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Clinical Research in Southampton
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Great saphenous vein harvesting for a coronary artery bypass graft (CABG) - patient information
Description
This factsheet explains what great saphenous vein harvesting is and what the procedure involves, so you know what to expect.
Url
/Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Great-saphenous-vein-harvesting-for-a-coronary-artery-bypass-graft-CABG-3401-PIL.pdf
Altruism in stem cell donation
Description
Mr Wheeler considers whether a person without capacity can be a stem cell donor.
Url
/HealthProfessionals/Clinical-law-updates/Altruism-in-stem-cell-donation.aspx
HSCTCyclophosphamide-Priming-1500
Description
Chemotherapy Protocol Haematopoietic Stem Cell Transplant (Autograft) CYCLOPHOSPHAMIDE PRIMING (1500mg/m2) Regimen • Haematopoiet
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/hsctcyclophosphamide-priming-1500.pdf
HSCTCyclophosphamide Priming (1500)
Description
Chemotherapy Protocol Haematopoietic Stem Cell Transplant (Autograft) CYCLOPHOSPHAMIDE PRIMING (1500mg/m2) Regimen • Haematopoiet
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Transplant/HSCTCyclophosphamide-Priming-1500.pdf
Public given rare behind the scenes access to city's hospitals
Description
Members of the public will be given rare behind the scenes access to Southampton's teaching hospitals on Saturday (9 September) as
Url
/AboutTheTrust/Newsandpublications/Latestnews/2017/September-2017/Public-given-rare-behind-the-scenes-access-to-citys-hospitals.aspx
Stem cell collection from the umbilical cord - maternity information
Description
This factsheet is designed to offer information to families who are considering private (commercial) umbilical cord blood collection following delivery of
Url
/Media/UHS-website-2019/Patientinformation/Pregnancyandbirth/Stem-cell-collection-from-the-umbilical-cord-880-PIL.pdf
Collecting your colostrum while you are pregnant - patient information
Description
This factsheet explains what colostrum is, what collecting your colostrum while you are pregnant involves, and what the advantages of it
Url
/Media/UHS-website-2019/Patientinformation/Pregnancyandbirth/Collecting-your-colostrum-while-you-are-pregnant-1461-PIL.pdf
Annual report 15-16
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University Hospital Southampton NHS Foundation Trust Annual report and accounts 2015/16 incorporating the quality account 2015/16 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 3 ©2016 University Hospital Southampton NHS Foundation Trust TABLE OF CONTENTS Performance report Statement from the chief executive 7 Statement of purpose and activities 8 History of UHS 8 Key issues and risks 9 Going concern disclosure 9 Performance reporting 10 Regulatory body ratings 14 Environmental matters 14 Social, community and human rights issues 15 Accountability report Directors’ report 17 Introducing the Board of Directors 20 The people 21 Audit and assurance committee 25 Disclosures 28 Council of Governors 33 Annual remuneration statement 40 Appointment and remuneration committee 43 Governors’ nomination committee 45 Staffing data 50 Regulatory ratings 57 Statement of chief executive’s responsibilities as the accounting officer 59 Annual governance statement 60 Voluntary disclosures 69 Quality account and report 2015/16 Chief executive’s welcome 121 Overview of University Hospital Southampton NHS Foundation Trust 122 Activity levels during 2015/16 122 Our 2015/16 priorities for improving quality 123 Our 2015/16 priorities for outcomes and clinical effectiveness 124 Our 2015/16 priorities for patient experience 126 Our 2015/16 priorities for patient safety 129 Never events 130 Our quality priorities for 2016/17 130 Participation in national clinical audits and confidential enquiries 131 Participation in clinical research 133 Data quality 133 Review of services 134 Registration with the Care Quality Commission (CQC) 136 Our standard core indicators of quality 139 Overview of performance 146 Further information about our Trust 150 Conclusion 153 Responses to our quality account 154 Statement of directors’ responsibilities 160 Independent auditor’s report 161 Annual accounts Statement from the chief financial officer 79 Foreward to the accounts 81 Independent auditor’s report 82 Financial statements 87 FTC summarisation schedules for UHS NHS Foundation Trust 118 Appendix Appendix A – pulse KPI’s 165 Appendix B – national clinical audit activity 166 Appendix C – local clinical audit activity 167 Appendix D – patient improvement framework 2016/17 175 Appendix E – glossary of acronyms 176 5 Statement from the chief executive 2015/16 has been a challenging year for University Hospital Southampton (UHS) but we are proud of the achievements we have made. In order to meet the needs of the population, we have seen 706,931 patients (total inpatients and outpatients), which is over 25,000 more patients than in the previous year. You’ll find a more detailed breakdown of activity on page 11. Overall, patients were happy with the care that we gave them, with 96%* likely to recommend UHS. We have worked hard to maintain and improve the quality of our services. In particular, we are pleased that our Hospital Standardised Mortality Rate (HSMR) is now below nationally expected levels. You can find more detail on this within the quality account section of this report. We are very aware that healthcare is a ‘risky business’ and that, internationally, healthcare is not as safe as it could be. In order to address this it is crucial that we encourage a safety conscious culture, including the reporting and analysis of all incidents and untoward events. In February 2016 the NHS published a ‘transparency league’ designed to assess how open and transparent NHS organisations are with regards to errors. We were pleased to be ranked as ‘good’ in this assessment. Patient waiting times is another important aspect of quality – whether that be waiting at home for a cancer diagnosis or elective surgery, or waiting in the emergency department for treatment or an inpatient bed. Throughout the year we met the national standards for cancer treatment, diagnostics and elective care, but we did not meet the four hour emergency access standard. We have, however, improved our performance compared to 2014/15, and we are committed to improving this performance in 2016/17. Feedback from our staff is important to us and is another important indicator of quality. The most recent staff Friends and Family Test indicated that 90% of our staff would recommend us as a place to be treated, and 76% as a place to work. Whilst we still have work to do, these figures are significantly better than the national average, and the highest that we have ever achieved. Other highlights of the year include being selected for two national initiatives: 1. to be one of the early implementers for the seven day service standards for emergency and inpatient services, and 2. to be one of the pilots for supporting staff health and wellbeing. Both of these initiatives are an important part of our journey towards becoming a higher quality provider of healthcare and an exemplary employer. Following extensive consultation, we also launched our new vision ‘Forward’ which can be found at www.uhs.nhs.uk/AboutTheTrust/Ourvision. Our Trust chair, John Trewby, left the Trust at the end of March 2016 when his second term of office came to an end. John has been an exceptional leader and over the last eight years he has steered UHS to achieve great things in some truly difficult circumstances. Under his leadership we achieved foundation status in 2011, developed as a clinical academic centre with a growing reputation for research, and have gained an outstanding reputation for the excellence and outcomes of our clinical services. I would like to take this opportunity to thank him for his commitment to UHS and welcome his successor, Peter Hollins, to the role. Finally, we continued to invest in our buildings and equipment. This included the creation of a new main entrance opened in May 2016, and ongoing major investment into radiological equipment. We also expanded our emergency department to create an ambulance assessment area and, in March 2016, chancellor George Osborne announced that the government will invest £2m in a new £4.8m children’s emergency and trauma department for our Southampton Children’s Hospital. Fiona Dalton Chief executive *figure based on April 2016 survey 7 Statement of purpose and activities UHS is a large teaching hospital located on the south coast of England. We have a tripartite mission to provide clinical care, educate current and future healthcare professionals, and undertake research to improve healthcare for the future. Our clinical care encompasses local acute and elective care for 650,000 people who live in Southampton, the New Forest, Eastleigh and Test Valley. We also provide care for the residents of the Isle of Wight for many services. As the major university hospital on the south coast, UHS provides the full range of tertiary medical and surgical specialities (with the exception of transplantation, renal services and burns) to more than three million people in central southern England and the Channel Islands. UHS is a centre of excellence for training the doctors, nurses and other healthcare professionals of the future. We work with the University of Southampton and Solent University to educate and develop staff at all levels, including a large apprenticeship programme, undergraduate and post-graduate education. Our role in research, developed in active partnership with the University of Southampton, is to contribute to the development of treatments for tomorrow’s patients. This work distinguishes us as a hospital that works at the leading edge of healthcare developments in the NHS and internationally. In particular we have nationally-leading research into cancer, respiratory disease, nutrition, cardiovascular disease, bone and joint conditions and complex immune system problems. We are one of the largest recruiters of patients into clinical trials in the country. Over 10,500 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the time of over 1,000 volunteers. Our turnover in 2015/16 was £693m. History of UHS The Trust has its origins in the 1900s when the Shirley Warren Poor Law Infirmary was built on the site of what is now Southampton General Hospital. In the early half of the century, the site began to expand, including the opening of the school of nursing and the creation of the Wessex Neurological Unit. In 1971 a new medical school was opened in Southampton and the 1970s and 1980s saw a significant building programme encompassing the current footprint of Southampton General Hospital, Princess Anne Hospital and Countess Mountbatten House. During the 1990s, services were increasingly centralised at the general hospital, with the eye hospital and cancer services being relocated from elsewhere in the city. The Wellcome Trust funded a clinical research facility at the hospital in 2001 and this unit remains the foundation for much of the Trust’s groundbreaking medical research. In the last decade, development has continued with the opening of the North Wing Cardiac Centre in 2006, the creation of a major trauma centre with on-site helipad and the opening in 2014 of Ronald McDonald House for the relatives of sick children. Organisationally, Southampton University Hospitals Trust was formed in 1993, creating a single management board for acute services in Southampton. Fourteen years later, University Hospital Southampton NHS Foundation Trust (UHS) was formed (1 October 2011) when Southampton University Hospitals NHS Trust was licensed as a foundation trust by the regulator, Monitor. 8 Key issues and risks that could affect achievement of our objectives There are three key issues that could affect our ability to achieve our objectives, these are: 1. Failure to deliver the four hour emergency department target, which impacts both patient experience and safety. There is a recovery action plan in place which has been formally reviewed by our commissioners. The main focus for 2016/17 is working with partners to reduce delayed transfers in care, improving the numbers of discharges that occur before midday and improving processes for emergency patients between the ED and inpatient teams. 2. Capacity and occupancy, which impacts on patient flow and timeliness of care. Increased risk in 2016/17 through unplanned transfers in service by other local providers and support for emergency flows. We have mitigated this by minimising the bed closures refurbishment programme, focusing on seven day service, improving patient flow (such as home before lunch), developing a hospital without walls, investing in a capital programme to improve capacity (surgical robot, hybrid theatres and minor ops rooms) and reducing length of stay. 3. Staffing, plans are in place for both recruitment and retention. To mitigate this risk we will continue to focus on making UHS an attractive employer by: - continuing to recruit from overseas - working with universities to increase student nurses - developing band 4 posts and apprentices - rolling out a new, consistently branded, ‘Think UHS’ recruitment campaign - enhancing overseas fellows posts - reviewing all junior rotas in light of the new contract - using flexible and temporary staff when needed - creating different roles linked to our research agenda - reviewing training and education to enhance retention Going concern disclosure After making enquiries, the directors have a reasonable expectation that the Trust has adequate resources to continue in operational existence for the foreseeable future. For this reason, they continue to adopt the going concern basis in preparing the accounts. 9 Performance reporting Reporting structure As a large NHS university hospital foundation trust, UHS monitors performance within individual teams throughout the year with feedback processes in place to escalate issues to more senior management teams. At a corporate level we have an established executive reporting structure. This begins with the monthly Trust Board meeting where the executive directors of the Trust will present a high level summary to the chairman and non-executive directors, as well as providing greater detail on key performance changes, risks and issues. Below this are a number of executive sub-committees attended by a subset of executive and non-executive directors. These are the audit and assurance committee, the strategy and finance committee and the quality and performance committee. These committees will review performance and issues in greater depth, feeding back to Trust Board as appropriate. In addition, there are regular Trust Board study sessions which focus on specific individual issues with the entire Board present. The Trust executive committee (TEC) meets monthly and is made up of the executive board members and the divisional management teams. Performance and service issues are discussed with greater granularity at this meeting. Finally, there are regular performance meetings between the operational management team, led by the chief operating officer, and the division and care group management teams. These meetings focus on the individual patient and service pathways and developing the detailed plans for improvement. Key performance indicators (KPIs) The Trust publishes a monthly Integrated KPI Board Report on its website which provides both the Board and the public with an overview of performance within the Trust. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. The monthly report features the following sections: • Executive digest – a textual update on the previous month’s performance across the Trust written by the director of transformation and improvement • Pulse KPIs – the top KPIs identified by Trust Board, RAG-rates for the previous 13 months (see appendix A) • Performance • Activity • Capacity • Emergency department (ED) • Referral to Treatment (RTT, or 18 Weeks) • Cancer waiting times • Finance • Patient experience • Patient safety • Outcomes • Staffing (HR) and estates • Education and training • Research and development This report also includes summary versions of quarterly reports submitted to TEC which go into greater detail about patient experience, patient safety, clinical effectiveness and outcomes, and infection prevention In addition, a separate Finance Board Report is submitted to Trust Board on a monthly basis. 10 How we monitor performance In addition to reviewing the data submitted to the Trust Board in these papers, we have a suite of tools available to compare UHS performance to that of comparable trusts around the country. Depending on the measures being monitored, UHS has a number of peer groups to benchmark against including other local providers, major trauma centres and university hospital teaching trusts. Each NHS trust will serve a different size and type of population and will offer a slightly different range of services so it is important to understand that this benchmarking provides an initial indication of performance rather than an absolute guide to our position nationally. We will build on this knowledge by meeting and working with other trusts around the country and the world in order to share learning and build the best patient pathways and most efficient uses of resources possible. Detailed analysis and explanation of the development and performance of UHS Over the past four years we have seen significant increases in all types of activity. Some of this is due to an increase in the range of specialist services we offer, becoming a major trauma centre and the building of the helipad, but much of it is due to the increased and aging population in Southampton and the surrounding area. The graphs below demonstrate this increase in activity. UHS Growth in Activity - 2012/13 to 2015/16 600000 500000 400000 300000 200000 100000 2012/13 2013/14 2014/15 2015/16 0 Inpatient Spells (inc day cases) Outpatient Appointments ED Attendances (type 1) Referrals 2012/13 Inpatient spells (inc day cases 133,712 Outpatient appointments 447,122 ED attendance (type 1 & 2) 115,917 Referrals 165,597 2013/14 138,868 493,471 115,660 181,761 2014/15 144,934 536,949 111,297 182,402 2015/16 145,524 561,407 113,569 190,170 Increase 2012/13 to 2015/16 8.8% 25.6% -2.0& 14.8% In order to manage these increasing pressures we have focused our attention on the flow through the hospital. Our adult midday bed occupancy decreased by 4.3% in 2015/16 (to the end of February) compared to the same period in 2014/15, allowing the Trust greater flexibility when dealing with periods of high demand. This is reflected in the reduction in the number of red and black alerts issued in 2015/16. 11 The hospital alert status is decided by the operations centre after assessing the bed and staffing position, and is recorded twice daily at the Trust bed meetings (though the status may change at any time). Black alert is the highest level of alert and is issued when there are no empty beds available across the Trust with no expected discharges, the emergency department is full, and several ambulances are likely to be delayed for long periods of time, stopping them from responding to 999 calls. In 2014/15 a black alert was recorded 91 times at the twice daily bed meetings. In 2015/16 this was reduced to seven. A central pillar of this change has been the stabilisation of Length of Stay (LoS) despite the increased number of patients requiring a complex package of care after their discharge. These patients can often have their discharges delayed while beds in community care homes are found and supporting community care packages are arranged. The chart below demonstrates the change in LoS for elective and non-elective (emergency) patients over the past four years. Rolling 12-Month Average Length of Stay - Elective and Non-Elective 6.50 6.00 5.50 5.00 4.50 4.00 3.50 R-12 Non-Elective LoS R-12 Elective LoS 3.00 2015/16 saw an increased focus on discharging patients earlier in the day and at the weekend. This will remain a major focus for the Trust in 2016/17. Each of the above metrics will have an impact on the Trust’s performance against the three primary nationally reported targets for Referral to Treatment (RTT, or 18 Weeks) performance, emergency department performance and cancer waiting times performance. Referral to Treatment (18 Weeks) performance At the start of 2015/16 there were three targets the Trust was responsible for delivering: 1. Incomplete Pathways – 92% of all patients on an 18 week pathway and not yet treated should have waited 18 weeks or less at the end of the month. 2. Admitted Stops – 90% of all patients requiring an inpatient treatment should receive this treatment within 18 weeks of referral. 3. Non-Admitted Stops – 95% of all patients either receiving treatment in an outpatient setting or discharged without requiring treatment should have their pathway stopped within 18 weeks of referral. The government announced that, from July 2015 onwards, only the achievement of the Incomplete Pathways target would be required. This change allowed trusts to treat greater numbers of long-waiting patients each month. UHS met all three targets in quarter 1 of 2015/16 and continued to meet the Incomplete Pathways target throughout the rest of the year. 12 This continuing good performance should be set against the aforementioned rise in patient referrals, which highlights the increased demands being placed on the Trust. It is only due to the increased efficiency shown by the Trust’s inpatient and outpatient services that it has been possible to meet these targets on an ongoing basis. Emergency department (ED) performance We have failed to meet the national target of 95% of all ED attendances being treated and either admitted or discharged within four hours of arrival in any month in 2015/16. However, this has been a challenging target nationwide with the winter period providing the worst performance the NHS in England has ever recorded. Against this, the year on year improvement seen at UHS is good progress. There are three types of ED that can be included in these figures: Type 1 A consultant led 24-hour service with full resuscitation facilities and designated accommodation for the reception of accident and emergency patients. Type 2 A consultant led single specialty accident and emergency service (e.g. ophthalmology, dental) with designated accommodation for the reception of patients. Type 3 Other type of A&E/minor injury units (MIUs)/Walk-in Centres, primarily designed for the receiving of accident and emergency patients. A type 3 department may be doctor led or nurse led. It may be co-located with a major ED or sited in the community. A defining characteristic of a service qualifying as a type 3 department is that it treats at least minor injuries and illnesses (sprains for example) and can be routinely accessed without appointment. UHS has a type 1 and a type 2 (ophthalmology) department. The Trust also had a type 3 (MIU) department until July 2014. Due to the nature of the activity at the MIU, the transfer of this department to another provider reduced UHS performance against the four hour target by approximately 3%. When comparing performance over the long term, it is important to factor this change in. ED performance reduced fractionally in quarters 1 and 2 of 2015/16 compared to 2014/15, despite the loss of the MIU activity. In quarter 3, when the comparative activity was the same, performance improved by 4.7%. This was due in part to the improvements in hospital flow outlined earlier, and also linked to improvements in the operational performance of the department itself. While performance fell by 1.2% in quarter 4 of 2015/16 compared to the same time the previous year, this must be set against an increase in activity of over 3,000 additional ED attendances (12.1%). The graph below shows UHS performance against the four hour target over the past four years. Year-On-Year ED Performance by Quarter 98.00% 96.00% 94.00% 92.00% 90.00% 88.00% 86.00% 84.00% Cancer waiting times 82.00% 80.00% 78.00% 76.00% Q1 Q2 Q3 Q4 2012/13 2013/14 2014/15 2015/16 13 There are 10 separate cancer waiting times measures that the Trust reports to the Department of Health on a monthly basis, each of which can then be split into tumour site specific performance groups. In 2015/16 (to the end of February) the Trust met all 10 of these measures, an improvement on 2014/15 when one target was failed. This performance against the targets should be set against the significant rise in activity seen on the cancer pathways. The three central targets are the percentage of two week wait urgent suspected cancer patients seen within two weeks of their referral, which saw a rise in demand of 13% in 2015/16, the percentage of these patients diagnosed with cancer treated within 62-days of their referral (for which demand increased by 20.1%) and the number of all patients treated within 31 days of an agreed treatment plan being put in place (for which demand rose by 14.2%). The chart below shows the rise in demand for UHS cancer services over the past five years. 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 - UHS Growth in Activity - 2012/13 to 2015/16 Two Week Waits 62-Day Target Patients 31-Day Target Patients 2011/12 2012/13 2013/14 2014/15 2015/16* * 2015/16 data covers April to February only These targets are a leading priority for the Trust and will be the focus of in depth work in 2016/17, especially given the ongoing increases in demand for these services. Regulatory body ratings In the last quarter of 2015/16 Monitor rated UHS ‘2’ for our financial sustainability risk rating (1 being the most serious risk and 4 the lowest risk) and ‘green’ for our governance risk rating, which means that no governance concern is evident and no formal investigation is being undertaken. More details can be found on page 57. The Care Quality Commission (CQC) gave us an overall rating of ‘requires improvement’ as at December 2014. You can see the full report by visiting www.uhs.nhs.uk or www.cqc.org.uk. Environmental matters A number of projects were undertaken in 2015/16 to reduce our impact on the environment. We installed a large anaerobic digester which will provide renewable energy by naturally breaking down waste and turning it into fuel. We have also replaced one of our combined heat and power engines so that we can generate more of our own electricity on site and get the benefit of free heating that is a by-product of running a large gas engine. 14 In conjunction with these two developments we have implemented a range of measures to ensure that we are using energy more efficiently. For example, we are now ensuring that large water pumps are only running when needed and we are in the process of replacing old fluorescent lighting with more efficient LED systems. More information can be found within the environmental sustainability and climate change section of this report. Social, community and human rights issues We recognise our responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK), which are relevant to health and social care. These rights include the: • right to life • right not to be subjected to torture, inhuman or degrading treatment or punishment • right to liberty • right to respect for private and family life The Trust is committed to ensuring it fully takes into account all aspects of human rights in our work. 15 Directors’ report Composition of the Board The Board is currently comprised as follows: Non-executive directors: Peter Hollins, chair Simon Porter, senior independent director Professor Iain Cameron Lynne Lockyer Dr David Price Dr Mike Sadler Jenni Douglas Todd Executive directors: Fiona Dalton, chief executive Gail Byrne, director of nursing and organisational development Jane Hayward, director of transformation and improvement Dr Derek Sandeman, medical director Dr Caroline Marshall, chief operating officer David French, chief financial officer Name John Trewby Lena Samuels Judy Gillow Dr Michael Marsh Mike Murphy Alastair Matthews Gail Byrne Dr Derek Sandeman Position Chairman Non-executive director Director of nursing and organisational development Medical director Director of strategy Director of finance and deputy chief executive Director of nursing and organisational development Medical director Paul Goddard Acting director of finance David French Chief financial officer Note Left the organisation on 31 March 2016 Left the organisation on 29 February 2016 Left the organisation on 30 September 2015 Left the organisation on 31 May 2015 Left the organisation on 31 December 2015 Left the organisation on 1 November 2015 Commenced from within the organisation on 1 October 2015 Commenced from within the organisation on 1 June 2015 Acting director from 23 October 2015 to 2 February 2016 Joined the organisation on 3 February 2016 It should be noted that the size of the Board has been reduced to seven non-executive directors (including the chair) and six executive directors. This decision was agreed by our appointments and remuneration committee on 25 August 2015. Each director confirms that at the time the annual report and accounts is approved: • so far as the director is aware, there is no relevant audit information of which the NHS foundation trust’s auditor is unaware • the director has taken all the steps they ought to have taken as director in order to make themselves aware of any relevant audit information and to establish that the NHS foundation trust’s auditor is aware of that information. 17 There are no important events since the year end affecting the foundation trust. No political donations have been made. The Trust has no overseas branches. Trust Board declarations of interest John Trewby Council member University of Southampton; chair Exelis Defence Ltd; associate of Group 4 Securicor. Peter Hollins Partner in the Jubilee Film Partnership; chair of CLIC Sargent Cancer Care for Children (a company limited by guarantee). Lena Samuels Shareholder and director, 37 Patshull Road NW5 Limited; magistrate of Southampton Bench; member of staff at BBC; shareholder and director of Wessex Creative Media Ltd; chair of Pylewell Park Cricket Club; trustee Cultural Development Trust; prospective Labour Party parliamentary candidate for the New Forest West constituency (until 7 May 2015); communications and development specialist advisor for the Hampshire Cultural Trust (from 4 May 2015) Iain Cameron Dean of Faculty of Medicine and Member of University Executive Board, University of Southampton; board member of Wessex Academic Health Science Network; director (chair) of Medical Schools Council; director of Medical Schools Council Assessment; director of UK Clinical Aptitude Test; trustee of Wessex Medical Trust; joint chair of University Hospital Southampton/University of Southampton Joint Research Strategy Board; joint chair, National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) Southampton Executive Board. Simon Porter Independent member of audit committee Amicus Horizon (until 21 October 2015); Former partner in Ernst & Young LLP; non-executive director and chair of audit committee, Radian Group; non-executive director and chair of audit committee, Octavia Housing. Lynne Lockyer Board member/trustee of the Brendoncare Foundation. David Price Public member of Network Rail Ltd (until 30 June 2015); chair of RTL Materials Ltd; chair of Telesoft Technologies Ltd; chair of Optitune Plc; chair of Symetrica Ltd; member of Advisory Board, Silverstream Technologies BV; treasurer, University of Southampton. Michael Sadler GP specialist advisor for the Care Quality Commission; external clinical associate for PricewaterhouseCoopers. Fiona Dalton Trustee of Gingerbread, the national charity for one-parent families (until 31 December 2015). Judy Gillow Trustee of Naomi House Children’s Hospice, Winchester (until 31 August 2015); trustee of Enham House Disability Charity, Andover. Gail Byrne Husband is a consultant surgeon in the Trust; trustee of Naomi House Children’s Hospice (from 1 January 2016). 18 Caroline Marshall Nothing to declare Jane Hayward Father is mental health act manager, Southern Foundation Trust (voluntary position), member of Mental Health Act Committee, Southern Foundation Trust (voluntary position), member of Assessment Committee for Clinical Excellence Awards (lay member), a UHS Simulated Patient (voluntary position), Lay member on Medical School undergraduate interview panels (until 31 December 2015); Mother is a UHS Simulated Patient (voluntary position). Michael Marsh Married to Sarah Marsh, who works within Specialised Commissioning of NHS Commissioning Board; selfemployed Medico Legal Expert on ad hoc basis independently to solicitors, Medical Defence Union (MDU) and NHS Litigation Authority. Derek Sandeman Nothing to declare. Alastair Matthews Non-executive director of NHS Innovations South East Ltd. Paul Goddard Partner works for the Trust as projects officer within the contracting department and previously PA to the director of research and development. David French Non-executive director and chair of audit and risk committee, Sentinel Housing Association; governor and chair of audit committee, South Wilts Grammar School for Girls; chair of Hampshire & Isle of Wight NHS Counter Fraud Board. Mike Murphy Parent governor, Mountbatten School, Romsey. 19 Introducing the Board of Directors Trust Board The Board is made up of the chair, six non-executive directors and six executive directors including the chief executive. Together they bring a wide range of skills and experience to the Trust, such that the board achieves balance and completeness at the highest level. The non-executive directors, including the chair, are people who live or work in the local area and have shown a genuine interest in helping to improve the health of local people. The non-executive directors are determined by the Board to be independent in both character and judgement. The chair, executive directors and non-executive directors have declared any business interests that they have. The Board is satisfied that no conflicts of interest are indicated in any external involvement. The register of Board members’ interests is updated at least annually and is maintained by the company secretary and associate director of corporate affairs. It is available for public inspection from the company secretary and associate director of corporate affairs. The ‘reservation of powers to the Board and delegation of powers policy’ sets out the business to be conducted by the Board, or by one of its committees. Any enquiries should be made to: company secretary and associate director of corporate affairs, Trust Headquarters, Mailpoint 18, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD or telephone 023 8120 6829. Senior independent director The role of senior independent director has been established and, until 31 March 2016, was held by Peter Hollins, a non-executive director. The senior independent director role provides a channel through which foundation trust members and governors are able to express concerns, other than the normal route of the chair or chief executive. Appointments Non-executive directors are appointed via open advertisement in accordance with the ‘Appointment of a foundation trust non-executive director good practice guide’ procedure adopted by the Trust. The process is managed through the governors’ nomination committee, a sub-committee of the Council of Governors. This committee also determines the remuneration and terms and conditions of the non-executive directors. For further details on the appointment of non-executive directors please see page 45. Development of the Board The Board held monthly study sessions during 2015/16 where strategic issues, along with emerging issues, were discussed. Meetings of the Board The Board meets once a month in public. Additional private meetings with only the board, and associated employees of the Trust making presentations to the board in attendance, are held as required. Other committees of the Board include: appointment and remuneration committee; audit and assurance committee, strategy and finance committee; quality and performance committee and charitable funds committee. Generally the other committees of the board meet monthly with the exception of the audit and assurance committee, which meets five times a year and the appointments and remuneration committee which meets every other month. The frequency of the meetings is set out in each committee’s terms of reference. These terms of reference are reviewed at least annually. 20 The performance of individual Board members is reviewed as set out on page 44 of this report. Engagement with Council of Governors The Trust Board engages with the Council of Governors through the chair and senior independent director. Non-executive and executive directors engage with sub-groups of the council where these are related to their portfolios. Board members meet regularly with governors and have an open invitation to attend formal Council of Governor meetings. The people Non-executive directors John Trewby, chair to 31 March 2016 John joined the Trust on 1 April 2008, bringing with him a wealth of leadership experience after a distinguished career in the Navy where he rose to the rank of rear admiral and became the first chief executive of the Naval Bases and Supply Agency. After 36 years in the Navy, John joined the defence company British Aerospace (latterly BAE Systems) where he was their chief naval advisor for eight years. He is an associate of Group4Securicor and chair of Exelis Defence Ltd. He is a fellow of the Royal Academy of Engineering; sitting on its proactive membership committee and in 2009 chaired a study into “ICT for the UK’s Future”. He is currently chairing a study on wind turbines. He is a council member of the University of Southampton. Professor Iain Cameron Iain Cameron is a professor of obstetrics and gynaecology and dean of the Faculty of Medicine at the University of Southampton. After graduating in medicine at the University of Edinburgh, he underwent postgraduate clinical and research training in Edinburgh, Melbourne and Cambridge. He held the regius chair of obstetrics and gynaecology at the University of Glasgow from 1993 and moved to Southampton in 1999. His main clinical and research interests are reproductive endocrinology and investigation of the impact of the maternal environment on early pregnancy. Iain is chair of the Medical Schools Council; a member of the UK Clinical Research Collaboration board; the National Institute for Health Research advisory board; the Health Education England medical advisory group; and the Wessex Academic Health Science Network delivery board. Peter Hollins Peter Hollins graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, he was appointed in 1992 as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, returning in 1998 to the UK as chief executive officer of British Energy where he remained until 2001. From 2001, he held various chairmanships and non-executive directorships. In 2003, he decided to return to an executive role as chief executive of the British Heart Foundation in which post he remained until retirement in March 2013. Lynne Lockyer Lynne’s background is in human resource management and strategic management. She became a nonexecutive director for Southampton and South West Hampshire in 1996 and the vice chair in 2000. She was chair of Eastleigh and Test Valley South PCT from its inception in 2002 until its disestablishment in 2006. She has taken many roles in the local health economy including being a member of Hampshire’s Local Area Agreement Board and nationally was a member of the NHS Confederation Council and the National NHS Leaders Steering Group. She was until recently a course director at the University of Portsmouth and is now an organisation development consultant. She is a trustee of the Brendoncare Foundation. 21 Simon Porter Simon was born and educated in Southampton and then Oxford, graduating with a degree in modern languages (Italian and French). He is a qualified chartered accountant, having spent most of his career with the London office of Ernst & Young, where he specialised first in audit, then in transactions and finally management. He was a partner with Ernst & Young from 1994 to 2010. He joined the Trust Board on 1 January 2011 as a designate non-executive director and became non-executive director and co-chair of the audit and assurance committee from 1 June 2011. He has chaired the quality and performance committee since it was established in January 2014. He also holds non-executive board positions in the social housing sector. Dr David Price David is a former chief executive of a FTSE-250 company with broad experience within the electronics, chemical, aerospace, defence, marine, and nuclear industries. He has a successful track record of developing highly complex companies in international markets. He is currently non-executive chairman of Symetrica Ltd, Telesoft Technologies Ltd, RTL Materials Ltd and Optitune Plc. He is treasurer of the University of Southampton and a member of the advisory board of Silverstream Technologies BV. David is a chartered engineer and chartered scientist. He has a degree in electronic engineering, a PhD from University College London and, in 2001, he was awarded an honorary doctorate by Cranfield University for his services to science and engineering. David was made a Commander of the Order of the British Empire (CBE) for his services to industry. Dr Mike Sadler Mike joined us as a clinical non-executive director in September 2014, from a similar position at an NHS Foundation Trust providing mental health, learning disability and community services. He works for the CQC as a specialist adviser in primary care and works as an advisor and consultant on health and social care services. Mike was a GP principal in Hampshire before moving into public health medicine. Having achieved an MSc with distinction at the London School of Hygiene and Tropical Medicine, he joined Portsmouth and South East Hampshire Health Authority, holding the joint posts of deputy director of public health and medical adviser. He has since held a series of senior clinical leadership roles in national organisations in both the public and private sector, including as a chief operating officer at NHS Direct and Serco’s health division. His last full time role, up until July 2013 when he commenced his portfolio career, was as director of health and social care at West Sussex County Council. Jenni Douglas Todd – appointed 1 April 2016 Jenni is a former chief executive of Hampshire Police Authority and the office of the Hampshire police and crime commissioner. After beginning her career in the probation service, she was head hunted into the civil service, at the Home Office, where she spent four years before being becoming director of policy and research for the Independent Police Complaints Commission. In the latter role she was responsible for establishing governance of the new police complaints system. She then spent two-and-a-half years as a resident twinning adviser for the UK, based in Turkey to help set-up a law enforcement complaints system before taking up the role of chief executive of the county’s Police Authority. During her three years in the post, she supported the authority in developing effective governance processes to increase accountability and transparency. She also helped the organisation deliver cost-savings whilst still improving performance and developing closer working relations with neighbouring forces. In 2012, she became chief executive and monitoring officer for the Hampshire police and crime commissioner, where she led the development of the office’s vision, mission, values and organisational strategy. She took on the role of investigating committee chair for the general dental council in 2014 and, in April that year, founded the Diversa Consultancy, which supports organisations with changes in business, culture and behaviour. She is also a member of the Judicial Conduct Investigating Office, a public appointment. 22 Executive directors Fiona Dalton, chief executive Fiona was appointed as chief executive in 2013. Prior to re-joining the Trust she held the combined position of deputy chief executive and chief operating officer at Great Ormond Street Hospital for Children. Fiona joined the NHS management training scheme after graduating from Oxford University with a degree in human sciences and began her career in hospital management at Oxford Radcliffe Hospitals NHS Trust in 1996. She then spent four years at UHS as director of strategy and business development before moving to Great Ormond Street Hospital. Gail Byrne, director of nursing and organisational development Gail joined the Trust in 2010 as deputy director of nursing and head of patient safety. Prior to this, she has worked at the Strategic Health Authority as head of patient safety, and director of clinical services at Portsmouth Hospital. Gail has also worked in Brisbane, Australia as a hospital Macmillan nurse, and as general manager of a special purpose vehicle company for the private finance initiative at South Manchester Hospitals. Jane Hayward, director of transformation and improvement Jane joined the Trust in 2000 as a clinical services manager for the cardiothoracic directorate after spending two years in Hertfordshire as director of performance and 11 years at Barts and the London Hospitals in various roles including planning, finance and commissioning. Jane has led on human resources, information management and technology, improvement and modernisation and has been chief operating officer. Jane joined the Trust Board in February 2008 and became director of transformation and improvement in January 2014. Dr Derek Sandeman, medical director Dr Derek Sandeman was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional endocrine service. Throughout his career he has had extensive clinical leadership experience, most recently serving eight years as clinical director. Derek’s leadership roles have also included programme director for postgraduate education and the Wessex Endocrine Royal College representative. He has a strong history of wider system engagement, working collaboratively with partners to improve systems resilience and pathways. Dr Caroline Marshall, chief operating officer Caroline joined the Trust in 1997 as a consultant hepatobiliary and neuroanaesthetist. She has held the posts of college tutor for the Royal College of Anaesthetists and UHS mentoring and coaching lead. In 2008, she became clinical service director for critical care before holding the position of divisional clinical director between 2010 and 2013. Caroline served as interim chief operating officer before being appointed in December 2014. David French, chief financial officer David joined the Trust in February 2016 and leads on finance, estates and commercial development. He read Economics and Social Policy at the University of London before joining ICI plc, where he qualified as a chartered management accountant. David has extensive healthcare experience from the pharmaceutical industry, mostly Eli Lilly and Company where he held many commercial and financial roles in the UK and overseas. He joined the NHS in 2010 as chief financial officer of Hampshire Hospitals NHS Foundation Trust. He also serves as a non-executive director for Sentinel Housing Association, a Hampshire-based social housing provider. Board effectiveness On the basis of the expertise and experience described above, the Trust is confident that the necessary range of knowledge and skills exists within the Board of Directors and that its balance, completeness and appropriateness to the requirements of the NHS Foundation Trust constitutes a high performing and effective Board. The chairman has held no other significant commitments during 2015/16. A register of interests of Board members is outlined within this report and is also available from the associate director 23 of corporate affairs. The effectiveness of the Board of Directors meetings is reviewed at the end of each meeting. Effectiveness of Board sub-committees are monitored through monthly board reports and annual evaluation/review of the terms of reference and work programmes. Schedule of Decisions Reserved to the Board The NHS Foundation Trust Code of Governance requires that there should be a formal schedule of matters specifically reserved for decision by the Board. The Scheme of Delegation shows the ‘top level’ of delegation within the Trust. The Scheme should be read in conjunction with Trust’s Standing Financial Instructions and Standing Orders. A copy of the Schedule of Matters Reserved for the Board can be obtained from the associate director of corporate affairs. Attendance at board meetings in 2015/16 Board Apr member 28 John Trewby chair 3 Peter Hollins SID & 3 deputy chair Iain Cameron NED 5 Lena Samuels NED 3 Simon Porter NED 3 Lynne Lockyer NED 3 David Price NED 3 Mike Sadler NED 3 Fiona Dalton CEO 3 Alastair Matthews finance 3 director and deputy CEO (until 1/11/15) Paul Goddard acting director of finance (from 24/10/15 until 2/2/16) David French chief financial officer (from 3/2/16) Michael Marsh medical 3 director (until 31/5/15) Derek Sandeman medical director (from 8/10/15 previously interim from 1/6/15) Judy Gillow director of 3 nursing and organisational development (until 30/9/15) Gail Byrne director of nursing and organisational development (from 1/10/15) Caroline Marshall chief 3 operating officer Jane Hayward director 3 of transformation and improvement Mike Murphy director 5 of strategy and business development May 26 May Jun Jul Extra 28 30 28 CS only 3 3 3 3 3 3 3 3 Sept Oct Nov Dec 18 Jan 29 29 24 CS only 28 3 3 3 3 3 3 3 3 3 3 3 telecon 3 3 3 3 3 5 3 3 5 3 3 5 3 3 5 5 5 3 telecon 3 3 3 3 3 3 3 3 5 3 3 3 3 3 3 3 3 3 telecon 3 3 3 3 3 3 3 3 3 telecon 3 3 3 3 3 3 3 5 3 3 3 3 3 3 3 3 3 3 3 3 3 3 5 (CS only) n/a 3 3 3 3 n/a n/a 5 5 n/a 5 5 3 3 3 3 3 n/a 3 3 3 3 3 n/a 3 3 3 3 n/a 5 3 3 3 5 3 5 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 5 Feb Mar 23 31 3 3 3 3 3 3 5 n/a 3 5 3 3 3 5 3 3 3 3 n/a 3 3 3 3 3 3 3 3 3 5 n/a 24 Audit and assurance committee attendance 2015/16 Board member Simon Porter NED and co-chair Iain Cameron NED and co-chair Peter Hollins NED senior independent director/ deputy chair Lena Samuels NED Lynne Lockyer NED David Price NED Mike Sadler NED Alastair Matthews finance director and deputy CEO (until 1/11/15) Paul Goddard acting director of finance (from 24/10/15 until 2/2/16) David French chief financial officer (from 3/2/16) Michael Marsh medical director (until 31/5/15) Derek Sandeman medical director (from 8/10/15 previously interim from 1/6/15) Judy Gillow director of nursing and organisational development (until 30/9/15) Gail Byrne director of nursing and organisational development (from 1/10/15) May 18 3 3 3 3 3 3 3 3 3 n/a 5 July 20 3 3 3 3 3 3 3 5 n/a 5 3 n/a Oct 19 3 3 3 3 5 3 3 3 n/a 3 3 Jan 18 3 3 3 Mar 21 3 3 3 3 n/a 3 3 3 3 5 3 n/a 3 n/a 3 n/a 3 3 n/a 3 3 Audit and assurance committee Introduction The audit and assurance committee is a non-executive committee of the Trust Board with delegated authority to review the estab
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InP (RICE) Carboplatin Etoposide Ifosfamide Rituximab
Description
Chemotherapy Protocol LYMPHOMA CARBOPLATIN-ETOPOSIDE-IFOSFAMIDE-RITUXIMAB (RICE) Inpatient Regimen Regimen • Lymphoma – InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab Indication • Non Hodgkin’s Lymphoma that is CD20 positive Toxicity Drug Carboplatin Etoposide Ifosfamide Rituximab Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Hypotension on rapid infusion, hyperbilirubinaemia Haemorrragic cystitis, encephalopathy, nephrotoxicity Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, LFTs (including albumin) and U&Es prior to day one of treatment • EDTA or calculated creatinine clearance prior to each cycle • Urine diptest for protein every four hours the day of and the day after ifosfamide administration • Fluid balance monitoring every four hours the day of and the day after ifosfamide administration. Urine output should be maintained above 100ml/hour • Check hepatitis B status before starting treatment with rituximab Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Version 1.3 (May 2023) Page 1 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab In principle all dose reductions due to adverse drug reactions should not be re-escalated 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. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological There are no dose modifications for haematological toxicity. Treatment should be delayed until the minimum criteria, described in the table below, are reached. Criteria Neutrophil Platelets Eligible Level equal to or more than 1x109/L equal to or more than 50x109/L Consider blood transfusion if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Carboplatin Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment needed Etoposide Ifosfamide *30-51 or more than 51 or 60-180 more than 180 more than 20 or more than 2.5xULN or ALP more than 2.5xULN 50% Clinical decision Not recommended Rituximab N/A N/A No dose adjustment needed *Limit reflects local practice and may vary from published sources Version 1.3 (May 2023) Page 2 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab Renal Impairment Drug Carboplatin Creatinine Clearance (ml/min) less than 20 Dose (% of original dose) omit Etoposide more than 50 15-50 less than15 100% 75% 50% Ifosfamide more than 60 40-59 Less than 40 100% 70% Clinical decision Rituximab N/A No dose adjustment needed 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. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Ifosfamide In the case of a NCI-CTC grade 1 neurological toxicity, the dose of ifosfamide may be reduced for the next cycle. If a NCI-CTC grade 2 neurological toxicity appears or neurological toxicity worsens despite dose reduction, the ifosfamide should be stopped. Risk factors for CNS toxicity include a low albumin, renal impairment, prior administration of cisplatin, poor performance status, CNS tumour, bulky pelvic disease, concomitant psychotropic drugs and younger age. Methylene blue 50mg four times a day intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes can be used to prevent or treat ifosfamide induced encephalopathy. Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to Version 1.3 (May 2023) Page 3 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection prior to treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu like symptoms prior to treatment. Regimen 3 cycles (1 cycle will be set in Aria) Please note in the original CORAL study1 an additional dose of rituximab 375mg/m2 was given on day -2, cycle 1 only. This does not appear in Aria but can be added manually at the clinician’s discretion. Drug Carboplatin Etoposide Mesna Ifosfamide Mesna Mesna Rituximab Dose AUC 5 (max 790mg) 100mg/m2 Day 2 1, 2, 3 1000mg/m2 2 2500mg/m2 twice a day (total daily dose 5000mg/m2) 2 2500mg/m2 twice a day (total daily dose 5000mg/m2) 2 3000mg/m2 3 375mg/m2 1 Administration Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Intravenous infusion in sodium chloride 0.9% 100ml over 15 minutes Intravenous infusion in sodium chloride 0.9% 1000ml over 12 hours (the ifosfamide and mesna are mixed in the same bag) Intravenous infusion in sodium chloride 0.9% 1000ml over 8 hours Intravenous infusion in 500ml sodium chloride 0.9% New cycles begin on the day that the neutrophil count recovers to more than 1x109/L and the unsupported platelet count is more than 50x109/L. Version 1.3 (May 2023) Page 4 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab Dose Information • Carboplatin will be dose banded in accordance with national dose bands (10mg/ml) • The maximum dose of carboplatin is 800mg in this regimen. This has been set at 790mg in aria to comply with national dose bands. • Etoposide will be dose banded in accordance with national dose bands (20mg/ml) • Ifosfamide will be dose banded in accordance with national dose bands (80mg/ml) • Mesna will be dose banded in accordance with national dose bands (100 NS) • Rituximab dose will be rounded to the nearest 100mg (up if halfway) Administration Information Extravasation • Carboplatin - irritant • Etoposide – irritant • Ifosfamide – neutral • Mesna – neutral • Rituximab – neutral Other • The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines Additional Therapy This is an inpatient regimen please ensure all supportive and take home medicines are prescribed on the inpatient chart or general electronic prescribing system. • Rituximab premedication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm Version 1.3 (May 2023) Page 5 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to corticosteroids. • Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 4mg twice a day for 5 days starting oral or intravenous - metoclopramide 10mg three times a day when required oral or intravenous - ondansetron 8mg twice a day for 5 days oral or intravenous • Growth factors continued until the neutrophil count is above 1x109/L. For example: - filgrastim or bioequivalent 30 million units once a day from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 6 subcutaneous pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous Please check the intention is not to collect stems following the chemotherapy. In this instance the dose of biosimiliar filgrastim will be 10mcg/kg (rounded to the nearest 300microgram or 480microgram). This normally occurs after cycle three. • 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. • In female patients consider norethisterone 5mg three times a day oral to delay menstruation • Allopurinol 300mg once a day for the first cycle only • Anti-infective prophylaxis as follows: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only oral References 1.CORAL (Collaborative trial in relapsed aggressive lymphoma) protocol. June 18 2007 2.Kewalramani et al. Rituximab and ICE as second line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B cell lymphoma. Blood 2004; 103:3684-3688. Version 1.3 (May 2023) Page 6 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab REGIMEN SUMMARY InP-RICE-Ifosfamide-Carboplatin-Etoposide-Rituximab Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart / general e-prescribing system Day 1 1. Warning – Check supportive medication prescribed Administration instructions 1. Dexamethasone 4mg twice a day, days 1 to 5 oral or intravenous 2. Metoclopramide 10mg three times a day as required oral or intravenous 3. Ondansetron 8mg twice a day, days 1 to 5 oral or intravenous 4. Aciclovir 400mg oral twice a day oral 5. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral 6. Growth factor continued until the neutrophil count is above 1x109/L, for example: - filgrastim or bioequivalent 30 million units once a day from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 6 subcutaneous pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous Please check the intention is not to collect stems following the chemotherapy. In this instance the dose of biosimiliar filgrastim will be 10mcg/kg (rounded to the nearest 300microgram or 480microgram). This normally occurs after cycle three. 7. Allopurinol 300mg once a day oral (cycle one only) 8. Consider gastric protection 9. Consider mouthwashes 10.Consider norethisterone for menstruating women 11.Consider pethidine 25-50mg intravenous for rituximab related rigors unresponsive to corticosteroids 2. Chlorphenamine 10mg intravenous 3. Hydrocortisone 100mg intravenous injection 4. Paracetamol 1000mg oral 5. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 6. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 7. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 8. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Version 1.3 (May 2023) Page 7 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab Day 2 9. Warning – Check supportive medication prescribed Administration instructions 1. Dexamethasone 4mg twice a day, days 1 to 5 oral or intravenous 2. Metoclopramide 10mg three times a day as required oral or intravenous 3. Ondansetron 8mg twice a day, days 1 to 5 oral or intravenous 4. Aciclovir 400mg oral twice a day oral 5. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral 6. Growth factor continued until the neutrophil count is above 1x109/L, for example: - filgrastim or bioequivalent 30 million units once a day from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 6 subcutaneous pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous Please check the intention is not to collect stems following the chemotherapy. In this instance the dose of biosimiliar filgrastim will be 10mcg/kg (rounded to the nearest 300microgram or 480microgram). This normally occurs after cycle three. 7. Allopurinol 300mg once a day oral (cycle one only) 8. Consider gastric protection 9. Consider mouthwashes 10.Consider norethisterone for menstruating women 11.Consider pethidine 25-50mg intravenous for rituximab related rigors unresponsive to corticosteroids 10. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 11. Carboplatin AUC 5 (max 790mg) intravenous infusion in 500ml glucose 5% over 60 minutes 12. Mesna 1000mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 15 minutes 13. Ifosfamide 2500mg/m2 and mesna 2500mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 12 hours Administration Instructions The ifosfamide infusions should be run one after the other. That is, as one infusion ends, the next should begin immediately. The total dose over 24 hours is 5000mg/m2 ifosfamide and 5000mg/m2 mesna in a total volume of 2000ml sodium chloride 0.9%. 14. Ifosfamide 2500mg/m2 and mesna 2500mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 12 hours Administration Instructions The ifosfamide infusions should be run one after the other. That is, as one infusion ends, the next should begin immediately. The total dose over 24 hours is 5000mg/m2 ifosfamide and 5000mg/m2 mesna in a total volume of 2000ml sodium chloride 0.9%. Day 3 15. Warning – Check supportive medication prescribed Administration instructions 1. Dexamethasone 4mg twice a day, days 1 to 5 oral or intravenous 2. Metoclopramide 10mg three times a day as required oral or intravenous 3. Ondansetron 8mg twice a day, days 1 to 5 oral or intravenous 4. Aciclovir 400mg oral twice a day oral 5. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral 6. Growth factor continued until the neutrophil count is above 1x109/L, for example: - filgrastim or bioequivalent 30 million units once a day from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 6 subcutaneous pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous Please check the intention is not to collect stems following the chemotherapy. In this instance the dose of biosimiliar filgrastim will be 10mcg/kg (rounded to the nearest 300microgram or 480microgram). This normally occurs after cycle three. 7. Allopurinol 300mg once a day oral (cycle one only) 8. Consider gastric protection 9. Consider mouthwashes 10.Consider norethisterone for menstruating women Version 1.3 (May 2023) Page 8 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab Consider pethidine 25-50mg intravenous for rituximab related rigors unresponsive to corticosteroids 16. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 17. Mesna 3000mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 8 hours Administration instructions To start immediately at the end of the last ifosfamide/mesna infusion bag. If required this may be given as oral mesna. A dose of 1800mg/m2 oral mesna tablets (rounded upwards to the nearest 400mg) should be given at 0, 2 and 6 hours after the end of the last ifosfamide infusion. Version 1.3 (May 2023) Page 9 of 11 Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab DOCUMENT CONTROL Version Date Amendment National dose banding applied to etoposide, ifosfamide, carboplatin and 1.3 May 2023 mesna. Maximum dose of carboplatin amended. Coding removed 1.2 July 2017 Dose change of growth factors noted for harvesting stem cells Written By Approved By Alexandra Pritchard Pharmacist Tom Hurst Pharmacy Technician Donna Kimber Pharmacy Technician Dr Deborah Wright Pharmacist Header changed Toxicities removed Hepatic impairment guidance updated Administration instructions for hydrocortisone pre med removed Days of dexamethasone administration updated Metoclopramide dose and duration updated 1.1 Aug 2016 “Bolus” removed from “intravenous bolus” for supportive medication throughout text Growth factor units updated Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Mucositis recommendation changed CSCCN bands removed Administration instructions added to ifosfamide and mesna infusions Mesna infusion changed to 8 hours Disclaimer added 1 August 2012 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Dr Alison Milne Consultant Haematologist Dr Andrew Davies 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 University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust Version 1.3 (May 2023) 11 Page 10 of Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.3 (May 2023) 11 Page 11 of Lymphoma-InP-RICE-Carboplatin-Etoposide-Ifosfamide-Rituximab
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InP-LEAM
Description
Chemotherapy Protocol LYMPHOMA LOMUSTINE-CYTARABINE-ETOPOSIDE (split)-MELPHALAN (LEAM) Inpatient Regimen Regimen Lymphoma – InP-LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan Indication Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with either Non Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma Toxicity Drug Lomustine Cytarabine Etoposide Adverse Effect Pulmonary toxicity CNS toxicity, conjunctivitis, flu-like syndrome, pulmonary toxicity, gastro-intestinal toxicity Hypotension on rapid infusion, hyperbilirubinaemia Melphalan Gastro-intestinal disturbances, stomatitis Patients treated with LEAM are at risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive irradiated blood products for the 1 week prior to harvest and for at least 12 weeks after the transplant has taken place. Patients with Hodgkin lymphoma carry a lifelong risk of graft versus host disease and must always receive irradiated blood products. Local blood transfusion departments must be notified as soon as a diagnosis is made and the patient must be issued with an alert card to carry with them at all times. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (September 2022) Page 1 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Monitoring Drugs FBC, LFTs (including albumin) and U&Es prior to day one of treatment EDTA or calculated creatinine clearance prior to each melphalan infusion Monitor the fluid balance during the administration of melphalan, including throughout the administration of the pre and post hydration. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Dose Modifications The dose modifications listed are for haematological, liver and renal function and some limited drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated 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. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Lomustine Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Cytarabine more than 34 50% The dose may be escalated dependent on toxicity Etoposide Melphalan 30-51 or more than 51 or N/A 60-180 more than 180 N/A Consider dose reducing to 50% Clinical decision No dose adjustment necessary Version 1 (September 2022) Page 2 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Renal Impairment Drug Lomustine Creatinine Clearance (ml/min) more 60 45-60 30-<45 less than 30 Dose (% of original dose) 100% 75% 50% Clinical decision Cytarabine N/A No dose adjustment necessary Etoposide more than 50 15-50 less than 15 100% 75% 50% Melphalan more than 50 30-50 less than 30 100% 75% Clinical decision Other Lomustine It may be necessary to reduce the dose of lomustine in patients with reduced pulmonary function. Lomustine dose reductions in this situation are to be made at the discretion of the consultant oncologist/haematologist only. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Regimen 1 cycle will be set in Aria Drug Lomustine Cytarabine Etoposide Melphalan Dose 200mg/m2 200mg/m2 every 12 hours 200mg/m2 140mg/m2 Days -6 -5,-4,-3,-2 -5,-4,-3,-2 -1 Administration Oral Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 2000ml sodium chloride 0.9% over 120 minutes (this will be administered as two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes administered sequentially) Intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Dose Information Version 1 (September 2022) Page 3 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Lomustine will be dose rounded to the nearest 40mg (down if halfway) Cytarabine will be dose banded in accordance with the national dose bands (20mg/ml) Etoposide will be dose banded in accordance with the national dose bands (20mg/ml) The melphalan dose will be dose rounded to the nearest 10mg (down if halfway). The National Dose Banding Team have advised not to use dose banding tables for this product in view of the 90 minute expiry (must be made locally for individual patient), the 50mg vial size and frequent stock shortages. Administration Information Extravasation Cytarabine – non-vesicant Etoposide – irritant Melphalan – irritant Other Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Additional Therapy This is an in-patient regimen. Please ensure all supportive and take home medicines are prescribed on the in-patient chart or general electronic prescribing system. Please refer to the transplant schedule for the individual patient. Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 2mg twice a day for 10 days oral or intravenous starting on day -6 of the cycle - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -6 of the cycle - ondansetron 8mg twice a day for 10 days oral or intravenous - aprepitant 125mg once only orally on the day of the melphalan infusion then 80mg once a day for the subsequent two days Version 1 (September 2022) Page 4 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Anti-infectives - aciclovir 400mg oral twice a day until day +90 - ciprofloxacin 250mg oral twice a day from day+1 (stop when neutrophils are greater than 1) - pentamidine 300mg by nebuliser prior to discharge - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge, if neutrophils are greater than 1 and platelets are greater than 50, and continue until day +120) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) Thromboprophylaxis, continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion) Intravenous hydration before and after melphalan infusion The evening before melphalan infusion (to be completed by 0930 on the morning of the infusion) sodium chloride 0.9% with potassium chloride 27mmol 1000ml The day of melphalan infusion 0900hrs Start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1010hrs 20mg furosemide intravenous bolus 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus check urine output since 0900hrs again at 1100hrs: if more than 500ml go ahead with melphalan if less than 500ml contact the prescriber. 1100hrs – give melphalan intravenous infusion over thirty minutes (This product has a short expiry so adhering to set timing is essential) Version 1 (September 2022) Page 5 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 240 minutes 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 360 minutes 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 480 minutes The day after melphalan infusion; 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 480 minutes then restart routine intravenous fluids Furosemide 20mg oral or intravenous bolus to maintain fluid balance and a urine output of more than 250ml/hour immediately prior to melphalan administration In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Additional Information Irradiated blood products must be used Autologous stem cells/ bone marrow will be infused on day 0, at least 24 hours after the melphalan infusion Coding Version 1 (September 2022) Page 6 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Procurement – X70.5 Delivery – Not Required References 1.Mills W, Chopra R, McMillan A et al. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol (1995);13(3): 588-95 2.Kelsey P, Pearce R, Perry J et al. Substituting carmustine for lomustine is safe and effective in the treatment of relapsed or refractory Lymphoma – a retrospective study from the BSBMT (BEAM versus LEAM) Version 1 (September 2022) Page 7 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan REGIMEN SUMMARY InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day -6 1. Warning – Check blood transfusion status Administration Instructions Patients treated with LEAM carry a lifelong risk of transfusion associated graft versus host disease. Where blood products are required these patients must receive ONLY IRRADIATED BLOOD PRODUCTS for life. Ensure transfusion departments are notified and the patient has been issued with an alert card to carry with them at all times. 2. Warning – Check supportive medication prescribed Administration instructions Please refer to the individual transplant schedule. In general the following is required; 1. Aprepitant 125mg once a day oral on the day of melphalan administration followed by 80mg once a day for two days after melphalan administration 2. Dexamethasone 2mg twice a day, days -6 to +3 oral or intravenous 3. Metoclopramide 10mg three times a day, days -6 to +3 then as required oral or intravenous 4. Ondansetron 8mg twice a day, days -6 to +3 oral or intravenous 5. Growth factors such as biosimiliar filgrastim 30million units once a day from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours or are greater than 3x109/L on any occasion 6. Aciclovir 400mg oral twice a day until day +90 7. Ciprofloxacin 250mg twice a day from day +1 and continued until neutrophils are greater than 1x109/L. 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge if the neutrophils are greater than 1x109/L and platelets are greater than 50x109/L and continue until day +120) 9. Fluconazole 100mg once a day (stop when neutrophils are greater than 1x109/L) 10.Pentamidine 300mg nebuliser prior to discharge 11.Thromboprophylaxis with a low molecular weight heparin until platelets are less than 50x109/L 12.Furosemide 20mg when required oral or intravenous bolus 13.Melphalan pre and post hydration 14.Gastric protection 15.Consider mouthwashes 16.Consider norethisterone for menstruating women 3. Lomustine 200mg/m2 once a day for one day oral Administration Instructions This should be given before midday. Swallow whole with a full glass of water. Do not open or chew Day -5, -4, -3, -2 4. Warning – Cytarabine is TWICE a day (12hrs apart) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 5. Cytarabine 200mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes every 12 hours (9am and 9pm) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 6. Warning – Etoposide is TWO infusions () Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 7. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Version 1 (September 2022) Page 8 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 8. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -1 9. Warning – Check hydration and fluid balance Administration Instructions See separate fluid prescription for the pre hydration: 1. Overnight to be completed at 0930hrs on day of melphalan infusion, 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion The day of melphalan infusion: 2. 0900hrs on the day of melphalan start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 3. 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 4. 1010hrs 20mg furosemide intravenous bolus 5. 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus and recheck urine output since 0900hrs again at 1100hrs: • if more than 500ml go ahead with melphalan • if less than 500ml contact prescriber. 10. Time– Administer melphalan at 1100 11. Melphalan 140mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Administration Instructions - see separate fluid prescription for the post hydration requirements 1. 1100hrs – give melphalan intravenous infusion over thirty minutes 2. 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over two hours 3. 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over four hours 4. 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over six hours 5. 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over eight hours 6. The day after melphalan infusion: 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over eight hours and then restart routine intravenous fluids Version 1 (September 2022) Page 9 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Version Date DOCUMENT CONTROL Amendment Written By Approved By 1 September 2022 None Nanda Basker Pharmacist Dr Rob Lown Consultant Haematologist 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 Hospitals 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1 (September 2022) 10 Page 10 of Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan
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Last updated: 14 September 2019
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