Route/method of administration I.V. -manual injection or automatic injector Dose and frequency Details are listed under each protocol for each individual CT scanner in the appropriate protocol folder (also see Appendix 1). Usually once but can be up to 2 administrations during the examination,
This Patient Group Direction (PGD) must only be used by registered health professionals who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used. Patient Group Direction For the administration of Omnipaque 300 by Radiographers with current HCPC (Health and Care Professions Council) registration and Registered nurses with a current NMC (Nursing & Midwifery Council) registration. For patients undergoing CT examinations in the Imaging department, BSUHT. Version number: 3 Change history Version number 3 3 Change details Existing PGD reviewed and transferred onto NICE/BSUH template Reviewed and approved by PGD group Date Dec 2019 Dec 2019 Approved date: May 2020 Expiry date: Dec 2022 PGD development Name Lead author Lead doctor Lead pharmacist* Representative of other professional group using PGD *Review of Version 3 Job title and organisation Edward Hussey Joon Lee David Annandale Jemma Deane, Lead Superintendent Radiographer Signature Via email Via email Via email Via email Date Dec 2019 Dec 2019 Dec 2019 Dec 2019 Organisational authorisations Brighton & Sussex University Hospitals NHS Trust authorises this PGD for use by the services or providers listed below: Imaging department BSUH Limitations to authorisation Radiographers with HCPC registration and registered nurses with current NMC only Name PGD GROUP Chief Pharmacist Medicines Governance Group chair Signature & Name Joanne Pendlebury Michael Cross Michael Okorie Date December 2019 May 2020 May 2020 Local enquiries regarding the use of this PGD may be directed to Bsuh.pgdgroup@nhs.net or PGD group chair. Appendix 1 provides a practitioner authorisation sheet. Individual practitioners must be authorised by name to work to this PGD. Approved date: May 2020 Expiry date: Dec 2022 Training and competency of registered health professionals Qualifications and professional registration Requirements of registered health professionals working under the PGD Radiographers with current HCPC registration and a minimum of 12 months post qualification clinical experience Additional requirements Registered nurse with a current NMC (Nursing & Midwifery Council) registration and a minimum of 12 months post qualification acute clinical experience THE INDIVIDUAL PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. The individual practitioner is required to have a working knowledge of adverse reactions to the medication used with the PGD and how to identify drug interactions. Initial training Has undertaken appropriate IV administration training with relevant updates as required by the Brighton and Sussex University Hospitals NHS Trust IV policy and has been assessed as competent in the role. Has undertaken appropriate training for working under patient group directions for administration of contrast media and has been assessed as competent in the role by a consultant radiologist or the author of this PGD. Has undertaken training appropriate to recognise and manage allergic/anaphylactic reactions. Has undertaken appropriate training for working under patient group directions for administration of barium sulphate and has been assessed as competent in the role. Has undertaken appropriate Trust resuscitation training and anaphylaxis training Competency assessment Continued training requirements PGD users will be responsible for collecting data and contributing to the audit of their practice. Annual Trust resuscitation and anaphylaxis training update. PGD audit and training session at each renewal period. Complete NICE Competency PGD Framework PGD e-learning 3 yearly Up to date with mandatory training Maintain knowledge and skills within specialist area Approved date: May 2020 Expiry date: Dec 2022 Clinical condition Clinical condition or situation to which this PGD applies Omnipaque 300 is a contrast agent used in CT examinations to investigate vascular anatomy and demonstrate pathology. Indications for a CT examination include: - Renal obstruction - Trauma - Infection - Diagnosis or suspicion of primary or secondary cancer - Possible vascular abnormality - Brain perfusion - Exclusion of a bleed Inclusion criteria In-patient and out-patient adults, 17 years and over. Exclusion criteria Patients with any risk factors associated with renal disease and/or taking Metformin with an eGFR of 30-59ml/min within the last month, must be managed in accordance with the departmental Policy for Managing Patients at risk of Contrast Induced Nephrotoxicity. Patients 16 years of age and under. Patients with known sensitivity to iodine preparations and the excipients. Patients who have an eGFR of <30ml/min within the last month. Patients with asthma that is currently not well controlled (Royal College of Radiologists guidelines) i.e. patient states currently experiencing increased use of medication and is wheezy. Patients with infections around the injection site for IV cannulation and a VIP score of 1. Patients who are pregnant. Manifest thyrotoxicosis. Cautions (including any relevant Please refer to the Imaging Department SOP for Management of action to be taken) Patients at Risk of Contrast Induced Nephrotoxicity intravenous use. Arrangements for referral for medical advice Action to be taken if patient excluded Action to be taken if patient declines treatment Refer to Radiologist overseeing examination Refer to Radiologist overseeing examination Refer to Radiologist overseeing examination Approved date: May 2020 Expiry date: Dec 2022 Details of the medicine Name, form and strength of medicine Include for black triangle medicines Omnipaque 300 Injection solution containing 647mg Iohexol per ml (equivalent to 300mg iodine per ml). For more detailed information, please refer to SPC. Legal category Indicate any off-label use (if relevant) Route/method of administration POM N/A I.V. -manual injection or automatic injector Dose and frequency Details are listed under each protocol for each individual CT scanner in the appropriate protocol folder (also see Appendix 1). Usually once but can be up to 2 administrations during the examination, for timing scan and actual scan or for different phases of renal function on the same scan. One administration at the start of the examination for hand injections. Quantity to be administered and/or supplied Details are listed under each protocol for each individual CT scanner in the appropriate protocol folder (see Appendix 1). Maximum or minimum treatment period Adverse effects Up to 2 administrations during the examination, for a timing scan and for the main acquisition scan as per protocol. See Appendix 1. Please refer to the Imaging Department SOP for Management of Patients at Risk of Contrast Induced Nephrotoxicity intravenous use. Special precautions for use of non-ionic monomeric contrast media in general: A positive history of allergy, asthma, or untoward reactions to iodinated contrast media. Patients using -blockers may present with atypical symptoms of anaphylaxis which may be interpreted as vagal reaction. Adequate hydration should be assured before and after contrast media administration. Patients with acute cerebral pathology, tumours or a history of epilepsy are predisposed for seizures and merit particular care. Also alcoholics and drug addicts have an increased risk for seizures and neurological reactions. Use of iodinated contrast media may cause contrast induced nephropathy, impairment of renal function or acute renal failure. · The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis. · Special care should be exercised in patients with hyperthyroidism. Patients with multinodular goitre may be at risk of developing hyperthyroidism following injection of iodinated contrast media. In the case of extravasation, please refer to the departmental procedure. Approved date: May 2020 Expiry date: Dec 2022 A detailed list of adverse reactions is available in the SPC, which are available from the electronic Medicines Compendium website: www.medicines.org.uk. BNF/C also has information on adverse effects. Drug interactions A detailed list of drug interactions is available in the SPC (summary of product which are available from the electronic Medicines Compendium website: www.medicines.org.uk BNF/C also has drug interaction information Supplies Storage Reporting procedure of adverse reactions Protocols for the ordering, storage and handling of medicines should be followed to prevent wastage Protocols for the ordering, storage and handling of medicines should be followed Healthcare professionals and individuals/parents/carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: http://yellowcard.mhra.gov.uk For Black triangle any suspected adverse reactions should be reported via the Yellow Card Scheme. Special considerations / additional information Records to be kept N/A - Patient's name, address, date of birth and hospital number. - Patient's checklist to include positive ID of patient and consent given, radiologist cover, emergency equipment available, precautions taken due to allergies, asthma, and if on metformin. - The site and size of cannula and whether eventful, or uneventful IV contrast bolus. - Contrast media used, dose, batch number and expiry date. - Saline flush. A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local policy. OR the patients should be identifiable in a timely manner for audit purposes. Written/verbal information to be given to patient or carer Ensure written patient information has been given at time of appointment. Verbal explanation of common side effects as part of consent prior to procedure. Aftercare letters for the patient and information letters for the GP will also be given to those patients who have temporarily stopped taking metformin and/or had an eGFR of <30ml/min. Patient information leaflet (PIL) available: Approved date: May 2020 Expiry date: Dec 2022 https://www.nhs.uk/medicines/ Follow-up advice to be given to patient or carer Routine or emergency CT examinations will be reported by a radiologist and a copy of the report sent to the referring clinician. Patient instructed to arrange follow up with referring clinician at the time of examination. Patients are asked to remain in the department for 15 minutes post contrast injection and in the hospital environment for a further 15 minutes post injection. Patient must return to radiology if any symptoms develop. Any unwanted side effects following the appointment patient advised to report to GP. Audit Plan for audit, It is essential for PGD renewal that audits have occurred. Frequency Nominated lead to manage audit Retrospective audit of compliance with PGD to be completed. At each renewal period Jemma Deane, Lead Superintendent Radiographer Key references Key references Omnipaque injection 300mg I/ml solution for injection, Summary of Product Characteristics, www.products.mhra.gov.uk Standards for intravascular contrast administration to adult patients, 3rd edition, Royal College of Radiologists, https://www.rcr.ac.uk/sites/default/files/Intravasc_contrast_web.pdf accessed April 2020 Management of Patients at Risk of Contrast Induced Nephrotoxicity intravenous use, Imaging department BSUH, T: drive, accessed April 2020 Approved date: May 2020 Expiry date: Dec 2022 Appendix 1 Omnipaque 300 doses for CT scans are variable dependent on the scan protocol and scanner manufacturer. Please refer to the following guidance on the dose differentials between protocols; BSUH SCANNERS Scan protocol Bladder TCC follow up Traumagram Urogram Chest and Neck Staging Cardiac Coronary artery TAVI Grafts All other routine body and head scans Dose Up to 100mls single bolus 140mls single bolus Up to 120mls (two administrations) Up to 90mls single bolus Up to a total of 100mls Up to a total of 120mls Up to a total of 100mls Up to 90mls single or double bolus Approved date: May 2020 Expiry date: Dec 2022 Appendix 2 Health professionals' agreement to practise PGD Title....................................................... Practitioner, by signing this patient group direction you are indicating that you agree to its contents and that you will work within it. Patient group directions do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practise only within the bounds of their own competence and professional code of conduct. I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of conduct Name of health professional Role Signature Date Authorising manager I confirm that the practitioners named above have declared themselves suitably trained and competent to work under this PGD. I give authorisation on behalf of Brighton & Sussex University Hospitals NHS Trust for the above named health care professionals who have signed the PGD to work under it. Name Role Signature Date Approved date: May 2020 Expiry date: Dec 2022Microsoft Word 2010 Microsoft Word 2010