15 minute read
New opportunities in accessing international cancer trials
Raising Kidney Disease Awareness
World Kidney Day took place recently, Thursday 10 March marks a global campaign aimed at raising awareness of the importance of our kidneys and encourages everyone worldwide to be aware of the disease and actively know what their own kidney health measures are.
Chronic Kidney Disease (CKD) is a common disease with an estimated one in 10 adults worldwide having the disease. In addition, kidney disease related mortality continues to increase yearly and is projected to be the 5th leading cause of death by 2040. Dr Paul O’Hara, Consultant General Physician and Nephrologist in Portiuncula University Hospital (PUH) explains, “The main job of your kidneys is to remove toxins and excess water and salts from your blood. Kidneys also help to control your blood pressure, produce red blood cells and keep your bones healthy. Diabetes, obesity and high blood pressure are key risk factors for Chronic Kidney Disease. To mark World Kidney Day on Thursday 10 March clinical staff from the Portiuncula Kidney Clinic will hold an information awareness stand for patients in the outpatient department from 9am, from left: Grace Gannon, Advanced Nurse Practitioner Cardiology; Dr Paul O’Hara, Consultant General Physician and Nephrologist and Hilda Clarke, Clinical Nurse Specialist Diabetes
“Education is a key part of managing any chronic illness and kidney disease is no different. World Kidney Day allows us to highlight the importance of screening for CKD in high risk groups, including all patients with diabetes, obesity (Body Mass Index >30) and hypertension. I encourage everyone to protect their kidneys by stopping smoking, eating a healthy diet low in salt, exercising daily, having regular health checks for diabetes and high blood pressure and avoiding
New Opportunity to Access International Cancer Trials
Roche Products (Ireland) Ltd. and Cancer Trials Ireland have announced a new partnership to deliver the first nationally accessible educational Molecular Tumour Board (MTB) in Ireland, following a successful pilot programme. The MTB is aimed at improving patients’ lives by identifying the most appropriate treatment options for oncology patients, including innovative new cancer trials both here in Ireland and internationally. This educational MTB aims to support treatment teams by providing insights through multidisciplinary discussions on the genomic findings, their clinical implications, and potential treatment options. The new partnership between Roche Ireland and Cancer Trials Ireland follows a successful pilot programme, which was rolled out between November 2020 and December 2021. During that time, sixteen institutions participated in discussing more than 30 patient cases, all with complex genomics or novel biomarkers identified via multigene sequencing reports. Of the cases discussed, 80% of presenters confirmed that the MTB discussions helped to confirm, modify or change the treatment plan for at least one of their patients. Speaking about the plans for the next phase of the MTB, Dr. Verena Murphy, Head of Research & Business Development with Cancer Trials Ireland, said, “We are excited to take over the management of the Molecular Tumour Board, and we will make this valuable, innovative resource available to the entire Cancer Trials Ireland network. We are planning to collect gained insights to build a national knowledge platform for personalised treatment, which will be of enormous benefit for cancer patients.” Precision oncology holds the promise of improved efficiency, better care and the reduction of ineffective treatments and costs. Speaking about the first nationally accessible Molecular Tumour Board in Ireland, Dr. Brian Bird, Consultant Medical Oncologist at the Bon Secours Hospital Cork, commented, “The MTB helps me confidently choose the best targeted therapies for my lung cancer patients based on modern Next Generation Sequencing prolonged use of anti-inflammatory pain killers. In those with advanced kidney failure and who are suitable, transplantation remains the best treatment option. The act of organ donation is a life-saving event and everyone is encouraged to carry an organ donor card and discuss their wishes with their loved ones.
“I started the Portiuncula Kidney Clinic in December 2021 to serve the needs of patients with kidney problems within the hospital catchment area, mainly East Galway and Roscommon and we deal with the entire spectrum of kidney conditions with referrals from both the hospital and GPs. Patients with kidney transplants and those who are on haemodialysis are cared for in the main centre in Galway University Hospitals.” Clinical staff from the Portiuncula Kidney Clinic recently held an information awareness stand for patients in the outpatient department. Advanced nurse practitioners from the Cardiology and Diabetes clinics were also available to raise awareness of high blood pressure, obesity and diabetes as the leading causes of kidney disease in Ireland.
Verena Murphy, CTI and Deirdre Poretti, Roche Ireland
of blood and tissue and deal with unexpected findings like hereditary cancer syndromes in pancreatic cancer. I’ve also learnt the value of testing for the same target using different methods to get a full understanding of how to help the patient.” For more information about Cancer Trials Ireland, visit: https://www.cancertrials.ie/
24
Dr Nicola Maher has a special interest in medical conditions in pregnancy and in particular epilepsy. Together with Sinead Murphy Advanced Nurse Practitioner in Epilepsy they run a dedicated antenatal service for women with epilepsy. Patients are seen throughout their pregnancy and preconceptual counselling is also provided. Dr Maher also is a member of the Irish Medicines in Pregnancy Service (IMPS), a multidisciplinary service based at the Rotunda Hospital which provides information and expertise to support safe and effective use of medicines before, during and after pregnancy. In Ireland approximately 25% (10000) of all people diagnosed with epilepsy are women of childbearing potential. Pharmacists are among the most trusted professions by society and are ideally placed to support and advise women who maybe planning a pregnancy or indeed are pregnant. Whether at the point of collecting prescribed regular anti-seizure medication or indeed at initiation or ceasing of contraception, opportunities exist for pharmacists to discuss pregnancy in women with epilepsy. Fortunately most women with epilepsy remain well during their pregnancy. However, up to 30% of women with epilepsy will notice a worsening of seizure control in pregnancy which can place mothers and their unborn babies at risk during the pregnancy. Some of the most commonly prescribed anti-seizure medications enjoy excellent safety profiles. None the less pregnant women often have significant anxiety around taking medication. The legacy of Valproate and the general cautions and warnings that surround medication use in pregnancy have led to many women choosing to stop medications without advice from their doctor or pharmacist. Poorly controlled epilepsy is not without serious risk to pregnant women. While these are rare, many are often preventable. Maternal mortality reports across the UK and Ireland frequently refer to maternal deaths where patients had stopped their medication due to pregnancy. Ensuring patients are fully informed of the often reassuring safety profile of their medication and providing them with accurate, up to date information are key to caring for women with epilepsy. Patients with epilepsy should be advised not to stop taking their anti-seizure medication without first speaking to their doctor.
Pre Pregnancy
All women planning a pregnancy should be offered preconceptual counselling with their neurology service and an obstetrician. This affords the opportunity to review medications and assess seizure history as well as perform serum drug levels if needed. Women with epilepsy of childbearing potential should be prescribed Folic Acid 5mg daily to reduce the incidence of neural tube defects which can be higher with some anti-seizure medications.
Contraception choice in women with epilepsy depends on their antiseizure medication. Carbamazepine for example a cytochrome enzyme inducer can lead to reduced efficacy of the combined oral contraception. Lamotrigine levels can be affected by the combined oral contraceptive pill and can lead to toxicity side effects on the pill free interval. The FSRH have excellent guidance on contraceptive use for women taking anti-seizure medication.
Written by Dr Nicola Maher, Consultant Obstetrician and Gynaecologist, Rotunda Hospital, Dublin
Nausea and Vomiting in Pregnant Women with Epilepsy
Many women experience infrequent nausea and vomiting in pregnancy and this can place women at epilepsy at risk of seizures due to lost medication doses. As a general rule, if a woman vomits within one hour of taking her anti-seizure medications a second dose can be taken. If persistent vomiting is a problem, women should see their GP or visit their obstetric caregiver. Effective antiemetics are essential in managing hyperemesis in pregnancy which can affect up to 3% of all pregnant women.
Anti-Seizure Medications Safety Profiles LAMOTRIGINE AND
LEVETIRACETAM are amongst the most commonly prescribed antiseizure medications in use today and pose no additional risks to the fetus in pregnancy. The background rate of all congenital anomalies (babies born with structural birth defects) in pregnancy is approximately 2% and neither of these drugs affect this rate. Patients taking these medications should be reassured that they are safe to take in pregnancy and that they should be encouraged to continue to take their medications to reduce seizure risks. Studies in relation to risk of developmental delay are also reassuring.
CARBAMAZEPINE, TOPIRAMATE and PHENYTOIN
Carbamazepine is a very effective anti-seizure medication. Many women who take carbamazepine have very well controlled epilepsy for years. Carbamazepine confers a small additional risk to the fetus in pregnancy. The congenital anomaly rate associated with Carbamazepine use in pregnancy is 4-5%. Similarly Topiramate which is less commonly prescribed for epilepsy confers a risk of approximately 6% of congenital abnormality. Women being prescribed these medications would especially benefit from preconceptual consultations with their neurologist and obstetrician. Individualised risk benefit discussions can be made to discuss medication best suited to the woman to optimise seizure control, while minimising risks of congenital anomaly. Phenytoin, less commonly prescribed is associated with a 6% risk of congenital anomaly. Studies in relation to developmental delay with these medication are contradictory and a risk cannot be excluded.
SODIUM VALPROATE. A pregnancy prevention programme is in existence in Ireland since 2018 for Valproate containing medications. Children exposed in utero have up to 40% risk of serious developmental disorders in addition to 10% risk of congenital abnormality. It is important that any woman prescribed Valproate does not stop taking it without consulting their doctor. Should a woman who is taking valproate become pregnant an urgent review with a neurologist should be arranged.
Lacosamide, Brivaracetam, eslicarbamazepine, clozapam, zonisamide, gabapentin and pregabalin.
There is not enough data to confirm or rule out any additional risks in pregnancy in women taking the above medication. These are second line agents often used where other treatments have been unsuccessful in controlling seizures. Studies are ongoing to evaluate their safety profile in pregnancy. The absence of this data does not equate to known harm for the fetus and again women should be advised not to stop their medication without consulting with their doctor.
Serum Drug Levels - what role do they play?
Physiologic and pharmacokinetics changes in pregnancy (e.g. increased volume of distribution, changes to renal elimination, altered hepatic enzymes) may alter serum plasma levels of antiseizure medication in pregnancy. Lamotrigine and Levetiracetam are particularly susceptible to variation in serum plasma level, especially in the third trimester and regularly require increased dosages in latter stages of pregnancy. Ideally a pre-pregnancy serum level at a time of good seizure control or an early pregnancy level is taken in order to have a target pregnancy level. Levels are then repeated each trimester to maintain target levels. Often patients will remain on a higher dose for the initial two weeks postpartum due to the increased fatigue related seizure risk at this time. Any postpartum dose changes should be made following consultation with their neurology team. It should be noted that the use of drug levels varies in clinical practice and some studies do not support routine use. Should a pregnant woman experience a seizure a drug level is always taken and doses often increased prior to the result being available. Thankfully pregnancy for most women with epilepsy remains uncomplicated and they are not at increased risk of any obstetric complications of pregnancy. Maintaining seizure control while providing up to date information on medication safety profiles are key to the care of women with epilepsy in pregnancy.
Your patients, your profession, our passion.
ABBREVIATED PRESCRIBING INFORMATION: Consult the Summary of Product Characteristics for further information. Additional information is available upon request. Noradrenaline (Norepinephrine) Kabi 1mg/ml concentrate for solution for infusion. Active ingredient: 1ml concentrate for solution for infusion contains 1mg noradrenaline (norepinephrine) base equivalent to 2mg noradrenaline (norepinephrine) tartrate. Contains 3.4mg sodium per ml. Indications: In adults for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension. Posology and method of administration: When diluted as recommended, each litre contains 40mg noradrenaline base equivalent to 80mg noradrenaline tartrate. If dilutions other than 40mg per litre are used, check infusion rate calculation carefully before starting treatment. Initial rate of infusion – 10-20ml/hour (0.16-0.32ml/min); equivalent to 0.4-0.8mg/hour noradrenaline base. Lower initial infusion rate of 5ml/hour (0.08ml/min); equivalent to 0.2mg/hour noradrenaline base may be preferred. Titration of dose – Once infusion has been established, titrate dose in steps of 0.05-0.1mcg/kg/min of noradrenaline base according to pressor effect observed (see SmPC for details). Continue infusion until adequate blood pressure and tissue perfusion maintained without therapy. Carefully monitor patient. Should only be administered by healthcare professionals familiar with use of noradrenaline and with appropriate monitoring facilities. Avoid abrupt infusion withdrawal; reduce infusion gradually. No experience in treatment of hepatic or renal impairment. Dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. Safety and efficacy in patients less than 18 years old has not been established. Method of administration – Intravenous use only after dilution. Infuse at a controlled rate using either syringe pump, infusion pump or drip counter. Administer via a central venous catheter. If not using a central venous catheter administer into a large vein whenever possible, particularly an antecubital vein to minimize risk of ischemic necrosis. Avoid catheter tie-in technique if possible. Contraindications: Hypersensitivity to the active substance or to any of the excipients, hypotension due to blood volume deficit. Do not use with cyclopropane and halothane anaesthetics as this may cause serious cardiac arrhythmias including ventricular fibrillation. Special warnings and precautions for use: Do not use undiluted. Contraindicated in patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. Should only be used in conjunction with appropriate blood volume replacement. If whole blood or blood plasma is indicated to increase blood volume, administer separately (e.g. use Y-tubing, individual containers). Prolonged administration may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. Frequently check blood pressure and rate of flow to avoid hypertension. Particular caution in patients with coronary, mesenteric or peripheral vascular thrombosis, hypotension following myocardial infarction, angina (particularly Prinzmetal’s variant angina), diabetes, hypertension or hyperthyroidism, major left ventricular dysfunction associated with acute hypotension (supportive therapy should be initiated simultaneously with diagnostic evaluation; reserve noradrenaline for patients with cardiogenic shock and refractory hypotension, in particular those without elevated systemic vascular resistance), liver failure, severe renal dysfunction, ischemic heart diseases and elevated intracranial pressure. Reduce dose if heart rhythm disorders occur during treatment. Cardiac arrhythmias may arise when used in conjunction with cardiac sensitizing agents and may be more likely in patients with hypoxia or hypercarbia. Elderly patients may be especially sensitive to the effects of noradrenaline. Not recommended in children. Where indicated, appropriate replacement therapy of blood or fluid together with adoption of the supine position with elevation of the legs, must be instituted and maintained prior to and/or during therapy with noradrenaline. During infusion, record blood pressure every two minutes from the time the administration started until the desired blood pressure is obtained and then every five minutes thereafter if infusion continued. Constantly watch flow rate and never leave patient unattended. Hypertension may eventually lead to acute pulmonary oedema, arrhythmia or cardiac arrest. Caution in patients receiving pressor amines with chloroform, enflurane or other halogenated anaesthetics (may cause serious cardiac arrhythmias) or any other cardiac sensitising agent or in patients who exhibit profound hypoxia or hypercarbia. Extreme caution in patients receiving monoamine oxidase inhibitors or within 14 days of cessation of such therapy and in patients receiving tricyclic antidepressants, adrenergic- serotoninergic drugs or linezolid. Overdoses or conventional doses in hypersensitive persons may cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating and vomiting. The infusion site should be checked frequently for free flow. Care should be taken to avoid extravasation of noradrenaline tartrate into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug (see SmPC for antidote for extravasation ischaemia). Blanching along the course of the infused vein warrants consideration of changing infusion site at intervals. Avoid administration via the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases. Noradrenaline interacts with other medicinal products; some combinations are inadvisable or require additional precautions and close medical supervision – see SmPC. Undesirable effects: Anxiety, insomnia, confusion, weakness, psychotic state, transient headache, tremor, acute glaucoma, bradycardia, arrhythmia, electrocardiogram change, tachycardia, cardiogenic shock, stress cardiomyopathy, palpitations, increase in the contractility of the cardiac muscle resulting from the beta- adrenergic effect on the heart (inotrope and chronotrope), acute cardiac insufficiency, hypertension, peripheral ischaemia including gangrene of the extremities, plasma volume depletion with prolonged use, dyspnoea, respiratory insufficiency or difficulty, nausea, vomiting, paleness, scarification of the skin, bluish skin colour, hot flushes or skin redness, skin rash, hives or itching, retention of urine, extravasation, necrosis at injection site. Legal Category: POM Marketing Authorisation Number: PA2059/073/001 Marketing Authorisation Holder: Fresenius Kabi Deutschland GmbH; Else-Kröner Straße 1, 61352 Bad Homburg v.d.Höhe, Germany Further Information: See the SmPC for further details. Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie, E-mail: medsafety@hpra.ie. Adverse events should also be reported to Fresenius Kabi Limited via email Pharmacovigilance.GB@Fresenius-Kabi.com. Date of Preparation: January 2022 FPI-0041
Fresenius Kabi Limited Fresenius Kabi Ireland Unit 3B Fingal Bay Balbriggan, Co. Dublin Ireland Website: www.fresenius-kabi.com/ie/ Email: FK-enquiries.ireland@fresenius-kabi.com Phone: +353 (0)1 841 3030
Date of Prep: March 2022 Job Code: IE-IVF-2200006
