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Inotuzumab Ozogamicin

Description: Relapsed or refractory CD22-positive B-Cell acute lymphoblastic leukaemia.
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/ALL/Inotuzumab-Ozogamicin.pdf

University Hospital Southampton NHS Foundation Trust Constitution

Description: Read our constitution here.
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/University-Hospital-Southampton-NHS-Foundation-Trust-Constitution.pdf

UHS adult major trauma guidelines

Description: Adult Major Trauma Guidelines University Hospital Southampton NHS Foundation Trust Dr Mark Baxter Director of Major Trauma, Consultant in Older Persons Medicine Prof Rob Crouch Deputy Director of Major Trauma, Consultant Nurse in Emergency Medicine Emma Bowyer Major Trauma Centre and Wessex Trauma Network Manager Amendment’s log No. Amendments 1. Update Wessex Trauma Network Automatic acceptance tool 2. Hyperlinks added from contents page Page No. 22 4 3. Updated Guideline on the management of chest 107 injuries and chest decompression 4. Burns Operational Guidance added 55 5. Adult Major Trauma: Prophylactic Antibiotics guideline 81 Flowchart added to section 3 6. Adult Major Trauma; Prophylactic Antibiotic guideline 124 added to section 4 Date Sept 2021 Oct 2021 (v7.1) Apr 2022 (v7.2) Apr 2022 (v7.2) May 2022 (v7.3) May 2022 (v7.3) 2 NOTE: These guidelines are regularly updated. Check the intranet for the latest version. DO NOT PRINT HARD COPIES Please note these Major Trauma Guidelines are for UHS Adult Major Trauma Patients. The Wessex Children’s Major Trauma Guidelines may be found at http://staffnet/TrustDocsMedia/DocsForAllStaff/Clinical/WessexChildre nsMajorTraumaGuideline/WessexChildrensMajorTraumaGuidelines.pdf NOTE: If you are concerned about a patient under the age of 16 please contact SORT (02380 775502) who will give valuable clinical advice and assistance by phone to the Trauma Unit and coordinate any transfer required. http://www.sort.nhs.uk/home.aspx Please note current versions of individual University Hospital Southampton Major Trauma guidelines can be found by following the link below. http://staffnet/TrustDocuments/Departmentanddivisionspecificdocuments/Major-trauma-centre/Major-trauma-centre.aspx 3 Table of Contents (Hyperlinked) 1 SECTION 1: PREPARATION FOR MAJOR TRAUMA ADMISSIONS ................................................................................ 7 1.1 PRE-HOSPITAL TRIAGE & TRAUMA UNIT BYPASS TOOL ............................................................................................................ 7 1.2 ATMIST....................................................................................................................................................................... 10 1.3 ADULT MAJOR TRAUMA TEAM ACTIVATION ........................................................................................................................ 11 1.4 ADULT MAJOR TRAUMA TEAM COMPOSITION ..................................................................................................................... 12 1.5 RESPONSIBILITIES & ROLES OF TRAUMA TEAM MEMBERS ...................................................................................................... 13 1.6 HANDS-OFF HANDOVER................................................................................................................................................... 19 1.7 TRAUMA TEAM LEADER: EXECUTIVE ROLE ........................................................................................................................... 20 1.8 SITE MANAGER .............................................................................................................................................................. 21 1.9 SECONDARY TRAUMA TRANSFERS ...................................................................................................................................... 22 2 SECTION 2: TRAUMA RESUSCITATION ( ABCDE) ................................................................................................. 25 2.1 CATASTROPHIC HAEMORRHAGE......................................................................................................................................... 25 2.2 AIRWAY ........................................................................................................................................................................ 35 2.3 BREATHING ................................................................................................................................................................... 38 2.4 CIRCULATION ................................................................................................................................................................. 41 2.5 DISABILITY..................................................................................................................................................................... 46 2.6 EXPOSURE & ENVIRONMENT ............................................................................................................................................ 54 2.7 TRAUMA IMAGING.......................................................................................................................................................... 55 2.8 BURNS – OPERATIONAL GUIDANCE .................................................................................................................................... 56 2.9 ADMISSION DESTINATION ................................................................................................................................................ 57 3 TRAUMA RESUSCITATION SUPPORTING DOCUMENTS............................................................................................ 58 3.1 APPLICATION OF CELOXTM GAUZE .................................................................................................................................... 58 3.2 BELMONT RAPID INFUSER ................................................................................................................................................ 59 3.3 RESUSCITATIVE THORACOTOMY......................................................................................................................................... 60 3.4 MAJOR TRAUMA AIRWAY ALGORITHM ............................................................................................................................... 63 3.5 FRONT OF NECK ACCESS PROCEDURE ................................................................................................................................. 65 3.6 PRE-RSI CHECKLIST......................................................................................................................................................... 66 3.7 IMMEDIATE RSI CHECKLIST............................................................................................................................................... 67 3.8 TRAUMA BAY CHECKLIST.................................................................................................................................................. 68 3.9 RSI PACK LIST ................................................................................................................................................................ 71 3.10 RIB FRACTURE PATHWAY ................................................................................................................................................. 73 3.11 SCOOP STRETCHERS ........................................................................................................................................................ 77 3.12 MAJOR TRAUMA CT HOT REPORT ..................................................................................................................................... 79 3.13 ADULT MAJOR TRAUMA: PROPHYLACTIC ANTIBIOTICS GUIDELINE - FLOWCHART ......................................................................... 81 4 STANDARD OPERATING PROCEDURES .................................................................................................................... 83 4.1 UHS MANAGEMENT OF EXTREMITY BLEEDING & TOURNIQUET SOP........................................................................................ 83 4.2 UHS MAJOR HAEMORRHAGE PROTOCOL............................................................................................................................ 92 4.3 UHS GUIDELINE FOR THE MANAGEMENT OF CHEST INJURIES AND CHEST DECOMPRESSION IN ADULT MAJOR TRAUMA ................... 107 4.3.1 Executive Summary ........................................................................................................................................ 107 4.3.2 Introduction.................................................................................................................................................... 108 4.3.3 Scope .............................................................................................................................................................. 108 4.3.4 Aim/purpose................................................................................................................................................... 108 4.3.5 Definitions ...................................................................................................................................................... 109 4.3.6 Guideline for the management chest injuries and chest decompression in Adult Major Trauma ................. 109 4.3.7 Implementation.............................................................................................................................................. 112 4.3.8 Roles and responsibilities ............................................................................................................................... 112 4.3.9 Document review ........................................................................................................................................... 112 4.3.10 Process for monitoring compliance ........................................................................................................... 112 4.3.11 Appendices ................................................................................................................................................ 113 4.3.12 References ................................................................................................................................................. 113 4.4 UHS MAJOR TRAUMA TEAM SOP................................................................................................................................... 114 4.5 ADULT MAJOR TRAUMA: PROPHYLACTIC ANTIBIOTIC GUIDELINE............................................................................................ 124 4.5.1 Version control ............................................................................................................................................... 124 4 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.5.7 4.5.8 4.5.9 4.5.10 4.5.11 4.5.12 4.5.13 Index............................................................................................................................................................... 125 Introduction.................................................................................................................................................... 126 Scope .............................................................................................................................................................. 126 Aim/purpose................................................................................................................................................... 126 Definitions (if necessary) ................................................................................................................................ 126 Adult Major Trauma Antibiotic Flowchart ..................................................................................................... 127 Implementation.............................................................................................................................................. 128 Roles and responsibilities ............................................................................................................................... 128 Document review....................................................................................................................................... 128 Process for monitoring compliance ........................................................................................................... 129 Appendices ................................................................................................................................................ 129 References ................................................................................................................................................. 129 5 Introduction ‘These guidelines are the current policies and practice for the management of adult major trauma patients at University Hospital Southampton. They have been designed to provide a day to day framework for the management of patients; including the roles and responsibilities of clinical teams and their members. The guidelines were produced to try and ensure timely, consistent, high-quality care for all patients whatever day or time of day they present, recognising that these are challenging and often stressful cases. There will be situations when it is appropriate to deviate from the guidelines or where the guidelines do not cover the specific circumstances. In these cases it is essential that care of the patient is the foremost consideration, that senior staff are directly involved and that documentation is clear. If in doubt, seek senior advice and document their involvement. This second edition of the guidelines reflects the changes in practice in major trauma over the last 6 years together with changing national guidance and policy. My personal thanks to all members of the clinical and support teams who have contributed to the development of excellent practice at UHS and who have contributed to this revision. Thanks in particular to Dr Liz Shewry and Dr Simon Hughes, who begun these revisions and to Major Alan Weir who continued with this unenviable task. In addition, this second edition would not be possible without such a comprehensive first edition. Thanks for the first edition go to Dr Andy Eynon, Dr Liz Shewry and Dr Simon Hughes, who authored the first edition of these guidelines in 2012. The first edition has guided Major Trauma Care across Wessex and further afield for nearly a decade.’ Dr. Mark Baxter Director of Major Trauma, University Hospital Southampton, 6 1 Section 1: Preparation for Major Trauma Admissions 1.1 Pre-hospital Triage & Trauma Unit Bypass Tool The pre-hospital triage & trauma unit bypass tool was developed by the Wessex Trauma Network (WTN) to identify patients who have or are at high risk of having sustained major trauma. Patients who are within a 60 minute travel time of UHS may be transferred direct to UHS as the Major Trauma Centre (MTC), bypassing hospitals closer to the scene of the accident. The rationale for this is that it is time to definitive treatment rather than time to arrival in hospital that makes the biggest difference in outcomes. UHS was chosen as the MTC as it has all major trauma services on site. The pre-hospital team (Ambulance Service, BASICS, HIOWAA) will alert the ED that a patient with major trauma is en route. It is expected that a basic ATMIST (see p9) handover will be received with details of the mode and likely time of arrival of the patient. Patients who are outside a 60 minute travel time or who are deemed to be at risk of imminent airway compromise or have catastrophic haemorrhage will go initially to their nearest trauma unit (TU) for resuscitation. Once resuscitated, if the TU feel that the patient’s injuries are beyond their local facilities, the patient will be transferred on to either the MTC or another TU with specialist facilities (see Section 1.09 Secondary Trauma Transfers, p22). Certain hospitals have been designated as local receiving hospitals (LRH) by the Wessex Trauma Network. Trauma patients will only go to these hospitals if there is an imminent cardiac arrest or immediate airway problem. Patients will be expected to have only these immediate life-threatening conditions controlled before onward transfer to a TU or MTC. 7 8 Figure 1. Trauma Triage Tool (2021) 9 1.2 ATMIST Ambulance services, including the air ambulance service, are using the ATMIST handover tool. This gives basic information to enable preparations to be made to receive the patients. The sticker below is completed by the team leader and then it is stuck into the trauma booklet on arrival in ED resus. Figure 2. Pre-hospital alert ATMIST sheet 10 1.3 Adult Major Trauma Team Activation A two-tier response to trauma has been developed at UHS. A full trauma team response (Level 1 trauma call) should be instigated by the ED Consultant where a patient triggers a pre-hospital major trauma call and there is concern by the ED team that a full trauma team response is required. For less severe trauma it may be appropriate to activate the ED trauma team alone (Level 2 trauma call), which can be escalated if more significant injury is found. Criteria for activating a Level 1 trauma call (Figure 3) are based on physiology, anatomical injury, and mechanism of injury, however, this is not an exhaustive list and full trauma team activation is at the discretion of the receiving clinicians. To activate a Level 1 trauma call, contact Switchboard on 2222 and request “Adult Trauma Team, ED Resus” Physiological Respiratory rate 29 Or Pre hospital Sp02 o 110 GCS Motor Score of 4 or less Or Pre- hospital GCS of 1 fractured long bone Suspected major pelvic injury Trauma Triage Tool Activation (Trauma Unit Bypass) Other Considerations Pre-hospital intubation (Mandates Level 1 Call) Senior Clinician Concern (including mechanism) Gunshot wounds, stabbing, impaling Falls > 6 metres High impact RTC (Ejection, death of vehicle occupant, pedestrian struck by vehicle > 30mph) For the ≥ 65 age group consider • Systolic BP of ≤ 110 mmgHg • Heart Rate of ≥ 100 bpm • Fall with GCS of ≤ 12 • Taking Anticoagulants • Co-morbidities; Liver disease, renal failure, heart failure, COPD Figure 3. Criteria for Level 1 Trauma Response (December 2020) 11 1.4 Adult Major Trauma Team Composition Level 2 Trauma Team ED Consultant or ED ST4+ ED Doctor/ACP ED Nurse in charge ED Nurse x 2 HCA Level 1 Trauma Team Level 2 Trauma Team Members plus: ED Consultant Trauma Orthopaedic Consultant Major Trauma Anaesthetist Named Anaesthetist (Day) GICU SpR ODP / tech General Surgery SpR / Cons Orthopaedic Surgery SpR Site manager (if helipad arrival) Radiographer Major Trauma Clinical Coordinator (Daytime) bleep 1780 (Daytime) bleep 1783 bleep 1646 bleep 2110 bleep 1784 bleep 9990 bleep 2702 bleep 2238 bleep 1781 bleep 1963 There is agreement that the Neurosurgical SpR (bleep 2877) and Cardiothoracic SpR (bleep 9211) will not be part of unselected Level 1 calls. They may be contacted at the discretion of the Trauma Team if the pre-alert suggests their presence may be of benefit. Other specialists (eg ENT and MaxFax) may be contacted in a similar fashion. 12 1.5 Responsibilities & Roles of Trauma Team Members On receiving a major trauma alert, all members of the major trauma team should assemble in the ED Resus area to be briefed on the nature of the patient expected. This information should be written on a board or flipchart for the team to view throughout the trauma call. The Trauma Team Leader (TTL) will lead a team briefing and allocate roles in advance of the patient’s arrival. If a member of the team cannot attend within the given timeframe they should notify the ED immediately (x3807). If a specialty SpR cannot attend, the duty specialty Consultant must be informed and attend. CT CT should be informed that a potential major trauma patient will be arriving so that the scanner can be cleared and be on stand-by to perform a trauma series CT. The default emergency CT is the C level scanner adjacent to the ED (x6108 / x4999). Transfer equipment should be made ready in the expectation that the patient will be moving from resus to CT. Trauma mattresses are NOT to be used for Level 1 trauma cases. They should managed in the initial resuscitation phase on scoop, and transferred to CT/ Theatre / ITU on this scoop. If the patient remains in ED for a period of time following resuscitation then they may be transferred to a trauma mattress at this point. There is an agreed protocol for requesting a trauma series CT +/- limb angiography. The request is made electronically and then a single telephone call is made to the CT Radiographer to inform them of the request. The CT Radiographer will then inform the duty Radiology SpR who will approve request and provide the Hot Report to the trauma team. Major Haemorrhage (Code Red) If the pre-hospital information suggests that the patient has severe, life-threatening haemorrhage a ‘CODE RED’ should be called. This facilitates prompt requests for blood products from Blood Bank and allows the major trauma team to make adequate preparations for management e.g. preparation of tourniquet, preparation of rapid infuser. There is an allocated ‘Code Red Nurse’ for every shift. They should be identified when the trauma team assembles and if required prime the rapid infuser. A team of two is required for effective major haemorrhage management – a transfusion assist will be allocated to work with the ‘Code Red Nurse’ from the ED team. Consider allocation of ‘T’ (Transfusion) number for patients who have Code Red declared prehospital. A number of patient note folders and ‘T’ numbers have been pre-assigned. Blood Bank must be informed if a ‘T’ number is used, and they can issue FFP using a ‘T’ number. If a 13 ‘T’ number has already been allocated by HIOWAA then this must continue to be used on arrival at UHS. Most of the Air Ambulances carry blood for prehospital use. If HIOWAA has given blood please inform blood bank before their arrival as the Air Ambulance will need restocking. Helicopter Transfers If the patient is being transferred by helicopter, switchboard will be informed and asked to alert the helipad team (Site Manager, Portering staff). The Trauma Team is far more effective looking after major trauma patients in ED Resus rather than on the Helipad. Therefore, the priority is to transfer the patient from the Helipad to Resus before Hospital resuscitation commences. NOTE: Aside from the helipad team, no members of UHS staff are to attend the helipad even if the patient is critical 14 Trauma Team Roles Trauma Team Leader • Controls and manages the trauma team resuscitation • Makes decisions in conjunction with specialists • Priorities investigations and treatments • Is responsible for the handover and transfer • Undertakes the trauma transfer checklist, prior to departure from ED Before patient arrival • Ensures trauma team activated (consider additional specialties andseniority) • Liaises with Scribe • Ensures team members are booked in with Scribe • Introductions and roles assigned • Activates Code Red (if required). Consider plain film (CXR/PXR) if toounstable for CT • Ensures tranexamic acid is available • Briefs team. Rehearse emergency plan • Ensures Airway Assistant has started clock on patient arrival NOTE: It is imperative that the Trauma Team Leader maintains control and insists on MINIMUM noise from the Trauma Team members NOTE: The Team Leader will read aloud the Checklist for actions prior to leaving ED – the main indication for this is transfer to the CT Scanner. 15 Anaesthetist • Ensures equipment and anaesthetic drugs (Blue/Red CD pack and yellow fridge Pack) are available on patients arrival • Verbalises airway and anaesthetic plan to team leader and airway assistant • Communicates airway patency and issues to team leader and scribe on arrival • Communicates with team leader airway decision making following assessment. Ensure cervical spine immobilisation • Assess pupil size and reactivity • If indicated, RSI and ongoing sedation and ventilation • Provide ongoing assessment of GCS. Reassures patient on arrival, takes AMPLE history: A- Allergies M- Medications P- Past medical history L- Last meal E- Everything else relevant • Ensures neuro protective measures are undertaken for significant head injuries (30 degree trolley tilt, sedation, muscle relaxation, avoid tube ties and tight cspinecollar, avoid hypercapnia) • Arterial lines are rarely indicated. To avoid delay to CT this can usually be done after CT or in the operating theatre • Ensures theatres are informed as appropriate (bleep 2894 or named consultanton 1646) • Ensures CD book is signed NOTE: Insertion of invasive lines should not delay transfer to CT or theatre Airway Assistant • Completes airway check list prior to patients arrival and that difficultairway trolley is accessible if required (ask if c-mac is required) • Ensures Blue/ Red CD pack and yellow fridge pack are readily available with appropriate anaesthetic drugs drawn up in conjunctionwith Anaesthetist • Confirm airway plan • Start the clock on patient arrival • May assist with removing patients clothing, have scissors to hand • Assists anaesthetist in all airway interventions • Ensure time of intubation is recorded by scribe • Takes emergency airway equipment / drugs on any transfer(CT, Theatre, ICU) • Assists in the preparation patient for transfer to CT/theatres ASAP • Ensures CD book is signed 16 Primary Survey • Undertakes primary survey ABCDE. Clearly states findingsto Team leader and scribe • Performs procedures depending on skill levels and training. Confirmsskill level with team leader prior to patient arrival • If thoracostomies are present, re-finger to ensure patency.Is lung up or down? Delegate opposite side, if necessary • FAST scan if accredited and does not delay CT • Neurological exam needed before paralysing anaesthetic agent given • Ensure patient is kept warm • Ensures CT notified. Where indicated convey urgency of completingthe CT. Order any other radiology in discussion with the team leader,should this be appropriate Circulation • Ensures patient has two patent peripheral lines in situ (IV/IO • Ensures bloods are taken: FBC U&E LFT Crossmatch Coagulation Screen Venous Gases • Requests bloods and ensures these are sent to the lab • Performs procedures depending on skill levels and training. Confirms skill level with team leader prior to patient arrival • Administer drugs in conjunction with Drugs role • Undertakes secondary survey • Ensure patient is kept warm Monitoring/Packaging • Prepares for trauma call with warming devices • Removes all patient clothes including underwear and stored securely • Checks that all monitoring equipment is available • Connects patient monitoring on arrival • Ensures Bair Hugger / blankets are covering patient at all time • Ensures temperature is taken • Prepares patient for transfer to CT/theatres ASAP • Checks transfer stack as per the checklist • Helps with any procedures as identified e.g. catheter, chest drainand ART line 17 Drugs • Manages any external major haemorrhage if present on arrival • Assists Monitoring/Packaging with clothes removal • Liaise with Airway specialist and airway assistant to support a promptanaesthetic if required • Draws up drugs and administers them as prescribed • Helps with getting IV/IO access in conjunction with Circulation • Helps with any procedures as identified e.g. catheter, chest drainand ART line • Assists Monitoring/Packaging to prepare for transfer Scribe • Ensures correct PPE and identification worn • Use ED documentation • Records names, grades and specialities of all clinical staff attending plus time of arrival • Ensures clock is started when patient arrives • Records primary survey findings • Records all observations (including time of intubation). • Records all findings and interventions • Ensures wrist bands are applied including allergy • Observe for abnormal observation and signs indicatingpotential reactions to blood products Relative Liaison • Identify any relatives on their arrival to the department and take tothe relatives room • Ensure that relatives are kept up to date with information,where possible • To assist medical team in the delivery of patient updates and to stay with the family for further questions • If CPR is in progress discuss with team leader regarding witnessedresuscitation and if suitable offer to the relatives • Where appropriate accompany the relatives/important others to the area where the patient is to be care for next (or make sure theyare escorted) • If relatives/important others are not present whilst the patient is in theED resus room – ensure that a named individual is responsible for greeting them and passing on the necessary information 18 Code Red Prior to Arrival • Inform transfusion of code red being called and ask for MajorHaemorrhage Pack 1 • Ensure you are wearing the correct PPE and designated label • Remove x2 units of Emergency blood and scan into BloodTrak On Patient Arrival • Ensure blood products have been prescribed on the transfusion chart • Contact transfusion if major haemorrhage pack 2 is required andinform them of the requirements • Ensure the transfusion are aware of the patients destination andwhere further blood products are required to be sent Code Red Infuser Prior to Arrival • Ensure you are wearing the correct PPE and designated label • If appropriate prime the Belmont ready to infuse • Ensure Tranexamic acid 1g is available and consider second dose in massive haemorrhage On Patient Arrival • Administer blood products, under the direction of the team leaderas per the trust policy • Inform team leader when boluses have been delivered • Monitors compliance with 1:1 transfusion ratio (RBC:FFP) • Ensure the scribe has documented the number of boluses administered Code Red HCA Prior to Arrival • Ensure you are wearing the correct PPE and designated label On Patient Arrival • Takes crossmatch blood sample directly to the lab & waits for the Major haemorrhage pack 1 and bring back to ED resuscitation room • Brings blood products to ED resuscitation room and scans unitson arrival 1.6 Hands-off Handover Generally unless CPR is in progress, or there is airway compromise or concern over catastrophic haemorrhage, an ATMIST handover will be given by the ambulance staff whilst UHS staff stand-off the patient. The trauma team leader will first ask where the pre-hospital team are happy to give a 'hands off handover'. Ambulance staff assisted by UHS staff will transfer the patient from the stretcher to the trolley in resus. Patients should remain on the scoop-stretcher. 19 The ATMIST handover should be completed within 30 seconds and is designed to give ALL members of the trauma team the information necessary to proceed with the immediate care of the patient. Further information regarding the patient can be relayed to the Trauma team leader following the ATMIST handover. 1.7 Trauma Team Leader: Executive Role The ED Consultant has authority from the Chief Executive and Medical Director to request any specialty Consultant to attend. All UHS Consultants have a statutory duty to be able to respond in an emergency within 30 minutes of request. The Trauma Team Leader will: • Determine and arrange the appropriate destination for the patient i.e. theatre, ICU, ward • Ensure that medical staff of the appropriate seniority are involved in the care of the patient • Ensure that only essential imaging is performed • Ensure that necessary documentation has been completed a. Major trauma activation b. Trauma team attendance (including time of arrival and grade of doctor) c. The extent of examination performed in the ED and whether a further secondary examination is required d. The secondary survey must be signed off as complete at the earliest opportunity. The team leader is responsible for ensuring the survey is performed and documented. The default specialty to complete the secondary survey is the T&O Doctor e. Ensure spinal precautions are applied throughout where indicated f. Ensure that handover of a multi-trauma patient to a specialty service is formally documented. Until this has occurred, the patient will remain under the care of the Trauma Team Leader g. Handover between the Trauma Team Leader and the receiving team Doctor should always be done in person with a written handover of all admissions and any necessary actions NOTE: The MTC Consultant or Trauma Team Leader must always attend the CT scanner and liaise with the Anaesthetist as to the patient’s injuries and planned destination after CT. In exceptional circumstances the TTL can delegate escorting the patient to CT to an appropriately senior Doctor from outside ED – e.g. the T&O Consultant. Their principal role is not to guide resuscitation (typically this will be performed by the anaesthetist) but to ensure prompt liaison with other teams (e.g. Neurosurgery) as required. 20 1.8 Site Manager It is essential that patients can move as swiftly as possible from the ED to their place of definitive care. Patients may require immediate theatre / ICU bed / ward bed. Patients requiring immediate theatre: • Coordination of theatre will be done by the TTL with the Named Anaesthetic Consultant • Patients with isolated head / spinal cord injury requiring immediate theatre should be managed in the appropriate specialist theatre • The duty Anaesthetic Consultant will be responsible for coordinating the ongoing resuscitation NOTE: F Level Theatres recovery can be used for patients requiring ongoing resuscitation after CT whilst theatre is being prepared. Patient requiring ICU bed In principle, patients with a primary neurological diagnosis (head or spinal cord injury) should be managed on Neuro ICU with the proviso that there are very limited resuscitation facilities available in the Wessex Neurological Centre. As such, patients with ongoing resuscitation needs or with significant cardiovascular injury are best managed initially on General ICU. Patient requiring Ward bed Patients with single system injury are best managed on wards with experience of managing that injury. Patients with multi-system injury requiring a ward bed should by default go to the Major Trauma Ward (F1). Patients with isolated thoracic injuries will be admitted to the thoracic ward under the care of Thoracic surgery. NOTE: The Trauma & Orthopaedics Consultant is responsible for polytrauma patients where there is no clear single specialty. 21 1.9 Secondary Trauma Transfers The secondary transfer tool has been developed by the Wessex Trauma Network to ensure that patients with certain categories of major injury, who are managed initially in a trauma unit or local receiving hospital, are rapidly transferred to the Major Trauma Centre without delay. The categories of patient to which this applies are: a. Injuries exceed Trauma Unit capabilities b. Pre intubation GCS Motor Score 4 or Less AND evidence from CT of intracranial bleeding (any variant) c. Life threatening haemorrhage not amenable to control at Trauma Unit d. Successful resuscitative thoracotomy at Trauma Unit These patients fulfill automatic acceptance criteria for transfer to the MTC. At the Trauma Unit the senior doctor will call the Ambulance Service and state that they have a “Time Critical Trauma Transfer”. The Trauma Unit Team Leader will then inform the Major Trauma Centre via the red phone in the Emergency Department and state that there is a “Secondary Trauma Transfer”. When prompted the Trauma Team Leader will give an extended ATMIST summary of patient. • NOTE: Do not negotiate terms of admission to UHS with the Trauma Unit. The transfer tool has been specifically written to ensure automatic acceptance by the MTC. The phone call from the Trauma Unit is purely to alert the MTC rather than to seek permission for the transfer. NOTE: Any paediatric secondary transfer referrals must go via SORT (02380 775502) who will not only coordinate the transfer but also give valuable clinical advice and assistance by phone to the Trauma Unit. http://www.sort.nhs.uk/home.aspx 22 Figure 4. Major Trauma Automatic Acceptance Tool (2020) 23 After receiving a secondary trauma transfer pre-alert, the optimum response is to activate a full Level 1 Trauma Call when the patient arrives. It is expected that these patients will have a management plan in place before arrival at UHS and should move swiftly from ED to their destination. Secondary Transfer due to Pre-intubation Motor Score 4 or less • Contact Neurosurgery SpR and Site Manager • Obtain plan from Neurosurgery – Critical Care bed or direct to Theatre • Site manager to arrange Level 3 Bed - Preference NICU > GICU > CICU • Site Manager to discuss with NICU Consultant regarding patient moves if NICU is full • Site Manager to ensure relevant ICU resident medical team and Neurosurgical registrar aware of location of bed if going direct to ICU Secondary Transfer due to Life Threatening Haemorrhage • When Trauma Team arrive, brief that this is a secondary transfer, review imaging with relevant teams and plan for patient’s arrival. This may include activating Theatre or Interventional Radiology teams • Patient will go to ED Resus on arrival unless exact cause of haemorrhage known and time to prepare theatre/Interventional Radiology prior to arrival • Any decision to Bypass ED Resus is only to be made by a Consultant Team Leader Secondary Transfer due to Successful Resuscitative Thoracotomy • Inform Cardiothoracic SpR (Bleep 9211) and Site Manager • Cardiothoracic team should prepare to receive patient in Theatre. Cardiothoracic SpR to inform Consultant, activate theatres and Anaesthetist/ Perfusionist • Site manager to arrange Level 3 Bed, preference Cardiac > General > Neuro • The initial destination in UHS, ED Resus versus cardiac/thoracic theatres may need to be decided on a case by case basis by the TTL. 24 2 Section 2: Trauma Resuscitation ( ABCDE) 2.1 Catastrophic Haemorrhage Recognition and management of catastrophic haemorrhage is the first priority in trauma resuscitation. Catastrophic haemorrhage is poorly defined and simply describes bleeding that is imminently life threatening. Major haemorrhage is variously defined as: • Loss of more than one blood volume in 24 hours • Loss of 50% total blood volume in less than 3 hours • Bleeding in excess of 150ml/min A clinical based approach to defining major haemorrhage is any bleeding which results in a systolic BP 110 bpm. Pre-hospital management focuses primarily on the prevention of further blood loss and the active management of hypothermia and hypoperfusion to prevent Trauma Induced Coagulopathy (TIC). • Tranexamic Acid (TXA) should be given within three hours of injury • Minimal non-haematological fluids should be administered to maintain a central pulse • Blood is available in the pre-hospital setting via HEMS and the Air Ambulances • Tourniquets may be applied in the pre-hospital setting for the management of catastrophic limb haemorrhage 25 Non-torso Catastrophic Haemorrhage Figure 5. Management of Non-torso Catastrophic Haemorrhage 1. Direct signs of vascular injury – pulsatile haemorrhage, expanding haematoma, absence of pulse / ischaemic limb, bruit, palpable thrill, Indirect signs of vascular injury – observed pulsatile bleeding, decreased pulse, nonexpanding haematoma, injury to adjacent nerve, anatomical location of injury near vessel 2. Vascular surgery input should be obtained prior to any imaging if there are direct signs of vascular injury. This can be via the registrar bleep (1322) between 0800 and 1900 and via switch for the on-call consultant after 1900. 3. CT angiography should be undertaken in all cases of suspected vascular injury unless a. There is active haemorrhage b. There is a tourniquet in situ c. Management of other injuries have taken precedence over a controlled vascular injury Discussion with vascular surgery should follow if there is injury to a named vessel which requires surgical management i. Isolated vascular injuries at or distant to the antecubital fossa (ACF) should be referred to Plastic Surgery at Salisbury District Hospital ii. Polytrauma patients with vascular injury at or distant to the ACF should be discussed with Plastic Surgery at UHS 8am – 6pm seven days a week; 6pm – 8am seven days a week these cases should be discussed with Plastic Surgery at Salisbury 4. Pressure should be applied for at least 10 minutes but ideally 20 directly over the wound using sterile gauze. If the bleeding clearly has no prospect of being controlled in the context of a junctional injury then proceed immediately to theatre 5. CeloxTM gauze (Section 4.1) 26 6. Trauma team to transfer patient to theatre for ongoing resuscitation Tourniquets Tourniquets may be required to control life threatening limb haemorrhage. The Wessex Major Trauma Network has an agreed SOP for the use of tourniquets in the pre-hospital and hospital setting (Section 5.1). Apply direct pressure and elevate Apply haemostatic dressing and blast / Oleas bandage and keep direct No pressure on for 5 minutes Successful? Yes Successful? No Observe wound closely for Yes recurrence of bleeding and continue assessment of the patient Apply Tourniquet 5cm proximal to the bleeding wound, if pneumatic, inflate up to 180mmhg – 200mmhg Time tourniquet applied indicated on the label if available. Clearly document in the patient record the time and application of the tourniquet Refer to TUB tool and transfer appropriately Pre alert receiving hospital and advise patient with Tourniquet applied being transferred On arrival at hospital clearly inform the receiving team of the presence of the tourniquet and the time of application Figure 6. Pre-hospital Tourniquet Use 27 A TOURNIQUET INSITU IS NOT A STABLE SITUATION AND REQUIRES URGENT INTERVENTION Advised by Pre hospital team to expect a transfer with tourniquet in situ Yes Position Pneumatic tourniquet, if available (box 1), take down pre hospital dressing, reassess wound. No Can Tourniquet be released? Yes Is Bleeding No controlled? No Apply celox gauze and blast / Oleas bandage Yes Level 1Trauma call raised Are patients ABC stable on Primary Survey? No Inflate Pneumatic tourniquet if available if not reapply tourniquet Ensure a robust plan is in place to release tourniquet for 10 mins every 2hours to allow limb to re-perfuse (box 2) Contact Theatre coordinator on bleep 2894 to obtain pneumatic Tourniquet Consider early activation on Major Hameorrhage protocol Optimise patients Coagulation • 1g TXA bolus • 1g TXA infusion over 8 hours • Reverse Anticoagulation • Keep Ionised Calcium > 1mmol//l • Warm patient to normothermia • TEG to guide coagulation (if available) • Resuscitate to permissive hypotension • Activate and transfuse in accordance with the major hemorrhage protocol Plan to take patient from resus directly to theatre for surgery – Consider Vascular Surgery input Is Bleeding controlled? Yes Observe wound closely for recurrence of bleeding and continue assessment of the patient Box 1 Pneumatic Tourniquet should be placed above the CAT before removing the CAT. Remove the CAT, if bleeding recurs and cannot be controlled by direct pressure, inflate the pneumatic tourniquet. If no longer bleeding, leave pneumatic tourniquet in place, but deflated until definitive decision made about destination of patient Figure 7. In-hospital Tourniquet Use Box 2 –Release of Tourniquet Limb is acutely ischaemic as soon as the tourniquet is applied and ATP stores deplete. Tourniquet should be released for a minimum of 10 mins every 2 hours to allow period of reperfusion. This is in order to reduce the risk of irreversible microvascular injury. Risks with release of tourniquet. • Potentially fatal arrhythmia • Increased PaCO2 and lactate • Increased intracranial pressure • Severe pain • Compartment syndrome • Rhabdomyolysis 28 Cavity Catastrophic Haemorrhage Evidence of cavity catastrophic haemorrhage (persistent hypotension and/or tachycardia presumed secondary to cavity blood loss) that cannot be stabilized in ED Resus requires urgent definitive control via Surgical or Interventional Radiology means. This requires a timely discussion between the TTL, Interventional Radiologist, and relevant Surgical Consultants. Further detail can be found in Section 2.4 Circulation. Massive haemorrhage in the presence of haemodynamic instability should prompt consideration of calling in the oncall Consultant for the cavity of concern. This should be done as soon as possible, and may be considered based on the pre-hospital information received. The decision to go straight to Theatre, either bypassing Resus on arrival or bypassing CT, carries great risk, particularly as the Theatre Suite is not located in close proximity to the ED. This decision must only be taken after consultation between the Team Leader and the relevant Surgical and Anaesthetic Teams. CODE RED Patients with life threatening haemorrhage require urgent replacement of lost circulating volume with blood products. Code Red refers to the activation of the UHS massive transfusion policy (Figure 8 & Section 4.2). Rapid transfusion of blood products is achieved via the Belmont Rapid Infuser (Section 3.2). This is an extremely powerful rapid transfuser which, left unchecked, can deliver huge volumes of blood/fluids within an extremely short period of time e.g. 750ml/minute. The default is to administer repeated boluses (e.g. 250 ml) with regular reassessment of the patient. The CODE RED nurse will be in charge of the Belmont and is also responsible for ensuring an accurate running total of the volume and type of fluids / blood products administered. They should regularly liaise with the Anaesthetist and Team Leader as to ongoing requirements. The benefits of the Belmont include the ability to transfuse when disconnected from a power source but the Belmont will not heat fluids whilst running on battery power and the rate will be reduced to 50ml/minute. 29 Suspected Major Haemorrhage (MH) Action Send G+S to transfusion lab Activate CODE RED (pick up the MH red phone OR call 2222 and state ‘Major Haemorrhage’) Request Pack 1 Allocate staff member/ Code Red practitioner to coordinate transfusion activity Make plan to stop bleeding: Consider splinting, tourniquets, contacting on-call Surgeons (general surgeon bleep 9990) Endoscopist or Interventional Radiologist via switchboard Give Tranexamic acid 1g IV stat bolus dose, followed by 1g over 8 hours infusion. Ensure reversal of anti-coagulants: Warfarin: Octaplex 30iu/kg + give Vit K 10mg IV Heparin: Protamine 6U Blood: Major Haemorrhage Pack 1 Group O from nearest fridge (O-ve for women, O+ve for men) or type specific/cross matched blood from lab (dictated by urgency) Pre-thawed (type A until group specific available) available in ED for ED patients or from the Blood Transfusion Laboratory Request Major Haemorrhage Pack 2 Aims of Transfusion Haemodynamic Stabilisation Hb > 80g/l Platelet count > 75x109/l (> 150x109/l in CNS trauma) INR and APTT ratio 2 Keep iCa2+ above 1.1mmol/l with calcium chloride (starting adult dose 10ml of 10%) Temp > 36oC pH > 7.2 Lactate 13kPa Aim PaCO2 4.5-5kPa Aim MAP > 90mmHg (CPP > 60mmHg if ICP monitored) Maintain normothermia Loading with 1g IV Phenytoin should be considered In addition, the patient’s neck should be in a neutral position and the cervical collar checked to ensure venous outflow is not obstructed. Loosen cervical collar in intubated patients while keeping the head immobilised (e.g sand bags and tape). NOTE: In the absence of hypotension the whole bed should be placed on a 300 head up tilt for patients with severe head injury. This simple manoeuvre47 can significantly help in reducing raised intracranial pressure. Scoop stretchers are for extrication of patients and are used to facilitate transfers. They are uncomfortable and present a significant risk of pressure damage for all patients but particularly those with spinal cord injuries. NOTE: It is the responsibility of the team leader to ensure that the scoop stretcher or spinal boards are removed as soon as possible. Mannitol & Hypertonic Saline The European Brain Injury Consortium and the Brain Trauma Foundation recommend the use of mannitol as the osmotic drug of choice in brain injured patients. Mannitol reduces intracranial pressure within a few minutes. Patients with 1 or 2 fixed & dilated pupils, which is felt to be due to raised intracranial pressure, should receive an IV bolus of either • 10% Mannitol 1g/kg (10ml/kg 10% Mannitol), or • 2.7% saline 6ml/kg Traumatic Brain Injury: Ventilated Patients www.neuroicu.org.uk for up to date guidance. Rapid assessment including pupils and monitoring parameters. Airway Breathing Circulation Disability Environment ET tube type & length at lips; EtCO2 monitoring FiO2; RR; Tidal Volume; Bilateral air entry & SpO2 > 97% HR; BP (MAP > 90mmHg); Presence and positioning of arterial line Pupils (remove contact lenses); Sedation; ?Muscle relaxation Temperature; Glucose Ensure adequate sedation and determine level of pre-existing neuromuscular blockade using a Nerve stimulator/ TOF device. All patients should be assumed to have an unstable spinal injury unless the spinal algorithm (Figure 16) has been completed and Consultant Radiologist report confirms the absence of any acute spinal injury. Transfer patient onto Neuro ICU bed maintaining spinal alignment. • Patient should be placed in a hard cervical collar • Transfer of patient will require spinal turns or the use of a scoop stretcher • 30o head up tilt of whole bed Follow Intracranial Injury Pre-transfer Checklist (Figure 15). 48 Figure 15. Intracranial Injury Pre-transfer Checklist 49 Traumatic Brain Injury: Self-ventilating Patients www.neuroicu.org.uk for up to date guidance. Rapid assessment including pupils and monitoring parameters. Airway Breathing Circulation Disability Maintained and clear; No signs of upper airway obstruction Adequate rate and depth of respiration with Sp
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Papers Council of Governors 20 July 2022

Description: Agenda attachments 1 CoG Agenda - 20.07.2022.docx Date Time Location Chair Agenda Council of Governors 20/07/2022 14
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2022-Trust-documents/Papers-Council-of-Governors-20-July-2022.pdf

Acquiescence, not consent

Description: A court decides whether a Jehovah's Witness teenager should receive a blood transfusion when both he and his mother have refused it.
Url: /HealthProfessionals/Clinical-law-updates/Acquiescence-not-consent.aspx

Cetuximab-Irinotecan (21day)

Description: Chemotherapy Protocol COLORECTAL CANCER CETUXIMAB-IRINOTECAN (21 day) This regimen may require funding Regimen • Colorectal Cancer–Cetuximab-Irinotecan (21 day) Indication • Metastatic colorectal cancer that is positive for the wild type KRAS genotype and that has progressed after failure of oxaliplatin and irinotecan based therapy. • WHO performance status 0, 1 Toxicity Drug Cetuximab Irinotecan Adverse Effect Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation Acute cholinergic syndrome, diarrhoea (may be delayed) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • Prior to starting therapy confirm a positive wild type KRAS status • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.4 (October 2020) Page 1 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for seven days If the counts recover at this time restart the irinotecan at 80% of the original dose. If a fourteen day delay is required to allow counts to recover or there are two separate delays of seven days during treatment consider reducing the dose of irinotecan to 50% of the original dose or stopping treatment. This is one of the few regimens where asymptomatic low nadir neutrophil counts are an indication for dose modification. Where this figure is less than 0.5x109/L or where there has been an episode of febrile neutropenia the subsequent irinotecan dose should be reduced to 80% of the original dose. There is little need to adjust the dose of cetuximab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Drug Cetuximab Irinotecan Hepatic Renal Administer only when the Administer only where the serum transaminases are 5xULN or creatinine is 1.5xULN or below below and the bilirubin is 1.5xULN or below For the 350mg/m2 dose if the No adjustments are necessary bilirubin is 26 to 51umol/L although there is limited inclusive prescribe 200mg/m2. If information the bilirubin is above 51umol/L consider stopping therapy. Other Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reactions reduce the infusion rate by 50% (the total should not exceed 240 minutes). For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. Once the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. Version 1.4 (October 2020) Page 2 of 10 Colorectal – Cetuximab-Irinotecan (21 day) If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acniform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions to 200mg/m2 and 150mg/m2 respectively. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Irinotecan Irinotecan is associated with a number of toxic reactions. The next cycle of treatment should not be administered until all toxicities have resolved to 0 or 1 of the National Cancer Institute Common Toxicity Criteria scale (NCI-CTC). Seek advice if this takes longer than 14 days. Diarrhoea must have resolved completely. Where a NCI-CTC grade 2 to 4 non-haematological event has occurred the irinotecan dose must be reduced to 300mg/m2 in the first instance. If a second episode occurs despite this dose reduction delay until the symptoms have resolved and re-start the irinotecan at 250mg/m2. Stop treatment for a third episode. Regimen 21 day cycle for 6 cycles In those individuals who have had prior radical radiotherapy to the pelvis or who are 70 years of age and above or who have a performance status of 2 consider using a starting dose of irinotecan of 300mg/m2 (maximum dose 600mg). Cycle 1 Drug Cetuximab Cetuximab Irinotecan Dose 400mg/m2 250mg/m2 350mg/m2 Days 1 8, 15 1 Route Intravenous infusion over 120 minutes Intravenous infusion over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Version 1.4 (October 2020) Page 3 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Cycle 2, 3, 4, 5, 6 Drug Cetuximab Irinotecan Dose 250mg/m2 350mg/m2 Days 1, 8, 15 1 Route Intravenous infusion over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Dose Information • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) • Irinotecan will be dose banded in accordance with the national dose bands (20mg/ml) • The maximum daily dose of irinotecan is 700mg Administration Information Extravasation • Cetuximab – neutral • Irinotecan – irritant Other • Individuals should be monitored for hypersensitivity for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 10mg/min. The first infusion is given over 120 minutes. If this infusion rate is well tolerated subsequent infusions may be given over 60 minutes • Irinotecan may be administered over 30-90 minutes Additional Therapy • 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral Version 1.4 (October 2020) Page 4 of 10 Colorectal – Cetuximab-Irinotecan (21 day) • Antiemetics 15-30 minutes prior to chemotherapy on day one only - ondansetron 8mg oral As take home medication - dexamethasone 4mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral • Subcutaneous atropine 250microgram immediately prior to irinotecan for the prevention of acute cholinergic syndrome. A further 250microgram subcutaneous dose may be given to relieve cholinergic symptoms if they develop. • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • Oral loperamide 4mg single dose after the first loose stool and then 2mg every two hours continued until 12 hours after the last liquid stool. Do not use for longer than 48 hours (maximum daily dose is 16mg). Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea. • Consider oral ciprofloxacin 500mg twice daily where diarrhoea continues for more than 24 hours. Review the patient before starting this treatment. Please refer to the CSCCN guidelines on treatment of irinotecan related diarrhoea References 1. Cunningham D, Humblett Y, Sienna S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-335. 2. Wilke H et al. Cetuximab plus irinotecan in heavily pre-treated metastatic colorectal cancer progressing on irinotecan. The MABEL study. JCO 2008; 26 (33): 5335-5343. Version 1.4 (October 2020) Page 5 of 10 Colorectal – Cetuximab-Irinotecan (21 day) REGIMEN SUMMARY Cetuximab-Irinotecan (21 day) Day One Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 400mg/m2 over 120 minutes intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and the irinotecan 6. Atropine 250microgram subcutaneous for the prevention of irinotecan associated cholinergic symptoms 7. Ondansetron 8mg oral or intravenous 8. Irinotecan 350mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 9. Atropine 250microgram subcutaneous for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 10. Dexamethasone 4mg twice a day for 3 days oral starting the day after chemotherapy 11. Metoclopramide 10mg three times a day when required for the relief of nausea oral Version 1.4 (October 2020) Page 6 of 10 Colorectal – Cetuximab-Irinotecan (21 day) Cycle One Day Eight and Fifteen 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 over 60 minutes intravenous infusion Day One Cycle Two Onwards 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 250mg/m2 over 60 minutes intravenous infusion 6. Atropine 250microgram subcutaneous for the prevention of irinotecan associated cholinergic symptoms 7. Ondansetron 8mg oral or intravenous Version 1.4 (October 2020) Page 7 of 10 Colorectal – Cetuximab-Irinotecan (21 day) 8. Irinotecan 350mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 9. Atropine 250microgram subcutaneous for the treatment of irinotecan associated cholinergic symptoms Take Home Medicines 10. Dexamethasone 4mg twice a day for 3 days oral starting the day after chemotherapy 11. Metoclopramide 10mg three times a day when required for the relief of nausea oral Day Eight and Fifteen Cycle Two Onwards 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 over 60 minutes intravenous infusion Version 1.4 (October 2020) Page 8 of 10 Colorectal – Cetuximab-Irinotecan (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Update of premedication due to shortage of IV ranitidine. 1.4 October 2020 IV ranitidine changed to H2 antagonist according to local formulary choice and availability Arum Shortland Pharmacist Dr Debbie Wright Pharmacist Coding removed Dose banding updated Header changed Bolus removed from chlorphenamine Irinotecan administration instructions added Metoclopramide dose changed 1.3 May 2014 to 10mg Atropine added as a standard Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician treatment before irinotecan Dexamethasone administration route clarified Dexamethasone TTO clarified Coding updated Disclaimer added Duration if infusion of irinotecan changed from 30 minutes to 90 1.2 Oct 2012 minutes in the regimen and regimen summary. Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist OPCS delivery code changed from X72.2 to X72.1 & X72.4. In the treatment summary ondansetron moved to be given after the cetuximab but before 1.1 the irinotecan. Spelling of Nov 2011 chlorpheniramine changed to chlorphenamine and fifeteen to Dr Debbie Wright Pharmacist Rebecca Wills Pharmacist fifteen. In the additional therapy single dose of loperamide 4mg added. 1 Sept 2011 None Dr Debbie Wright Pharmacist Dr Tim Iveson Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust Version 1.4 (October 2020) Page 9 of 10 Colorectal – Cetuximab-Irinotecan (21 day) University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.4 (October 2020) Page 10 of 10 Colorectal – Cetuximab-Irinotecan (21 day)
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EC-PPH Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab

Description: Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-EPIRUBICIN-PACLITAXEL-PERTUZUMABTRASTUZUMAB (EC-PPH) Regimen • Breast Cancer – Cyclophosphamide-Epirubicin-Paclitaxel-PertuzumabTrastuzumab (EC-PPH) Indication • Neo-adjuvant / adjuvant therapy of breast cancer • WHO Performance status 0, 1, 2 Toxicity Drug Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab Adverse Effect Dysuria, haemorrhagic cystitis, taste disturbances Cardio-toxicity, urinary discolouration (red) Hypersensitivity, hypotension, bradycardia, peripheral neuropathy, myalgia and back pain on administration Diarrhoea, hypersensitivity reactions, headache, reduced appetite, dyspnoea, cough, vomiting, nausea, constipation, rash, pain, oedema, fatigue, asthenia, cardiotoxicity Cardio toxicity, acute respiratory distress syndrome, infusion related effects The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. The diarrhoea can be severe in patients treated with pertuzumab. It is important to ensure patients are given appropriate therapy for the treatment of diarrhoea. This is not included in the regimen on Aria and must be added from the support folder. Monitoring Regimen • FBC, U&E’s and LFT’s prior to day 1 for cycles containing cyclophosphamide, epirubicin and paclitaxel. A full blood count should also be conducted before days 8 and 15 of paclitaxel administration. During the administration of trastuzumab with pertuzumab alone this may be reduced to once every three months. • Ensure adequate cardiac function before and at regular intervals during treatment. Baseline LVEF should be measured, particularly in patients with a history of cardiac problems or in the elderly. An echocardiogram should be Version 1 (Feb 2021) Page 1 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) conducted before cycle four and then three monthly thereafter. • HER2 status before initiating therapy Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. The following guidelines apply to chemotherapy only. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met on day 1 of treatment. Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL (80g/l) In the adjuvant / neo-adjuvant setting always check with the relevant consultant before delaying or reducing the dose in response to a toxicity. If counts on day one are below these criteria for neutrophils and platelets then delay treatment for seven days. Treatment should only be re-started when these levels are reached. Treatment may be resumed at the original dose or reduce the dose of cyclophosphamide and epirubicin to 80% of the original dose where a NCI-CTC grade 3 or above haematological event has occurred. Consider stopping the paclitaxel. If a second episode of neutropenia and / or thrombocytopenia occurs, despite dose reduction or the time to reach the eligible level is longer than seven days consider changing or stopping therapy. No dose modifications for haematological toxicity are necessary for pertuzumab or trastuzumab. If treatment is not tolerated it should be stopped. Version 1 (Feb 2021) Page 2 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Kidney Impairment Drug Creatinine Clearance (ml/min) more than 20 Cyclophosphamide 10-20 Less than 10 Dose (% of original dose) 100 75 50 Paclitaxel No dose adjustment necessary Epirubicin Dose reduce in severe impairment only Pertuzumab The safety and efficacy of pertuzumab has not been established in renal impairment Trastuzumab No dose adjustment necessary Liver Impairment Drug Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab Recommendation Dose reduction may not be necessary Bilirubin (umol/L) Dose (% of original) 24-51 50 52-85 25 85 or greater Contra-indicated If AST 2-4 x ULN and bilirubin 21-51μmol/L give 50% dose , if the AST greater than 4 x ULN or bilirubin greater than 51μmol/L then give 25% dose less than 26 90mg/m² 27-51 75mg/m² greater than 51 50mg/m² If bilirubin less than 1.25xULN and transaminase less than 10xULN then prescribe the last dose otherwise consider a dose reduction or stopping treatment. The safety and efficacy of pertuzumab has not been established in hepatic impairment No dose adjustment necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1 (Feb 2021) Page 3 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Epirubicin Discontinue epirubicin if cardiac failure develops. Paclitaxel NCI-CTC grade 2 peripheral neuropathy withhold paclitaxel only until the neuropathy recovers to NCI-CTC grade 1 then dose reduce to 75% of the original dose. Where the peripheral neuropathy is NCI-CTC grade 3 again withhold the paclitaxel until it resolves to NCI-CTC grade 1 and then reduce the dose of paclitaxel to 50% of the original dose. Paclitaxel should be discontinued if the neuropathy does not resolve to NCI-CTC grade 1. Pertuzumab The diarrhoea can be severe in patients treated with pertuzumab. It is important to ensure patients are given appropriate therapy for the treatment of diarrhoea. This is not included in the regimen on Aria and must be added from the support folder. Pertuzumab and Trastuzumab Cardiac The LVEF should be fifty or above before starting cycle one of pertuzumab and trastuzumab. Subsequent Echocardiograms The flow chart below describes the process to be followed if there is an asymptomatic decline in LVEF during pertuzumab and trastuzumab treatment. This is taken from the study protocol as used in the reference section. Study treatment refers to pertuzumab and trastuzumab. Version 1 (Feb 2021) Page 4 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) In general patients who develop symptomatic cardiac dysfunction should have pertuzumab and trastuzumab discontinued, be commenced on ACE inhibitor therapy and be referred to a cardiologist. Further treatment should be discussed with the relevant oncology consultant. Version 1 (Feb 2021) Page 5 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Regimen Cyclophosphamide-Epirubicin (EC) 21 day cycle for 4 cycles (cycles 1, 2, 3, 4) Drug Dose Days Administration Cyclophosphamide 500mg/m2 1 Intravenous bolus Epirubicin 90mg/m² 1 Intravenous bolus Followed by; Paclitaxel-Pertuzumab-Trastuzumab 21 day cycle for 4 cycles Cycle 5 Drug Paclitaxel Pertuzumab Trastuzumab Dose 80mg/m2 840mg 8mg/kg Days 1, 8, 15 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Followed by; Cycle 6, 7, 8 Drug Paclitaxel Pertuzumab Trastuzumab Dose 80mg/m2 420mg 6mg/kg Days 1, 8, 15 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Cycles 9-22 inclusive Drug Pertuzumab Trastuzumab Dose 420mg 6mg/kg Days 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Version 2 (July 2024) Page 6 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) Dose Information • Cyclophosphamide will be dose banded in accordance with the national dose bands (20PM). • Epirubicin will be dose banded in accordance with the national dose bands (2PM). • The maximum lifetime cumulative dose of epirubicin is 900mg/m². • Paclitaxel will be dosed banded in accordance with the national dose bands (6mg/mL) • If the time between two sequential infusions of pertuzumab is less than six weeks, the 420mg dose should be administered as soon as possible without regard to the next planned dose. If the time between two sequential infusions is 6 weeks or more, the initial loading dose of 840mg should be readministered as a 60 minute intravenous infusion followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes. • Trastuzumab will be dose banded in accordance with national dose bands (21mg/ml) • If the patient misses a dose of trastuzumab by seven days or less, then the usual maintenance dose of 6mg/kg should be given as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses should be given according to the previous schedule • If the patient misses a dose of trastuzumab by more than seven days, a reloading dose of 8mg/kg should be given over 90 minutes. Subsequent maintenance doses should then be given every 21 days from that point Administration Information • Hypersensitivity reactions tend to occur with the first or second infusion of paclitaxel. Paclitaxel infusions should be interrupted for minor symptoms such as flushing or localised rashes. If these resolve promptly (within 5 minutes) the infusion may be restarted at a lower rate with intensive monitoring. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. • Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter. • Pertuzumab has been associated with hypersensitivity and infusion related reactions. Patients should be observed for 60 minutes after the first infusion and for 30 – 60 minutes after subsequent infusions. If patients have tolerated the first two infusions with no infusion related reactions consideration can be given to reducing this observation period. • Trastuzumab is associated with hypersensitivity reactions. The SPC recommends patients should be observed for six hours following the start of Version 2 (July 2024) Page 7 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) the first infusion of trastuzumab and for two hours following the start of subsequent infusions. In practice these times have been reduced. If the patient has tolerated the first two infusions with no infusion related effects consideration can be given to reducing or stopping this observation period. Extravasation • Cyclophosphamide – neutral • Epirubicin – vesicant • Paclitaxel - vesicant • Pertuzumab – neutral • Trastuzumab - neutral Additional Therapy • EC EC antiemetics day 1 15-30 minutes prior to chemotherapy; - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication - aprepitant 80mg once a day for 2 days - dexamethasone 2mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle • Paclitaxel 15-30 minutes prior to chemotherapy with paclitaxel − metoclopramide 10mg oral or intravenous As take home medication Version 2 (July 2024) Page 8 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) − metoclopramide 10mg three times a day when required oral • Premedication to reduce of risk of paclitaxel hypersensitivity reaction 30 minutes prior to chemotherapy with paclitaxel − chlorphenamine 10mg intravenous − dexamethasone 10mg intravenous − H2 antagonist according to local formulary choice and availability • For treatment of pertuzumab or trastuzumab infusion reactions ‘once only when required’ doses of the following should be prescribed; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg once oral • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. References 1.von Minckwitz G, Proctor M, de Azambuja et al. Adjuvant pertuzumab and trastuzumab in early HER 2 positive breast cancer. N Engl J Med 2017; 377 (2): 122-131. 2. Ramshorst M, van der Voot A, van Werkhoven E et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncology 2018: 19 (12); 1630-1640 Version 2 (July 2024) Page 9 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) REGIMEN SUMMARY Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Cycle 1, 2, 3, 4 1. Aprepitant 125mg oral 2. Dexamethasone 4mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Epirubicin 90mg/m² intravenous bolus over 10 minutes 5. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Take Home Medicines 6. Aprepitant 80mg once a day oral for 2 days starting on day 2 of the cycle Administration Instructions Take 80mg once a day for 2 days starting on day 2 of the cycle 7. Dexamethasone 2mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 2mg twice a day (morning and lunch) for 3 days starting on day two of the cycle 8. Metoclopramide 10mg three times a day when required oral Administration Instructions When required for nausea. Please supply five days or an original pack if appropriate. 9. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of the cycle Administration Instructions Take 8mg twice a day for three days starting on the evening of day one of the cycle 10. Growth factor according to local formulary choice. Administration Instructions Dispense according to local formulary choices; - filgrastim or bioequivalent 30 million units once a day subcutaneous for 5 days starting on day 5 of the cycle - lenograstim or bioequivalent 33.6million units once a day subcutaneous for 5 days starting on day 5 of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day 2 of the cycle Paclitaxel-Pertuzumab-Trastuzumab Cycle 5 Day 1 11. Pertuzumab 840mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes Version 2 (July 2024) Page 10 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 12. Trastuzumab 8mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes 13. Chlorphenamine 10mg intravenous 14. Dexamethasone 10mg intravenous 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Metoclopramide 10mg oral or intravenous 17. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 18. Chlorphenamine 10mg intravenous when required for infusion related reactions 19. Hydrocortisone 100mg intravenous when required for infusion related reactions 20. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Day 8, 15 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 10mg intravenous 3. H2 antagonist according to formulary choice and availability. Administration Instructions Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. Version 2 (July 2024) Page 11 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 4. Metoclopramide 10mg oral or intravenous 5. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter Take Home Medicines (Day 1 only) 21. Metoclopramide 10mg three times a day when required oral 22. Loperamide 4mg after the first loose stool and 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours Administration Instructions Take 4mg after the first loose stool and then 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours. Please supply one original pack size Cycle 6, 7, 8 Day 1 23. Pertuzumab 420mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 24. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes 25. Chlorphenamine 10mg intravenous 26. Dexamethasone 10mg intravenous 27. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 28. Metoclopramide 10mg oral or intravenous 29. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Version 2 (July 2024) Page 12 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 30. Chlorphenamine 10mg intravenous when required for infusion related reactions 31. Hydrocortisone 100mg intravenous when required for infusion related reactions 32. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Day 8, 15 32. Chlorphenamine 10mg intravenous 33. Dexamethasone 10mg intravenous 34. H2 antagonist according to formulary choice and availability. Administration Instructions Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 35. Metoclopramide 10mg oral or intravenous 36. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter Take Home Medicines (Day 1 only) 37.Metoclopramide 10mg three times a day when required oral Cycles 9 – 22 Day 1 33. Pertuzumab 420mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 34. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes Version 2 (July 2024) Page 13 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 35. Chlorphenamine 10mg intravenous when required for infusion related reactions 36. Hydrocortisone 100mg intravenous when required for infusion related reactions 37. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Version 2 (July 2024) Page 14 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) DOCUMENT CONTROL Version Date Amendment Written By Approved By 2 July 2024 Trastuzumab updated with national dose bands Alexandra Pritchard Pharmacist Nanda Basker Pharmacist 1 Feb 2021 None Dr Deborah Wright Pharmacist Dr Sanjay Raj Consultant Clinical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 2 (July 2024) Page 15 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/EC-PPH-Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab.pdf

Capecitabine-Carboplatin(AUC5)-Cetuximab

Description: Chemotherapy Protocol HEAD AND NECK CANCER CAPECITABINE-CARBOPLATIN (AUC5)-CETUXIMAB Regimen • Head and Neck Cancer – Capecitabine-Carboplatin-Cetuximab Indication • The treatment of advanced head and neck cancer that has not been previously treated with cetuximab • WHO performance status 0, 1 Toxicity Drug Capecitabine Carboplatin Cetuximab Adverse Effect Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Neuropathy, hypersensitivity Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with capecitabine. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.2 (August 2022) Page 1 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following criteria must be met. Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL There is little need to adjust the dose of cetuximab for haematological toxicity. The following applies to capecitabine and carboplatin only. On day one if the neutrophils are less than 1.5x109/L in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. On day one if the platelets are less than 100x109/L in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Hepatic Impairment Drug Capecitabine Carboplatin Cetuximab Dose (% of original dose) There is little published information available. No dose reductions are necessary for those with mild to moderate hepatic dysfunction due to liver metastasis No adjustment necessary Administer only when the transaminases are 5xULN or below and the bilirubin is 1.5xULN or below Version 1.2 (August 2022) Page 2 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab Renal Impairment Drug Capecitabine Carboplatin Cetuximab Creatinine Clearance (ml/min) Dose (% of original dose) More than 51 30-50 less than 30 Less than 20 100 75 Do not use Do not use Changes in the GFR of more than 10% between cycles may require dose adjustment If the creatinine is more than 180 (1.5xULN), do not use Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. If any NCI-CTC grade 1toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities NCI-CTC grade 3 or above in general treatment should be withheld until recovery to at least NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes twenty-one days or longer then stop treatment. Capecitabine NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 then resume therapy at 75% of the original dose. If the same adverse effect develops on a third occasion once more interrupt treatment until it resolves to NCI-CTC grade 0-1 then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue treatment using 75% of the original dose with prophylaxis if appropriate. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 and then resume therapy at 50% of the original dose. If the same adverse effect develops on a third occasion discontinue capecitabine. Version 1.2 (August 2022) Page 3 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab NCI-CTC Grade 4 Discontinue treatment unless the responsible consultant considers it to be in the best interest of the patient to continue at 50% of the original dose once the toxicity has resolved to NCI-CTC grade 0-1. When capecitabine is stopped for toxicity the doses are omitted, not delayed. Consider stopping capecitabine therapy if chest pain occurs. Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reaction reduce the infusion rate by 50%. For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. When the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acneiform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions to 200mg/m2 and 150mg/m2 respectively. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of a NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Regimen The starting dose of carboplatin AUC5 is used with calculated GFR. AUC4 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC5 is 750mg. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. Consider a dose reduction in poor performance patients. Version 1.2 (August 2022) Page 4 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 21 day cycle for 6 cycles The starting dose of carboplatin AUC 5 is used with calculated GFR. AUC 4 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC5 is 750mg (creatinine clearance 125ml/min). This is not a dose included in the national dose banding table. The maximum dose has been set at 790mg in ARIA. Please check if this dose is appropriate. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. The cetuximab may be continued if the disease is at least stable at the end of six cycles until disease progression or toxicity occurs. Cycle One Drug Capecitabine Carboplatin Cetuximab Dose 1000mg/m2 twice a day AUC5 (max dose) 400mg/m2 Cetuximab 250mg/m2 Days 1-10 incl 1 1 8, 15 Route Oral Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion (see administration) Intravenous infusion (see administration) Cycle Two Onwards Drug Capecitabine Carboplatin Cetuximab Dose 1000mg/m2 twice a day AUC5 (max dose) 250mg/m2 Days Route 1-10 incl Oral 1 1, 8, 15 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion (see administration) Dose Information • Capecitabine will be dose banded in accordance with the national dose bands • Carboplatin will be dose banded in accordance with the national dose bands (10mg/ml) Version 1.2 (August 2022) Page 5 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab • The maximum dose of carboplatin for AUC 5 is 750mg. This will be set as 790mg in ARIA to comply with national dose bands. • It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) Administration Information Extravasation • Carboplatin - irritant • Cetuximab - neutral Other • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food • Individuals should be monitored for hypersensitivity reactions for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 5mg/min for the first infusion (minimum 120 minutes). If well tolerated subsequent infusions may be given at a rate of 10mg/min (minimum 60 minutes). Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy on day one only; - dexamethasone 8mg oral or intravenous or equivalent dose - ondansetron 8mg oral or intravenous As take home medication; - dexamethasone 4mg twice a day oral for 3 days - metoclopramide 10mg three times a day when required oral - 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral or intravenous (given as part of antiemetic regimen on day 1) - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral Version 1.2 (August 2022) Page 6 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab • Oral loperamide 4mg after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Ensure the total daily dose of capecitabine is divided into two doses given twelve hours apart (the first should be administered in the evening of day one of the cycle), Serious toxicity has occurred where the total daily dose has been given twice a day. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. Referen c es 1. Vermorken JB, Mesia R, Rivera F et al. Platinum based chemotherapy plus cetuximab in head and neck cancer. N Engl Med 2008; 359 (11): 1116-1126. Version 1.2 (August 2022) Page 7 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab REGIMEN SUMMARY Capecitabine-Carboplatin(AUC5)-Cetuximab Day One Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous or equivalent dose 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to SACT; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cyclethree onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 400mg/m2 intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and carboplatin 6. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg intravenous if required 7. Warning - Carboplatin Maximum Dose Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please check this dose is appropriate for your patient. 8. Carboplatin AUC 5 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please ch eck this dose is appropriate for your patient Take Home Medicines (day 1 only) 9. Capecitabine 1000mg/m2 twice a day for 10 days starting on the evening of day one of the cycle oral Administration Instructions Oral SACT Start on the evening of day 1 of the cycle 10. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 4mg twice a day (morning and lunch) for 3 days starting on day 2 of the cycle Version 1.2 (August 2022) Page 8 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 11. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate Day Eight and Fifteen Cycle One 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to SACT; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle th ree onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 intravenous infusion Day One Cycle Two Onwards 17. Chlorphenamine 10mg intravenous 18. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 19. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 20. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the foll owing 30 minutes prior to c h emo th erap y ; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 21. Cetuximab 250mg/m2 intravenous infusion Version 1.2 (August 2022) Page 9 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 22. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg intravenous if required An interval of 60 minutes should be left between administration of cetuximab and carboplatin 23. Warning - Carboplatin Maximum Dose Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please check this dose is appropriate for your patient. 24. Carboplatin AUC 5 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions The doseof carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please ch eck this dose is appropriate for your patient Take Home Medicines 25. Capecitabine 1000mg/m2 twice a day for 10 days oral Administration Instructions Oral SACT Start on the evening of day 1 of the cycle 26. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 4mg twice a day (morning and lunch) for 3 days starting on day 2 of the cycle 27. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate Day Eight and Fifteen Cycle Two Onwards 28. Chlorphenamine 10mg intravenous 29. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 30. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 31. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to c h emo th erap y ; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. Th ey have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. Version 1.2 (August 2022) Page 10 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 32. Cetuximab 250mg/m2 intravenous infusion Version 1.2 (August 2022) Page 11 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab DOCUMENT CONTROL Version Date Amendment Written By Approved By Carboplatin national dose bands added 1.2 Aug 2022 Administration instructions added in summary Dr Deborah Wright Donna Kimber Pharmacist Pharmacy Technician Warning added in summary Update of premedication due to shortage of IV ranitidine. IV ranitidine changed to H2 antagonist according to local formulary choice and availability Coding removed 1.1 Nov 2020 Dose banding statement updated Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Monitoring updated with DPD testing Carboplatin max dose added Paracetamol admin instructions updated 1 Dec 2014 None Dr Debbie Wright Dr S Ramkumar Pharmacist Consultant Clinical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (August 2022) Page 12 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Headandneckcancer/Capecitabine-Carboplatin-Cetuximab.pdf

Aria ePrescribing v13.6 MR1.2 user training guide

Description: Aria E-Prescribing v13.6 MR1.2 User Training Guide Every effort has been made to ensure that the material in this manual was correct at the time of publication but cannot be held responsible for any errors or inaccuracies. We reserve the right to change or replace information contained in the manual without notice. For the most up to date version please refer to the UHS website. All references made to patient records are fictitious for the purpose of training only. Page 1 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager CONTENTS This training guide has been produced as a generic document for the 6 Trust of the former Central south coast cancer NETWORK (CSCCN); it can be used as an aid to producing cascade training guides either by role or profession at each individual trust if required.1 ................................................................General Course Information 2 2 Information Governance....................................................... 5 3 Logging on to Aria ................................................................ 7 4 Creating and Modifying a New Patient ................................. 9 5 Adding Patient History........................................................ 16 6 Patient EXAM..................................................................... 29 7 patient Vital Signs .............................................................. 53 8 PRESCRIBING .................................................................. 60 nb Once prescription Approved by prescriber and pharmacy either prescriber/nurse/pharmacy can move the date without the need to re-issue the prescription. By moving the date this will not produce a different pharmacy order number (yellow file) because no clinical amendments have been made. ................................................... 95 9 Pharmacy........................................................................... 96 10 nurse drug administration ................................................. 115 11 scheduling........................................................................ 127 12 Patient journal .................................................................. 149 13 Logging Off ...................................................................... 151 14 re-setting your Password.................................................. 152 15 Icon Glossary ................................................................... 153 16 Fault Reporting................................................................ 157 17 Help with using Aria ......................................................... 158 18 Version Control LoG ............................................................ 160 Varian have produced two reports for the SACT data; 182 SACT – Public Health Data – Patient Drug Administration Details – 2015 182 SACT – Public Health Date – Patient Drug Dispensed Details - 2015 182 THIS TRAINING GUIDE HAS BEEN PRODUCED AS A GENERIC DOCUMENT FOR THE 6 TRUST OF THE FORMER CENTRAL SOUTH COAST CANCER NETWORK (CSCCN); IT CAN BE USED AS AN AID TO PRODUCING CASCADE TRAINING GUIDES EITHER BY ROLE OR PROFESSION AT Page 2 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager EACH INDIVIDUAL TRUST IF REQUIRED. Page 3 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 1 GENERAL COURSE INFORMATION COURSE TITLE METHOD OF TRAINING DURATION PRE-REQUISITES E-PRESCRIBING ABOUT THE COURSE The Aria E-Prescribing software is a computer system that is used across the 6 Trusts of the former Central South Central Cancer Network (CSCCN). This course is intended for users who will be prescribing chemotherapy to patients, approving and dispensing chemotherapy in pharmacy and recording the administration of chemotherapy by nursing staff within the Aria application. SUITABLE FOR This manual is suitable for any user requiring access to the Aria system. This includes Clerical and Administration staff, Nursing Staff, Pharmacy staff and Clinicians. OBJECTIVES This course will enable the student to perform the following: 1. To be able to log on and off of the system 2. To record relevant patient history, diagnosis and vital signs 3. To prescribe specific chemotherapy regimens 4. To approve and dispense drugs in pharmacy 5. To be able to record the administration of chemotherapy to patients 6. To be able to enter patients into the scheduling system Page 4 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 2 INFORMATION GOVERNANCE Information Governance (IG) sits alongside the other governance initiatives of clinical, research and corporate governance. Information Governance is to do with the way the NHS handles information about patients/clients and employees, in particular, personal and sensitive information. It provides a framework to bring together all of the requirements, standards and best practice that apply to the handling of personal information. Information Governance includes the following standards and requirements: Information Quality Assurance The NHS Confidentiality Code of Practice Information Security The Data Protection Act 1998 Records Management The Freedom of Information Act 2000 Caldicott Report December 1997 What can you do to make Information Governance a success? Keep personal information secure Ensure confidential information is not unlawfully or inappropriately accessed. Comply with the Trust ICT security policy and Staff Code of Confidentiality. Do not share your password with others. Ensure you "log out" once you have finished using the computer. Do not leave manual records unattended. Lock rooms and cupboards where personal information is stored. Keep personal information confidential Only disclose personal information to those who legitimately need to know to carry out their role. Do not discuss personal information about your patients/clients/staff in corridors, lifts or the canteen Ensure that the information you use is obtained fairly Inform patients/clients of the reason their information is being collected. Organisational compliance with the Data Protection Act depends on employees acting in accordance with the law. The Act states information is obtained lawfully and fairly if individuals are informed of the reason their information is required, what will generally be done with that information and who the information is likely to be shared with. Make sure the information you use is accurate Check personal information with the patient. Information quality is an important part of IG. There is little point putting procedures in place to protect personal information if the information is inaccurate. Page 5 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Only use information for the purpose for which it was given Use the information in an ethical way. Personal information which was given for one purpose e.g. hospital treatment, should not be used for a totally separate purpose e.g. research, unless the patient consents to the new purpose. Share personal information appropriately and lawfully Obtain patient consent before sharing their information with others e.g. referral to another agency such as, social services. Comply with the law The Trust has policies and procedures in place which comply with the law and do not breach patient/client rights. If you comply with these policies and procedures you are unlikely to break the law. Page 6 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 3 LOGGING ON TO ARIA Access to Aria is via a Citrix connection. However local Trust policy will govern how much you see of this login process. Most trusts will have an Icon on the desktop which will take them to the login boxes below. Type in your user ID in the User ID field Type password in to the Password field Select the appropriate institutions in the ‘From’ and ‘Login To’ drop down boxes. The ‘From’ field will always need to be CSCCN The ‘Login To’ field will define what work location you are logging into. For example, what Ward or Clinic do you wish to work in? Click OK On subsequent logins the above ‘From’ and ‘Login to’ fields will be pre-filled as the system remembers what you last logged into. This can be changed at any point. On your first login you will be required to change your password from the one issued to you with your username. The following box will display: Page 7 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager There are certain parameters that need to be observed when creating a new password. These are: The password must be between 6 and 10 characters long have a letter as the first character be mixed case contain at least 2 numeric's be unique from the previous 5 passwords Examples of how acceptable passwords may look are below: Sunsh1ne1 Sunshine01 sunSh11ne On your first login you will also be required to confirm your details are correct within the Aria System. DO NOT CHANGE any details in this box. If there are any changes that need to be made contact your local IT Support who will look into it. Click ok. Page 8 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 4 CREATING AND MODIFYING A NEW PATIENT When logging into Aria Manager, the first window you see is the ‘Open Patient’ window. It is also possible to add patient status icons to appear attached to the patient record on the open patient window and other screens. Select Patient Workup – Patient Status icon from drop down menu Two icon that may be useful would be C/R (Concurrent Chemo-Rad) and Ambulance that could be used to indicate transport. Page 9 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Eg Chemo-Rad and Transport have been added to this patient and the icons appear on the top right of the screen The ‘open patient window’ shows all the patients who have been entered into Scheduling or who have had a ‘chart’ opened today. By highlighting a patient and then clicking on blue tick the following Patient Tracking window opens (actual Institution list may vary). Page 10 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By highlighting a patient and then right clicking on it a brief Patient Information window appears By clicking on the clipboard icon (to right next to bar code) a list will appear of the last 15 patient charts opened by the user. Page 11 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager In this window you can add New patients or Modify an existing patient – click on the relevant button on right of screen. Either New, Modify or View. In most cases within the network the requirement to add new patients to the Aria system will not be needed as there will be a data feed from the local Patient Administration System that will populate it. However, to create a new patient click ‘New’ on the right hand side of the screen. This will open the Modify Patient Window. DO NOT create a patient on Aria if there is a PAS data feed within your Trust as this may create duplicates on the Aria database. In the event of duplicate patient entry found please contact system administrator (d.kimber@nhs.net or Debbie.wright@uhs.nhs.uk) who will investigate and contact Varian if required. Page 12 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Patient Modify window The Tabs are: General – Where name, DOB etc… is stored Patient IDs – contains NHS, Hospital etc… Temporary Address Contacts – Next of Kin details etc… Demographics – Patient personal details for example Ethnicity and Religion. This screen is useful to record Advance Directives such as ‘Organ Donor’ and Feeding Restriction alerts. Providers - Details of patient’s Consultant – needed for SACT report Referrals – Details of referring clinician unlikely to be used Photograph – Unlikely to be used within the NHS General Tab To enter a New Patient the same will appear but it will be a blank template You can enter details in any of the tabs, much of this information will be imported by the PAS interface, but anything can be updated or amended. Page 13 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Patient IDs Tab In this window the NHS number will always appear along with any internal hospital ID. If appropriate you can also add a CDF PT ID, a Private PT ID or a Study #. Temporary Address and Contacts can be amended as necessary. Demographics Tab Demographics – any of these can be amended, the down arrow on right of a field means a drop-down list will appear. Advance Directives, if yes then you can tick any of these and they will appear later on. Page 14 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Provider Tab Providers must be completed, top box is the consultant and the bottom box is the GP – this may, or may not, come over from PAS. When the Provider is added in this window it will automatically populate the Visit Provider in Scheduling. This field is required in many reports. NB Relationship must be entered as Consultant for GMC number to populate in SACT and other reports Page 15 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 5 ADDING PATIENT HISTORY Once you have your patient in the system then you need to add some History. Highlight the patient, you can change the first window you view by amending the ‘Proceed to’ button on the top right of screen (next to bar code) e.g. Patient History. Click Open…button on top right The patient has opened in the Patient History window because that is what was selected under Proceed To. The second tool bar has now become available to use (starts Chart, History etc). If history wasn’t the default page then it can be selected by clicking on History (3rd button from left on top tool bar). The main sections to be completed are: Medical Procedure / surgical Family Social Allergies – this is essential Medications – this is essential Page 16 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager As information is entered the tab will change to blue in colour. Medical – this shows and then can be amended as necessary. Procedure/Surgical can also be entered here. Page 17 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Family – this window opens and then can be updated. Page 18 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Social – following window opens to be updated Allergies and Medications can be entered and this will then work in conjunction with the First Data Bank to look at drug interactions. Allergies – following window opens to be updated Page 19 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click on New, select the Type eg Drug Page 20 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager For Drug allergy, start typing the drug name in the Allergy box eg asp and then click on the torch button (right of screen) Page 21 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager A list will of drugs will appear, select drug required eg penicillin V (tablet oral), OK Page 22 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Page 23 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Tick the Response or Other which will give a text box for comments. Click OK or Save – New to add another drug if necessary. The allergies will now appear on the Allergies window Page 24 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If no allergies tick “No Known Allergies” – these icons will be seen in numerous screen indicating whether an allergy has been recorded, no known allergy or no allergy information has been recorded. Medications – following window opens to be updated Page 25 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click New (bottom left) to add new medication, the following window will open Type in the start of the drug and then click the torch to search the First Data Bank and enter all relevant details, those will down arrows contain drop down selections. It is sufficient to only add the drug name because this is used to Page 26 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager check for drug interactions, contra indications etc, dose and frequency is not necessary. Click OK and drug now appears, this screen will also show any chemotherapy agents the patient is/has received. Page 27 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Page 28 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 6 PATIENT EXAM Once the patient has History updated the following stop is to enter Exam. Open the patient, from Open Patient window, you can change the Proceed To to Exam and then Exam window will open or if you Proceed To another window e.g. Patient History, the second Tool Bar will be highlighted and then select Exam (6th button from right), the following window will open. NB if you add Diagnosis/Problems via the History window you will not see the prompt for Performance Status, therefore it is recommended that you always use the Exam window when entering a diagnosis. Click New.., the following window opens Page 29 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager In the Code section, click the magnifying glass on the right and the following window opens Page 30 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager This code type is ICD-10. In the search criteria select either Code or Key words, by selecting Keywords and typing lung the following appears Select the correct Clinical Description eg C34.2 Malignant neoplasm of bronchus or lung, unspecified and the following appears Page 31 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager The Definition page has now opened, and any of the white boxes can now be updated. There are also four other “tabs” now available Pathology – includes Cell Histology which is required to populate morphology in the SACT report Lesions Staging – required for SACT report Tumour Markers Pathology – following window opens Page 32 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Pathology Item Select Cell History (morphology for SACT) – following window opens to be updated Page 33 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Cell Category – drop down menu Cell Type drop down will populate once cell category has been selected Page 34 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Cell Grade drop down Page 35 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Lesions – open the following window Click New in either Local Lesions or Metastatic Lesions and the following window opens Local – Page 36 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Metastatic – Page 37 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Staging – opens the following window Click New (left of screen), some disease site staging will also have G (grade), all Criteria must to be completed to give Stage of the disease Page 38 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Select Tumour eg T1 and add a date into the Date Staged box To get a complete staging also enter assessments for both nodes and metastasis; ensure a date is entered into the Date Staged box. Page 39 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Nodes Metastasis Page 40 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Approve and the information now appears as follows Click Save (left of screen). If you click Close you will be asked it you want to save changes as well. Page 41 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Close (right of screen) and the information appears on the Diagnosis / Problems window Page 42 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager RoS/PE – Review of Symptoms/Physical Exam – review of symptoms window opens Page 43 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Assess and the following window opens Select system(s) and disease site(s), click OK. It is advisable to tick all as normal and then only tick Abnormal to those that apply, as below Page 44 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Approve and the following appears on the ROS/PE window. You will see that the abnormal symptom appears with a red A. Page 45 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Physical Exam – following window opens Click Assess and the following window opens Page 46 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Select system(s) and disease site(s), click OK. It is advisable to tick all as normal and then only tick Abnormal to those that apply, as below Page 47 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Approve and the following appear in the Physical Exam window, again showing any abnormal PE with a red circle. Page 48 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager NB: Both RoS/Physical Exam list can be customised by each Provider to show a shorter list if required. This is carried out in Manager (System AdminProvider/RoS Exam Defaults – select the Provider then Sites) Performance Status – the following window will appear Select Scale from drop down Page 49 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Select Performance Status from drop down Page 50 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager The following appears Click Approve and the information now appears on the Performance Status window Page 51 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Page 52 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 7 PATIENT VITAL SIGNS Once Exam has been completed the next step is Vital Signs. In ‘Open Patient Window’ click to Open a highlighted patient, the second Tool Bar will then be available and click on Vital Signs, the following window will open. Enter the information; ALWAYS enter height and weight to calculate the BSA required to calculate drug doses. If a result is entered that is outside of the range set (see values in brackets) then alerts will be show; H = high value L = low value LL = very low value Alarm bell icon – can view extra information by clicking on it Page 53 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager See window below By clicking on the “pen” icon to the right of each line you can view Result History (selected from the drop down menu) Results can also be viewed in the Flow Sheet (click icon in second row) Page 54 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If you right click on any of the results you can also View Details eg BMI shows Page 55 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager You can also see the doses of each drug administered and the toxicities recorded. NB Each drug has to be administered in the Drug Admin window to appear in the Flow Sheet Dose Recordings, therefore it is important that nurses do complete the drug administration. With a pathology interface you will also be able to view results in this window. Page 56 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If a result has been entered incorrectly and then “errored” you can view the results by selecting Assessments from the top row, then Tests from the drop down menu and select the required date eg Dec 23, 2015 Select View from the Results section at the bottom of the screen Page 57 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click ERR Result Set (top right of screen) to view the errored result Click on the E to view Reason For Error By clicking on the “pen” icon in the Results View window and selecting Result History from the drop down menu you can also view history eg Result History: Height Page 58 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Once all the details for the patient have been entered then treatment can be allocated. You must check you have completed the following data before you can enter any treatment for the patient; Modifying patient details/ entered new patient details History – including allergies Exam – including diagnosis / morphology / staging / performance status Vital Signs Once all the above have been entered then open the patient , change ‘Proceed To’ to Medication and open the patient, the following window will appear you can then select the treatment required, from the diagnosis already entered the list will then filter by disease site e.g. lung, breast etc and show the regimens entered in those disease areas. Page 59 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 8 PRESCRIBING The system will default to regimens assigned to patient diagnosis No BSA (right of screen) indicated that no Vital Signs have been entered Eg for a lung diagnosis the following will appear in top box with sub folders, if applicable eg SCLC, NSCLC and mesothelioma Page 60 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click the folder to show the regimens for lung NSCLC Select the regimen required, the following will appear Page 61 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager You can see that this is the first cycle, see Cycle on right of screen. NB: Information page (right of screen below Cycle box) – this is the protocol summary, however from October 2010 protocol summary will no longer be shown here. You can view protocols by clicking Applications – Protocols (top row of the screen) this will then open the UHS website page which contains protocols. Alternatively you need to view the protocol please refer to UHS website (http://www.uhs.nhs.uk/HealthProfessionals/Extranet/Services/Cancercare/Chemotherapy-protocols/Chemotherapy-protocols.aspx ) Select Blue square in select box on right of screen to select all the Order button will be available and a tick will appear in the Day 1 and Day 8 box (or manually tick Day 1 and/or Day 8). Day 1 + 8 can be ordered at the same time as two separate files will be produced for pharmacy orders. Page 62 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Order…, if no value is present for creatinine the following message will appear NB although creatinine result might be available via pathology interface it needs to appear after height and weight have been entered to be able to calculate the dose, therefore at cycle 1 it may be necessary to enter the result manually. Click CrCl button on right of screen and enter the Creatinine result in this window, then Approve Page 63 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Now select Order on top right of screen you will see the Dose Calculation Management pop up box to enable the height, weight and BSA to be reviewed Page 64 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Enter consultant in Ordered by, and complete Line of Tx, Tx Intent and Tx Use (these are required for SACT report) Page 65 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By highlighting one of the drugs more buttons will become available on the right of the screen, as below To change the date for the whole regimen – click on the calendar page next to Start on below the Ordered by box. To change the date for an individual agent – click Adjust Start on right of the screen, and then select the required date. Page 66 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By highlighting an agent and then clicking on the up and down arrows on the bottom right of the screen you can change the order of an agent. OR By clicking the “pen” icon (next to the Approve box) you can change the order of an agent eg move pre-medication to the top of the list, change the Rx Seq # to the correct order. You can now add any support eg extra antiemetic support (that are not already included as part of the regimen) or favorites eg antibiotics, as required. Click Favorites and the following window appears Page 67 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager A list of files will appear eg antiemetics, antibiotics, skin care etc, click the file to open and the list of drugs in that file will appear. Page 68 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Select the drug required and click Add to add it to the regimen. Support – click the support tab on top right, and the following window appears The support regimens have been set up in files. Click the yellow file and a drop down will appear (the same way treatment is allocated) Click on TTO Levomepromazine and the support regimens will appear. Page 69 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Tick the regimen (the same way treatment is allocated) and click Add to add to the regimen. NB – some support regimens selected here need to be added to each cycle individually they have not all been set up for cycles of treatment only courses eg 21 days. (see Appendix 2 and 3). You can Adjust Dose, Adjust Start etc. It is advisable NOT to adjust any drug dose using the Modify button only use the Adjust Dose button. Any dose banding will be removed if the dose is amended in the Modify window. Dose banding is only applied when using Adjust Dose button. Click Adjust Dose and the following window appears Page 70 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager You can select Dose Modification from the top line eg 75%, 50% etc however this will reduce all agents including any antiemetics that have been prescribed unless you select Change Chemo. Therefore it is advised to dose reduce per agent and remember to include a reason in the Modification Reason, either by clicking on the drop down arrow or entering text in the bottom right text box. In the Calculation / Rounding column the red dots denote dose rounding and the red circle dose banding has been applied to that particular agent. You will see that gemcitabine has been reduced to 75% of the original dose and the reason given was infection. Page 71 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager This message will appear when agent appears in more than one day of the cycle. The Order / Rx page now shows the dose reduction to 75% in red and at the end of the drug line the Dose Mod. Reason has a page with lines on it. Page 72 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If the drug has been set up with dose banding (eg gemcitabine) when you Adjust Dose a red circle appears next to the Calculation/rounding dose Page 73 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By clicking on the red circle you can view the dose banding table set up for the drug dose eg gemcitabine The red dot with a number indicated the agent is rounded to the nearest eg carboplatin in this regimen is rounded to the nearest 50mg If no “rounding” match is found for an agent then the default rounding is used; Up to the nearest 1 for calculated doses > =10 Up to the nearest 1/100th (0.01 decimal place) for calculated doses <10 Page 74 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager When ordering subsequent cycles you can view the previous doses from the last cycle Click on the note pad to the left of Last Ordered This shows the dose of current order at the top and the dose of the last order at the bottom. Once all drug doses are correct then the prescription has to be approved. Page 75 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click the Approve button on the bottom of the screen and the following User Authentication will appear – this is the prescriber electronic signature Click Ok the First Databank Interaction Screening window appears Click Accept the printing window will appear select Internal to print agents for administration in hospital, select Pickup-Internal for TTOs or both as appropriate. Page 76 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If you click Cancel at this point the prescription is put as “pending” in the Orders/Rx window, and a prescription will not be printed despite the printing box just having appeared on the screen. However when the treatment is “approved” the prescription will print (along with any that you “cancelled” at this point previously eg if you clicked Cancel twice 3 prescriptions will print one for each of the cancelled actions and the actual approved one – they will however all be the correct version) Although you can only see the oral dexamethasone all the drugs have been approved. In this window you are approving the prescription to be printed either to pharmacy, in clinic etc. Click Approve and the following window appears (Treatment) Page 77 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By clicking on the pen in the Treatment box (next to 4 x 21 days) you can Modify / Delay / Discontinue / View Regimen decisions Modify – This currently shows the Active treatment days. Page 78 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Day 8 treatment can be omitted by clicking Inactive on the required drug Page 79 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Alternatively by clicking Custom you can state which cycle to Inactivate You need to click the speech bubble (next to Ordered By) before this action can be approved (NB the speech bubble only appears for a non-prescriber). Page 80 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager NB: Any notes that are entered when using the “speech bubble” do not show again anywhere on the screen in Aria but are kept in the database, they can only be viewed by a Varian database analyst if requested to do so for a full patient history audit. Therefore Varian suggests using the patient Journal (see section 12) which is aimed at being a running commentary of patient events. Click Ok and then Approve button will appear so that any modification can be approved. Page 81 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager This message will appear if no reason for making change is entered When back in the Treatment window the Inactive days will be shown in red. Page 82 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Delay – If a prescription has been Approved and Dispensed then use Delay here to move treatment date. You cannot Re-issue the prescription once dispensed. Also add a comment to the patient journal to record this action (see section 12). Page 83 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Ordered by must be selected and again the speech bubble (top right) must be completed before this action can be approved eg delay for 1 week Click OK then approve, the delayed regimen will show “delayed” in red against it Page 84 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If any agent has been missed off or there is a need to add another agent after the treatment has been approved, click New (top right of screen) and then add the Favorite/Support as required. Page 85 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager This will now show as “Other Drugs Ordered”. Page 86 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager If you need to add any additional information to an agent eg actual start date for GCSF – highlight agent Click Modify The Admin Instructions box on the bottom left of the screen contains the information that will print of any prescription. Therefore enter the start date in the Admin Instructions box. Page 87 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click OK Discontinue – the following message will appear By clicking yes the following box will appear, as above click the speech bubble before approving. Page 88 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager NB – If you are discontinuing a regimen but there are still agents to be administered ensure you select the correct dose recordings you wish to discontinue. It may be that you need to select “Starting from effective date ... “ to enable to the remaining agents from the cycle to be administered. Once approved the following will appear Page 89 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By clicking on the medication history you will see all previous treatment. Page 90 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager A patient must have treatment discontinued before any new treatment can be allocated. NB – any extra antiemetic support medication associated with the treatment must also be discontinued BEFORE the treatment, it will not automatically be discontinued with the treatment, you need to select each regimen and discontinue as above. To delete an agent in a regimen: By highlighting an agent the Delete button becomes available (NB it is preferable to delete rather than discontinue to enable ability to “undelete” the agent in future cycles if necessary). This confirmation message will appear. Page 91 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager The deleted agent appears on the Orders/Rx window scored out and also when Approved in the Treatment window Page 92 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Another useful way of finding information about the current treatment is in the Treatment window; by clicking on the pen icon at the end of each line you can view information about each drug for each specific day of each cycle, the same information can also be found in Flow Sheet (see section 7). For example, gemcitabine - shows dose given, the red cross indicates not Dispensed For example gemcitabine - indicates a drug modification any Dose Mod Reason can be viewed by clicking on page to show any reason entered. Page 93 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager NB a red star appears next to Ordered if the dose administered in Drug Admin differs from that Approved by the prescriber, the reason for this may be that pharmacy made an amendment when dispensing the drug, which would follow through to the Drug Admin window but would not change the original prescribed dose. For this amended dose to appear in future cycle the prescriber would need to adjust the dose in the Treatment window. If a prescriber has Approved treatment and then wishes to amend any part of the prescription, in the Orders Rx window the order can be re-issued (5th button down on right of screen) causing the treatment to be put back into a Pending state for the prescriber to amend and then Approved in the usual. Page 94 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager However a prescription cannot be re-issued if pharmacy has already dispensed it, it would need to be discontinued or ‘un-dispensed’ by pharmacy. If only the dates need changing this could be carried out in the Drug Admin window (see section 10). NB Once prescription Approved by prescriber and pharmacy either prescriber/nurse/pharmacy can move the date without the need to re-issue the prescription. By moving the date this will not produce a different pharmacy order number (yellow file) because no clinical amendments have been made. Page 95 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 9 PHARMACY Suggested order for pharmacy screening; Check patient journal to look at any relevant information entered by doctor, nurse, pharmacy etc Check bloods in flow sheet Check doctor approval time Pharmacy approve – check doses, can “review” prescription and screen Pharmacy dispense Once all the treatment has been approved pharmacy then need to review and approve the prescription. Click the Orders / Rx tab to open the following window (NB at this point the prescription can be re-issued back to the prescriber should any amendments be necessary – click Reissue button) You will now see that this treatment has been approved, if you click on the A after Approved you will see who prescribed (created), approved, signed (electronic authorisation box) and last modified the treatment (Prescription Order Audit Report). Page 96 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click on the yellow folder in the Order # column to open the treatment Click Review tab on the right to review the prescription details in pharmacy Page 97 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager View on the top tool bar will show all users who have accessed the patient record (select View - Access Log from drop down menu) – it shows user with date and time. Page 98 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager By clicking on the Rx button (right of screen) you can show the BSA (Dose Calculation Management) If “Cap” appears because Aria has capped the dose at 2.4m² you can click “Actual” OR “Cap” to switch between them should you have a large patient that you do not want to cap at 2.4m². You cannot reduce the capped dose to 2m² at this point the prescriber would need to “modify” the dose in the treatment window. By clicking the Screen… button on the right of the screen the following window appears, this links to the First Data Bank drug system showing interactions, contraindications, warnings etc. Page 99 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Once pharmacy has reviewed the prescription it then needs to be approved and dispensed by pharmacy. Page 100 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click on Pharmacy Approve button on the right of screen, following window appears Click on the yellow file to open the treatment, as below Tick the box next to the prescription and then click the Checked Approve button. Page 101 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager A button = Ordered by Audit eg prescriber By clicking on the Rx √ button you can see who approved the treatment in pharmacy This is for all agents you cannot select individual agents therefore when you see the Rx √ it means that the whole prescription will be approved and therefore OK to dispense. To dispense the prescription in pharmacy click the Pharmacy Dispense button, the following window appears Page 102 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click on each yellow folder to open each drug, the Admin Date will appear Click the Dispense button on bottom left of the screen, the following window appears Page 103 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager At this point, if necessary, a pharmacy batch number can be added in the Drug Lot # field eg 124578 This can then be viewed by nurses in the drug admin window Any additional dispensing comments can be added in the note pad at the end of each agent, this can also be view by nurses in the drug admin window by clicking on the page icon next to Dispensing Page 104 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager At this point, if necessary, a drug dose could be modified by pharmacy, click Modify Dose button for the specific drug to be modified and the following window will appear. However this function should only be used as a last resort ie for compounding error so that the nurse drug administration screen is correct for the agent/vehicle supplied by pharmacy eg prescribed volume was 250ml but 500ml has been made or needs to be substituted to reduce wastage. It would be better to re-issue the prescription back to the prescriber to make any amendments. Page 105 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager When this Aria message box appears select No – this is because may agents have been set up as non standard Form/Route when dose banding was applied and if you click Yes you will be selecting a non dose banded agent. The reason for the dose modification can be entered and then will appear with a red star against each modified line. Page 106 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager The modification information can be viewed by clicking on the page button next to the red star and the following will appear as Dispensing Comments. Click Approve button on button right of screen this will return to the Prescription Dispensing window and the Dispensing details modified star now appears and the treatment is now showing as Dispensed Page 107 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager A button = the audit button in this window shows who has “dispensed” each agent Page 108 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager You can print the prescription from this screen by clicking on the printer button at the botton, the following window appears, select Prescription Type You can check the printer by clicking on the yellow folder/printer icon on top right Page 109 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Pharmacy can view all treatment for a day or date range by clicking on Pharmacy button on the top Tool Bar, select Pharmacy Dispensing on the drop down that appears and the following window appears This is colour code to show when orders have been approved. Page 110 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Select Show Prescription Details at the bottom to show order and administration date and pharmacy status Click the “magnifying glass” icon to show the treatment Page 111 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Highlight the line below the patient name if the Rx box is showing then the following window will appear showing the Pharmacy Approval Details. If a patient is highlighted by clicking on the yellow file with red arrow on the far right of the screen that patient’s treatment window will open and the following will appear which takes you straight to the Orders / Rx details. Page 112 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Where patient scheduling is being used for patients prescribed treatment in Aria then Pharmacy can also view a list of treatment by selecting Pharmacy on the top Tool Bar, and then Schedule Drug Orders from the drop down list, the following window appears Page 113 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager There are several different filters on the top of the screen that can be applied e.g. date, Sort By and Drug To View either by Ordered, Pending or Planned e.g. select Ordered and click Show Orders the following list appears This can be printed off in pharmacy if necessary. Page 114 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager 10 NURSE DRUG ADMINISTRATION Once the pharmacy have dispensed the medication then the nurse needs to do the drug administration, to open click the Drug Admin button on the second Tool Bar, the following window appears The patient Date of Birth can be seen after the name and gender on the top right of screen above Dose Recordings tab By clicking View on the top bar you can check patient demographics. By highlighting an agent and then clicking on the up and down arrows on the bottom right of the screen you can change the order of an agent. The days of administration can be amended by clicking Adjust or Adjust All buttons on the bottom on the screen, the following window appears. However this should not be used routinely but only as a last resort if not previously adjusted by the prescriber. Page 115 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager This can be adjusted by Days or Date, if Date is selected the current date and a calendar will appear next to the Days to Adjust box. Page 116 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Click Adjust (top right of screen) and the Admin date will change Click OK and the screen will return to the Drug Administration window Page 117 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager Highlight the drug to be administered and click Record button on bottom left of screen, the following appears Page 118 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager You will see any Drug Lot # if entered by pharmacy when dispensing. If you click on page icon next to dispensing you can also view any pharmacy comments. Enter the time of administration and click OK, the screen will return to the Drug Administration window and a C will appear to the left of the date, showing the treatment has been started but not completed. Page 119 of 182 Version 1 December 2015 D Kimber Network e-Prescribing System Manager To enter the end of administration, highlight drug, click Record and enter the end time and click Approve the Drug Administration window is now only showing agents still to be administered. Page 120 of 182 Version 1 December 2015 D Kimber Network
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/User-guides/Aria-ePrescribing-v13.6-MR1.2-user-training-guide.pdf

Capecitabine-Cetuximab-Oxaliplatin

Description: Chemotherapy Protocol COLORECTAL CANCER CAPECITABINE-CETUXIMAB-OXALIPLATIN (21 day) This regimen may require funding Regimen • Colorectal Cancer – Capecitabine-Cetuximab-Oxaliplatin (21
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Capecitabine-Cetuximab-Oxaliplatin.pdf

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