44 minute read
Budget 2022: Critical moment for mental health services
Budget 2022: Critical Moment for Mental Health
Professor Anne Doherty, Consultant Liaison Psychiatrist and Chair of the IHCA Psychiatry Committee
Hospital consultants are calling on Government to set funding for Ireland’s mental health services at realistic levels, as the impact of Covid-19 continues to expose the decades-long detrimental effects of severe deficits across the service. Commenting on the launch of its Mental Health Pre-Budget 2022 Submission, the Irish Hospital Consultants Association (IHCA) says that there is now an opportunity to ensure that the mental health services are able to provide for ongoing increasing demand. However, there was a stark warning that providing psychiatric care to patients while living alongside Covid has and will continue to present significant challenges because of the overwhelming capacity deficits that have existed for more than a decade. With record numbers of people on waiting lists to be assessed and treated by a hospital consultant, as well as unprecedented numbers of patients presenting to Emergency Departments for mental healthcare, the IHCA says that targeted funding, beds and staffing is required now to deliver timely access to quality care for all patients.
Funding Inadequacies
While the 2021 Mental Health Budget of ¤1,114.1m is 9% above the equivalent 2009 expenditure level, given the population growth since then, the current mental health budget is actually ¤2,000 per 1,000 population below the spend 13 years ago. At 5.4% of the overall health budget, the mental health budget in 2021 is also half the level of spending compared with other European neighbours and is low by international standards. Germany, the Netherlands and Sweden all spend approximately 11% of government health spending on mental health, with France allocating 13%. For Budget 2022, the IHCA urges the Government to increase capital expenditure for Ireland’s mental health services and for its allocation to be expedited to address the physical infrastructure deficits that have resulted from more than a decade of capital cuts and underinvestment.
Immediate Capacity
With bed shortages and long waiting lists, the acute hospital system continues to feel the strain. Ireland has the third lowest number of inpatient psychiatric care beds in the EU, at just 32.69 per 100,000 inhabitants - this is half the EU27 average of 73.12 beds per 100,000. Yet more than 1 in 8 inpatients spend six months or longer in an acute mental health bed, highlighting the lack of a suitable alternative placement for those with severe and enduring mental illness, who often have inappropriately long acute inpatient stays due to the lack of suitable step-down facilities. Consultants say that the provision of an additional 28 acute psychiatric beds as outlined in the HSE’s National Service Plan 2021, while welcome, will not address the enormous shortfall in our psychiatric bed capacity, which reduced by 68% between 2004 and 2019. They estimate that an immediate increase of at least 300 acute adult psychiatric inpatient beds is required to meet recommended levels. In light of the pandemic and the challenges of infection control, the fact that the majority of mental health units are in dormitory style format is also a concern. The IHCA recommends a greater number of single occupancy rooms made available to reduce the risk of not just Covid-19, but any viral or contagious infection spreading between vulnerable patients.
Consultant Staffing
At a time where some Emergency Departments are witnessing 8-fold increases in the number of patients presenting with mental health crises – especially among young people – the IHCA says it is unacceptable that more than 1 in 5 approved Consultant Psychiatry posts are vacant or filled on a temporary basis across the country. The Association has long pointed to the ongoing salary inequity (applied since 2012) as the root cause of Ireland’s Consultant Psychiatrist recruitment and retention crisis, calling on Minister for Health Stephen Donnelly to deliver on his ‘unambiguous commitment’ to remedy the discrimination against consultants who have taken up contracts since 2012 and for future appointees. Consultant vacancies are contributing to persistent and damaging waiting lists for treatment which are likely to worsen over the coming months with the impact of the pandemic hitting all areas of the health service, especially mental health. First signs are already showing increased presentations of patients in crisis at Emergency Departments, which are often chaotic environments and not an appropriate setting for treating those who are acutely mentally unwell for a prolonged period of time. Commenting on the submission, Professor Anne Doherty, Consultant Liaison Psychiatrist and Chair of the IHCA Psychiatry Committee says, “The pandemic has completely exposed the cracks across our public hospital system, including in our mental health services. The combination of gaping mental health capacity deficits with significantly increased demand for treatment of mental illnesses impacted by Covid-19 is stretching our acute services to breaking point. It has focused our attention on the urgent need to dedicate specific funding and resources to mental health, anticipating the wider impact of the pandemic on our population. “We are at a pivotal moment and decision-making around this Budget is critical. It provides an opportunity to get it right, making a huge difference for our mental health patients. “The solution is obvious: we must open the necessary level of beds and recruit the required number of Consultant Psychiatrists - and quickly. Government action now will prevent the current pandemic healthcare crisis drawing out for the rest of the decade and impacting on the nation’s mental health for years to come.”
Enabling people with depression to feel, think and do better1
Brintellix is indicated for the treatment of major depressive episodes in adults1
Brintellix® (vortioxetine) film-coated tablets
Prescribing information: Please refer to the full Summary of Product Characteristics (SPC) before prescribing, particularly in relation to side effects, precautions and contraindications. Presentation: Tablets containing 5, 10, 15 or 20mg vortioxetine. Indication: Treatment of major depressive episodes in adults. Dosage: 10mg once daily. May be increased to a maximum 20mg daily or reduced to 5mg if necessary. After symptoms resolve, treatment recommended for at least 6 months. Can be taken with or without food. Elderly (≥65 years): Initial dosage is 5mg once daily. Caution advised if using doses above 10mg daily. Children (7-11 years): Not recommended. Adolescents (12-17 years): Not recommended in major depressive disorder; efficacy not established. Cytochrome P450 inhibitors and inducers: Consider a dose reduction of vortioxetine if a strong CYP2D6 inhibitor is added. Consider a dose adjustment if a broad CYP450 inducer is added to treatment. Renal or hepatic impairment: No dose adjustment; subpopulations are vulnerable and data on the use of Brintellix are limited. Contraindications: Hypersensitivity to the active substance or excipients. Concomitant use with non-selective, monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (e.g. moclobemide). Fertility, pregnancy and lactation: Limited data; should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus. Animal studies showed reproductive toxicity. Use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Potential risk of postpartum haemorrhage following exposure to an SSRI or SNRI within the month prior to birth. Excreted into human milk, risk to the breastfeeding child cannot be excluded. Animal data showed no effect on fertility, sperm quality or mating performance. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed. Please refer to SPC for more detail. Warnings & Precautions: Closely supervise patients, especially those at high risk for suicide-related behaviours during first few weeks of treatment and during dose changes. Use with caution in patients: at risk of hyponatraemia; with a history of mania/hypomania; aggression/agitation; undergoing ECT; with unstable epilepsy (discontinue if seizures begin for the first time or increase in frequency); with bleeding tendencies/disorders, taking anticoagulants or medicines affecting platelet function; in patients on lithium or tryptophan; with increased intraocular pressure, or those at risk of acute narrow angle glaucoma. Monitor patients for appearance of serotonin syndrome or neuroleptic malignant syndrome and discontinue if occurs. Patients may experience feelings of aggression, anger, agitation and irritability. Patients/caregivers should seek medical advice if such behaviour emerges or aggravates. SSRIs/SNRIs may increase the risk of postpartum haemorrhage. Brintellix tablets contain sodium (<1mmol/tablet). Drug interactions: Alcoholic drinks not advisable. Vortioxetine is extensively metabolised in the liver. Potential for interactions with: MAOIs, MAO-A and MAO-B inhibitors; serotonergic medicines; St John’s wort; products which may lower the seizure threshold, e.g. antidepressants, neuroleptics, mefloquine or bupropion. Lower dose may be considered if strong CYP2D6 inhibitor is added to treatment depending on patient response, these effects may be greater in patients who are poor metabolisers of CYP2D6. Dose adjustment may be considered if a broad cytochrome P450 inducer is added to treatment. Reports of false positive results in urine enzyme immunoassays for methadone in patients taking vortioxetine. Exercise caution in interpreting positive drug screen results. Effects on ability to drive and operate machines: No or negligible influence, dizziness has been reported; use caution at the start of treatment or when the dose is changed. Adverse events: Most common adverse reaction is nausea, usually mild or moderate, transient and occurs within first two weeks of treatment. The following have been reported in clinical trials and during post-marketing use: Very common (≥1/10 patients): nausea. Common (≥1/100 to <1/10): abnormal dreams, dizziness, diarrhoea, constipation, vomiting, pruritus, including generalised pruritus. Uncommon (≥1/1,000 to <1/100): flushing, night sweats. Rare (≥1/10,000 to <1/1,000): mydriasis (which may lead to acute narrow- angle glaucoma). Not known: anaphylactic reaction, hyponatraemia, insomnia, agitation, aggression, serotonin syndrome, haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding), angioedema, urticaria, rash. Sexual dysfunction: 20mg dose was associated with increase in sexual dysfunction. Class effect: Studies in patients ≥50 years of age, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. Not known if relevant to vortioxetine. Paediatrics: Higher incidences reported in adolescents for abdominal pain-related events and suicidal ideation. Prescribers should consult the full SPC in relation to other side effects. Overdose: Management consisting of treating clinical symptoms and relevant monitoring. Legal category: POM, for non-renewable supply. Brintellix Tablets, blisters of: 5mg (EU/1/13/891/002) 28 tablets. 10mg (EU/1/13/891/010) 28 tablets. 15mg (EU/1/13/891/019) 28 tablets. 20mg (EU/1/13/891/028) 28 tablets. Further information available from: Lundbeck Ireland Ltd, 4045 Kingswood Road, Citywest Business Park, Co. Dublin. Tel: 01 468 9800. Date of last revision of PI: November 2020. Reference: IE-BRIN-0254. Brintellix® is a Registered Trade Mark.
Job number: IE-BRIN-0261 Date of preparation: March 2021 Reference: 1. Brintellix Summary of Product Characteristics. Available at https://www.medicines.ie/medicines/brintellix-10-mg-film-coated-tablets-34817/smpc
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Lundbeck on: 01 468 9800 Email: SafetyLuIreland@lundbeck.com
76
Deep Vein Thrombosis Blood Clots (VTE) - The #1 Cause of Preventable Death In Our Hospitals
Written by Dr Barry Kevane, Consultant Haematologist, Mater Misericordiae University Hospital, Dublin/ Ann Marie O'Neill, Thrombosis Patient & Founder of Thrombosis Ireland
Dr Barry Kevane, Consultant Haematologist, Mater Misericordiae University Hospital, Dublin
Venous thromboembolism (VTE), which comprises of deep vein thrombosis (DVT) and pulmonary embolism (PE), is an incredibly common but frequently overlooked source of cardiovascular morbidity and mortality1, 2. Epidemiological data has consistently demonstrated that VTE is the third leading cause of cardiovascular death worldwide (after myocardial infarction and stroke)3. Survivors of VTE frequently experience life-altering chronic illness. However, it is also now clear that the majority of VTE events are likely to be preventable (particularly those which arise in association with hospital admission)4. Consequently, efforts to promote awareness of VTE risk and to implement strategies directed at improving prevention of VTE must be prioritised at national and local level. Ann Marie O'Neill, Thrombosis Patient & Founder of Thrombosis Ireland
In recent decades we have seen rapid advances in VTE care, including improvements in diagnostic technologies as well as therapeutic options. With these advances, analyses of global trends in VTE-related mortality suggest that progress in improving patient outcomes is being made5 . However, notwithstanding these incremental improvements in care, VTE remains a potentially devastating diagnosis which can be immediately fatal in severe cases and which requires expert clinical management in order to mitigate the risk of mortality and chronic morbidity3 . With the emergence of the COVID-19 pandemic and the associated thrombotic risk, patients and clinicians have been presented with new unprecedented challenges6, 7. In the field of thrombosis, we have seen ground-breaking research being undertaken nationally and internationally, with patient-centred clinical studies providing new avenues for treatment as well as presenting new paradigms for our understanding of the role of VTE and coagulation activation in systemic disease8, 9 . World Thrombosis Day is recognised on 13th October. It focuses attention on the often overlooked and misunderstood condition of thrombosis/VTE. World Thrombosis Day takes place every year on the birthday of Rudolf Virchow, who was the pioneer in the pathophysiology of thrombosis. A German physician, pathologist, biologist and anthropologist, Virchow developed the concept of ‘thrombosis’ and advanced understanding of this condition. Over a century ago, Rudolf Virchow described 3 factors that are critically important in the development of venous thrombosis. (1) venous stasis, (2) activation of blood coagulation, and (3) vein damage. These factors have come to be known as the Virchow triad. Every Year numerous events and campaigns are organised around World Thrombosis Day to raise awareness and save lives. As part of the World Thrombosis Day 2021 initiative, the VTE Dublin 2021 International Conference (in partnership with Thrombosis Ireland) will bring together some of the leading international experts in the field of VTE. Together with patient representatives supported by Thrombosis Ireland, the invited international faculty will discuss advances in the field of thrombosis with a particular emphasis on topics which have been identified as priorities by patients and their advocates, including cancerassociated VTE and thrombosis associated with COVID-19. This conference has been approved for 11 credits from the RCPI. There are three main sections of the conference. (1) Main Conference, (2) Nursing Session and (3) Patient Session. Attendance is free and you can register and see all programs at https://www.vtedublin.org/
VTE: A MAJOR GLOBAL AND NATIONAL BURDEN
VTE occurs at a frequency of approximately 1 per 1000 adults per year1, 10. VTE can happen to anyone at any age but it is strongly associated with increasing age and among individuals aged over 85 years, the incidence of VTE rises to 5-6 per 1000 per annum. Approximately two-thirds of VTE events present as DVT of the lower limbs with approximately one-third of cases presenting as pulmonary embolism (although the majority of individuals with PE will have evidence of concomitant DVT and vice versa). A small number of individuals with venous thrombosis present with blood clots at more unusual sites, including the cerebral veins and within the splanchnic circulation10 . The majority of VTE-related deaths are likely as a result of PE and recent data suggest that PE accounts for approx. 7 deaths per 100,000 individuals per annum5, 11. Untreated PE is thought to have a mortality rate approaching 30%. With advances in diagnostic and therapeutic strategies PE-related mortality appears to be decreasing, but even among patients who receive treatment, rates of early mortality may still be in excess of 10% in certain high-risk sub-groups3 . It is likely that many PE-related deaths occur suddenly or among
COMBINING POWER AND CONFIDENCE
Rosuvastatin + Ezetimibe 10 mg/10 mg
Rosuvastatin + Ezetimibe 20 mg/10 mg
Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and nonfamilial) or homozygous familial hypercholesterolaemia1
Prescribing Information: Suvezen (rosuvastatin/ ezetimibe) film-coated tablets Please refer to the Summary of Product Characteristics (SmPC) for full prescribing details. Presentations: Suvezen 10mg/10mg, 20mg/10mg and 40mg/10mg: Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe. Indication: Suvezen is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. Dosage and Administration: The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS. Special populations: Paediatric (<18 years): Safety and efficacy has not been established. Elderly (>70 years): Starting dose of 5 mg rosuvastatin is recommended. The combination is not suitable for initial therapy. Hepatic impairment: Mild: No dosage adjustment is required. Moderate/Severe: Treatment with Suvezen is not recommended. Renal impairment: Mild: No dose adjustment is necessary. Moderate (creatinine clearance <60 ml/min): The recommended start dose is rosuvastatin 5mg. Race: The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry due to increased systemic exposure. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg tablets are contraindicated in these patients. Genetic polymorphisms: In patients who are known to have specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure, a lower daily dose of Suvezen is recommended. Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5mg in patients with pre-disposing factors to myopathy. Suvezen 40 mg/10 mg tablets are contraindicated in some of these patients. Concomitant therapy: The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where coadministration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Contraindications: Hypersensitivity to the active substances or excipients. Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures. Active liver disease or any serum transaminase elevations which are unexplained, persistent or exceeding 3x the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30ml/min); myopathy or receiving concomitant ciclosporin. 40mg/10mg dose contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis; such factors include: Moderate renal impairment (creatinine clearance <60ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels of rosuvastatin may occur, Asian patients, concomitant use of fibrates. Precautions and Warnings: Skeletal muscle effects: have been reported in rosuvastatin-treated patients with all doses and in particular with doses >20mg. As with other HMG-CoA reductase inhibitors, reporting rate for rhabdomyolysis is associated with use at doses >40mg. Post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level, Suvezen and any of these other agents that the patient is taking concomitantly should be immediately discontinued. All patients starting therapy with Suvezen should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Creatine kinase (CK) measurement: CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase. If CK levels are significantly elevated at baseline (>5x ULN) a confirmatory test should be carried out within 5 – 7 days. If the repeat test confirms a baseline CK >5x ULN, treatment should not be started. Patients with pre-disposing factors for myopathy/ rhabdomyolysis: Caution should be exercised in these patients. Risk: benefit of treatment should be considered and clinical monitoring is recommended. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5x ULN) or if muscular symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, then consideration should be given to reintroducing treatment at the lowest dose. Immune-mediated necrotising myopathy (IMNM): Clinically characterised by proximal muscle weakness and elevated serum CK, has been reported very rarely during or after treatment with statins, including rosuvastatin, despite discontinuation of statin treatment. In clinical trials an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives. Suvezen should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Liver effects: In controlled co-administration trials in patients receiving ezetimibe with statin, consecutive transaminase elevations ≥3x ULN have been observed. It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment. Rosuvastatin should be discontinued or the dose reduced if the level of serum transaminases is >3x ULN. The reporting rate for serious events is higher at the 40mg dose. In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with rosuvastatin. Liver disease and alcohol: As with other HMG-CoA reductase inhibitors, rosuvastatin should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. Renal effects: Proteinuria has been observed in patients treated with higher doses of rosuvastatin and was transient or intermittent in most cases. Proteinuria has not been shown to be predictive of acute or progressive renal disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40mg. Diabetes mellitus: Some evidence suggests that statins raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 – 6.9mmol/l, BMI >30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines. Interstitial lung disease: Exceptional cases have been reported with some statins, especially with long term therapy. Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected, statin therapy should be discontinued. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir. Consideration should be given both to the benefit of lipid lowering by use of Suvezen in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and up titrating rosuvastatin doses in patients treated with protease inhibitors. The concomitant use with certain protease inhibitors is not recommended unless the dose of rosuvastatin is adjusted. Fibrates: The safety and efficacy of ezetimibe administered with fibrates have not been established. If cholelithiasis is suspected in a patient receiving Suvezen and fenofibrate, gallbladder investigations are indicated and therapy should be discontinued. Anticoagulants: If Suvezen is added to warfarin, another coumarin anticoagulant, or fluindione, the International Normalised Ratio (INR) should be appropriately monitored. Fusidic acid: Suvezen must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g., for the treatment of severe infections, the need for co-administration of Suvezen and fusidic acid should only be considered on a case by case basis and under close medical supervision. Suvezen contains lactose monohydrate and sodium: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Interactions: Contraindicated combinations: Ciclosporin. Not-recommended combinations: Fibrates and other lipid-lowering products, protease inhibitors, transporter protein inhibitors and fusidic acid. Other possible interactions: Cytochrome P450 enzymes, antacids, colestyramine, anticoagulants, Vitamin K antagonists, erythromycin, oral contraceptive/hormone replacement therapy. When co-administering rosuvastatin with other medicinal products known to increase exposure to rosuvastatin, doses should be adjusted (see SmPC for full details). The maximum daily dose should be adjusted so that the expected rosuvastatin exposure would not likely exceed that of a 40mg daily dose of rosuvastatin taken without interacting medicinal products. Fertility, Pregnancy and Breastfeeding: No clinical data are available on the use of ezetimibe during pregnancy. Potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of Suvezen, treatment should be discontinued immediately. Animal studies have shown excretion of medicinal product through breast milk. However, there are no data in humans. No clinical trial data on the effects of fertility in humans. Adverse Reactions: Adverse drug reactions previously reported with one of the individual components (ezetimibe or rosuvastatin) may be potential undesirable effects with Suvezen. Common (≥1/100 to <1/10): diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia, ALT and/or AST increased, asthenia and fatigue. Uncommon (≥1/1,000 to <1/100): decreased appetite, paraesthesia, hot flush, hypertension, cough, dyspepsia, gastroesophageal reflux disease, nausea, dry mouth, gastritis, pruritus, rash, urticaria, arthralgia, muscle spasms, neck pain, back pain, muscular weakness, pain in extremity, ALT and/or AST increased, blood CPK increased, gamma-glutamyltransferase increased, liver function test abnormal, chest pain, pain, asthenia, oedema peripheral. Rare (≥1/10,000 to <1/1,000): thrombocytopenia, hypersensitivity reactions including angioedema, pancreatitis, increased hepatic transaminases, myopathy (including myositis), rhabdomyolysis, lupus-like syndrome and muscle rupture. Very rare (<1/10,000): polyneuropathy, memory loss, jaundice, hepatitis, arthralgia, haematuria, gynaecomastia. Not known: thrombocytopenia, hypersensitivity (including rash, urticaria, anaphylaxis and angioedema), depression, peripheral neuropathy, sleep disturbances (including insomnia and nightmares), dizziness, paraesthesia, cough, dyspnoea, diarrhoea, pancreatitis, constipation, hepatitis, cholelithiasis, cholecystitis, Stevens Johnson syndrome, erythema multiforme, immune-mediated necrotising myopathy, tendon disorders (sometimes complicated by rupture), myalgia, myopathy/rhabdomyolysis, oedema, asthenia. See SmPC for full details on adverse reactions. Legal Category: POM. Marketing Authorisation Numbers: 10mg/10mg: PA0540/193/001; 20mg/10mg: PA0540/193/002; 40mg/10mg: PA0540/193/003. Marketing Authorisation Holder: Sanofi-Aventis Ireland Ltd. T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland. Further information is available from: Sanofi, 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com Date of Preparation: December 2020.
Rosuvastatin + Ezetimibe 40 mg/10 mg
Single-pill combination of rosuvastatin and ezetimibe available in 3 doses**
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie; email: medsafety@hpra.ie Adverse events should also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via email to IEPharmacovigilance@sanofi.com
individuals who did not receive a timely diagnosis (based on postmortem studies), an observation which highlights the importance of raising awareness of VTE risk and ensuring access to diagnostic pathways to all patients.
RISK FACTORS FOR VTE
Hospital-acquired VTE
The majority of all VTE events occur in association with admission to hospital (where patients are often unwell with acute medical illness and are often exposed to major provoking factors such as major surgery, prolonged immobilisation etc.)1, 10, 12. The risk of VTE which is conferred by hospital admission likely persists for weeks following discharge and consequently, hospital acquired thrombosis is defined as a VTE occurring either during admission or within 90 days of discharge. Hospital acquired VTE (HA-VTE) can be prevented in the majority of cases4, 13. This can be achieved through the systematic application of VTE risk assessment and prevention protocols for all patients admitted to hospital. In the UK (and in other regions) a systematic approach to VTE risk assessment, where high-risk individuals were identified using validated risk assessment tools and then prescribed pharmacological thromboprophylaxis, was shown to significantly reduce VTE-related. However, adherence to such protocols tends to be sub-optimal. These observations have prompted the World Health Organisation and other bodies, to recognise HA-VTE as being a leading cause of preventable death associated with hospital admission4, 13 . In Ireland, the HSE have recently prioritised the development of strategies for the prevention of HA-VTE in Irish hospitals. Initiatives have included the publication of a collaborative report (Preventing Blood Clots in Hospitals) incorporating clinical practice guidelines mandating that formal VTE risk assessment should be carried out on all patients admitted to hospital14. As part of this initiative, the HSE have also launched the ‘Thrombosis Alert Card’, as a tool for educating patients and healthcare providers regarding the risk factors for VTE as well as the associated signs and symptoms. The HSE have recommended that all patients admitted to Irish Hospitals should receive this alert card and supplies were issued to all Irish hospitals in 2020. Thrombosis Ireland insist that every Patient has the right to this information in order to protect themselves, particularly during the 90 days after discharge from hospital when they are still at increased risk of getting a blood clot. Venous thromboembolism (VTE) is preventable in many cases. It is also very treatable but potentially fatal if not diagnosed on time.
Signs and Symptoms of a blood clot
• Swelling or pain in the leg or arm • Warmth or redness in the leg or arm
• Shortness of breath or rapid breathing • Chest pain (particularly when breathing deeply) • Coughing or coughing up blood If you have one or more of these symptoms, you may have a blood clot and need urgent treatment. For more information go to www.thrombosis.ie
Cancer-associated VTE
Cancer is a major risk factor for venous thrombosis. Patients with cancer have a risk of VTE which is up to 7-times higher than that seen in the general population. It is estimated that up to 20% of patients with cancer will experience a VTE event at some point over the course of their disease10, 15. Moreover, a concurrent diagnosis of a VTE event in a patient with cancer has major implications for duration of survival (in contrast to cancer patients without VTE) and a VTE event is up to 5-times more likely to be fatal in an individual with cancer in contrast to a VTE patient without a concurrent cancer diagnosis15. Prevention of cancer-associated thrombosis (CAT) is a critical, but frequently overlooked, component of cancer care. Recent clinical studies suggest that oral anticoagulants should be considered in the primary prevention of thrombosis in patients receiving chemotherapy (which further increases thrombosis risk), particularly in high-risk subgroups of patients with cancer16, 17. Ensuring patients with cancer are counselled as to their risk of thrombosis (and issued with a Thrombosis Alert Card) should also be considered as an important part of any discussion relating to cancer and cancer therapy. Despite advances in the treatment of CAT, affected patients continue to have high-rates of thrombosis recurrence as well as high-rates of anticoagulant-associated bleeding (in contrast to the general population). Further clinical and translational research is required to optimise the prevention and treatment of thrombosis in this particularly high-risk and challenging patient group. 1 in 5 of your cancer patients will experience a blood clot. Awareness of their risk, knowledge of the signs and symptoms of a blood clot and understanding that they need to get medical attention fast if they suspect a clot is crucially important. It is potentially lifesaving information.
Hormonal factors and VTE-risk
Hormonal factors (including pregnancy and the use of exogenous oestrogen preparations) are frequently implicated in the occurrence of VTE events3. Pregnancy increases the risk of VTE approximately 5-fold from baseline, however for the majority of women, the absolute risk of VTE remains low. For women who have additional co-existing risk factors for VTE, such as a family history of VTE or certain medical comorbidities, additional measures may be required to reduce the risk of a potentially devastating pregnancy-associated VTE18 . Depending on the risk profile of the individual woman, decisions to commence antenatal or postnatal thromboprophylaxis may be made. Although, fortunately, the rate of pregnancy-associated VTE is low overall, clinicians must be vigilant as VTE remains the leading cause of direct maternal mortality in the developed world. Specific VTE risk assessment tools and clinical practice guidelines have been developed for this purpose. The use of certain hormonal contraceptives and postmenopausal hormone replacement therapies have been shown to confer an increased thrombosis risk in the region of approximately 3-5 fold from baseline18 .
Clexane Safety Syringe designed to protect against needle stick injuries
Needle completely covered by the protection shield immediately after the injection
Automatic release of the safety mechanism when the plunger is fully depressed 700m+ TREATED WORLDWIDE1
® Prescribing Information: Clexane (enoxaparin sodium) & Clexane Forte Solution for
Injection in pre-filled syringes Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentations: Clexane® single dose pre-filled syringes containing either: 2,000 IU (20mg) enoxaparin sodium in 0.2ml, 4,000 IU (40mg) enoxaparin sodium in 0.4ml, 6,000 IU (60mg) enoxaparin sodium in 0.6ml, 8,000 IU (80mg) enoxaparin sodium in 0.8ml or 10,000 IU (100mg) enoxaparin sodium in 1ml. Clexane® Forte single dose pre-filled syringes containing either: 12,000 IU (120mg) enoxaparin sodium in 0.8ml or 15,000 IU (150mg) enoxaparin sodium in 1ml. Indications: In adults for: prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery; prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism (VTE); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery; prevention of thrombus formation in extracorporeal circulation during haemodialysis; treatment of unstable angina and non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid; treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI). Dosage & Administration: Each pre-filled syringe is for single use only. Prophylaxis of VTE in Surgical Patients: With moderate risk of thromboembolism, recommended dose of enoxaparin sodium is 2,000 IU (20mg) once daily by subcutaneous (SC) injection. Initiation 2hrs before surgery was proven effective and safe in moderate risk surgery. Treatment should be maintained for at least 7-10 days whatever the recovery status (e.g. mobility) and should be continued until the patient no longer has significantly reduced mobility. In patients at high risk of thromboembolism, the recommended dose of enoxaparin sodium is 4,000 IU (40mg) once daily by SC injection preferably started 12hrs before surgery. Need for earlier than 12hrs enoxaparin sodium preoperative prophylactic initiation (e.g. high-risk patient waiting for a deferred orthopaedic surgery), the last injection should be administered no later than 12hrs prior to surgery and resumed 12hrs after surgery. For patients undergoing major orthopaedic surgery an extended thromboprophylaxis up to 5 weeks is recommended. For patients with high risk of VTE undergoing abdominal or pelvic surgery for cancer, extended thromboprophylaxis up to 4 weeks is recommended. Prophylaxis of VTE in Medical Patients: Recommended dose of enoxaparin sodium is 4,000 IU (40mg) once daily by SC injection. Treatment with enoxaparin sodium is prescribed for at least 6-14 days. Benefit is not established for treatment longer than 14 days. Treatment of DVT/PE: 150 IU/kg (1.5mg/kg) administered SC once daily should be used in uncomplicated patients with low risk of VTE recurrence. 100 IU/kg (1mg/kg) twice daily should be used in all other patients such as those with obesity, symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis. The regimen should be selected based on individual assessment including evaluation of the thromboembolic risk and risk of bleeding. Enoxaparin sodium treatment is prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate. Treatment of Acute Coronary Syndromes: For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1mg/kg) every 12hrs by SC injection administered in combination with antiplatelet therapy. Treatment should be for a minimum of 2 days and until clinical stabilization (usual duration 2 to 8 days). Acetylsalicylic acid recommended for all patients without contraindications at an initial oral loading dose of 150–300mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75–325mg/day long-term. For treatment of acute STEMI, recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30mg) plus a 100 IU/kg (1mg/kg) SC dose followed by 100 IU/kg (1mg/kg) administered SC every 12hrs (maximum 10,000 IU (100mg) for each of the first 2 SC doses). Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75mg to 325mg once daily) should be administered concomitantly unless contraindicated. Recommended duration of treatment is 8 days or until hospital discharge. When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. For patients managed with PCI, if the last dose of enoxaparin sodium SC was given less than 8hrs before balloon inflation, no additional dosing needed. If the last SC administration was given more than 8hrs before balloon inflation, an IV bolus of 30 IU/kg (0.3mg/kg) enoxaparin sodium should be administered. During haemodialysis: 100 IU/kg (1mg/kg) enoxaparin sodium introduced into arterial line of the circuit at beginning of dialysis. This dose is usually sufficient for a 4-hour session. If fibrin rings are found, e.g. after a longer session, a further 50 to 100 IU/kg (0.5 to 1mg/kg) may be given. In patients with high risk of haemorrhage reduce the dose to 50 IU/kg (0.5mg/kg) (double vascular access) or 75 IU/kg (0.75mg/kg) (single vascular access). Special Populations: Elderly ≥75 years of age: For treatment of acute STEMI, an initial IV bolus must not be used. Initiate dosing with 75 IU/kg (0.75mg/kg) SC every 12hrs (maximum 7,500 IU (75mg) for each of the first 2 SC doses only, followed by 75 IU/kg (0.75mg/kg) SC dosing for the remaining doses). Paediatric: Safety and efficacy not established. Renal impairment: Dosage adjustment required for patients with severe renal impairment (creatinine clearance 15-30 mL/ min). Not recommended for patients with end stage renal disease (creatinine clearance <15 mL/ min. Hepatic Impairment: Limited data in this population therefore caution should be used. Contraindications: Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including low molecular weight heparins (LMWH) or any of the excipients. Recent (<100 days) history of immune mediated heparin-induced thrombocytopenia (HIT) or in the presence of circulating antibodies. Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known/ suspected oesophageal varices, arteriovenous malformations, vascular aneurysms/ major intraspinal/ intracerebral vascular abnormalities. Spinal/ epidural/ loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24hrs. Warnings and Precautions: Do not use interchangeably (unit for unit) with other LMWHs. History of HIT (>100 days) without circulating antibodies: Use with extreme caution in these patients and only after careful benefit-risk assessment and non-heparin alternative treatments are considered. Monitoring of platelet counts: There is a risk of antibody-mediated HIT, which is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer. It is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment; or if clinical symptoms suggestive of HIT are experienced. Patients must be aware of the symptoms and told to inform their primary care physician if experienced. If a confirmed significant decrease of the platelet count is observed (30-50% of the initial value), enoxaparin sodium treatment must be immediately discontinued, and the patient switched to another non-heparin anticoagulant alternative treatment. Haemorrhage: Use with caution in conditions with increased potential for bleeding (e.g. impaired haemostasis, history of peptic ulcer, recent ischemic stroke, severe arterial hypertension, recent diabetic retinopathy, neuro- or ophthalmologic surgery, concomitant use of medications affecting haemostasis). Laboratory tests: Increases in activated partial thromboplastin time (aPTT) and activated clotting time (ACT) may occur at higher doses but not linearly correlated with increasing enoxaparin sodium antithrombotic activity. Spinal/epidural anaesthesia or lumbar puncture: must not be performed within 24hrs of administration of therapeutic doses of enoxaparin sodium; placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin sodium is low. Skin necrosis and cutaneous vasculitis: have been reported with LMWHs and should lead to prompt treatment discontinuation. Percutaneous coronary revascularization procedures: To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI and acute STEMI, adhere precisely to the intervals recommended between enoxaparin sodium injection doses. It is important to achieve haemostasis at the puncture site after PCI. In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation. Acute infective endocarditis: Use of heparin is usually not recommended in patients with this condition. Mechanical prosthetic heart valves: Enoxaparin sodium has not been adequately studied for thromboprophylaxis in patients (including in pregnancy) with mechanical prosthetic heart valves. Elderly patients (especially >80 years old): may be at increased risk of bleeding complications at therapeutic doses. Hepatic impairment: Enoxaparin sodium should be used with caution in these patients. In patients with liver cirrhosis dose adjustment based on monitoring of anti-Xa levels is unreliable and not recommended. Renal impairment: There is
® an increased risk of bleeding for these patients therefore careful clinical monitoring is advised and biological monitoring by anti-Xa activity measurement might be considered. Enoxaparin sodium is not recommended for patients with end stage renal disease. In patients with severe renal impairment (creatinine clearance 15-30 mL/min) a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. Low body weight patients: are at increased risk of bleeding at prophylactic and treatment dose ranges. Obese patients: are at higher risk for thromboembolism however there is no consensus for dose adjustment; these patients should be observed carefully. Hyperkalaemia: Heparins can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, taking medicinal products known to increase potassium; plasma potassium should be monitored regularly especially in patients at risk. Traceability: In order to improve the LMWH traceability, it is recommended that health care professionals record the trade name and batch number of the administered product in the patient file. Sodium: For patients receiving doses >210mg/day, this medicine contains >24mg sodium, equivalent to 1.2% of the recommended maximum daily intake of sodium for an adult. Pregnancy and Lactation: Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need. Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. If an epidural anaesthesia is planned, it is recommended to withdraw treatment before. Enoxaparin sodium can be used during breastfeeding. Interactions: Not Recommended: Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac. Other thrombolytics and anticoagulants. Caution: Platelet aggregation inhibitors including acetylsalicylic acid used at anti-aggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding, Dextran 40. Systemic glucocorticoids. Medicinal products increasing potassium levels. Adverse Reactions: Very Common: Hepatic enzyme increases (mainly transaminases >3 times the upper limit of normality). Common: Haemorrhage, haemorrhagic anaemia, thrombocytopenia, thrombocytosis, allergic reaction, headache, urticaria, pruritus, erythema, injection site haematoma / pain / other reaction (such as oedema, haemorrhage, hypersensitivity, inflammation, mass, pain, or reaction). Uncommon: Hepatocellular liver injury, bullous dermatitis, local irritation, skin necrosis at injection site. Rare: Eosinophilia, cases of immuno-allergic thrombocytopenia with thrombosis (in some cases thrombosis was complicated by organ infarction or limb ischaemia), anaphylactic/anaphylactoid reactions including shock, spinal/neuraxial haematoma resulting in varying degrees of neurologic injuries including long-term or permanent paralysis, cholestatic liver injury, alopecia, cutaneous vasculitis, skin necrosis, injection site nodules, osteoporosis following therapy >3 months, hyperkalaemia. Please refer to the SPCs for full details. Legal Category: POM. Marketing Authorisation (MA) Numbers: Clexane 2,000IU: PA540/97/4; Clexane 4,000IU: PA540/97/5; Clexane 6,000 IU: PA540/97/6; Clexane 8,000 IU: PA540/97/7; Clexane 10,000 IU: PA540/97/1; Clexane Forte 12,000 IU: PA540/97/8; Clexane Forte 15,000 IU: PA540/97/2. MA Holder and further information is available on request from: Sanofi Ireland Ltd., 18 Riverwalk, Citywest Business Campus, Dublin 24 or contact IEmedinfo@sanofi.com Tel: 01 403 5600. Date of Preparation: May 2020. Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie; E-mail: medsafety@hpra.ie Adverse events can also be reported to Sanofi Ireland Ltd. Tel: 01 403 5600. Alternatively, send via Email to IEPharmacovigilance@sanofi.com
Reference: 1. Data on File – Clexane IMS Data. MAT-IE-2000431 (v2.0). Date of preparation: October 2020. Clexane (enoxaparin) SPC available at www.medicines.ie
Counselling women with regards to the risk of thrombosis is crucial (particularly for women with significant VTE risk factors), while also giving due regard to the clear benefits associated with access to these products from a reproductive health perspective19, 20 . Blood Clots are the No.1 cause of direct maternal death in our Maternity Hospitals.
COVID-19 associated thrombosis
Since the emergence of the COVID-19 pandemic, it became apparent that this infection was associated with increased coagulation activation (which appears to contribute to disease severity) and an increased risk of thrombosis. The risk of VTE appears highest among patients admitted to hospital with COVID-19 and in particular, among those who require intensive care-level support7. A number of international clinical trials are ongoing currently which are aiming to determine the optimal approach to thrombosis prevention
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and management in COVID-19. Interestingly, recent data from two such trials (including the RAPID COVID COAG trial, for which the Mater Hospital in Dublin was the sole European recruitment site), demonstrated that escalated doses of heparin may reduce the risk of death associated with COVID-19 and reduce the risk of progression to severe disease8, 9. Data from further clinical and translational studies in this area are eagerly awaited.
THE INTERNATIONAL VTE DUBLIN 2021 CONFERENCE & Thrombosis Ireland VTE Exemplar Awards
On the 7th-8th of October 2021, the 6th annual international VTE Dublin Conference will take place. This year the conference will be entirely virtual, and registration will be free of charge. This conference was first held in 2015, organised by Professor Fionnuala Ní Áinle, Consultant Haematologist, Mater hospital and Dr Tomás Breslin, Consultant in Emergency Medicine, Mater Hospital, Dublin. Each year, international leaders in the field of VTE have been invited to discuss advances in the field of VTE and related specialities. This year, the organising committee are proud to welcome global experts in the field of cancer-associated thrombosis, COVID-19, TTP and other areas VTE. Reflecting the patient-centred focus of the conference, each lecture will be accompanied by a brief patient video, outlining their personal experience of the condition being discussed. The winners of the inaugural Thrombosis Ireland VTE Exemplar awards will also be announced at this year’s conference. These awards will highlight achievements in healthcare & research settings in a number of key areas and celebrate outstanding work in improving VTE Patient Safety through risk assessment, education, information, quality improvements and research. We have many nominations for individuals, teams, hospitals and hospital groups around the country and look forward to presenting awards to all category winners at VTEDUB21. Nominations are closed for this year but we look forward to your nominations in 2022.
FUTURE DIRECTIONS
Major advances have been made in the field of VTE in recent years. The development of risk prediction models, sophisticated diagnostic technologies and novel therapeutic agents have provided clinicians with opportunities to improve outcomes for affected patients. However significant challenges remain. In particular, awareness of the magnitude of VTE risk associated with hospital admission as well as other high-risk scenarios such as active cancer and traumatic injury remains low. Moreover, VTE risk assessment tools and VTE prevention protocols are under-utilised in Irish hospitals. Further engagement between organisations such as Thrombosis Ireland, VTE Ireland and the HSE with clinicians and representative bodies will be crucial in optimising VTE care and streamlining clinical pathways into the future.
References available on request
Blood Clotting may be Root Cause of Long COVID
Professor James O’Donnell, Director of the Irish Centre for Vascular Biology, RCSI and Consultant Haematologist in the National Coagulation Centre in St James's Hospital, Dublin
New evidence shows that patients with Long COVID syndrome continue to have higher measures of blood clotting, which may help explain their persistent symptoms, such as reduced physical fitness and fatigue. The study, led by researchers from RCSI University of Medicine and Health Sciences, is published in the Journal of Thrombosis and Haemostasis. Previous work by the same group studied the dangerous clotting observed in patients with severe acute COVID-19. However, far less is known about Long COVID syndrome, where symptoms can last weeks to months after the initial infection has resolved and is estimated to affect millions of people worldwide. The researchers examined 50 patients with symptoms of Long COVID syndrome to better understand if abnormal blood clotting is involved. They discovered that clotting markers were significantly elevated in the blood of patients with Long COVID syndrome compared with healthy controls. These clotting markers were higher in patients who required hospitalisation with their initial COVID-19 infection, but they also found that even those who were able to manage their illness at home still had persistently high clotting markers. The researchers observed that higher clotting was directly related to other symptoms of Long COVID syndrome, such as reduced physical fitness and fatigue. Even though markers of inflammation had all returned to normal levels, this increased clotting potential was still present in Long COVID patients. “Because clotting markers were elevated while inflammation markers had returned to normal, our results suggest that the clotting system may be involved in the root cause of Long COVID syndrome,” said Dr Helen Fogarty, the study’s lead author, ICAT Fellow and PhD student at the Irish Centre for Vascular Biology in the RCSI School of Pharmacy and Biomolecular Sciences. This work was funded by the Welcome Trust, the Health Research Board (HRB) Irish Clinical Academic Training (ICAT) programme as well as the HRB-funded Irish COVID-19 Vasculopathy Study (ICVS). The work was also supported by a philanthropic grant from the 3M Foundation to RCSI University of Medicine and Health Sciences in support of COVID-19 research. “Understanding the root cause of a disease is the first step toward developing effective treatments,” said Professor James O’Donnell, Director of the Irish Centre for Vascular Biology, RCSI and Consultant Haematologist in the National Coagulation Centre in St James's Hospital, Dublin. “Millions of people are already dealing with the symptoms of Long COVID syndrome, and more people will develop Long COVID as the infections among the unvaccinated continue to occur. It is imperative that we continue to study this condition and develop effective treatments.”
