC products were made prescription-only, that would be fine by me in terms of providing clarity. Instead of going through the current charade and trying to guess if the
person has a dependency problem, the most important question would be, ‘Do you have a prescription?’ However, the person will simply find a GP willing to write a prescription for 180 (or 240) tablets a month and continue to use them excessively. Any shortfall in availability between prescriptions will end up being sourced illegally.
that GPs are already swamped, so there’s no guarantee that they’ll have the time to help the situation, but there’s at least some hope.
The main benefit of a prescriptiononly requirement would be to create a barrier to codeine use that would hopefully cut down on the number of people who end up with a dependency. A similar result could be possible using a ‘codeine register’ linked to a central database of people purchasing codeine-containing products. Granted, pharmacists need yet another scheme like we need a hole in the head, but the sensible thing to do would be to slap an extra couple of euro onto each sale to fund the workload. The extra cost would act as a further deterrent and nudge people to safer alternatives. There’s no perfect solution to the problem, but I’m open to any practical suggestions.
In the absence of adequate addiction counselling, nothing will really change. The sad reality is that many of the people heavily dependent on codeine are a lost cause. However, there is a tier of people who stay at the limit of six-to-eight tablets a day, but use them every single day; and a prescription requirement would at least compel them to discuss the issue with a doctor. Of course, another sad reality is
I know it’s not perfect, and that it’s not proper e-prescribing, but I’m generally a fan of Healthmail. Used properly by doctors, it can improve their ability to provide care to their patients, with reduced travel, less crowded waiting rooms, and a convenient communication channel between pharmacist and prescriber. However, despite over two years of getting to grips with it, I still haven’t fully worked out the best way to
Trying to help people who are dependent on codeine to the extent that they’re touring pharmacies is no mean feat
There's no quick fix to codeine addiction and pharmacy-hopping behaviours but the phenomenon does require solutions and creative thinking, writes Fintan Moore
decipher what a person at the counter means when they say they’re in to ‘pick up a prescription that was ordered for Joe Bloggs’. In the early days, this phrase would automatically lead to a rummage through all the bags of prepared prescriptions looking for the one for Joe Bloggs. When that failed, I’d go the computer to see if that could shed some light. Then, with nothing becoming any clearer, I’d ask the patient when they had ordered the prescription, to be told ‘I rang the doctor and he said he’d send it over’. Lightbulb moment, and a clarifying question, ‘so you’ve just ordered it from the doctor, but you haven’t asked for it to be made up?’ Pause while they digest the question and reply, ‘that’s right’. As time went by, I started getting much quicker
to introduce that question, and it’s saved a lot of time.
The other Healthmail issue, and the single greatest time-waster, is the failure of GPs to send prescriptions when they’re supposed to, leading to the sequence of: ‘I’m in to pick up the prescription for Jane Doe. The doctor sent it over.’ Check healthmails – no prescription. Tell patient.
‘I was talking to him this morning. He said he was doing it right away.’ Check again. Definitely nothing. Tell patient.
‘They charged me €30. I‘ve got the receipt on my phone.’
Tell them again that it hasn’t arrived.
‘It should be here. Can you ring them?’
Tell them we’ve the same phone number that they have, so we will not ring because we won’t get through any faster than they can.
Eventually the patient leaves, but calls back, or phones us every hour until the prescription arrives or we close for the day. Rinse and repeat. l
Fintan Moore graduated as a pharmacist in 1990 from TCD and currently runs a pharmacy in Clondalkin. His email address is: greenparkpharmacy@ gmail.com.
5-8
Use
IMPORTANT NOTICE: Breastfeeding is best. Neocate Syneo is a food for special medical purposes for the dietary management of Cow’s Milk Allergy, Multiple Food Protein Allergies and other conditions where an amino acid based formula is recommended. It should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Suitable for use as the sole source of nutrition for infants under one year of age. Refer to label for details.
1. Burks AW et al. Pediatr Allergy Immunol. 2015 Mar 31; 26(4):316–322. 2. Candy DCA, et al. Pediatr Res. 2018 Dec 6; 83(3):677-686. 3. Fox A.T, et al. Clin. Transl. Allergy. 2019 Jan15; 9.5 4. Chatchatee P, et al. J Allergy Clin Immunol. 2021 Jul 2; S0091-6749(21)01053-8. 5. Martin R et al. Benef Microbes. 2010. 1(4):367–82.
6. Wopereis H et al. Pediatr Allergy Immunol. 2014. 25:428–38. 7. West CE et al. J Allergy Clin Immunol. 135(1):3–13. 8. Walker WA et al. Pediatr Res. 2015. 77(1):220–228.
9. Sorensen K, et al. Nutrients. 2021 Mar 14; 13(3):935. 10. Sorensen K, et al. Nutrients. 2021 Jun 27; 13(7):2205. ± Exploratory outcomes from randomised control trials, Neocate Syneo vs Neocate LCP; † Systematic review of 4 randomised controlled trials, Neocate Syneo vs Neocate LCP. ¥ UK Observational study of real world evidence in THIN GP database, Neocate Syneo vs Alfamino, Feb 2021 (Alfamino is not currently GMS listed in ROI); ^ Clinical journey: asymptomatic and not requiring hypoallergenic formula prescription for at least 3 months. § Product can be provided to patients upon the request of a healthcare professional. They are intended for the purpose of professional evaluation only.
Nutricia Ireland, Block 1 Deansgrange Business Park, Deansgrange, Co. Dublin. Date of publication: 02/2022
Vaccine season again. Community pharmacists in Ireland have been commissioned to provide seasonal flu vaccines and booster Covid-19 vaccines this autumn and winter. The cohort we are targeting is patients over 50 years. In addition to being an important service for the pharmacy network, it is also an important income stream. We were all convinced by the miracle that was the Covid-19 vaccine programme but, as we jab patients for the fifth time with a vaccine that has had little modification since introduced in December 2020, perhaps we need a critical assessment of real-world safety and efficacy data. So, I thought to myself, are there any emerging concerns beyond those of the lunatic fringe of anti-vaxxers? This is what I found. I never met Dr Kailash Chand, but I knew of him as Deputy Chair of BMA and a staunch and vocal supporter of the NHS. He died suddenly in July 2021 following an unexpected heart attack. He was in his early 70s and apparently in good health. Indeed his son, Dr Aseem Malhotra, a well-known cardiologist and evidence-based medicine expert, had assessed his father’s cardiac status a few months before and found excellent coronary blood supply. For Aseem, a fatal heart attack only a few months after a clean bill of health was a puzzle. This was a puzzle Aseem decided to address and in September 2022, he published a paper in the Journal of Insulin Resistance in which he suggested that the safely of the Pfizer Covid-19 vaccine needed to be more critically assessed and in particular, its potential role in cardiac side-effects and
possible deaths. He wondered if his father’s sudden CHD death might be linked to the two Pfizer vaccines he received Spring 2021. My interest in Aseem’s paper was piqued by an identical personal experience, yet I had never considered any role for the vaccine in my heart attack. I had a stent so, unlike Dr Chand, had existing heart disease but my stent was stable until the early summer of 2021, at which time I too had got two Pfizer vaccines, one in January and one in March.
cent risk of an event in the next five years, to a 25 per cent risk, mainly due to an increase in inflammatory markers associated with an increased CHD risk.
In the pivotal Pfizer study on its mRNA vaccine, in data on which an Emergency Use Licence was based, there were four cardiac events in the vaccine group compared to one in the control group. Small and statistically insignificant, but nonetheless a signal, and there is now evidence that serious ADRs were under-reported by study participants. Myocarditis was the most common side-effect noted, mostly in young adults, with relatively high rates identified in Israel and Hong Kong in independent studies. There is now an established causal link between mRNA vaccines and myocarditis.
When I had a heart attack in September 2021, it was six months from my last vaccine, just like Dr Chand. My heart attack was due to a failure in the existing stent, which effectively clotted up. This is a very rare event. There was no progression of arterial disease in other regions of my coronary arteries.
Aseem’s paper postulated a link between the Pfizer vaccine and an increased risk of CHD. A paper he cites, published in November 2021, showed that in a cohort of 500 CHD patients, their CHD risk doubled from 11 per
In the UK, the MHRA Yellow Card scheme that is used to monitor safety post-licensing had 500,000 adverse events reports from 150,000 individuals. MHRA do not distinguish between serious and non-serious Yellow Card reports but Norway does, and their data shows that one-in-1,000 patients after two Pfizer vaccine doses was hospitalised or had life-changing issues.
A paper in Nature revealed a 25 per cent increase in both acute coronary syndrome and cardiac arrest in young people and linked these to the administration of the first and second doses of the Pfizer vaccine. The mRNA technology to produce the Covid-19 vaccine is new and very different to traditional vaccine technology, so it cannot be taken at face value as safe. In this technology, also used by Moderna, mRNA is inserted into cells to manufacture proteins on the cell surface that
We can ask objective scientific questions about the safety and efficacy of the Covid-19 vaccines and potential side-effects without being 'anti-vaxxers', writes Terry Maguire
So, I thought to myself, are there any emerging concerns beyond those of the lunatic fringe of anti-vaxxers?
mimics the spike proteins on the SARs-CoV-2 virus. This activates and stimulates an immune response that provides immunity.
To many, Aseem Malhotra may just seem to be an over-zealous son doing what he can to understand the tragic loss of his father and to some extent, he may feel guilty he didn’t do more. My similar experience, again only an anecdotal report, certainly on its own proves nothing; no association and certainly no proof of causality. However, and completely independently, there is now concern that we are experiencing a persistent and sustained increase in excess deaths across the globe and these excess deaths have been happening since April 2022, and are certainly not a statistical blip but indicate a real phenomenon that needs explanation.
More importantly, these additional deaths are not due directly to Covid-19 infection. These are unexpected deaths occurring in younger-than-expected age groups. For Spain, Greece and Cyprus, these excess deaths — more deaths than would be expected taking into account the five-year average — were 37 per cent, 31 per cent and 35 per cent, respectively, across the summer months.
In the UK, the figure was 16 per cent and in Ireland, the rate is more than 15 per cent. These are big numbers of people dying that otherwise we would not expect to die.
A number of possible reasons are actively being investigated. They might relate to the impact of post-Covid complications. We know that about 10-to-20 per cent of those who contract the virus suffer from long-Covid, with specific impact on the respiratory system and the CNS. There is also the impact of lockdown, which includes less access to healthcare and delayed diagnosis, which potentially could cause additional deaths. And of course Europe had a significant heatwave in the summer of 2022 that we know increases the death rate. Yet if we look at the causes of deaths, we find that cardiac events are by far the most frequently-cited reason.
Aseem Malhotra’s main point is that to even suggest a link between CHD deaths and the mRNA vaccine is considered bordering on the criminal. Such has been the caution around making false statements about the vaccines that any dissent is viewed as being 'antivaccination'. He rightly points out that critical
appraisal of safety data on mRNA vaccines, was seen, and still can be seen, not as it should be, an essential part of the scientific process, but as anti-vaxxer sentiment that will only serve to support the crackpots who are hell bent on stopping any form of vaccination. I will continue to support the vaccination programme for Covid-19, but I find I am being biased by one paper and conflating it with reports of excess deaths. Yet, given the current prevalence of less dangerous strains of the virus, vaccines may only have more benefits than risks in older patients. With the booster vaccination cohorts targeted this winter, perhaps Government advisers are also seeing this. l
Terry Maguire owns two pharmacies in Belfast. He is an honorary senior lecturer at the School of Pharmacy, Queen’s University Belfast. His research interests include the contribution of community pharmacy to improving public health.
*To verify contact verify@perrigo.com
Solpa-Extra 500mg/65mg Soluble Tablets contain paracetamol and caffeine. For the treatment of mild to moderate pain. Adults and children over 16 years: 1-2 tablets dissolved in water every 4-6 hours. Max 8 tablets a day. Children 12-15 years: 1 tablet disolved in water every 4-6 hours. Max 4 tablets a day. Not suitable for children under 12 years. Contraindications: Hypersensitivity to the ingredients. Precautions: Particular caution needed under certain circumstances, such as renal or hepatic impairment, chronic alcoholism and malnutrition or dehydration. Precautions needed in asthmatic patients sensitive to acetylsalicylic acid, patients on a controlled sodium diet and with rare hereditary problems of fructose intolerance. Patients should be advised not to take other paracetamol containing products concurrently. Pregnancy and lactation: Not recommended during pregnancy and breastfeeding. Side effects: Rare: allergies. Very rare: thrombocytopenia, anaphylaxis, bronchospasm, hepatic dysfunction, cutaneous hypersentitivity reactions. Unknown: nervousness, dizziness. Further information is available in the SmPC. PA 1186/017/001. P. MAH
Dr Des Corrigan reviews the findings of a HSE report on the residual contents of
August saw the publication by the HSE of a report on a collaborative project between the National Drug Treatment Centre and Merchants Quay Ireland (MQI) that analysed the residual contents of syringes returned to the needle exchanges run by MQI. While the analysis confirmed the presence of heroin in most of the syringes, it also revealed worrying evidence of the injection of other drugs, notably cocaine, methamphetamine and a new psychostimulant 3-MethylCathinone (3-MMC).
This pilot-scale study aimed to gain insights into the injection of stimulants and 'New Psychoactive Substances', particularly because of HIV outbreaks linked to various cathinones, collectively called 'Snow Blow' and also the emergence of new drug-using groups through the 'chemsex' scene. It is part of the ESCAPE Project (European Syringe Collection and Analysis Project Enterprise) linked to the EU’s Drugs Agency. The syringes were collected from locations in Dublin, Longford and Offaly. Because of the small numbers, the results for the two rural centres were aggregated under the heading 'Midlands region'. The syringe contents were analysed for 232 different drugs and metabolites — 32 different drugs were detected and many syringes had residues of several different drugs indicating high levels of polydrug use.
Not surprisingly, 93 per cent of the Dublin and 98 per cent of the Midlands syringes were
positive for heroin. Methadone was detected in 62 per cent of the Dublin and 51 per cent of the Midland syringes, suggesting that the study sample involved those engaged in opioid treatment services or accessing diverted methadone. The presence of blood and the detection of methadone begs the question as to whether the drugs detected were in fact injected or ingested (orally, by snorting or by smoking), then finding their way into the blood. Among the other drugs detected were zopiclone, alprazolam, flurazepam and diazepam. The fact that no metabolites of flurazepam were detected is, the researchers believe, consistent with the presence of the drug itself in the syringe. Interestingly, the presence of benzos at 20 per cent was far greater in the Midlands than in Dublin (only 3 per cent). Oxycodone and ketamine were detected in 7 per cent of Dublin samples. Pregabalin was found in 35 per cent of Midlands syringes, while a third of the Dublin ones contained methamphetamine.
It is believed that 'meth' only plays a small part in the Irish drug market at present and that its detection may reflect the developing 'chemsex' scene. Significant and worrying evidence of cocaine injection emerged with 86 per cent (Dublin) and 89 per cent (rural) of syringes testing positive. Known cutting agents used to increase the profitability of cocaine were also detected, including levamisole, phenacetin and the two local anaesthetics, benzocaine and lidocaine. Diluents typical of street heroin included caffeine and paracetamol. The report refers to anecdotal evidence that it is the crack form of free-base cocaine that is being injected after being dissolved with the aid of citric acid. The use of excess acid may increase the risk of vein damage, and stimulant injection of any type is well recognised as being riskier due to the short duration of action leading to more frequent injections, reuse of needles, more sharing, and lowered inhibitions regarding sexual behaviour, thereby increasing HIV and HCV transmission risks.
This makes the 24 per cent positivity rate for 3-MMC in Midlands syringes (twice that of the Dublin ones) particularly concerning. It is a synthetic stimulant cathinone derivative chemically and pharmacologically similar to the so-called 'bath salts' such as mephedrone (4-MMC) that appeared on the market during
the heyday of the 'headshops'. It first appeared in 2012, but re-emerged as a problem in 2021. Much of the 3-MMC imported into Europe appears to have been manufactured on an industrial scale in India, although some was produced in illicit labs in Europe. Of concern is the possible use of potassium permanganate as an oxidising agent in some synthetic routes leading to residual manganese that could pose a risk of neurotoxicity, with features resembling Parkinson's.
confirmed exposure to 3-MMC were reported to the Drugs Agency between 2013 and 2021, most of them from Sweden, France and the Netherlands. Many involved polydrug use, with buprenorphine, ethanol, pregabalin and cocaine among the substances mentioned in the reports. Cases of driving under the influence of this drug have been reported from some Member States and Norway.
The Risk Assessment states that dependence is possible, but requires further study. It notes that the earlier onset of action and shorter duration of effect (3-MMC has an elimination half-life one-third that of MDMA) might explain a more compulsive pattern of use. It is also an obvious explanation of a heightened risk of more frequent injections, with all the negative consequences that arise from that.
There is limited information on the pharmacology and toxicology of 3-MMC according to the Risk Assessment Report prepared by the EU’s Drugs Agency. It is believed that it is likely to share the cardiovascular, neurological and psychiatric effects of related cathinones. Typically, these include sweating, tachycardia, hypertension, hyperthermia, tachypnoea, hyperactivity, dilated pupils, agitation, altered mental states, aggression, hallucinations, psychotic episodes and seizures. Liver injury has been reported in animal models, but also in case reports. Acute poisonings have been reported in nearly 300 cases in Europe. A total of 27 deaths following
On the basis of the Risk Assessment, the EU Commission adopted a Decision in March of this year to list 3-MMC as a drug as defined in EU legislation, laying down penalties in the field of illicit drug trafficking. This requires all Member States to introduce legal controls on it. It been controlled in Ireland for a number of years under the generic definition of cathinones within the Misuse of Drugs Acts.
Although it has been controlled here for some years, Ireland seems to have been free of it up until recently, as we were the only Member State not to report any seizures between 2012 and October 2021. The Syringe Project clearly shows that this is no longer the case and in that alone, the pilot project has been worthwhile. A wider application of the approach nationally used seems justified, as it has the potential to provide almost real-time information on changes in drug use that would allow more rapid and more focused prevention, harm reduction, and treatment responses. l
CONTRIBUTOR INFORMATION
Dr Des Corrigan, Best Contribution in Pharmacy Award (winner), GSK Medical Media Awards 2014, is a former Director of the School of Pharmacy at TCD and won the Lifetime Achievement Award at the 2009 Pharmacist Awards. He was chair of the Government’s National Advisory Committee on Drugs from 2000 to 2011. He currently chairs the Advisory Subcommittee on Herbal Medicines and is a member of the Advisory Committee on Human Medicines at the IMB. He is a National Expert on Committee 13B (Phytochemistry) at the European Pharmacopoeia in Strasbourg and he is an editorial board member of the Journal of Herbal Medicine and of FACT — Focus on Alternative and Complementary Therapy
Interestingly, the presence of benzos at 20 per cent was far greater in the Midlands than in Dublin (only 3 per cent)
I‘tchiness’ is a word used to describe an irritating sensation on your skin that must be scratched, but once you do, the need to scratch becomes more severe. It is a cycle that can cause considerable distress and discomfort, often interrupting concentration and sleep and affecting mood.
Head lice do not pose a serious health threat, but they are severe irritants. After about three months, untreated infections can cause repeated scratching and risk bacterial infection in the skin.
Adults are more likely to become desensitised to these bites as they grow older, which is why some elderly people can be unaware they have a lice infestation.
People are affected by three kinds of lice — the head louse, the clothing louse, and also the crab louse.
Head lice live in the head hair and eyebrows. Head lice, technically referred to as Pediculus Humanus Capitis, are wingless insects. Their translucent greyish-white bodies are 1-to-2mm in length and resemble a grain of rice with six legs. Their heads have two tiny eyes (too small to be seen without magnification) and two small antennae (usually visible).
Surrounding their mouth are six pairs of hooks, which they attach to the scalp for feeding. The mouth contains two retractable needle-like tubes that pierce the scalp.
These tubes inject salivary juices into the scalp to prevent blood from clotting, and then the lice feed.
Lice usually live for about one month, during which time they breed frantically. Male lice mate an average of 28 times a day. Typically females outnumber males five-toone, resulting in the laying of around seven-
to-eight eggs every 24 hours.
Lice eggs are called nits. Nits hatch in about seven-to-10 days, leaving the empty shell stuck to the hair shaft.
The newborn larvae become adults in about a week. During this life cycle, larvae and adult lice deposit their faeces on the scalp. This causes itching.
Many effective lice treatments are available in pharmacies. They are usually very effective at clearing the infestation.
Often, two applications are required. The second application should be applied around seven days after the first to kill any newly-hatched lice before they can produce new eggs.
If left untreated, lice can cause severe itching and skin breakage, inflammation and irritation.
Psoriasis of the scalp is a common cause of itching. This skin disease is a result of an immune system reaction. Psoriasis is not contagious. It is hereditary and passed along genetically. Forty-five to 55 per cent of people with psoriasis on the body also have scalp psoriasis. When the psoriatic plaques of psoriasis are scratched or picked, the skin will likely bleed.
These plaques form because the skin cells grow much faster than normal. Scalp psoriasis can also affect the hairline, forehead, back of the ears and back of the neck.
It can appear as fine scaling or thick, crusted plaques. Scalp psoriasis appears white or silverish in colour. There are several options for treating scalp
psoriasis. Trichologists (scalp specialists) often combine ultraviolet light therapy and laser therapy with hydrating scalp creams formulated to reduce itching and inflammation, slow skin cell growth and dislodge the layers of skin cell build-up.
Sometimes, trichologists are consulted about scalp itching and cannot see any obvious cause of the condition. Most itchy scalp conditions involve a lack or excess of scalp oil, broken skin or an excess of skin cell growth. There would usually be scaling, papules or pustules, inflamed hair follicles, scar tissue or follicular abnormalities. A lack of any such obvious problem may indicate that the cause could be a nutritional deficiency.
A blood test will show whether that may be the underlying cause.
A deficiency of vitamin B12, vitamin A, vitamin D or iron can cause itchy skin and scalp. A lack of essential fatty acids in the diet can also cause skin itching.
Contact dermatitis on the scalp will often result in itching. It is caused by a reaction to the chemicals in some shampoos, hair dyes or other grooming products. It may be that the person has an allergic reaction to certain ingredients that are that in the product, or that the ingredients simply irritate the skin.
This condition will be recognised by your trichologist and can be treated if necessary. l
Author: Deborah Whelan MIT is a Registered and Certified Trichologist. She has been a member of The Institute of Trichologists (London) since 1992. Deborah is based in Galway since 2005 but she also holds clinics in Dublin. www.trichologist.ie, email: info@ trichologist.ie. Phone: 091 565148.
• Provides protection from itching and dryness Soothes, moisturises and hydrates dry
• Restores the natural balance of your scalp
Testicular cancer is the most common cancer in men aged 15-to-45 years and represents one of the most common curable malignancies when identified promptly and treated with a multimodal approach
Testicular cancer (TC) represents 1 per cent of male cancers and 5 per cent of urological cancers; its incidence has increased in the past few years, especially in Western and industrialised countries.
Testicular cancer is a rare disease, accounting for 1 per cent of male cancers and 5 per cent of urological cancers worldwide.1 It is, however, the most common cancer found in young men aged between 15 and 34 years, and approximately 173 men are diagnosed with testicular cancer in Ireland each year.7
Mortality associated with testicular cancer is relatively low at approximately 0.1 per cent of all annual cancers, and cure rates are greater than 90 per cent for all stages, with over 95 per cent five-year survival rates.1,9
The incidence of testicular cancer has increased in Western and industrialised
countries in recent years, possibly due to an increased exposure to aetiological factors. The highest incidence of testicular cancer is observed in Western and Northern Europe at 8.7 and 7.2 per 100,000 men, respectively.9
Testicular cancer includes several types of cancer, such as germ cell tumours (GCT), sex cord-gonadal stromal tumours, and
secondary testicular tumours. About 90-to95 per cent of testicular tumours arise from germ cells to generate the GCT, followed by 5-to-10 per cent gonadal stromal tumour, mixed GCT and secondary tumours.2
The testes (male gonads) are located in a skin-covered, highly pigmented, muscular sack called the scrotum that extends from the body behind the penis. They produce both sperm and androgens, such as testosterone, and are active throughout the reproductive lifespan of the male.
Paired ovals, the testes are approximately 4-to-5cm in length and are surrounded by two distinct layers of protective connective tissue. The outer tunica vaginalis is a serous membrane that has both a parietal and a thin visceral layer. Beneath the tunica vaginalis is the tunica albuginea, a
The incidence of testicular cancer has increased in Western and industrialised countries in recent years
tough, white, dense connective tissue layer covering the testis which also inverts to form septa that divide the testis into 300to-400 structures called lobules. Within the lobules, sperm develop in structures called seminiferous tubules.8
The main non-modifiable risk factors for testicular cancer are cryptorchidism (undescended testicle), family history, previous history of testicular cancer, genetic predisposition, ethnicity,
congenital abnormalities and infertility.2
In cryptorchidism, the undescended testicle remains in the abdomen or groin, and the risk of developing the disease does not change even after surgery to move the testicle into the scrotum. In patients with cryptorchidism, the relative risk of developing testicular cancer ranges from 2.9 to 6.3. The risk is increased in both testes, although the risk is much higher in the ipsilateral testis (6.3 vs 1.7). 5 Family history correlates to an increased risk and testicular cancer risk is significant in men
whose father or brother had the disease. Patients with a father or brother with testicular cancer have a 3.8 and 8.6 times greater risk, respectively. 5
Those diagnosed with cancer in one testicle are also more likely to get cancer in the other testicle. Patients with a personal history of testicular cancer have a 12-times greater risk of developing a contralateral testicular cancer than the general population. However, the greatest risk is in the first five years after diagnosis, and the 15-year cumulative risk is 1.9 per cent. 5
Genetic and environmental factors play an important role in the genesis and development of testicular cancer. Several genes are implicated in its pathogenesis and different environmental factors have been investigated.1 Klinefelter’s syndrome, caused by a chromosomal abnormality, has been associated with testicular cancer and other cancer types, and congenital abnormalities of the testicles, penis or kidneys may also contribute to an increased risk of testicular cancer. Age represents one of the most frequent factors of testicular cancer occurrence and the highest incidence of GCT has been found in men between 15 and 35 years of age. Infertility is also strongly associated with testicular cancer. Caucasian men have a higher chance of getting the disease than Afro-Caribbean or Asian men.1, 3
Testicular cancer may present as a painless scrotal mass, an incidental radiologic finding, post-traumatic symptom, or scrotal pain.5 An enlarged testicle or a small lump or area of hardness are usually the first signs of testicular cancer. Any lump, enlargement, hardness, pain, or tenderness in the testicle should be evaluated as soon as possible. Other symptoms of testicular cancer usually do not appear until after the cancer has spread to other parts of the body.
Symptoms of testicular cancer may include:
A painless lump or swelling on either testicle. Found early, a testicular tumour may be about the size of a pea or a marble, but it can grow much larger.
Pain, discomfort, or numbness in a testicle or the scrotum, with or without swelling.
Change in the way a testicle feels or a feeling of heaviness in the scrotum. For example, one testicle may become firmer than the other or testicular cancer may cause the testicle to grow bigger or to become smaller.
Dull ache in the lower abdomen or groin.
Sudden build-up of fluid in the scrotum.
Although rare, some testicular tumours make hormones that cause gynaecomastia.
Lower back pain, shortness of breath, chest pain, and bloody sputum or phlegm can be symptoms of later-stage testicular cancer.
Swelling of one or both legs or shortness of breath from a blood clot can be symptoms of testicular cancer.
When cancer spreads to other sites such as the lungs, brain, abdomen or neck, symptoms including nausea, vomiting, gastric upset, cough, shortness of breath, weakness, sensory disturbances, abdominal pain, lumps in the neck/groin areas, and back pain, can occur. Prompt evaluation is important to ensure early diagnosis and treatment and decrease the burden of treatment in advanced disease.9
Testicular cancers are defined based on their cell type. The most common histology of testicular cancer is germinalseminoma and non-seminoma. About 95 per cent of testicular cancers begin in germ cells, specialised cells in the testicles that make sperm. While these tumours typically start in the testicles, they also occasionally arise in the abdomen, chest, or other areas of the body, even if there is no evidence of cancer in or near the testicles. Seminomas make up about half of all germ cell tumours. They usually grow slowly and are less likely to metastasise to other parts of the body. Nonseminomas are often more aggressive than seminomas, and are more likely to spread beyond the testicle. Approximately 5 per cent of testicular cancers start in stromal cells, which make testosterone. Testicular stromal tumours are often benign. 3
Evaluation by clinicians is guided by a complete history of the presenting symptoms, physical examination and
assessment for risk factors. Testicular examination should include the affected and unaffected testis for comparison.
The normal testis is 3.5-5cm in length, smooth, homogenous, movable and detached from the epididymis. Hard, firm, or fixed areas within or adjacent to the testes are abnormal and warrant further investigation. Physical examination should also include evaluation of the inguinal and supraclavicular lymph nodes, the abdomen, and the chest for gynaecomastia. 5 It is important to ask specifically about the history of cryptorchidism, orchiopexy, or inguinal hernia repair as an infant. A family history of testicular cancer in the father or a brother should be elicited. Physical examination findings of any solid intra-testicular mass should be considered to be testicular cancer until proven otherwise.9
Many signs and symptoms of testicular cancer are similar to those caused by non-cancerous conditions such as a spermatocele, varicocele, hydrocele, inguinal hernia, lymphoma, epididymoorchitis or epididymitis, and differential diagnosis is important.4
Blood tumour markers include alphafetoprotein (AFP), beta human chorionic gonadotrophin (bHCG) and Lactate dehydrogenase (LDH).6
Scrotal ultrasonography can confirm the presence of a mass, and has a sensitivity of 92-to-98 per cent and specificity of 95-to-99.8 per cent. 5
Once a solid intra-testicular tumour is identified, radical inguinal orchiectomy is performed both for diagnostic and therapeutic purposes.12 A biopsy of the suspect mass will be carried out and when suspicion for metastatic disease is present, additional imaging with CT of the chest and abdomen may be done for staging. 5 Staging is determined by the size of the tumour, lymph node involvement, whether the cancer has spread, and if tumour markers are present.10 Tumour staging guides further management with options including active surveillance, chemotherapy, retroperitoneal lymph node dissection, and radiation therapy.9
Stages are based on four categories:
T (Tumour): This describes whether the tumour has spread to tissues near the testicle.
N (Node): Indicates whether the testicular cancer cells have spread to regional lymph nodes.
M (Metastasis): This refers to whether the cancer has metastasised.
S (Serum): This indicates the level of tumour marker proteins in the serum, or blood.
Once the individual T, N, M and S components are scored, they are combined to determine the overall testicular cancer stage group. The stages of testicular cancer are:
Stage 0: The cancer cells have not spread beyond the testicle. At this stage, tumours are also referred to as carcinomas in situ.
Stage 1 testicular cancer: The cancer has invaded tissues next to the testicle, but has not spread to lymph nodes, or more distant sites in the body. Levels of tumour marker proteins may be normal or elevated. The three subcategories of stage 1 testicular cancer are:
Stage 1A: The tumour may have grown through the inner layer of tissue surrounding the testicle, but not the outer layer, and it has not spread to blood or lymph vessels. Serum levels of tumour markers are normal.
Stage 1B: Tumours at this stage may have spread to blood or lymph vessels or may have invaded the outer layer surrounding the testicle, the spermatic cord or the scrotum. Serum levels of tumour markers are normal.
Stage 1C: These cancers can demonstrate any degree of invasion of nearby tissues, and levels of tumour markers measured after the tumour has been removed by surgery are elevated.
Stage 2 testicular cancer: Testicular cancers at this stage have invaded tissues next to the testicle and can now be found in at least one nearby lymph node. Tumour marker levels may be normal or slightly elevated. Stage 2 testicular cancer has
Use
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Pelgraz▼(peg lgrastim) 6 mg solution for injection in pre- lled syringe or prelled injector. Presentation: Each pre- lled syringe or pre- lled injector contains 6 mg of peg lgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/mL if the PEG moiety is included. Indications: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Dosage and Administration: Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Posology: One 6 mg dose (a single pre- lled syringe or pre- lled injector) of Pelgraz is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy. Safety and e cacy of Pelgraz in children and adolescents has not yet been established and no recommendation on a posology can be made. No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Method of administration: Pelgraz is for subcutaneous use. The injections should be given subcutaneously into the thigh, abdomen or upper arm. See SmPC for instructions on handling of the medicinal product before administration.
Contraindications: Hypersensitivity to peg lgrastim or any of the excipients in Pelgraz. Warnings and precautions: To improve the traceability of biological medicinal products, the trade name of the administered product should be clearly recorded. The long-term e ects of peg lgrastim have not been established in acute myeloid leukaemia (AML); therefore, it should be used with caution in this patient population. Granulocytecolony stimulating factor (G-CSF) can promote growth of myeloid cells in vitro and similar e ects may be seen on some non-myeloid cells in vitro. The safety and e cacy of peg lgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML. The safety and e cacy of peg lgrastim administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established. The safety and e cacy of peg lgrastim have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dose regimens. Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary in ltrates or pneumonia may be at higher risk. The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary in ltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of adult respiratory distress syndrome (ARDS). In such circumstances peg lgrastim should be discontinued at the discretion of the physician and the appropriate treatment given. Glomerulonephritis has been reported in patients receiving lgrastim and peg lgrastim. Generally, glomerulonephritis resolved after dose reduction
or withdrawal of lgrastim and peg lgrastim. Urinalysis monitoring is recommended. Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care. Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of peg lgrastim. Spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Treatment with peg lgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic medicinal products which are known to cause severe thrombocytopenia. Peg lgrastim in conjunction with chemotherapy and/or radiotherapy has been associated with development of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) in breast and lung cancer patients. Patients treated in these settings should be monitored for signs and symptoms of MDS/AML. Sickle cell crises have been associated with the use of peg lgrastim in patients with sickle cell trait or sickle cell disease. Therefore, use caution when prescribing peg lgrastim in patients with sickle cell trait or sickle cell disease, monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vasoocclusive crisis. White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1% of patients receiving peg lgrastim. No adverse reactions directly attributable to this degree of leukocytosis have been reported. Such elevation in WBCs is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic e ects of this medicinal product. Consistent with the clinical e ects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 × 109/L after the expected nadir, this medicinal product should be discontinued immediately. Hypersensitivity, including anaphylactic reactions, have been reported with peg lgrastim. Permanently discontinue peg lgrastim in patients with clinically signi cant hypersensitivity. Do not administer peg lgrastim to patients with a history of hypersensitivity to peg lgrastim or lgrastim. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with peg lgrastim treatment. If the patient has developed SJS with the use of peg lgrastim, treatment must not be restarted at any time. As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against peg lgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. Aortitis has been reported after lgrastim or peg lgrastim administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased in ammatory markers (e.g. C-reactive protein and WBC count). In most cases aortitis was
diagnosed by CT scan and generally resolved after withdrawal of lgrastim or peg lgrastim. The safety and e cacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging ndings. This should be considered when interpreting bone-imaging results. The additive e ect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. Pelgraz contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free’. The needle cover contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Pregnancy and Lactation: Peg lgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from peg lgrastim therapy taking into account the bene t of breastfeeding for the child and the bene t of therapy for the woman. Adverse Events include: Adverse events which could be considered serious include: Common: Thrombocytopenia. Uncommon: Myelodysplastic syndrome, acute myeloid leukaemia, sickle cell anaemia with crisis, capillary leak syndrome, glomerulonephritis, hypersensitivity reactions (including angioedema, dyspnoea, anaphylaxis), splenic rupture (including some fatal cases), Sweet’s syndrome (acute febrile neutrophilic dermatosis), pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema and pulmonary brosis have been reported. Uncommonly cases have resulted in respiratory failure or ARDS which may be fatal. Rare: Aortitis, pulmonary haemorrhage, Stevens-Johnson syndrome. Other Very Common adverse events: Headache, nausea, bone pain. Other Common adverse events: Leukocytosis, musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain), injection site pain, non-cardiac chest pain. See SmPC for details of other adverse events. Shelf Life: 3 years. Store in a refrigerator (2∞C – 8∞C). Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely a ect the stability of Pelgraz. Keep the container in the outer carton in order to protect from light. Pack Size: One pre lled syringe or pre lled syringe injector with one alcohol swab, in a blistered packaging. Marketing Authorisation Numbers: Pre- lled syringe: EU/1/18/1313/001, Prelled injector: EU/1/18/1313/002. Marketing Authorisation Holder (MAH): Accord Healthcare S.L.U, World Trade Center, Moll de Barcelona, s/n, Edi ci Est, 6a planta, Barcelona, 08039 Spain. Legal Category: POM. Full prescribing information including the SmPC is available on request from Accord Healthcare Ireland Ltd, Euro House, Little Island, Co. Cork, Tel: 021-4619040 or www.accord-healthcare.ie/products Adverse reactions can be reported to Medical Information at Accord Healthcare Ltd. via E-mail: medinfo@accord-healthcare.com or Tel: +44(0)1271385257.
Date of Generation of API: May 2021. IE-01426
Adverse events should be reported. Reporting forms and information can be found on the HPRA website (www.hpra.ie), or by e-mailing medsafety@hpra.ie. Adverse events should also be reported to Medical Information via email; medinfo@accord-healthcare.com or tel:0044 (0) 1271 385257
three subcategories:
Stage 2A: Tumours at this stage have spread to one or more lymph nodes, but no node is larger than 2cm.
Stage 2B: Tumours at this stage have spread to at least one lymph node, which is between 2-5cm in size.
Stage 2C: These tumours have spread to at least one lymph node larger than 5cm.
Stage 3 testicular cancer: Testicular cancers at this stage have spread to distant lymph nodes or organs. Stage 3 testicular cancer has three subcategories:
Stage 3A: These cancers have spread to a distant lymph node or the lungs. Tumour marker protein levels are normal or slightly elevated.
Stage 3B: At this stage of testicular cancer, patients have moderately elevated levels of tumour marker proteins, and the disease has either spread to nearby or distant lymph nodes, or the lungs.
Stage 3C: These cancers have high levels of tumour marker proteins and may have spread to nearby or distant lymph nodes, or the lungs. Alternatively, they may have spread to other distant organs, such as the liver or the brain, but in this case serum tumour markers can be at any level.
Treatment options for testicular cancer include surgery, radiation therapy, chemotherapy and stem cell transplant. Sometimes more than one type of treatment might be used, including chemotherapy and/or radiotherapy.9
The management of seminomas depends on the extent of spread of the cancer. Surgery, radiotherapy and chemotherapy are used to treat seminomas and the stage of cancer will decide treatment options. Non-seminomas are usually treated with surgery and chemotherapy.10
When a diagnosis of testicular cancer is suspected based on physical examination and ultrasound findings, radical inguinal orchiectomy is performed, which removes the testicle, epididymis, and spermatic cord up to the level of the internal inguinal ring. In this procedure, these structures
are delivered through an inguinal incision made along Langer’s lines in the groin. If the mass is too large to pass through a standard 3-to-5cm inguinal incision, the incision can be carried inferiorly to the anterior scrotum to allow for removal of the testis in its tunics along with the spermatic cord. Trans-scrotal orchiectomy or biopsy is contraindicated, as doing so alters the lymphatic drainage patterns and impacts further management. Further surgery or radiotherapy or chemotherapy will be based on the disease's stage and response to the initial management.9
sperm in case there are problems with fertility later on.7 Adequate counselling should be given regarding the possibility of infertility, sperm-banking and also regarding the placement of a testicular prosthesis if required.9
Prognosis is determined by the histology, extent of distant tumour spread, and extent of tumour marker elevations. For men with disseminated seminomas, the main adverse prognostic variable is the presence of metastases to visceral organs other than the lungs. A tumour that originated in the mediastinum has a worse prognosis when compared to a tumour that originated within the testicle.9
Following radical inguinal orchiectomy, patients should avoid heavy lifting and high-impact activities for four weeks and should wear supportive underwear to prevent scrotal swelling or haematoma. Retroperitoneal lymph node dissection is major intra-abdominal surgery, after which dedicated postoperative rehabilitation should be undertaken.9
Removing one testicle does not affect libido or the ability to have an erection, providing the remaining testicle is normal. The removal of a testicle may be traumatic, especially for a young man, and a testicular prosthesis can be placed in the scrotum at the time of surgery. Fertility can be compromised by testicular cancer treatment. However, the potential to father children should not be greatly affected provided the other testicle is normal. Chemotherapy, however, does affect sperm production in this testicle and it is recommended that patients with testicular cancer arrange to freeze
There is no national screening programme for detecting testicular cancer in Ireland.6 Testicular self-examination is one of the simplest and most effective ways to identify testicular cancer early, although there is controversy about its efficacy.7 Despite opportunities for an early diagnosis, most men seek medical help only after some time has passed, when symptoms have intensified, or after receiving information about the condition from someone else or the media. Despite the fact that knowledge about testicular cancer and testicular self-examination in developed counties is higher, testicular self-examination is still rarely performed. Most patients present with a testicular mass, which suggests that testicular selfexamination could aid early detection.1
It is important to educate men of all ages about testicular cancer and testicular self-examination and that healthcare professionals, especially nurses, are well informed and able to discuss it with their patients. Healthcare professionals play a key role in providing information about testicular cancer risk factors and symptoms and in explaining the importance of testicular self-examination. Mortality associated with TC is relatively low at approximately 0.1 per cent of all annual cancer deaths.
Often, the best place to check is in the
Prognosis is determined by the histology, extent of distant tumour spread, and extent of tumour marker elevations
bath or shower where the scrotum is relaxed and the testicles can be felt easily.
Hold the scrotum in both hands.
Use your fingers and a thumb to examine the testicles.
It is common for one testicle to be slightly larger than the other.
Gently feel each testicle, one at a time.
You should be able to feel a soft tube at the top and back of both testicles. This tube, called the epididymis, carries the sperm. It may be slightly tender but do not confuse this with an abnormal lump in the testicles.
If you notice a lump or anything unusual, contact your GP immediately. The GP will be able to assess and if necessary, refer to a consultant for further investigations.
Do not be embarrassed or nervous.
Remember, early detection of the disease is the best chance of a cure.
TSE should be performed every month. Men tend to seek help late for
testicular problems for many reasons, such as anxiety, and fear of receiving an undesired diagnosis. Others feel ashamed, deprived of their masculinity and are too embarrassed to talk about it with anyone, even a partner. Researchers have found that when men are properly educated about testicular self-examination, they are more likely to carry it out and recognise symptoms of testicular cancer.1
Testicular cancer is the most common cancer in men aged 15-to-45 years and represents one of the most common curable malignancies when identified promptly and treated with a multimodal approach.9 It has excellent survival rates and having awareness about the disease and seeking prompt healthcare attention is of utmost importance. Since treatment is successful for most people with testicular cancer, one of the major
future goals is to reduce the side-effects of treatment for people with early-stage cancer. In addition, treatments for poorrisk and recurrent cancers are being studied in clinical trials, along with research on the causes and genetics of testicular cancer. Stem cell transplant is most often used to treat testicular cancers that have re-occurred after treatment with chemotherapy. Current studies are looking at whether a stem cell transplant may be valuable as part of the first treatment for some patients with advanced germ cell cancers. Clinical trials are also underway to find better ways of reducing symptoms and sideeffects of current testicular cancer treatments that can improve patients' comfort and quality of life.13 l
Author: Theresa Lowry-Lehnen, RGN, GPN, RNP, PhD, CNS and Associate South East Technological University (SETU)
References
1. Bresciani M, Boarin M, Facconi L, Manara F, Villa G. Awareness of testicular cancer among young men: A literature review. Int J Urol Nurs. 2020 Jul 17;15(1): 5-11. doi: 10.1111/ijun.12248.
2. Boccellino M, Vanacore D, Zappavigna S, Cavaliere C, Rossetti S, D'Aniello C, et al. Testicular cancer from diagnosis to epigenetic factors. Oncotarget. 2017 Sep 18;8(61):104654-104663. doi: 10.18632/oncotarget.20992.
3. MSK (2021). Testicular Cancer: Germ Cell Tumours. Available at: https://www. mskcc.org/cancer-care/types/testiculargerm-cell-tumors.
4. Cancer.Net (2020). Testicular Cancer: Symptoms and Signs. Available at: https://www.cancer.net/cancer-types/ testicular-cancer/symptoms-and-signs.
5. Baird D, Myers, G, Darnall
C, Hu J. Testicular Cancer: Diagnosis and Treatment. Am Fam Physician. 2018 Feb 15; 97(4):261-268. https://www.aafp.org/afp/2018/0215/ p261.html.
6. Irish Cancer Society (2021). Symptoms and Diagnosis of Testicular Cancer. Available at: https://www.cancer.ie/ cancer-information-and-support/cancertypes/testicular-cancer/symptoms-anddiagnosis-of-testicular-cancer.
7. Marie Keating Foundation (2021). Testicular Cancer. Available at: https:// www.mariekeating.ie/cancer-information/ testicular-cancer/.
8. Anatomy and Physiology of the Male Reproductive System. Available at: https://courses.lumenlearning.com/sunyap2/chapter/anatomy-and-physiologyof-the-male-reproductive-system/.
9. Gaddam, S. (2021). Testicular
Cancer. StatPearls: Available at: https:// www.statpearls.com/ArticleLibrary/ viewarticle/29984.
10. St James’s Hospital (2021). Testicular Cancer. Available at: https://www. stjames.ie/cancer/typesofcancer/ testicularcancer/.
11. MacMillan Cancer support (2021). Stages of Testicular Cancer. Available at: https://www.macmillan.org.uk/cancerinformation-and-support/testicularcancer/stages.
12. Markman, M. (2021). Testicular Cancer Stages. Available at: https:// www.cancercenter.com/cancer-types/ testicular-cancer/stages.
13. CancerNet (2020). Testicular Cancer: Latest Research. American Society of Clinical Oncology: ASCO. Available at: https://www.cancer.net/cancer-types/ testicular-cancer/latest-research.
Tackling infant pain presents its own particular challenges and the phenomenon has only been scientifically recognised as a real issue in recent decades
An extra challenge to accurately diagnose arises for pharmacists (and other health professionals) when a parent arrives at the pharmacy with an infant of two-to-12 months old, concerned that their child is in pain and seeking assistance. The normal route, the verbal-based technique of asking the patient themselves questions about their symptoms, is not an option in a child so young. Of course, you can question the
parent as regards symptoms or signs that has led them to their conclusion — however, without the input from the person experiencing the pain, the infant — establishing any type of diagnosis could prove challenging. In the case of a first-time parent, they may be quite distressed, as they ‘don’t know what they don’t know’, making their expectation of getting help more acute and immediate, which can bring an added level of pressure to the situation.
With pharmacy being actively promoted as a ‘first port of call’ regarding general healthcare, it’s increasingly likely that you will encounter this difficult scenario at your pharmacy. The purpose of this article therefore is to provide some background information regarding ‘infant pain’ and to help you develop more educated questions and observations that can establish likely causes and subsequent action, or at least allay the immediate fears of a worried parent.
Due to the simple fact that infants can’t tell us about the pain they’re experiencing, establishing the nature of infant pain is notoriously difficult. In fact, over 30 years or so, due to their underdeveloped brain and neural pathways, it was debated if infants actually experienced ‘pain’ at all.
In recent decades however, with the advent of technology, it has been proven beyond doubt that infants do experience pain in the same way that adults do. Clinical tests with various stimuli allied to real time MRI and neuro scanning techniques have shown that sensory receptors in infants ‘light up’ to a similar extent to those of adults exposed to the same stimuli. This ongoing research, aimed at improving and measuring infant response to pain medication, along with other research in the field clearly dispels any suggestion that infants do not feel pain.
You might think – ‘How can I help?’
The problem you have is like that faced by every health professional in this area, be it neonatal nurse, paediatrician, consultant — ‘I can’t ask the question’.
In much the same way as a farmer can spot that ‘something’s not right’ in one animal in a group of hundreds — because they know the animal and what is ‘normal behaviour’ — the parents of the infant also know what their infants ‘normal’ signs are in terms of feeding, sleeping, movement, mood, etc, and are therefore best placed to recognise changes in these areas that can help clinicians identify/eliminate possible causes of infant pain.
The most common causes of infant pain are:
Teething.
Infections (especially ear).
Colic (most often up to four months).
Pain through colds, flu transmitted at home through contact with others or toys, etc, if there are other children in the house.
As the infant is unable to describe their symptoms, there are signs to look for in
several key areas outlined below, some knowledge of which can help you ask relevant questions that can help identify the problem. Behavioural changes could be the first indication of a potential problem and are most likely to be recognised by the parents.
As with the farmer above, parents soon come to learn a ‘normal’ cry. It’s the infant’s only way of communicating a variety of needs. Through time, they can distinguish subtle differences in crying that represent being hungry or tired, for example. Maybe it’s discomfort, requiring a nappy change or the infant just needs a cuddle! If an infant is in
weight), then instances where food is refused, or feeds missed completely in the case of breastor bottle-feeding, may be a sign of underlying illness/pain which requires monitoring. Other signs may be that sucking (bottles) has become weaker, or a good latch is not achieved while breastfeeding. Irregularity in feeding routines, fewer soiled or wet nappies, leading to slower weight gain or weight loss, may be a further indication of underlying illness/pain.
FEVER
Colds, flu, ear infections, stomach bugs, along with viral or bacterial infections, can all cause fever and pain in infants. They are particularly susceptible, as their immune systems are underdeveloped. If fever is suspected, check the temperature. Normal temperature should be 37.8°c, however if the temperature is 38°c or above (<12wks old) or above 38.3°c (3-6mths), the doctor should be contacted immediately.
LETHARGY
pain, their cry may (not always) become more high-pitched and extended in duration and will certainly sound different than normal. If this crying cannot be eased by addressing the usual needs, ie, feed, change etc, this may be a reason to investigate further.
Colic is a painful intestinal issue, the cause of which is not known. Up to four months old, this prolonged (up to three hours per day) intense crying, especially if it occurs at roughly the same time each day, may be a sign of colic. The infant drawing their legs into the tummy at the same time can further indicate colic.
If the infant has a ‘healthy’ appetite, (ie, feeds regularly and well, is gaining
Infants, by their general nature, are active, bright, inquisitive, alert, and attentive. Any signs of sluggishness, drowsiness or sleeping for longer than usual may be a sign of infection or another underlying condition and should be monitored.
If pain is suspected, there are several steps, both medicinal and nonmedicinal, that can be taken to help alleviate symptoms. Consider advising any of the following:
NON - MEDICAL:
There is significant evidence to indicate that a variety of physical and environmental interactions can help soothe an infant experiencing pain or distress. These can also help the parent who may be experiencing feelings of helplessness in aiding their child.
Skin-to-skin contact (‘Kangaroo care’) between the parent and child can
Colds, flu, ear infections, stomach bugs, along with viral or bacterial infections, can all cause fever and pain in infants
have a pain-relieving effect and can help reduce stress levels of the parent too.
Breastfeeding — this promotes skin-to-skin contact with the added proven pain-relieving qualities offered by breast milk. In a clinical setting, for those unable to breastfeed, a 24 per cent sucrose solution administered via dropper onto the tongue also offer pain relief.
Massaging the infant’s tummy can help relieve tummy pain (not after feeding).
Holding the infant and moving with a slow, steady, rhythmic rocking movement can help reduce, relieve pain and stress.
Can be given to children in liquid syrup or suppository form from age two months.
Regularly used for relief from ear, head or stomach ache.
Mostly used to reduce high temperature.
Paracetamol 120mg/5ml liquid:
Dosage levels for 2-6 months 2.5ml (60mg) 4 times/24hrs (min 4-hour gap between doses)
6-24 months 5ml (120mg) 4 times/24hrs (min 4-hour gap between doses)v
Using distractions such as music, singing, reading stories aloud can help.
Changing the infant’s immediate environment to something more secure and nest-like can help them feel more contained, warm, and comforted.
Due to the difficulty in diagnosing pain in infants, especially outside of a hospital neonatal ICU environment, there is only a limited amount that can be offered to a concerned parent by way of medicinal relief over the counter.
As mentioned at the outset, it is increasingly likely that you may encounter infant pain issues at the counter. Hopefully this short article has given you some context to develop the right questions to ask. Within the first 12 months, most mothers and infants are still under the umbrella of GP and post-natal care, so it is likely anything serious would be caught early within
Can be given to children in liquid syrup form from age three months and weighing more than 5kgs.
Like paracetamol, regularly used for pain relief and to reduce temperature.
Unlike paracetamol, also reduces inflammation.
Best avoided in asthmatics due to risk of bronchospasm.
Ibuprofen 100mg/5ml liquid:
Dosage levels for Infants 3-6 months Weighing more than 5 kg
Infants 6 months-1 year
One 2.5ml (50mg) dose 3 times in 24 hours. Do not use for more than 24 hours.
2.5ml (50mg) three to four times a day
Children 1-4 years 5ml (100mg) three times a day
that framework.
Almost all infant fevers and pain are non-threatening in nature and will pass in a few days; some points below would necessitate immediate referral to GP:
Temperature levels outside of those indicated earlier (<3mths – 38°c or above – 38.3°c or above).
Vomiting.
Stiff neck.
Skin discolouration, rash.
Pain or sickness that’s been going on for more than a couple of days.
Any difficulty breathing due to coughing or wheezing. l
Written by Eamonn Brady MPSI (Pharmacist). Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore). www.whelehans ie. Whelehans specialises in the supply of medicines and training needs of nursing homes throughout Ireland. Email ebrady@whelehans.ie
Almost all infant fevers and pain are non-threatening in nature and will pass in a few days
Easofen for Children Strawberry 100 mg/5 ml Oral Suspension and Easofen for Children Six Plus Strawberry 200 mg/5 ml Oral Suspension. Contains maltitol liquid & sodium. Sugar free and colour free. *Easofen for Children Strawberry is for infants from 3+ months and should only be given to infants aged 3-6 months who weigh more than 5 kg. Easofen 200 mg Film-coated Tablets and Easofen Max Strength 400 mg Film-coated Tablets are for adults and adolescents (over the age of 12 years). Contains ibuprofen. Retail sale through pharmacies only. A copy of the summary of product characteristics is available upon request. PA 126/60/1-4 PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: December 2019. 2019/ADV/EAS/140H
I will discuss three types of wounds in this article. The three types are:
Diabetic foot ulcers.
Post-operative wounds (the basics).
Pressure sores.
The aim of this article is not to go in depth into the causes and management of wounds, but to give the basic advice patients and their carers need to prevent, manage, and treat these wounds under the supervision of health professionals.
Diabetics have more foot problems than the general population due to their condition. Unfortunately, diabetics are at increased risk of serious foot problems, including gangrene, which can lead to amputation. However, these problems are preventable with proper foot care. Foot care is very important for diabetics, but especially if there is a loss of feeling in the feet, changes in the shape of feet, and foot ulcers or sores that do not heal. Nerve damage can cause loss of feeling in the feet. A diabetic may
not feel a pebble inside their sock that is causing a sore, or a blister caused by poorlyfitting shoes. Foot injuries like these can cause ulcers, which may lead to amputation. Keeping blood sugar under control can help avoid serious foot problems.
None: No signs and symptoms.
Mild: With at least two of below: Erythema 0.5-2cm/induration/tenderness/warmth/ pus discharge.
Moderate: Erythema >2cm and one of the findings above/OR: Infection penetrating to muscle tendon/bone/joint.
Severe infection/sepsis: Presence of systemic signs with at least two of below: Temperature >39°C or 90bpm/ respiratory rate >20/mi.
*Ref: IWGF (2019) IWGDF Guideline on the classification of diabetic foot ulcers. IWGDF Guidelines on the Prevention and Management of Diabetic Foot Disease
With a five-year mortality rate of more than 50 per cent in diabetes patients with foot ulcers and 80 per cent in patients who have a diabetes-related amputation, diabetes-related foot ulcer five-year mortality rates are similar or even worse than many types of common cancers. The key is prevention and regular checkups. The basic tips below are essential, as prevention is easier than cure.
Diabetics may have serious foot problems but feel no pain. Look for cuts, sores, red spots, swelling, or infected toenails. Find a time (evening is best) to check feet each day. If you have trouble bending, use a mirror to help.
A diabetic may not feel a pebble inside their sock that is causing a sore, or a blister caused by poorly-fitting shoes
WASH FEET DAILY
Wash feet in warm, not hot, water. However, do not soak feet, as this will cause the skin to get dry. Before bathing or showering, test the water to make sure it is not too hot. Use a thermometer (32 to 35oC is safe) or elbow. Dry feet well, taking care to dry between toes.
KEEP FEET MOISTURISED
Rub a thin coat of skin lotion, cream, or petroleum jelly on the tops and bottoms of the feet. Do not put lotion or cream between toes, because this might cause an infection.
If using a pumice stone to smooth corns and calluses after bathing or showering, rub gently, in one direction only, to avoid tearing the skin. Do not cut corns and calluses. Diabetics should not use razor blades, corn plasters or liquid corn and callus removers, as they can damage skin.
SINBAD SCORING FOR INDEX ULCER
NO=0 YES=1
KEEP TOENAILS TRIM
Cut toenails each week or when needed. Wash and dry your feet first. Trim toenails straight across and smooth them with an emery board or nail file. Do not cut into the corners of the toenail, as this can cause in-growing toenails. If eyesight is poor, if toenails are thick or yellowed, or nails curve and grow into the skin, have a chiropodist trim them.
WEAR SHOES AND SOCKS
Wear shoes and socks at all times. Do not walk barefoot — not even indoors — because it is easy to step on something and cause skin damage. Always wear socks, stockings, or nylons with shoes to help avoid blisters and sores. Socks that have no seams are best. Specially-designed socks for diabetics are ideal.
AVOID HOT AND COLD
Always wear shoes at the beach or on hot ground and put sunscreen on the top of feet
Site: rearfoot? No Yes
Ischaemia: clinical signs of peripheral vascular disease? No Yes
Neuropathy: Sensory loss? No Yes
Bacterial infection: clinical signs? No Yes
Area: 1cm2 or more? No Yes
Depth: to tender or bone? No Yes
Total (yes only) /6
Assessing a diabetic foot ulcer using a SINBAD ulcer classification Score = or > than 4/6 highest risk of amputation
SINBAD = Site, Ischaemia, Neuropathy, Bacterial Infection and Depth
to prevent sunburn. Keep feet away from radiators and open fires and do not put hot water bottles or heating pads on feet. Check feet often in cold weather to avoid frostbite.
KEEP THE BLOOD FLOWING
Put feet up when sitting. Wiggle the toes for five minutes, twice or three times a day. Move ankles up and down and in and out to improve blood flow. Do not cross your legs for long. Do not wear tight socks, elastic or rubber bands, or anything restrictive around your legs. Stop smoking, as it reduces blood flow to feet.
SEE A HEALTH PROFESSIONAL Diabetics should visit a chiropodist once every six months. Chiropodists are experts in foot health and should be the first stop if foot problems occur, especially in diabetics, as even minor issues can turn into serious problems very rapidly. Pharmacists and GPs can also help with foot problems.
Many patients with postoperative wounds will be required to treat the wounds at home with the help of their healthcare professionals, including their GP, practice nurse and public health nurse.
A surgical wound is the cut made to the skin by the surgeon during an operation. At the end of the operation, the cut is joined back together with either stitches, Steristrips or adhesive dressings (glue) to allow the skin edges to come together and heal. The skin edges usually form a seal within a day or two of the operation. The time this takes varies from person-toperson and from operation-to-operation.
Not all surgical wounds need dressings. The purpose of a dressing is to:
Absorb any leakage from the wound.
Provide ideal conditions for healing.
Protect the area until the wound is healed.
Prevent stitches catching on clothing.
Stitches are also known as sutures. Adhesive dressings (glue), Steristrips or tape may also be used. Most types of stitches are removed by a nurse or doctor, but some stitches do not need to be removed, as they dissolve. Stitches are usually removed 14 days after treatment, depending on the type of operation.
PROBLEMS WITH WOUND - HEALING
Most wounds heal without any problems. The most common complication after surgery is wound infection. An infection usually delays normal wound-healing.
WOUND INFECTIONS
Some people are more likely to develop wound infections than others. People are at an increased risk of infection if they:
Smoke.
Are diabetic.
Have a condition or are having treatment which affects the immune system, such as leukaemia or chemotherapy.
It is important for the patient to know the signs of infection after going home. If a wound becomes infected, it may:
Become more painful.
Look red or swollen.
Leak some blood-like liquid, pus, or blood.
Have an unpleasant smell. If the patient develops a high temperature (above 37.5°C), or notices any of the signs mentioned above, or have any concerns about the wound, they should contact the surgery team or GP as soon as possible.
There are measures to prevent infection and increase healing.
The original dressing can be left in place for up to two days (or as advised by the nurse/doctor) if it is not oozing. The wound must be kept dry for two days. If the dressing becomes wet from blood or any other liquid, it must be changed. When changing the dressing:
Wash hands with soap and water.
Carefully take the dirty dressing off, without touching the used side.
Do not touch the healing wound with fingers.
Take care not to touch the inside of the new dressing, so that it remains clean.
Do not apply antiseptic cream under the dressing.
If the wound is healing, it can be left without a dressing, but the patient may prefer to have a dressing to cover the
wound for protection, especially if clothing can rub against it.
Dissolving stitches usually disappear in seven-to-10 days. Other stitches need to be removed after 14 days. The surgery team will explain when to have these stitches removed on the day of discharge from hospital. Nylon threads (the ends of the stitches) may poke out of the healing scar. Do not pull on these. If the loose ends are catching on clothes, cover the wound until the stitches are removed, to prevent them catching.
Wait 24 hours after surgery before showering. When washing, follow this advice:
Showering is preferable to bathing. Soaking the wounds might soften the scar tissue and cause it to open. Only take a bath if sure the wounds can be kept dry.
Some waterproof dressings can be left in place whilst taking a bath or shower. Other dressings may need to be removed beforehand.
Do not put any soap, shower gel, body lotion, talcum powder or other bathing products directly onto a healing wound. This will cause discomfort and may also encourage an infection.
Do not worry if splashing occurs on the wound, but do not rub the wound area. This will cause pain and might delay the healing process.
Pat the wound dry gently with a clean towel after bathing or showering.
Pressure ulcers are lesions caused by unrelieved pressure that results in damage to the underlying tissue. Generally, these are the result of soft tissue compression between a bony prominence and an external surface for a prolonged time.
Pressure ulcers are usually easy to identify by their appearance and location overlying a bony prominence. It is important to distinguish pressure ulcers from ulcers
that result from diabetic neuropathy or arterial or venous insufficiency. They also may be confused with other conditions that cause redness of skin, such as cellulitis. Superficial moisture-induced lesions, such as maceration (softening and whitening of skin) over a bony prominence, should not be labelled as pressure ulcers. Characteristics of lesions that need to be distinguished from pressure ulcers are:
Diabetic neuropathic ulcers are seen in patients with diabetes who have peripheral neuropathy. The diabetic ulcer characteristically occurs on the foot, usually on the ball of the foot just behind big toes or on the top of toes.
Venous insufficiency ulcers are usually found on the inner part of the lower leg, usually just above the ankle. Approximately 70 per cent of all leg ulcers are venous ulcers. They can occur either on one or both legs and each leg may have more than one ulcer. They can range from painless to extremely painful. These types of ulcers are common in people who have a history of leg and feet swelling. The ulcer usually presents itself as an open sore in an area that already typically exhibits a red-tobrown discolouration that has probably been present for some time. The area will
also be swollen. Prior to the formation of the ulceration, the skin may have also been somewhat flaky and itchy as well. So long as there is no arterial disease, venous leg ulcers benefit from elevation and compression dressings.
Arterial ulcers occur as the result of arterial occlusive disease. Approximately 10 per cent of all leg ulcers are arterial ulcers. Feet and legs often feel cold and may have a whitish or bluish, shiny appearance. Arterial leg ulcers can be painful. Pain often increases when the legs are at rest and elevated.
CLASSIFICATION SYSTEM
Grade 1: Redness that does not whiten on touch. Discolouration of the skin, warmth, oedema, and hardness may also
be used as indicators, particularly on individuals with darker skin in whom it may appear blue or purple. Grade 1 may be more difficult to detect in those with dark skin tones.
Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Surrounding skin may be red or purple. If bruising is visible at this stage, it can indicate deep tissue injury.
Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue. Subcutaneous fat may be visible, but tendon, muscle or bone are not exposed. Slough may be present.
Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. Extremely difficult to heal and can lead to fatal infection.
Unstageable — Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, grey, green, or brown) and/or eschar (tan, brown or black) in the wound bed.
Eschar often covers deep ulcers, making it difficult to determine whether lesions are stage 3 or 4. Until enough slough and/ or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined.
Repositioning of the patient regularly prevents pressure sores, ie, turning on the bed regularly if bed-bound.
Treatment of concurrent conditions which may delay healing, ie, poor circulation.
Pressure-relieving support surfaces such as beds, mattresses, overlays, or cushions.
Local wound management using modern or advanced wound dressings and other technologies.
Patients with identified grade 1 pressure ulcers are at a significant risk of developing more severe ulcers and should receive interventions to prevent deterioration.
TABLE 1: European Pressure Ulcer Advisory Panel (EPUAP) grading system (Ref: Huntleigh Healthcare Ltd)
So long as there is no arterial disease, venous leg ulcers benefit from elevation and compression dressings
Pain is often significant and disabling for those with pressure ulcers.
Paracetamol may be sufficient, but patients often require stronger analgesia.
Non-steroidal anti-inflammatory drugs may increase peripheral oedema and are inappropriate for patients with pressure ulcers, ie, Ibuprofen, Diclofenac.
Opioid analgesics may be needed for moderate-to-severe pain.
Topical local anaesthetics such as lidocaine can provide numbness for a short period of time and can be useful for a specific procedure, but should not be used as the only method of pain relief.
Wound-cleansing and dressing techniques may need to be reconsidered if they are causing severe pain. Adequate pain control should be provided for dressing changes and debridement.
Patients may require a referral to a pain clinic.
If oral intake is not adequate to ensure sufficient calories, protein, vitamins, and minerals, nutritional supplementation with enteral and parenteral nutrition (PEG feed) is recommended to correct deficiencies. Increased dietary protein intake promotes the healing of pressure ulcers. The protein target is usually 1.5g/ kg/day. Cubitan is an example of a highenergy, high-protein oral nutritional supplement (ONS) with wound-specific nutrients (arginine, vitamin C, zinc, vitamin E). It increases healing times of pressure sores in under-nourished patients. However, it is important that oral nutritional supplements are reviewed regularly by a dietitian. While high-protein ONS such as Cubitan have a role in helping heal ulcers and other wounds, they should be discontinued promptly once the wound has healed. Food is the best vehicle for appropriate
nutrient consumption. According to the National Medicines Information Centre in St James’s Hospital, Dublin, no studies have yet determined the optimum usage of ONS in terms of the most appropriate patients, the optimum dose, and duration of use. Despite lack of evidence, ONS has a role in many circumstances; therefore, it is important to liaise with nutrition specialists such as dieticians before ONS can be recommended. For the added reason of the high cost of ONS to the State, the HSE also recommends that ONS is only commenced after the patient is assessed by a dietician.
There is no conclusive research evidence to guide healthcare professionals’ decisionmaking about which dressings are most effective in pressure ulcer management. However, professional consensus recommends that modern dressings (ie, hydrocolloids, hydrogels, foams, films, alginates, soft silicones) should be used in preference to basic dressing types, ie, gauze, paraffin gauze and simple dressing pads.
Grade 1 ulcers may be dressed in transparent films for protection, ie, Tegaderm, Opsite. Grade 2 pressure ulcers usually require an occlusive or semipermeable dressing that will maintain a moist wound environment, ie, Comfeel Plus, Granuflex.
Ulcers with heavy exudate require an absorptive dressing to avoid build-up of chronic wound fluid that can lead to wound maceration and inhibit healing. An appropriate wound dressing can remove excess wound exudate while maintaining a moist environment to accelerate wound healing. Dressings with absorptive qualities include alginates, ie, Kaltostat, foams, ie, Allevyn, Biatain, and hydrocolloids, ie, Aquacel, Comfeel, Granuflex.
Desiccated ulcers are dry ulcers that lack wound fluids which help promote
healing. Thus, pressure ulcer healing is promoted by dressings that maintain a moist wound environment while keeping the surrounding intact skin dry. Choices for a dry wound include hydrogels, ie, Granugel, Intrasite Gel, and hydrocolloids, ie, Aquacel, Comfeel, Granuflex.
Necrotic tissue promotes bacterial growth and impairs wound-healing. Wound debridement may involve any of five approaches: Use of sharp dissection (take care when doing this on heels); mechanical debridement (wet-to-dry dressings); application of proteolytic enzymes; autolytic debridement under occlusive dressings (hydrocolloids or hydrogels); or biosurgery with sterilised maggots.
Reduce risk of infection and enhance wound-healing by hand-washing, wound-cleansing, and debridement. Protect from external sources of contamination, ie, faeces.
If purulent material or foul odour are present, more frequent cleansing and possibly debridement are required.
When there are clinical signs of infection which do not respond to treatment, x-rays should be undertaken to exclude osteomyelitis and joint infection.
Systemic antibiotics are required for patients with bacteraemia, sepsis, advancing cellulitis or osteomyelitis. l
References available upon request
Disclaimer: Brands mentioned in this article are meant as examples only and not meant as preference to other brands. Written by Eamonn Brady MPSI (Pharmacist), owner of Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore). www.whelehans.ie
Hydrocellular foam dressings for highly exudating wounds, ulcers, second degree burns & traumatic wounds.
Non-adherent • Sterile • Absorbent • Breathable
Soft silicone dressings for moderate to highly exuding wounds, ulcers, second degree burns & traumatic wounds.
Non-adherent • Silicone Layer • Absorbent • Gentle
Surgical dressings designed to treat low to moderately exuding wounds such as surgical incisions, cuts & abrasions.
Air-Permeable
Sterile
Non-Woven
Flexible and breathable strips for post-operative wound support, skin tears or following early suture removal.
Sterile
Flexible
Okay, pay attention. I often get asked what the best electric vehicle (EV) on sale is. It isn’t an easy question to answer.
Even though the electric car world remains in its infant, if not toddler, phase, there are quite considerable differences between prices, sizes, and abilities.
I can tell you what my favourite EV is, though: It is the Polestar 2. I bought a Skoda Enyaq in July 2021. It was the family car until just recently, but I sold it because, well, being honest, I got an offer on it that I couldn’t refuse, such is the strength of pricing in the used car market right now. It has been replaced, temporarily at least, with a Skoda Octavia, a good car, but a little bit of a backwards step in terms of technology and emissions. But when I
return to an EV, it will be to a Polestar 2, because this is the EV sweet spot for me.
Let me give you some context. I love Volvos. As a middle-aged man, no longer coveting GTIs, I have now developed a mild perversion toward Volvo’s 240s and 760s from the 1980s. I always liked what Volvo stood for: Safety, stability, and not wanting to show off too much because you don’t need to. There is a certain sense that the Volvo driver has their life well-organised. They pay their taxes and never miss their kid’s sports day. They are probably the coach and made brownies for after the game.
It was inevitable that a brand that seemed so conscientious would get around to making electric vehicles, and indeed they have. The XC40 Recharge, in particular, is a belter. But they went one further and
decided to create another entire brand so that they could be a little bit more mischievous. Enter Polestar. Polestar used to be the performance wing of Volvo; think BMW’s M Division. Still, now it is its electric-only brand, which is very separate from Volvo, like Lexus’ relationship with Toyota. The Polestar 2 is, as the name suggests, the second Polestar to appear. We didn’t get the Polestar 1 in Ireland, but that was a plug-in hybrid vehicle. But the Polestar 2 and subsequent models will be EV-only (there is a Polestar 3 SUV coming).
The Polestar 2 is a five-door model, with a slightly elevated stance and discreet, but striking styling. Our test car sat on 20” alloy wheels, which despite their large size, looked entirely in proportion to the rest of the vehicle. The car is generously sized, in line with BMW’s
i4 or the Tesla Model 3. These models have an interior dominated by a large infotainment screen, with an otherwise minimalist style. The Polestar 2 is very handsome; for me one of the best designs of 2022.
The standard battery is the 69kWh unit (67kWh usable), which gives a quoted 474km of range, and the power goes to the front wheels. Next up, we were driving the long-range, single motor, which had a larger battery, but one electric motor. This gives a 78kWh battery (75kWh usable) with a maximum range of 540km and can charge at 155kW. That is seriously fast charging, especially if you are at an Ionity station where you can gobble up kilowatts in minutes.
There is a more powerful version at the top of the range, with two electric motors and 408hp and 660Nm of torque. It is faster, but at the sacrifice of content (484km).
For us, the sweet spot is the bigger battery and the single electric motor, which offers excellent coverage and enough power. Of course, as you know by now, the EV range isn’t always as stated. But for us, any car that can habitually do north of 400km without
too much effort, as this can, is okay.
Prices start at just over €51,000 and for that, you are getting quite a lot – an 11.5-inch touchscreen; a 12.3-inch digital instrument panel; an eight-speaker premium audio system; Bluetooth phone connection; online Google services provided for three years; rain-sensing wipers; an electric tailgate; keyless entry; partelectric front seats; front and rear parking sensors; two-zone climate control; heated front seats; tons of safety kit (as you might expect); 19-inch alloy wheels; and cloth upholstery. There is also a Plus Pack and a Performance Pack, with the €4,815 Plus Pack well worth the money, with items, such as a panoramic roof, Harmon Kardon premium sound system, and heat pump.
I am a proper fanboy for this car. I like how it handles, how it delivers its power, the infotainment is excellent, and the space is good. It also looks brilliant. For me, this is probably my car of the year.
If you want a Polestar 2, some are in stock, unusually for an EV these days, but you can also order for 2023. Go to www.polestar. com/ie to find out more. l
AbbVie has participated in a new national campaign highlighting how scientific innovation is improving standards of care and offering Irish haematology patients increased treatment opportunities.
Retired engineer Geoffrey McDonald (81) outlines his 14-year journey with leukaemia in the ‘Six Degrees of Innovation’ video initiative.
The short film explains the purpose of new medicines creation. It also highlights the close connections that exist between a wide variety of workers in Ireland who are creating new treatments and helping bring them to those in medical need.
Geoffrey has successfully battled illness with the help of his medical team, who also appear in the video. They include Professor of Haematology Ruth Clifford, Nurse Practitioner Fidelma Hackett, and Senior Medical Scientist Ailín McMahon.
The video explains how the development of new treatments helped Geoffrey resume his active lifestyle. For the Limerick-based sailing enthusiast, the availability of innovative medicines meant he achieved remission and a break from the disease.
The video, which has been supported by the biopharmaceutical company AbbVie, is one of a series created by the Irish Pharmaceutical Healthcare Association (IPHA). The film also features two AbbVie employees from the company’s plants in Sligo and Cork who support the creation and availability of medicines used to treat blood cancer around the world.
The video was distributed on social media channels to mark September’s Blood Cancer Awareness month. Across the overall campaign, a total cast of 26 participate including
doctors, patients, scientists, and ordinary people whose lives have been touched by innovation.
With record exports, jobs and tax revenues, the biopharmaceutical industry is a major engine of Irish economic growth. The industry has shown leadership during Covid-19, with vaccines and treatments helping to turn the tide on the disease.
IPHA’s Director of Communications and Advocacy, Bernard Mallee, said: “In human health, the industry continues
to innovate for solutions for unmet medical needs and for the diseases we all know about. Medicines innovation is a lot closer to the Irish public than many people may suspect.
“In that context, it is important that we continue to protect intellectual property as the formula for the invention of new medicines. Innovate For Life, in capturing so cinematically the impact of innovation, is a way for us of us to engage with science for the public good.
Accord Healthcare is delighted to announce the launch of Midazolam 1mg/ml solution for injection/infusion, the first in their Liberandum range, which comes in a twist box containing 1 x 5ml prefilled syringe.
The Liberandum range is designed in response to the needs of HCPs who work in critical care, when every second counts.
Midazolam 1mg/ml Solution for injection/infusion in prefilled syringe is a short-acting sleep-inducing drug that is indicated for:
Conscious sedation before and during diagnostic or therapeutic procedures with
or without local anaesthesia in adult and paediatric patients.
Anaesthesia in adult patients:
Premedication before induction of anaesthesia; Induction of anaesthesia; As a sedative component in
combined anaesthesia.
Anaesthesia in paediatric patients: Premedication before induction of anaesthesia; Sedation in intensive care units, in adult and paediatric patients.
Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available at www.hpra.ie
Midazolam 1mg/ml Solution for injection/infusion in pre-filled syringe will be available from Uniphar.
For further information please contact Oliver Lawrence by email at oliver_lawrence@ accord-healthcare.com, by phone on +353 87 949 3918 or contact Accord Healthcare Ireland Ltd in Cork on 021 461 9040, or visit www.accord-healthcare.ie.
Accord Healthcare is delighted to announce the launch of another High-Tech medicine to their already extensive portfolio of High-Tech medicines: Fingolimod Accord 0.5mg, which comes in a pack size of 28 Hard Capsules.
This medicine is indicated as a single disease-modifying therapy in highly-active relapsing remitting multiple sclerosis for adult patients and paediatric patients aged 10 years and older:
Patients with highly active disease despite a full and adequate course of treatment with at least one disease-modifying therapy (for exceptions and information about washout periods see
sections 4.4 and 5.1 of SPC); or
Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year,
and with one or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available from the launch date at www.hpra.ie and for healthcare professionals at www.accord-healthcare.ie.
Fingolimod Accord will be available from both full-line wholesalers from launch. For further information you may contact Accord in Cork on 021-461 9040.
Diabetes is a difficult condition to manage and the number of people living with it is on the rise. When diabetes is poorly controlled and not managed properly it can lead to health complications for people.
While diabetes medications have evolved, people with diabetes are often still required to manually record their insulin doses, yet only achieve normal blood glucose control for around half of every day.
A Swedish study conducted by Novo Nordisk from 2017-2018 showed that, in a real-world setting, using the NovoPen 6 smart insulin pen to administer insulin can give people with type 1 diabetes up to two extra hours of glycaemic control per day.
The potential for NovoPen 6 and NovoPen Echo Plus smart insulin pens to improve the lives of people with diabetes
Novo Nordisk believes that digital health solutions such as smart insulin pens will help close the gap between the potential of modern diabetes medicines and the reality that most people struggle to use them to their best effect.
“Technology is rapidly changing the way we manage and live with diabetes, mainly Type 1 diabetes, and is enabling us to manage our condition better and achieve better long-term outcomes. The availability of new technologies, such as Smart Insulin pens, further enables us to achieve better clinical and quality of life outcomes each day and is a welcome diabetes tool in Ireland,” Dr Kate Gajewska, Clinical Manager for Advocacy and Research, Diabetes Ireland, said.
"Digital health tools such as the smart insulin pen will improve diabetes management by empowering patients with data," Prof Derek O’Keeffe, Consultant Endocrinologist at University Hospital Galway (UHG) and Professor of Medical Device Technology at the National University of Ireland, Galway, added.
We are partnering with best-in-class
providers who specialise in various tools and systems (including glucose monitoring and consumer apps) to ensure that we bring digital health solutions that meet people where they are.
With a long heritage in diabetes, NovoPen 6 and NovoPen Echo Plus smart insulin pens build on our more than 25 years’ experience developing the NovoPen. We are continuing to build understanding of the needs of people with diabetes to be able to address challenges in the day-today management of their condition and to improve the health and quality of life of people with diabetes.
About NovoPen 6 and NovoPen Echo Plus: NovoPen 6 and NovoPen Echo Plus automatically record accurate and reliable insulin dosing information, giving people insight into their own data, and enabling more productive conversations with their healthcare provider that can lead to better health outcomes.
NovoPen 6 and NovoPen Echo Plus smart insulin pens collect dose data and time and date of dose to better inform the management of diabetes alongside blood glucose monitoring.
Data from NovoPen 6 and NovoPen Echo Plus smart insulin pens can be wirelessly transferred via NFC* technology and are compatible with various diabetes management apps and existing in-clinic solutions, where injection history can be viewed side-byside with glucose information.
Patients can easily share their data with their diabetes team.
The pens are compatible with all Novo Nordisk insulins available in Ireland in a 3mL Penfill cartridge.
NovoPen 6/NovoPen Echo Plus have been available to purchase in pharmacies from 12 September 2022. Each NovoPen 6 and NovoPen Echo Plus is expected to last 4-5 years. NovoPen 6/NovoPen Echo Plus comes with a three-year full guarantee
and Novo Nordisk will replace any pens that are faulty within that period. In 2021, Novo Nordisk submitted an application to the Health Service Executive for reimbursement on the NovoPen 6 and NovoPen Echo Plus and we are still awaiting an outcome from that process. In the meantime, we believe it is important to make NovoPen 6 and NovoPen Echo Plus available now to those people who wish to use this technology to help manage their diabetes.
Visit www.diabeteswhatsnext.ie for more information on living with diabetes and NovoPen 6 and NovoPen Echo Plus smart insulin pens.
For more information contact: Novo Nordisk Ireland Limited, First Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, DO9 X8W3, Ireland. Email infoireland@ novonordisk.com, Tel: (01) 862 9700.
References
1. Adu Mary, et al. Enablers and barriers to effective diabetes self-management: A multinational Investigation. https://doi. org/10.1371/journal.pone.0217771.
2. Beck RW, et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care 2019;42:400-405.
3. Adolfsson P, et al. Increased time in range and fewer missed bolus injections after introduction of a smart connected insulin pen. Diabetes Technol Ther 2020; 22 (10): 709718. NovoPen®, NovoPen Echo®, Penfill® and the Apis bull logo are registered trademarks owned by Novo Nordisk A/S. Date of preparation: September 2022. IE22NP600015. *NFC= Near Field Communication.
Accord Healthcare is delighted to announce the launch of Zolsketil pegylated liposomal 2mg/ml concentrate for dispersion for infusion in a 20mg/10mL and 50mg/ 25mL vial.
Zolsketil is the first ever generic version of Caelyx in Europe and is crafted to the equally exacting standards as the originator product. This medicine is indicated for the treatment of several cancers:
As monotherapy for patients with metastatic breast cancer with
increased cardiac risk.
For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
In combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
For treatment of AIDS-related Kaposi’s sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/
mm3) and extensive mucocutaneous or visceral disease.
Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available from the launch date at www.hpra.ie and for Healthcare Professionals on the Accord Healthcare website www.accordhealthcare.ie.
For further information please contact Accord in Cork on 021-461 9040 or visit their website www.accord-healthcare.ie
Windzor Pharma Ireland Ltd is please to announce the launch of SOLFEROL Softgel Capsules, a range of Vitamin D3 medicines , for the treatment of Vitamin D deficiency.
This brand offers the widest range of presentations on the market 5 different strengths,, including two unique strengths, 400iu for the treatment of pregnant and breast feeding women, and 20,000iu for patients who are severely deficient in Vitamin D3.
The demand for Vitamin D3 has grown strongly in recent years due to the Covid pandemic and the need for bone health in elderly patients.
Solferol Softgel Capsules were developed in Ireland and are sold all across Europe.
The product range is now available in all pharma wholesalers
and listed on all software prescribing systems nationally.
All five presentations are available on the reimbursement schemes, with a better price for all pack sizes. The full range is as follows:
SOLFEROL Softgel Capsules
400iu x 90
SOLFEROL Softgel Capsules
800iu x 30
SOLFEROL Softgel Capsules
800iu x 90
SOLFEROL Softgel Capsules
1000iu x 28
SOLFEROL Softgel Capsules
20000iu x 4.
Full prescribing information available on www.windzorpharma.com.
As a result of an innovative scientific study from the Nutrition Research Centre Ireland (NRCI) at South East Technological University (SETU), a brand new patented nutritional supplement is now being launched onto the Irish market.
The unique ReMind food supplement was scientifically developed to contain the exact nutrient formula tested in the most recent NRCI study, which demonstrated positive effects on Alzheimer’s patients' quality of life. It reflects the very latest scientific understanding of brain nutrition and offers an over-the-counter, simple but effective addition to the overall management of a progressive disease.
The clinical trial named Re-MIND (Memory Investigation with Nutrition for Dementia), during which this product was used, finds that patients with mild-moderate Alzheimer’s disease who consume three daily supplement capsules containing fish oil, carotenoids and vitamin E demonstrate benefits from this targeted nutritional intervention.
This double-blind, placebo-controlled, randomised clinical trial is a follow-on from an earlier breakthrough study by the NRCI which took place in 2018. The trial was led by Prof John Nolan and Dr Rebecca Power of the NRCI, working with Professor Ríona Mulcahy, Consultant Physician in General and Geriatric Medicine at University Hospital Waterford.
Individuals consuming the nutritional supplement demonstrated statistically significant increases in their blood concentrations of carotenoids (plant-based pigments that give fruits and vegetables their colours), omega-3 fatty acids (the building blocks of our cells), and vitamin E (one of four essential fat-soluble vitamins) after 12 months in comparison to patients receiving a placebo.
The main outcomes of the trial include slower rates of disease progression and greater improvements in mood and memory, as reported by the carers of patients receiving the active intervention.
The research team concluded that this supplement formulation should be used as part of the overall management of Alzheimer’s disease.
The ReMind supplement, which is now patented in Ireland, the UK and the USA, contains protective active ingredients that are naturally found in the brain but decrease with age and disease. Omega-3 fatty acids are one of the key building blocks of the brain, with DHA fatty acids making up 40% of our brain. Carotenoids have been discovered in both our eyes (at the macula) and our brain. ReMind offers individuals an easy way to deliver a targeted daily boost of 500mg Omega-3 DHA, 150mg Omega-3 EPA, 15mg vitamin E, 10mg lutein, 10mg meso-zeaxanthin, and 2mg zeaxanthin to the brain.
“The relationship between targeted nutrition and brain health is now well established, and even more important than ever because of our growing and ageing population,” says Prof John Nolan at the Nutrition Research Centre Ireland.
Explaining the evidence base behind the supplement, Prof Nolan said: “The many scientific discoveries over the last two decades have led us to this point. Our earlier published studies clearly demonstrated that carotenoids are related to cognitive function in the general population across all ages. When combined
with omega-3 fish oil, we saw improved response of the carotenoids in blood, and improvements in cognitive function can be achieved with supplementation of these nutrients. Then, we observed that these positive effects can also be achieved in individuals with mild cognitive impairment. In 2014, we reported that patients with Alzheimer’s disease have very low levels of carotenoids compared to aged-matched controls, so the results of the Re-MIND trial are compelling when all the evidence is considered.”
Speaking of the ReMind product launch, Prof Nolan stated: “We are delighted that the general population can now benefit from our scientific findings with the launch of the exact nutritional supplement formulation we used in the Re-MIND trial. Only by using nutritional supplements that have a scientific evidence base, with confirmed efficacy, and quality in terms of product stability and label claim, will patients be able to benefit.”
Approved by the Supplement Certified which is an independent testing programme. ReMind is gluten-free and diabetic-friendly. It is available to order in all pharmacies for next-day availability and is in stock in selected totalhealth and Haven pharmacies nationwide. It can also be purchased at www.remind.eu. It is priced at €49.95 for a one-month supply.
