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Description: ANNUAL REPORT AND ACCOUNTS 2019/20 Incorporating the quality account 2019/20 Page 2 University Hospital Southampton NHS Foundation Trust Annual report and accounts 2019/20 incorporating the quality account 2019/20 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 Page 4 ©2020 University Hospital Southampton NHS Foundation Trust Page 5 TABLE OF CONTENTS Overview and performance report Welcome from our chair A word from the chief executive Overview of the Trust Statement of purpose and activities History of UHS Our executive team structure Structure of our services Our vision and values Our priorities, key issues and risks Voluntary disclosures Equality, diversity and inclusion 92 8 9 Environmental sustainability and climate chan ge 95 Quality account 10 Chief executive welcome 101 10 11 Annual accounts 12 Statement from the Chief financial officer 183 13 Independent Auditors report 185 14 Foreword to accounts 192 Performance report Going concern disclosure 16 Reporting structure 16 Key performance indicators 18 How we monitor performance 19 Overview of performance of UHS 18 Regulatory body ratings 19 Environmental matters 23 Social, community, anti-bribery and human rights issues 23 Accountability report Members of the Trust Board 25 Trust Board purpose and structure 30 Board meeting attendance record 2018/19 31 Well-led framework 32 Finance and investment committee 34 Quality committee 33 Audit and risk committee 35 External auditors 36 Governance code 36 Performance evaluation of Trust Board and its committees 36 Remuneration 36 Countering fraud and corruption 37 Independence of external auditor 37 Internal audit service 37 Better payment practice code 37 Statement as to the disclosures to auditors 38 Disclosures 38 Income disclosures 38 Governance disclosures 38 Approach to quality governance 38 Council of Governors 41 Annual remuneration statement 51 Remuneration and appointments committee 54 Governors’ nomination committee 57 Staffing report 61 Staff survey results 65 Trade union facility time 68 Statement of chief executive’s responsibilities as the accounting officer 72 Annual governance statement 73 Page 6 OVERVIEW AND PERFORMANCE REPORT Page 7 OVERVIEW AND PERFORMANCE REPORT Welcome from our chair 2019/20 was another challenging year for University Hospital Southampton NHS Foundation Trust (UHS). Demand for our services continued to rise rapidly, partly because of the ageing of the population we are here to serve and partly because of challenges in the external environment, but also because of our ability to offer exciting innovations for a range of conditions. As a result, we were not always able to offer treatment as rapidly as we wished. A major challenge towards the end of the year was the need to prepare the Trust for the COVID-19 pandemic, resulting in the need to re-engineer services on an unprecedented scale. The response of UHS staff to these challenges has, from start to finish, been magnificent. We saw major innovation in improved patient pathways to accommodate rising demand, and the creativity of colleagues in readying the Trust for COVID-19 was truly breath-taking in its scope and energy. UHS has had a long record of effective financial management. By constantly seeking operational innovation and better value for money in procurement, the Trust has been able to generate the funds necessary to make a number of capital investments which will provide huge patient benefit in future. There has been rapid progress in our major project to refurbish and extend our general intensive care unit. Our £2.2m investment in our new urology unit was completed this year; it will transform our patients’ experiences. We have continued wherever possible to work with partners and we are delighted that work on the £5m Maggie’s Centre has started. Quite apart from the need to navigate our way through the COVID-19 crisis and into the world beyond it, the Trust needs to prepare to play its full role in the Hampshire and Isle of Wight healthcare system as it develops in a way consistent with the NHS Long Term Plan. The responsibility for this falls of course to the Trust Board and I believe that even after having had more change on the Board this year than for some time, we continue to have a strong and committed leadership team. Following the retirement of Caroline Marshall, our long-serving chief operating officer, in September 2019 we welcomed Joe Teape into the position. Joe had not been at the Trust long before we were thrust into the COVID-19 pandemic and got to grips with it impressively rapidly. During the year we said farewell to three non-executive directors (NEDs); Catherine Mason who left us to become chair of Solent Healthcare, Mike Sadler our clinical NED and Simon Porter. After a series of rigorous selection processes, we were delighted to welcome Dave Bennett, Dr Tim Peachey and Keith Evans as replacements. Simon had been both deputy chair and senior independent director (SID) and on his departure Jenni Douglas-Todd succeeded him in both roles. The work of the Board is supported, stimulated and, quite correctly, challenged by the Council of Governors (COG) whose enthusiasm is of huge value to the proper governance of UHS. All of the elections to the COG were competitive, in some cases by a multiplicity of candidates. Unfortunately, one of those vacancies resulted from the death of Edward Osmond. Although Edward had only recently been elected as a governor, he had shown huge commitment to the role and I am sure would have gone on to make a major contribution to UHS. We welcomed nine new governors and one new young governor. I look forward to working with them and all the other governors as we move through and beyond the COVID-19 world. Peter Hollins Chair Page 8 OVERVIEW AND PERFORMANCE REPORT A word from the chief executive My first full year as chief executive officer of UHS has been exciting, inspiring, and extremely rewarding but not, as you would expect, without a considerable degree of challenge! The pressures on the NHS have been well publicised as we strive to provide the highest possible standard of care at a time when demand for our services escalates rapidly. At the same time, at UHS we need to play our full part in working out how we shape and deliver the health and care provision for our community into the future. During the year we have done a great deal of work on how we turn our vision for the Trust, world-class care for everyone, into what happens on the front line every day. While the vision may be new it is built firmly on our long-standing values; patients first, working together, and always improving, which together describe who we are as an organisation. These values were central to the development of our new clinical and corporate strategy which sets out an exciting future for UHS over the coming decade. It includes how we will deliver the safest care, delivering the best outcomes, as well as how we will focus on improving the health of our population, supporting both health and wellbeing. The values also provided the basis for our CQC rating of ‘Good’ awarded during the year as were some other fantastic accolades. These included a prestigious British Medical Journal award for improving care for older patients with the development of our frailty unit and activity hub. Our women’s and maternity care at the Princess Anne Hospital was named as being among the best in the world. In addition, we adopted prehabilitation for cancer patients, a pioneering service. There are countless other examples of innovation which have sprung from the creativity and innovative spirit at UHS. Some of these have involved better outcomes for patients, some an improved patient experience and others simply lower the cost of doing things, liberating money which we can then invest in improving other services. I’d like to thank every one of our staff for creating the spirit of UHS which means that the extraordinary happens every day. The world of health and social care is changing dramatically and we continue to be integral to the Hampshire and Isle of Wight Sustainability and Transformation Partnership (STP). UHS will have a leading part to play in ensuring that, with our partners, we forge a pattern for the provision of healthcare across the local system and beyond, delivering the highest possible standards of care on an enduring basis. As we entered 2020, we began preparing to face COVID-19, the largest pandemic we have seen. Some areas of the hospital are truly unrecognisable as we have adapted to the fight against this virus. The loss of life as a result of COVID-19 has been utterly devastating and it has, I am sure, touched us all personally. It has also challenged the health and wellbeing of all our staff, but particularly our frontline staff, in a unique way. I am not sure whether I am prouder of the spirit with which our staff have responded to the challenge or of the fact that they made us by common consent one of the best prepared trusts in the country. Finally, I’d like to recognise the acts of kindness I see throughout the Trust on a daily basis. It is one of the things that has struck me the most as I have got to know this organisation and the people within it. I watch how they support one another through challenging times, how they support patients and visitors in their own time and in work time, and how they go above and beyond every day for the people they’re caring for. Every day they make me hugely privileged to lead this amazing organisation. Paula Head Chief executive officer Page 9 OVERVIEW AND PERFORMANCE REPORT Overview of the Trust 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 680,000 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 over 3.7 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 postgraduate 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 12,000 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the contributions of over 1,000 volunteers. Our turnover in 2019/20 was £912m. 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. Eighteen 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 then regulator, Monitor (now known as NHS Improvement (NHSI)). Page 10 OVERVIEW AND PERFORMANCE REPORT Our executive team structure Executive team structure as at 31/03/2020 Page 11 OVERVIEW AND PERFORMANCE REPORT Structure of our services Our organisation is split into five areas, with our clinical services grouped into four divisions. Within each division there are care groups. Each division, with the exception of Trust headquarters, is led by a divisional management team consisting of: • divisional clinical director (DCD) • divisional director of operations (DDO) • divisional head of nursing/professions (DHN) • divisional research and development lead • divisional finance manager • divisional planning and business development (or strategy) manager • divisional education lead • division HR business partner • divisional governance manager (DGM) The diagram below outlines the five divisions and care groups/services within each. Each care group has a clinical lead, care group manager and matron/s for specific services as a minimum. Page 12 OVERVIEW AND PERFORMANCE REPORT Our vision and values Our vision outlines who we are and what we stand for, as well as describing the current challenges we face and our priorities for the future. It also provides an in-depth review of our three Trust values, which are summarised below: Patients first Patients and families will be at the heart of what we do and their experience within the hospital, and their perception of the Trust, will be our measure of success. Working together Our clinical teams will provide services to patients and are crucial to our success. We have launched a leadership strategy that ensures our clinical management teams are engaged in the day-today management and governance of the Trust. Always improving Our growing reputation in research and development and our approach to education and training will continue to incorporate new ideas, technologies and greater efficiencies in the services we provide Page 13 OVERVIEW AND PERFORMANCE REPORT Our priorities, key issues and risks Our goals 1. Improving patient journeys (system focus, integration) We will: • Write a strategic plan for integrated ‘front door; services to address capacity and demand mismatch and enable flow • Secure influence in primary care by establishing the hospital’s role in supporting primary care networks • Promote value-based healthcare, particularly: Introduce ‘advanced decision making’ • Redesign services to provide timely safe care and meet constitutional access trajectories • Deliver priorities relevant to UHS in the first year of the long-term plan including commissioning and long-term changes 2. Delivering value-based health and care We will: • Deliver the Trust financial plan and maximise any national funding • Prepare UHS for the new NHS financial regime • Deliver the Trust Quality Improvement plan to improve safety/experience and outcomes • Build capability for change by embedding quality improvement, innovation and transformation at a leadership level • Deliver the Cost Improvement Plan (CIP) without compromising on quality 3. Supporting health lives (prevention, wellbeing inequalities, outcomes and experience) We will: • Improve staff health and wellbeing • Improve population health, maximising the impact of UHS touch points • Develop an early warning tool to identify any deterioration in quality 4. Building an expert and inclusive workforce (diversity, engagement, leadership) We will: • Close the staffing supply gap in priority groups/services to provide high quality and timely care • Manage overall workforce cost to meet CIP challenge • Measure improvement in staff engagement by increasing participation in staff survey • Increase representation of diverse groups in leadership and decision making • Improve the staff engagement score 5. Being agile in meeting people’s needs (organisational elegance/design/flexibility) We will: • Reset organisational structure as necessary, responding to changes outlined in the NHS long-term plan • Leverage digital capability to support patient empowerment and self-care • Measure staff user satisfaction with the Trust IT systems and use this to support the digital strategy • Be agile in flexing resources, responding to fluctuating demand • Secure strategic influence by establishing UHS role in the transition from STP to ICS 6. Leading edge research, education and innovation (research and outcomes) We will: • Identify the capacity constraints to expand research and plan to address • Identify priority areas without a research base and set strategy • Improve quality and breadth of education and training programme Page 14 OVERVIEW AND PERFORMANCE REPORT The novel coronavirus (COVID-19) will continue to have a significant impact on public health, morbidity and mortality if adequate prevention and control is not in place. The Trust put rapid and robust arrangements in place early on to prepare for the potential surge in COVID-19 patients. As the government now announces the easing of the lockdown restrictions, the COVID-19 challenge continues to unfold and still represents a very significant future risk to the organization. Our response and mitigations will continue to evolve through 2020/21. Further details on our response to the COVID-19 challenge are in included in the Annual Governance Statement on page 73.. Key issues and risks 1. Inability to develop partnerships and redesign services innovatively renders the Trust unable to meet the expectations of the NHS long-term plan, our strategic plan, and sustainable elective and non-elective pathways. UHS continues to actively develop partnerships across the region and work within the Integrated Care System whilst promoting value-based healthcare and delivering priorities relevant to UHS in the first year of the longterm plan. 2. Failure to deliver regulatory requirements results in license breach and loss of local control with an enforced change in leadership, impacting on Goals 1 to 6. UHS continues to monitor progress against NHSI Performance framework at committee and Board level and build capability for change by embedding quality improvement, innovation and transformation at a leadership level. 3. Failure to achieve financial targets results in a shortfall in cash required to deliver the capital programme. A robust cost improvement programme is in place, continuously monitored through governance processes with a focus on delivery of the Trust’s financial plan. 4. Reduced access to resources compromises the quality of services. We will implement the Trust Quality Improvement plan to improve safety/ experience and outcomes. 5. Capacity and capability gaps in the workforce lead to an inability to provide safe and timely care. To mitigate this risk, we will continue to develop initiatives to improve staff health and wellbeing with proactive recruitment and retention initiatives in place. Staff engagement is monitored through staff survey and leadership and development training in place. 6. Lack of inclusion and diversity results in the failure to get the best from every individual. UHS has an equality, diversity and inclusion strategy, with established Trust networks and inclusive talent management programmes. Page 15 OVERVIEW AND PERFORMANCE REPORT Performance report 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. 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. Page 16 OVERVIEW AND PERFORMANCE REPORT Monthly Trust Board Public meeting where executive directors present high level summary to chairman and non-executive directors. Audit andrisk committee Finance and Investment committee Quality Committee People & Organisational Development Committee Trust executive committee (TEC) Review performance/issues/risks in greater depth For further detail on role of these committees please refer to the annual governance statement section. Trust Board study sessions Trust Board members meet to focus on a specific issue. Performance meetings Operational management team (led by chief operating officer) and division and care group management teams focus on individual patient and service pathways to develop improvement plans. Page 17 OVERVIEW AND PERFORMANCE REPORT Key performance indicators (KPIs) The Trust publishes a monthly integrated KPI Board report on our website which provides both the Board and the public with an overview of our performance. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. The format of the monthly report follows our six strategic goals: • Improve patient journeys • Value-based health and care • Healthy lives • An expert and inclusive workforce • Being agile in meeting people’s needs • Leading edge research, education and innovation The monthly report features the following sections: • Overview – Aggregation of commentary supporting all sections of the report • Safe • Effective • Caring • Activity • Emergency access • Referral to treatment and diagnostics • Cancer waiting times • Flow • Staffing • Research and development • Estates • Digital This report also includes summary versions of quarterly reports submitted to the Trust executive committee, which go into greater detail about patient experience, patient safety, clinical effectiveness outcomes, and infection prevention. In addition, a separate finance Board report is submitted to Trust Board on a monthly basis. The Emergency Access, Activity and Flow section has several KPIs that are relevant to the key risk of delivering the national access target. Some of the KPIs are: • Number of attendances • Time to initial assessment • Delayed transfers of care • Non-elective length of stay The Activity and Flow sections have several KPIs that are relevant to the key risk of capacity and occupancy. Some of the KPIs are: • Length of stay • New referrals • Number of attendances • Bed occupancy The Staffing (HR) section has several KPIs that are relevant to the key risk of Staffing. Some of the KPIs are: • Staff turnover • Nursing vacancies • Friends and Family Test – percentage of staff who recommend UHS as a place to work You can see full copies of the monthly report by visiting www.uhs.nhs.uk Page 18 OVERVIEW AND PERFORMANCE REPORT 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 service 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. In 2020/21 we continue to review the National Model Hospital data as it is published from NHS Improvement. The data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. The Trust is engaging with the model hospital team and has a member of staff on the ‘model hospital ambassador program’, as well as reviewing areas highlighted as having potential opportunities alongside finance and operational teams. Overview of performance Improving patient journeys 2019/20 was a challenging year in which we made only modest progress against some objectives to ‘Improve Patient Journeys’, and deteriorated in performance against others. • Inpatient length of stay remained stable but didn’t reduce as significantly as we had intended. The percentage of bed days used due to ‘Delayed Transfers of Care’ to other settings increased to nearly twice the national target. This, combined with growth in non-elective admissions (2.8% YTD excluding M12), resulted in occupancy rates which often exceeded our target, and an increase in patients cared for as ‘outliers’ away from their own speciality wards. • Emergency Access Performance (patients spending less than four hours in the emergency department) remained below both the national and local targets, though performance did show modest improvement during the year. There has been a further substantial increase in the volume of emergency department attendances. • The number of ‘elective’ patients waiting for treatment, the percentage of patients waiting within 18 weeks, and also the waiting time for first outpatient appointments, deteriorated significantly during the year. This has, in part, been impacted upon by reduced availability of clinical capacity due to staff concerns about the impact of new pension/tax regulations. There are, however, good indications that service changes are being implemented to increase consultation capacity in an efficient way as we had aimed to. There has been a substantial increase in consultations provided through ‘non-face-to-face’ routes, and a small decrease in the number of more traditional face-to-face consultations. • Urgent GP referrals for suspected cancer seen within two weeks saw a substantial and sustained improvement compared to the previous year, exceeding that target. • Performance against treatment within 62 days measures also demonstrated modest improvement during the year. Significant improvement in cancer performance continues to be required in order for UHS to deliver the national targets for timeliness of treatment. Page 19 OVERVIEW AND PERFORMANCE REPORT Delivering value-based healthcare • Complaints about UHS care have remained low, with the percentage of complaints ‘closed’ within 35 days above target for the first 11 months of 2019/2020. • Pleasingly, the availability of nursing care to our inpatients (expressed as care hours per patient per day) has increased progressively through the year from 8.6 to 8.9. An active overseas nursing recruitment and induction process has supplemented domestic recruitment and training. • The Trust has formed a 50/50 joint venture company with Hampshire Hospitals NHS Foundation Trust called Wessex NHS Procurement Limited (WPL). From 1 December 2019, WPL is providing procurement, supply chain and materials management services to the Trust. The objectives of this innovative partnership include the consolidation of supplies purchases for both Trusts (combined revenue £1.4bn) to leverage better prices from suppliers and increased productivity through the elimination of previously duplicated procurement activity. Supporting healthy lives • There was very good performance on the Hospital Standardised Mortality Ratio. The standard is 100 and we are consistently below this (83 in December, results are reported nationally retrospectively). This measure includes all patients in England with the same condition and compares those who have died with those that have survived. Being below 100 is a strong indicator of good care. • We continue to receive feedback, which is largely positive, through the national ‘Friends and Family’ survey for both our inpatient and maternity care. • The Board monitors a range of quality indicators. Of these, exceeding the target number of patients infected with clostridium difficile by six is of some concern, we are pleased that the number of severe/moderate medication errors has been maintained well below our target level, and following an increase in the number of Serious Incidents Requiring Investigation (SIRI) that were reported to Board in the early part of the year both the number of SIRIs has reduced and the timeliness of investigation has significantly improved. • Staff sickness levels were on target through the summer months, but significantly in excess of this through the winter months. As a whole, this is a cause for some concern. Building an expert and inclusive workforce • Very pleasingly, nursing vacancies were reduced significantly during the year, from 18% to 15%. Though still a challenge, this supports increases in the treatment capacity we can make available in the Trust, in our ability to open additional bed capacity to reduce our inpatient occupancy rates, and increases the care hours provided per patient per day. • Turnover rates have been in excess of our target throughout the year and there has also been a reduction in the percentage of staff who would recommend UHS as a place to work, though we remain above our target of 76%. The percentage of non-medical appraisals taking place within 12 months remains below target and is declining. • We have made steady progress this year towards our target of 15% of staff at Band 7 and above being from Black and Minority Ethnic backgrounds by 2023 (above 9% in March 2020). Being agile in meeting people’s needs • 2019/2020 has seen further progress in the implementation of digital tools that enable patients and clinicians to review and discuss patient specific clinical information in new ways, for example, large increases in usage of ‘My Medical Record’ and ‘digi-rounds’, modest further progress in electronic requesting and acknowledgement of tests, and stable usage of other tools. Page 20 OVERVIEW AND PERFORMANCE REPORT Leading edge research, education and innovation • The majority of recruitment targets have been achieved during 2019/20. • In Q4 UHS ranked 13th for contract commercial study recruitment, which is the same position achieved in the previous year and thus did not achieve our target of Top 10, with a constraint on pharmacy research capacity being a contributing factor. • The proportion of commercial studies closing in the 2019/20 financial year on time and to recruitment target ended the year below the 80% target at 68%, though the year-end target for the proportion of non-commercial studies closing on time and to recruitment target was exceeded at 88% compared to 80% target. Details of UHS performance can be found in the Integrated Performance report which is available in the Trust Board papers section of our website www.uhs.nhs.uk. UHS performance is scrutinised by the Board on a monthly basis. Paula Head, chief executive officer 22 June 2020 Regulatory body ratings Single Oversight Framework NHS Improvement’s Single Oversight Framework provides the framework for overseeing providers and identifying potential support needs. The framework looks at five themes: 1. Quality of care 2. Finance and use of resources 3. Operational performance 4. Strategic change 5. Leadership and improvement capability (well-led) Based on information from these themes, providers are segmented from one to four where ‘4’ reflects providers receiving the most support, and ‘1’ reflects providers with maximum autonomy. A foundation trust will only be in segments three or four where it has been found to be in breach or suspected breach of its licence. Segmentation During 2019/20 the Trust was confirmed as being placed within segment ‘2’. This segmentation information is the Trust’s position as at 31 March 2020. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. Finance and use of resources The finance and use of resources theme is based on the scoring of five measures from ‘1’ to ‘4’, where ‘1’ reflects the strongest performance. These scores are then weighted to give an overall score. Given that finance and use of resources is only one of the five themes feeding into the Single Oversight Framework, the segmentation of the Trust disclosed above might not be the same as the overall finance score here. The Trust was on track to deliver a use of resources score of ‘2’. However, as a direct result of COVID-19 our staff were unable to take their full complement of annual leave. The Trust was required Page 21 OVERVIEW AND PERFORMANCE REPORT to allow for this additional cost, which was an unfunded cost pressure allowable by NHS Improvement. This had the impact of moving the distance from financial plan score to a ‘4’ and subsequently the overall use of resources score to a ‘3’. Area Financial sustainability Financial sustainability Financial sustainability Overall scoring Metric Capital service cover Liquidity Income and expenditure margin Distance from financial plan Agency spend Q1 Q2 Q3 Q4 Year 3 3 2 2 2 1 1 1 1 1 3 1 1 1 1 1 1 2 4 4 1 1 1 1 1 2 1 2 3 3 Care Quality Commission ratings: Overall rating for this trust Are services at this trust safe? Are services at this trust effective? Are services at this trust caring? Are services at this trust responsive? Are services at this trust well-led? Good Requires improvement Outstanding Good Requires improvement Good In December 2018, the CQC inspected four core services; urgent and emergency care, medicine, maternity and outpatients. It also looked at management and leadership, and effective and efficient use of resources. The CQC report (published on the 17 April 2019) rated the Trust as ‘good’ overall and ‘outstanding’ for providing effective services. All sites and services across the organisation are now rated as ‘good’ in the effective and caring domains, with Southampton General Hospital rated as ‘outstanding’ in these areas. The Well-Led section of this report provides further details of the inspectors’ findings. “Our inspectors found a strong patient-centred culture with staff committed to keeping their people safe, and encouraging them to be independent. Patients’ needs came first and staff worked hard to deliver the best possible care with compassion and respect. Inspectors saw many areas of outstanding practice, with care delivered by compassionate and knowledgeable staff. Several teams led by example with a continuous focus on quality improvement. The Trust did face some challenges especially with the ageing estates. Some patient environments were showing significant signs of wear and tear – but again staff were doing their utmost to deliver compassionate care”. Dr Nigel Acheson Deputy chief inspector of hospitals (South) Page 22 OVERVIEW AND PERFORMANCE REPORT Environmental matters We recognise that the Trust’s business has an impact on the environment. As a large hospital, we undertake a wide range of activities and use a large amount of resources. We are committed to environmental sustainability and consider it as part of the business culture. We continue to invest in energy saving initiatives and staff awareness campaigns that focus on promoting sustainability. We acknowledge that reducing waste and minimising the consumption of scarce resources is consistent with financial sustainability. Our sustainability disclosure section on pages 86 and 95 provides greater detail on the steps we are taking to reduce our activities’ impact on the environment. Social, community, anti-bribery 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. At University Hospital Southampton we value our reputation for top quality care and financial probity and conduct our business in an ethical manner. The Bribery Act 2010 was introduced to make it easier to tackle the issue of bribery which is a damaging practice. Bribery can be defined as ‘giving someone a financial or other advantage to encourage them to perform their duties improperly or reward them for having done so’. To limit our exposure to bribery we have in place an Anti-Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Freedom to Speak Up (formerly Raising Concerns) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. We also employ a local counter-fraud specialist who will investigate, as appropriate, any allegations of fraud, bribery or corruption. The success of our anti-bribery approach depends on our staff playing their part in helping to detect and eradicate bribery. Therefore, we encourage staff, service users and others associated with UHS to report any suspicions of bribery and we will rigorously investigate any allegations. In addition, we hold a register of interest for directors, staff, and governors, and ask staff not to accept gifts or hospitality that will compromise them or the Trust. The Board of Directors carries out its business in an open and transparent way. We are committed to the prevention of bribery as well as to combating fraud, and expect the organisations we work with to do the same. Doing business in this way enables us to reassure our patients, members and stakeholders that public funds are properly safeguarded. 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. Page 23 OVERVIEW AND PERFORMANCE REPORT Page 24 ACCOUNTABILITY REPORT Members of the Trust Board Board member Name Title Paula Head Chief executive officer David French Deputy chief executive officer and chief financial officer Gail Byrne Director of nursing and organisational development Biography Paula joined the Trust as chief executive in September 2018, having been chief executive at the Royal Surrey County NHS Foundation Trust in Guildford and before that at Sussex Community NHS Foundation Trust. She began her career as a pharmacist working in the community, in hospitals and at health authorities before moving into general management and her first board position at Kingston Hospital. Since then she has spent time on the boards of commissioners and providers, including director of transformation at Frimley Park Hospital NHS FT. Paula lives in Hampshire and has a daughter studying medicine at the University of Southampton. David joined the Trust in February 2016 and served as interim chief executive officer from April to September 2018. 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 Vivid Housing Limited, a social housing provider across Hampshire and the Solent. 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. Declarations Daughter is a medical student at University of Southampton; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Executive Delivery Group Non-executive director and chair of audit and risk committee, Vivid Housing Limited; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a joint-venture company owned 50/50 by UHSFT and Prime plc; Member of Hampshire & Isle of Wight Counter Fraud Board; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Capital Planning Panel; Director of Wessex NHS Procurement Limited (WPL), a joint venture company owned 50/50 by UHSFT and Hampshire Hospitals NHS Foundation Trust (from December 2019) Husband is a consultant surgeon at UHS; Daughter is a midwife at UHS (from March 2019) Dr Derek Sandeman Joe Teape Medical director Chief operating officer Derek was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional Director of UHS Pharmacy Limited, endocrine service. Throughout his career he has had a wholly-owned subsidiary of 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. UHSFT; Member of Hampshire & Isle of Wight Sustainability and Transformation Partnership Clinical Executive Group Joe joined the Trust as chief operating officer in December Nil 2019. Previously he was deputy chief executive and director of operations of a large health board in Wales which managed integrated services across three counties including four district general hospitals as well as mental health, learning disability and community services. Prior to this, Joe worked in director roles across finance and strategy within provider acute trusts across the south west of England. Joe is passionate about providing leadership and support for all staff, whatever their profession, and contributing to excellent patient care. He is committed to open and ongoing engagement with the general public and often uses social media to engage with colleagues and with those who have an interest in healthcare. Page 25 ACCOUNTABILITY REPORT Non-executive directors Name Title Peter Hollins Chair Dr Tim Peachey Non-executive director David Bennett Non-executive director Biography Declarations Peter graduated in chemistry from Hertford College, Chair of CLIC Sargent Cancer Care Oxford. Joining Imperial Chemical Industries in 1973, for Children (a company limited by he undertook a series of increasingly senior roles in guarantee) (until December 2019); marketing and then general management. Following Council member of University of three years in the Netherlands as general manager of Southampton 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. He joined Southampton University Hospital Trust as a non- executive director in 2010, became senior independent director and deputy chairman of UHS in 2014, and was appointed chair in April 2016. Tim qualified as a doctor from Kings College Hospital Director, TP Medcon Ltd; Clinical School of Medicine in 1983. For nearly 20 years, he Safety Officer, Block Solutions Ltd; worked as a consultant anaesthetist at the Royal Free Non-executive director and Quality Hospital in London, specialising in pancreatic cancer Committee chair, Isle of Wight NHS surgery, liver surgery and liver transplantation. He also Trust developed an interest in medical leadership and management and has held positions such as clinical director, divisional director and medical director at the Royal Free. In 2012, Tim moved into full-time management as chief executive of Barnet and Chase Farm Hospitals NHS Trust until its acquisition by the Royal Free. He then worked as the London associate medical director at the NHS Trust Development Authority before moving to Barts Health NHS Trust as improvement director and subsequently became deputy chief executive. Tim now holds two NHS non-executive posts. In addition to his role at University Hospital Southampton, Tim also serves on the board for Isle of Wight NHS Trust as deputy chair. He is a practicing mediator specialising in the healthcare sector. He also consults for companies in the medical information technology industry. Dave graduated in chemistry from the University of Director, Davox Consulting Limited; Southampton before entering management consulting, Non-executive director, Faculty of becoming a partner in Accenture’s strategy practice. Leadership and Medical In 2003 he joined Exel Logistics (later bought by DHL), Management (from November managing the company’s healthcare business across 2019); Director Royal College of Europe and the Middle East. During this time, he General Practitioners (RCGP) established NHS Supply Chain, a UK organisation Enterprises Ltd and RGCP responsible for procuring and delivering medical Conferences Ltd (from November consumables for the NHS in England, as well as sourcing 2019) capital equipment. Dave joined the board of Cable & Wireless as sales director in 2008. He later set up his own strategy consulting practice serving the healthcare sector, completing numerous projects in the UK and the US. Dave has also served as a non-executive director at The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust between 2009 and 2016. He chaired the Trust’s quality committee. Page 26 ACCOUNTABILITY REPORT Board member Name Title Jenni DouglasTodd Senior independent director/deputy chair (from 01/02/2020) Biography 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 headhunted into the civil service, at the Home Office, where she spent four years before 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. Declarations Independent chair, Dorset Integrated Care System. Managing director, Diversa Consultancy Limited; Member of the Judicial Conduct Investigative Office; Nonexecutive director, Hampshire Cricket Board; Trustee, NACRO; Member of English Cricket Board’s Regulatory Committee. Professor Non-executive Cyrus director Cooper 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. Cyrus Cooper is professor of rheumatology and director of the MRC Lifecourse Epidemiology Unit. He’s also vicedean of the faculty of medicine at the University of Southampton and professor of epidemiology at the Nuffield Department of Orthopaedics (rheumatology and musculoskeletal sciences, University of Oxford). He leads an internationally competitive programme of research into the epidemiology of musculoskeletal disorders, most notably osteoporosis. His key research contributions have been: • discovery of the developmental influences which contribute to the risk of osteoporosis and hip fracture in late adulthood • demonstration that maternal vitamin D insufficiency is associated with sub-optimal bone mineral accrual in childhood • characterisation of the definition and incidence rates of vertebral fractures • leadership of large pragmatic randomised controlled trials of calcium and vitamin D supplementation in the elderly as immediate preventative strategies against hip fracture. Director and professor of rheumatology, Medical Research Council (MRC) Lifecourse Epidemiology Unit; Vice-D
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Deprivation in Essex

Description: Mr CP was a 91 year old man living alone. He had early dementia, but coped at home with assistance.
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RFC PO (Lite) - Cyclophosphamide-Fludarabine- Rituximab PO (Lite) Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE–FLUDARABINE–RITUXIMAB (RFC Oral Lite) Regimen Lymphoma – RFC PO (Lite) - Cyclophosphamide-Fludarabine-Rituximab PO (Lite) Indication CD20 Positive Non-Hodgkin Lymphoma (Follicular) Toxicity Drug Cyclophosphamide Fludarabine Rituxumab Adverse Effect Dysuria, haemorrhagic cystitis (rare), taste disturbances Transfusion related GVHD, neurotoxicity, opportunistic infections, GI disturbances Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Patients treated with fludarabine carry a lifelong risk of transfusion associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive only irradiated blood products for life. Local blood transfusion departments must be notified as soon as the decision to treat 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. Monitoring Drugs FBC, LFTs and U&Es prior to day one of treatment Direct Coombs test prior to starting treatment 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. 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. Version 1.2 (Jan 2015) Page 1 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) 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 Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used (fludarabine). Dose modifications based on haematological parameters apply to cyclophosphamide and fludarabine Please note these dose adjustments are taken from the PACIFICO study and vary from CSCCN standard dose adjustments for oral fludarabine and cyclophosphamide. Neutrophils (x109/L) greater than or equal to 1 less than 1 Platelets (x109/L) greater than or equal to 75 Less than 75 Dose Modifications (cyclophosphamide and fludarabine) 100% Delay until recovery to 1x109/L or above. If recovery occurs within 7 days continue with 100% dose and give prophylactic growth factors with all subsequent courses If recovery takes more than 7 days give 75% of the original dose by omitting day 4 of treatment and give prophylactic growth factors with all subsequent courses If recovery takes longer than 3 weeks discontinue treatment Dose Modifications (cyclophosphamide and fludarabine) 100% Delay until recovery to 75x109/L or above. If recovery occurs within 7 days continue with 100% dose If recovery takes more than 7 days give 75% of the original dose by omitting day 4 of treatment If recovery takes longer than 3 weeks discontinue treatment Haemoglobin Patients who develop red-cell transfusion dependent or develop increasing transfusion requirements reduce the dose of subsequent cycles to 75% dose by omitting day 4 of treatment. If red-cell transfusion requirements continue to increase despite dose reduction then discontinue treatment. Version 1.2 (Jan 2015) Page 2 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Recommendation Evidence suggests dose reduction not necessary Fludarabine No dose adjustment required Rituximab No dose adjustment needed Renal Impairment Please note these dose adjustments are taken from the PACIFICO study and vary from CSCCN standard dose adjustments for oral fludarabine and cyclophosphamide. The table below shows the recommended dose of each drug based on surface area and renal function. BSA (m2) less than 1.4 1.4 - 2 more than 2 Fludarabine eGFR 30-49 20mg 30mg 40mg Cyclophosphamide eGFR 30-49 100mg 150mg 200mg No dose adjustment is necessary for rituximab in patients with impaired renal function. 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. Severe Nausea and Vomiting Consider changing to an intravenous version of this regimen if severe nausea and vomiting becomes a problem. Version 1.2 (Jan 2015) Page 3 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) 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 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 may be 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 flulike symptoms prior to treatment Regimen Cycles 1 – 4, 28 day cycle Drug Dose Cyclophosphamide 120mg/m2 Fludarabine 25mg/m2 Rituximab 375mg/m2 Days Administration 1,2,3,4 Oral 1,2,3,4 Oral 1 Intravenous infusion in 500ml sodium chloride 0.9% Cycles 5 – 8, 28 day cycle Drug Rituximab Dose 375mg/m2 Days 1 Administration Intravenous infusion in 500ml sodium chloride 0.9% Version 1.2 (Jan 2015) Page 4 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) Dose Information Cyclophosphamide is available as 50mg tablets and will be rounded to the nearest 50mg (up if halfway). Fludarabine is available as 10mg tablets and will be rounded to the nearest 10mg (up if halfway). Rituximab will be dose rounded to the nearest 100mg (up if halfway) Administration Information Extravasation Rituximab – neutral Other Cyclophosphamide should be taken with food, swallowed whole with a full glass of water Fludarabine should be taken with food, swallowed whole with a full glass of water The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy Antiemetics As take home medication - ondansetron 8mg oral twice a day for 6 days - metoclopramide 10mg oral three times a day when required Rituximab pre-medication 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 - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids. Version 1.2 (Jan 2015) Page 5 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) Allopurinol 300mg once a day oral for the first cycle only Anti-infective prophylaxis as follows: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only continued for 6 months after the completion of treatment or in accordance with CD4 count. Please note that patients treated with fludarabine are at higher risk of fungal and atypical infections. A high level of suspicion must be maintained coupled with a low threshold for prompt and appropriate treatment. 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. 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. Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. Coding (OPCS 4.6) Procurement – X71.5 Delivery – X72.2 References 1. Forconi F, Fabbri A, Lenoci M et al. Low-dose oral fludarabine plus cyclophosphamide in elderly patients with untreated and relapsed or refractory chronic lymphocytic leukaemia. Haem Oncol 2008;26:247-51 2. Pacifico Study Version 6 Version 1.2 (Jan 2015) Page 6 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) REGIMEN SUMMARY RFC PO (Lite) - Cyclophosphamide-Fludarabine- Rituximab PO (Lite) Cycle 1 Day One 1. Warning – Check blood transfusion status Administration Instructions Patients treated with fludarabine 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. Chlorphenamine 10mg intravenous 3. Hydrocortisone 100mg intravenous 4. Paracetamol 1000mg oral 5. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 6. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 7. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take home medicines 8. Cyclophosphamide 120mg/m2 once a day oral for 4 days 9. Fludarabine 25mg/m2 once a day oral for 4 days 10. Allopurinol 300mg once a day for oral 28 days 11. Aciclovir 400mg twice a day oral for 28 days 12. Co-trimoxazole 960mg once a day oral on Mondays, Wednesdays and Fridays for 28 days 13. Metoclopramide 10mg three times a day oral when required 14. Ondansetron 8mg twice a day oral for 6 days starting prior to the first dose of oral chemotherapy Cycles 2, 3 and 4 Day One 1. Chlorphenamine 10mg intravenous 2. Hydrocortisone 100mg intravenous 3. Paracetamol 1000mg oral Version 1.2 (Jan 2015) Page 7 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 6. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take home medicines 7. Cyclophosphamide 120mg/m2 once a day oral for 4 days 8. Fludarabine 25mg/m2 once a day oral for 4 days 9. Aciclovir 400mg twice a day oral for 28 days 10. Co-trimoxazole 960mg once a day oral on Mondays, Wednesdays and Fridays for 28 days 11. Metoclopramide 10mg three times a day oral when required 15. Ondansetron 8mg twice a day oral for 6 days starting prior to the first dose of oral chemotherapy Cycles 5, 6, 7 and 8 Day One 1. Chlorphenamine 10mg intravenous 2. Hydrocortisone 100mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 6. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take home medicines 7. Aciclovir 400mg twice a day oral for 28 days 8. Co-trimoxazole 960mg once a day oral on Mondays, Wednesdays and Fridays for 28 days Version 1.2 (Jan 2015) Page 8 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite) DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed “a diagnosis” replaced with “the decision to treat” in TA-GVHD warning Hepatic impairment table updated Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus Donna Kimber 1.2 Jan 2015 throughout text Pharmacy Mucositis recommendation changed Technician Rebecca Wills Pharmacist “Warning-Check blood transfusion status” added to cycle 1 Ondansetron TTO clarified OPCS codes updated Disclaimer added In the regimen summary the 1.1 ondansetron instructions changed to Sept 2013 remove the words start on the evening of day 1. Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician Toxicity removed. Dr Andrew Davies Rebecca Wills Consultant Medical Pharmacist Oncologist 1 July 2012 None Dr Debbie Wright Dr Alison Milne Pharmacist 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 which occur as a result of following these guidelines. Version 1.2 (Jan 2015) Page 9 of 9 Lymphoma- RFC PO (Lite) -Cyclophosphamide-Fludarabine-Rituximab PO (Lite)
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ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine

Description: Chemotherapy Protocol LYMPHOMA CHLORAMBUCIL-DOXORUBICIN-ETOPOSIDE-PREDNISOLONE-PROCARBAZINEVINBLASTINE-VINCRISTINE (ChlVPP-EVA) Regimen • Lymphoma – ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-PrednisoloneProcarbazine-Vinblastine-Vincristine Indication • Hodgkin’s Lymphoma Toxicity Drug Chlorambucil Doxorubicin Etoposide Prednisolone Procarbazine Vinblastine Vincristine Adverse Effect Gastro-intestinal disturbance Cardiomyopathy, alopecia, urinary discolouration (red) Hypotension on rapid infusion, hyperbilirubinaemia Weight gain, gastro-intestinal disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Insomnia, ataxia, hallucinations, headache Peripheral neuropathy, constipation, jaw pain, ileus Peripheral neuropathy, constipation, jaw pain, ileus The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Patients diagnosed with Hodgkin’s Lymphoma carry a lifelong risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive only irradiated blood products for life. 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. Monitoring Drugs • FBC, LFTs and U&Es prior to day one and eight of treatment Version 1 (May 2018) Page 1 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine Dose Modifications The dose modifications listed are for haematological, liver and renal function and limited drug specific toxicities. 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 Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used in Hodgkin’s Lymphoma patients. Treatment will proceed if the neutrophils are greater than or equal to 1×109/L) and the platelet count is greater than or equal to 100×109/L. For values lower than these, treatment should be delayed by 7 or 14 days to allow full haematologic recovery. Growth factors are not normally required. Version 1 (May 2018) Page 2 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Chlorambucil Bilirubin (µmol/L) AST/ALT (units/L) Dose (% of original dose) Dose reduce in severe hepatic impairment Doxorubicin less than *30 and *30-50 and/or 51-85 more than 85 2-3xULN More than 3xULN N/A N/A 75% 50% 25% omit Etoposide 30-51 or more than 51 or 60-180 more than180 Consider dose reducing to 50% Clinical decision Procarbazine more than 50 more than 85 or more than 180 Consider dose reduction Omit Vinblastine *30-51 or more than 51 and more than 51 and 60-180 normal more than180 Vincristine *30-51 or more than 51 and more than 51 and 60-180 normal more than 180 * Limits reflect local practice and may vary from published sources 50% 50% Omit 50% 50% omit Version 1 (May 2018) Page 3 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine Renal Impairment Drug Chlorambucil Doxorubicin Etoposide Procarbazine Vinblastine Creatinine Clearance (ml/min) less than 10 more than 50 15-50 less than15 more than 177 µmol/L less than 10 N/A Dose (% of original dose) No dose adjustment needed Consider dose reduction in severe renal failure 100% 75% 50% 50% Not recommended No dose adjustment needed Vincristine 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. Doxorubicin Discontinue doxorubicin if cardiac failure develops Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Vinblastine Reduce the vinblastine dose to 3mg/m2 if NCI-CTC grade 2 motor or a NCI-CTC grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vinblastine. Vincristine Reduce the vincristine dose to 1mg if NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1 (May 2018) Page 4 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine Regimen 28 day cycle for 6 cycles Cycle 1 Drug Chlorambucil Doxorubicin Etoposide Prednisolone Procarbazine Vinblastine Vincristine Dose 6mg/m2 (max 10mg) 50mg/m2 75mg/m2 50mg 90mg/m2 (max 200mg) 6mg/m2 (max 10mg) 1.4mg/m2 (max 2mg) Days 1, 2, 3, 4, 5, 6, 7 8 1, 2, 3, 4, 5 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 8 1 Administration Oral Intravenous bolus over 10minutes Oral Oral Oral Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Cycle 2, 3, 4, 5, 6 The dose of etoposide is increased to 100mg/m2 for five days with second or subsequent cycles if the oral mucositis is no worse than NCI-CTC grade 1 after the first exposure at 75mg/m2 Drug Chlorambucil Doxorubicin Etoposide Prednisolone Procarbazine Vinblastine Vincristine Dose 6mg/m2 (max 10mg) 50mg/m2 100mg/m2 50mg 90mg/m2 (max 200mg) 6mg/m2 (max 10mg) 1.4mg/m2 (max 2mg) Days 1, 2, 3, 4, 5, 6, 7 8 1, 2, 3, 4, 5 1, 2, 3, 4, 5, 6, 7 1, 2, 3, 4, 5, 6, 7 8 1 Administration Oral Intravenous bolus over 10minutes Oral Oral Oral Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Dose Information • Chlorambucil is available as 2mg tablets and will be rounded to the nearest 2mg (up if halfway) • Chlorambucil tablets should be stored in a refrigerator Version 1 (May 2018) Page 5 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine • Doxorubicin will be dose banded according to the national dose bands (2mg/ml) • The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal/pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m² • Etoposide is available as 50mg capsules. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway) - if the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - if the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day - if the calculated dose is 225mg please dispense 250mg alternating with 200mg once a day • Vinblastine dose will be dose banded according to the national dose bands (1mg/ml) • The maximum dose of vinblastine is 10mg • Vincristine will be dose banded according to the national dose bands (1mg/ml) • The maximum dose of vincristine is 2mg • Prednisolone is available as 5mg and 25mg tablets • Procarbazine is available as 50mg capsules. The daily dose will be capped at 200mg. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway). - If the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - If the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day Administration Information Extravasation • Doxorubicin – vesicant • Vinblastine – vesicant • Vincristine - vesicant Other • Chlorambucil may be taken at night to avoid daytime nausea • Prednisolone should be taken in the mornings with or after food • Procarbazine has weak MAOI activity. Alcohol and foods rich in tyramine (including some wines and cheeses) should be avoided. Do not use with other MAOIs. Version 1 (May 2018) Page 6 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy on day 1 - metoclopramide 10mg oral or intravenous 15-30 minutes prior to chemotherapy on day 8 - metoclopramide 10mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication day 1 only - metoclopramide 10mg oral three times a day when required • Allopurinol 300mg once a day oral for 7 days for the first cycle only • Consider anti-infective prophylaxis in high risk patients including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only 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. Additional Information • The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • 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. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. Coding • Procurement – X70.3 • Delivery – X72.1 Day 1 + X72.4 Day 8 References 1.ChlVPP therapy for Hodgkin’s Disease: experience of 960 patients. The International ChlVPP Treatment Group. Ann. Oncol. 1995;6(2):167-172 2. Radford JA, Rohatiner ZS, Ryder JA et al. ChlVPP/EVA Hybrid Versus the Weekly VAPEC-B Regimen for Previously Untreated Hodgkin’s Disease. J Clin Oncol 2002; 20 (13): 2988-2994. Version 1 (May 2018) Page 7 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine REGIMEN SUMMARY ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-PrednisoloneProcarbazine-Vinblastine-Vincristine Cycle 1 Day One 1. Warning – Check blood transfusion status Administration Instructions Patients with HODGKIN’S lymphoma 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 – Do not cap doses Administration Instructions ARIA automatically caps doses at 2.4m2. This is not recommended for this regimen. Please ensure that doses are not capped. 3. Metoclopramide 10mg oral or intravenous 4. Vincristine 1.4mg/m2 (maximum 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Take Home Medicines 5. Chlorambucil 6mg/m2 (max 10mg) once a day oral for 7 days Administration Instructions Oral chemotherapy. 6. Etoposide 75mg/m2 once a day oral for 5 days Administration Instructions Oral chemotherapy. Etoposide is available as 50mg capsules. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway) - if the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - if the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day - if the calculated dose is 225mg please dispense 250mg alternating with 200mg once a day 7. Prednisolone 50mg once a day oral for 7 days 8. Procarbazine 90mg/m2 (max 200mg) once a day oral for 7 days Administration Instructions Oral chemotherapy Procarbazine is available as 50mg capsules. The daily dose will be capped at 200mg. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway). - If the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - If the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day 9. Allopurinol 300mg once a day oral for 7 days 10. Metoclopramide 10mg three times a day oral when required Administration Instructions Please supply 28 tablets or an original pack Cycle 1 Day Eight 11. Metoclopramide 10mg oral or intravenous Version 1 (May 2018) Page 8 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine 12. Ondansetron 8mg oral or intravenous 13. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 14. Vinblastine 6mg/m2 (maximum 10mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Cycle 2, 3, 4, 5, 6 Day One 15. Warning – Do not cap doses Administration Instructions ARIA automatically caps doses at 2.4m2. This is not recommended for this regimen. Please ensure that doses are not capped. 16. Metoclopramide 10mg oral or intravenous 17. Vincristine 1.4mg/m2 (maximum 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Take Home Medicines 18. Chlorambucil 6mg/m2 (max 10mg) once a day oral for 7 days Administration Instructions Oral chemotherapy. 19. Etoposide 100mg/m2 once a day oral for 5 days Administration Instructions Oral chemotherapy. Etoposide is available as 50mg capsules. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway) - if the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - if the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day - if the calculated dose is 225mg please dispense 250mg alternating with 200mg once a day 20. Prednisolone 50mg once a day oral for 7 days 21. Procarbazine 90mg/m2 (max 200mg) once a day oral for 7 days Administration Instructions Oral chemotherapy Procarbazine is available as 50mg capsules. The daily dose will be capped at 200mg. To facilitate alternate day dosing in ARIA the dose will be rounded to the nearest 25mg (up if halfway). - If the calculated daily dose is 125mg please dispense 150mg alternating with 100mg once a day - If the calculated daily dose is 175mg please dispense 200mg alternating with 150mg once a day 22. Metoclopramide 10mg three times a day oral when required Administration Instructions Please supply 28 tablets or an original pack Cycle 2, 3, 4, 5, 6 Day Eight 23. Metoclopramide 10mg oral or intravenous 24. Ondansetron 8mg oral or intravenous 25. Doxorubicin 50mg/m2 intravenous bolus over 10 minutes 26. Vinblastine 6mg/m2 (maximum 10mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Version 1 (May 2018) Page 9 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine DOCUMENT CONTROL Version Date 1 June 2018 Amendment None Written By Dr Debbie Wright Pharmacist Approved By 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 (May 2018) Page 10 of 10 Lymphoma- ChlVPP-EVA-Chlorambucil-Doxorubicin-Etoposide-Prednisolone-Procarbazine-Vinblastine-Vincristine
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B-AVD (Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine)

Description: Chemotherapy Protocol LYMPHOMA BRENTUXIMAB VEDOTIN-DACARBAZINE-DOXORUBICIN-VINBLASTINE (B- AVD) Regimen • Lymphoma – Brentuximab vedotin - Dacarbazine-Doxorubicin-Vinblastine Indication • Previously untreated stage III or IV CD30 positive Hodgkins lymphoma in adult patients Toxicity Drug Brentuximab vedotin Dacarbazine Doxorubicin Vinblastine Adverse Effect Peripheral sensory neuropathy, cough, diarrhoea, infusion related reactions, upper respiratory tract infections, progressive multifocal leukoencephalopathy Fatigue, facial flushing, rash, flu-like syndrome, photosensitivity Cardiotoxicity, urinary discolouration (red) Peripheral neuropathy, constipation, jaw pain, ileus The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Patients diagnosed with Hodgkin’s Lymphoma carry a lifelong risk of transfusion associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive only irradiated blood products for life. 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. Monitoring Drugs • FBC, LFTs and U&Es prior to day one and fifteen of treatment • Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems, cardiac risk factors or in the elderly. Discontinue doxorubicin if cardiac failure develops. 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. Version 1 (Jun 2025) Page 1 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine 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 Deliver on time and at full dose regardless of haematological counts unless there is an overriding clinical reason not to do so. Any dose modifications or delays must be discussed and approved by the responsible consultant. Prophylactic filgrastim was not mandated on the Echelon-1 clinical trial but should be considered in patients felt to be at higher risk of febrile neutropenia, at the discretion of the treating clinician. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used in Hodgkin’s Lymphoma patients. Hepatic Impairment If abnormal liver function tests are lymphoma related proceed with treatment at full dose unless there is an overriding clinical reason not to do so. Drug Brentuximab vedotin Bilirubin μmol/L AST/ALT units/L Child Pugh score A,B or C Dose (% of original dose) The recommended starting dose in patients with hepatic impairment is 0.9 mg/kg. Patients with hepatic impairment should be closely monitored for adverse events Dacarbazine Activated and metabolised in the liver. Can be hepatotoxic. Consider dose reduction or omission in severe hepatic impairment Doxorubicin less than *30 and *22-50 and/or 51-86 more than 86 or Child-Pugh C 2-3xULN more than 3xULN N/A N/A 75% 50% 25% Omit Vinblastine *22-51 more than 51 75% 50% * Limits reflect local practice and may vary from published sources Version 1 (Jun 2025) Page 2 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Renal Impairment Drug Brentuximab vedotin Creatinine Clearance (ml/min) <30mL/min Dose (% of original dose) The recommended starting dose in patients with severe renal impairment is 0.9 mg/kg. Patients with renal impairment should be closely monitored for adverse events Dacarbazine 45-60 30-44 less than 30 80% 75% 70% Doxorubicin less than10 Consider dose reduction in severe renal failure Vinblastine 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. Brentuximab vedotin Brentuximab vedotin can cause peripheral sensor or motor neuropathy, if a NCI-CTC grade 2 occurs reduce Brentuximab vedotin dose to 0.9mg/kg up to a maximum of 90mg every two weeks. If grade 3 occurs then withhold Brentuximab vedotin until toxicity is at grade 2 then reduce Brentuximab vedotin dose to 0.9mg/kg up to a maximum of 90mg every two weeks Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in patients who received Brentuximab vedotin. If patients experience any skin reactions during treatment, they should be monitored closely and, in the case of any suspicion of the skin reaction evolving to a serious muco-cutaneous reaction, treatment with Brentuximab vedotin should be withheld until complete resolution of the event or discontinued. Other potential causes of skin toxicity should be evaluated and suspected agents discontinued accordingly. Version 1 (Jun 2025) Page 3 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Infusion reactions Infusion related adverse reactions, including anaphylaxis, have been observed in patients treated with Brentuximab vedotin. If anaphylaxis occurs, immediately and permanently discontinue Brentuximab vedotin and administer appropriate medical therapy. For other infusion related reactions including chills, nausea, dyspnoea, pruritus, pyrexia and cough interrupt the infusion and institute appropriate medical management. Give pre-medication consisting of chlorphenamine, hydrocortisone and paracetamol for all subsequent infusions. Progressive multifocal leukoencephalopathy Use of Brentuximab vedotin has been 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 Brentuximab vedotin must be permanently discontinued Doxorubicin Discontinue doxorubicin if cardiac failure develops. Vinblastine Reduce the vinblastine dose to 3mg/m2 if a NCI-CTC grade 2 motor or a NCI-CTC grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vinblastine. Version 1 (Jun 2025) Page 4 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Regimen 28 day cycle 6 cycles will be set in Aria Drug Dose Dacarbazine 375mg/m2 Doxorubicin Vinblastine 25mg/m2 6mg/m2 Brentuximab vedotin 1.2mg/kg (max 120mg) Days 1 & 15 1 & 15 1 & 15 1 & 15 Administration Intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes Intravenous bolus over 10 minutes Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes In 100 mL sodium chloride 0.9% over 30 minutes. Must be administered after completion of AVD, starting approximately 1 hour after the end of dacarbazine infusion. Dose Information • Brentuximab vedotin will be dose banded according to the national dose bands 50mg/10ml) • The dose of Brentuximab vedotin will be capped at 120mg • Dacarbazine will dose banded according to national dose bands • Doxorubicin will dose banded according to the national dose bands • The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal / pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m². • Vinblastine dose will be rounded to the nearest 1mg (up if halfway) • There is no maximum dose of vinblastine in this protocol . Administration Information Extravasation • Brentuximab vedotin - neutral • Dacarbazine – vesicant • Doxorubicin - vesicant • Vinblastine - vesicant Version 1 (Jun 2025) Page 5 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Other • Dacarbazine can cause considerable pain at the infusion site. This may be helped by adjusting the infusion time or infusion volume and protecting the infusion from light. Additional Therapy • When required for the treatment of Brentuximab vedotin infusion related reactions - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • When required for the relief of Brentuximab vedotin related bronchospasm - salbutamol 2.5mg nebule • Loperamide 4mg initially then 2mg after each loose stool when required for diarrhoea. • Antiemetics 15-30 minutes prior to chemotherapy - Aprepitant 125mg D1 and D15 - dexamethasone 8mg oral or equivalent intravenous dose - ondansetron 8mg oral or intravenous As take home medication - Aprepitant 80mg D2 and D3, D16 and 17 - domperidone 10mg three times a day when required oral - ondansetron 8mg twice a day for three days oral • Anti-infective prophylaxis as follows: - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only - aciclovir 400mg TWICE a day Co-trimoxazole and Aciclovir should continue for three months after final dose of BVAVD • Allopurinol 300mg once a day oral for the first cycle only • 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. • Growth factors may be considered at the discretion of the treating clinician Version 1 (Jun 2025) Page 6 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Additional Information • The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. References 1. Ansell SM, Straus DJ, Connors JM, Jurczak W, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani RH, Hutchings M, Evens AM. Seven-year overall survival analysis from ECHELON-1 study of A plus AVD versus ABVD in patients with previously untreated stage III/IV classical Hodgkin lymphoma. JCO 2024 Jun 1;42(16). 2. Ansell SM, Radford J, Connors JM, Długosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM. Overall survival with Brentuximab vedotin vedotin in stage III or IV Hodgkin’s lymphoma. New England Journal of Medicine. 2022 Jul 28;387(4):310-20. 3. NICE. Brentuximab vedotin vedotin in combination for untreated stage 3 or 4 CD30-positive Hodgkin lymphoma [TA1059]. Technology appraisal guidance. Published 7 May 2025. Last updated 7 May 2025. Available at https://www.nice.org.uk/ guidance/ta1059 4. Takeda UK Ltd. Adcetris® (Brentuximab vedotin vedotin) 50 mg powder for concentrate for solution for infusion. Summary of Product Characteristics (SmPCs). Last updated 20/03/2025. Available online at https://www.medicines.org.uk/emc/ 5. Medac GmbH. Doxorubicin hydrochloride 2mg/ml solution for infusion. Summary of Product Characteristics (SmPC). Last updated 05/09/2024. Available at https://www.medicines.org.uk/emc/ 6. Hospira UK Ltd. Vinblastine Sulfate 1 mg/ml solution for injection. Summary of Product Characteristics (SmPC). Last updated 29/08/2024. Available at https://www.medicines.org.uk/emc/ 7. Medac GmbH. Dacarbazine 100 mg powder for solution for injection/infusion. Summary of Product Characteristics (SmPC). Last updated 18/01/2024. Available at https://www.medicines.org.uk/emc/ 8. Giraud EL, de Lijster B, Krens SD, Desar IME, Boerrigter E, van Erp NP. Dose recommendations for anticancer drugs in patients with renal or hepatic impairment: an update. Lancet Oncol 2023; 24: e229 Version 1 (Jun 2025) Page 7 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine REGIMEN SUMMARY B-AVD – Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine Cycle 1 Day 1 1. Warning –Check blood transfusion status Administration Instructions Patients with HODGKIN’S lymphoma 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. Aprepitant 125mg oral 3. Dexamethasone 4mg oral or equivalent intravenous dose 4. Ondansetron 8mg oral or intravenous 5. Dacarbazine 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes 6. Doxorubicin 25mg/m2 intravenous bolus over 10 minutes 7. Vinblastine 6mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Brentuximab vedotin 1.2mg/kg intravenous infusion in 100mL Sodium Chloride 0.9% over 30 minutes Administration instruction Must be administered after completion of AVD, starting approximately 1 hour after the end of dacarbazine infusion 9. Hydrocortisone 100mg intravenous once only when required for the relief of brentuximab vedotin infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of brentuximab vedotin related bronchospasm 11. Paracetamol 1000mg oral when required for the treatment of Brentuximab vedotin infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4g/24hours Take Home Medicines 12. Aprepitant 80mg oral once a day on days 2,3, 16 and 17 13. Dexamethasone 4mg once a day on days 2,3 16 and 17 14. Domperidone 10mg three times a day when required oral Administration Instructions Please supply sufficient for day 1 and 15 (30 tablets or nearest whole pack equivalent) 15. Ondansetron 8mg twice a day oral for 3 days to start on the evening of the day of chemotherapy administration (day 1 and 15) Administration Instructions Please supply sufficient for day 1 and 15 (12 tablets or nearest whole pack equivalent) Version 1 (Jun 2025) Page 8 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine 16. Allopurinol 300mg once a day oral for 7 days 17. Aciclovir 400mg twice a day oral for 28 days 18. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral for 28 days Cycle 1 Day 15 19. Aprepitant 125mg 20. Dexamethasone 4mg oral or equivalent intravenous dose 21. Ondansetron 8mg oral or intravenous 22. Dacarbazine 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes 23. Doxorubicin 25mg/m2 intravenous bolus over 10 minutes 24. Vinblastine 6mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 25. Brentuximab vedotin 1.2mg/kg intravenous infusion in 100mL Sodium Chloride 0.9% over 30 minutes Administration instruction Must be administered after completion of AVD, starting approximately 1 hour after the end of dacarbazine infusion 26. Hydrocortisone 100mg intravenous once only when required for the relief of brentuximab vedotin infusion related reactions 27. Salbutamol 2.5mg nebule once only when required for the relief of brentuximab vedotin related bronchospasm 28. Paracetamol 1000mg oral when required for the treatment of Brentuximab vedotin infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4g/24hours Cycle 2 - 6 Day 1 29. Warning –Check blood transfusion status Administration Instructions Patients with HODGKIN’S lymphoma 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. 30. Aprepitant 125mg oral 31. Dexamethasone 4mg oral or equivalent intravenous dose 32. Ondansetron 8mg oral or intravenous Version 1 (Jun 2025) Page 9 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine 33. Dacarbazine 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes 34. Doxorubicin 25mg/m2 intravenous bolus over 10 minutes 35. Vinblastine 6mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 36. Brentuximab vedotin 1.2mg/kg intravenous infusion in 100mL Sodium Chloride 0.9% over 30 minutes Administration instruction Must be administered after completion of AVD, starting approximately 1 hour after the end of dacarbazine infusion 37. Hydrocortisone 100mg intravenous once only when required for the relief of brentuximab vedotin infusion related reactions 38. Salbutamol 2.5mg nebule once only when required for the relief of brentuximab vedotin related bronchospasm 39. Paracetamol 1000mg oral when required for the treatment of Brentuximab vedotin infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4g/24hours Take Home Medicines 40. Aprepitant 80mg oral on days 2,3, 16 and 17 41. Dexamethasone 4mg on days 2,3 16 and 17 42. Domperidone 10mg three times a day when required oral Administration Instructions Please supply sufficient for day 1 and 15 (30 tablets or nearest whole pack equivalent) 43. Ondansetron 8mg twice a day oral for 3 days to start on the evening of the day of chemotherapy administration (day 1 and 15) Administration Instructions Please supply sufficient for day 1 and 15 (12 tablets or nearest whole pack equivalent) 44. Aciclovir 400mg twice a day oral for 28 days 45. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral for 28 days Cycle 2 - 6 Day 15 46. Aprepitant 125mg 47. Dexamethasone 4mg oral or equivalent intravenous dose 48. Ondansetron 8mg oral or intravenous 49. Dacarbazine 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes Version 1 (Jun 2025) Page 10 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine 50. Doxorubicin 25mg/m2 intravenous bolus over 10 minutes 51. Vinblastine 6mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 52. Brentuximab vedotin 1.2mg/kg intravenous infusion in 100mL Sodium Chloride 0.9% over 30 minutes Administration instruction Must be administered after completion of AVD, starting approximately 1 hour after the end of dacarbazine infusion 53. Hydrocortisone 100mg intravenous once only when required for the relief of brentuximab vedotin infusion related reactions 54. Salbutamol 2.5mg nebule once only when required for the relief of brentuximab vedotin related bronchospasm 55. Paracetamol 1000mg oral when required for the treatment of Brentuximab vedotin infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4g/24hours Version 1 (Jun 2025) Page 11 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 June 2025 New regimen Nanda Basker Pharmacist Robert Lown Consultant 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 which occur as a result of following these guidelines. Version 1 (Jun 2025) Page 12 of 12 Lymphoma- B-AVD-Brentuximab vedotin-Dacarbazine-Doxorubicin-Vinblastine
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AtezolizumabSC Bevacizumab Carboplatin Paclitaxel

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) ATEZOLIZUMAB-SC-BEVACIZUMAB-CARBOPLATIN (AUC6)-PACLITAXEL Regimen • Lung-Atezolizumab-SC-Bevacizumab-Carboplatin (AUC6)-Paclitaxel Indication • Atezolizumab in combination with bevacizumab, carboplatin and paclitaxel for the first line treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer with a PD-L1 tumour proportion score of 0-49% and without EGFR and ALK mutations (ATE4). • Atezolizumab in combination with bevacizumab, carboplatin and paclitaxel for the treatment of adult patients with EGFR or ALK or ROS1 or MET exon 14 or KRAS G12C or RET or BRAF mutation positive locally advanced or metastatic nonsquamous non-small cell lung cancer after failure of appropriate targeted therapy (ATE5). • After completion of the combination of atezolizumab, bevacizumab, carboplatin and paclitaxel and in the absence of disease progression, maintenance treatment with atezolizumab and bevacizumab will continue until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent or for a maximum treatment duration of 2* years, whichever comes first. 2* years treatment is defined as a maximum of 35 x 3-weekly cycles including the initial 4 induction cycles. All indications require a Blueteq application, see individual form (ATE4 or ATE5) for specific eligibility criteria. Ensure patient meets Blueteq criteria before consenting patient for treatment. Toxicity Drug Atezolizumab Bevacizumab Carboplatin Paclitaxel Adverse Effect Fatigue, rash, pruritis, pneumonitis, colitis, pancreatitis, diarrhoea, diabetes mellitus, adrenal insufficiency, thyroid disorders, nausea, electrolyte disturbances, hepatitis, myasthenic syndrome, Guillain Barre syndrome Haemorrhage, hypertension, proteinuria, impaired wound healing, gastrointestinal perforations, fistulae, arterial thrombosis Thrombocytopenia, peripheral neuropathy, nephrotoxicity at high doses, electrolyte disturbances Hypersensitivity, hypotension, bradycardia, peripheral neuropathy, myalgia and back pain on administration The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1.0 (November 2023) Page 1 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel Monitoring Drugs • FBC, LFTs, U&Es and cortisol prior to day each cycle • EDTA or calculated creatinine clearance prior to each cycle • Blood pressure and dipstick urinalysis for proteinuria prior to treatment with bevacizumab • Thyroid function tests prior to starting atezolizumab treatment and then every 6 weeks or when clinically indicated. 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. 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 Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Day 1 Neutrophils (x109/L) 1 or greater less than 1 Platelets (x109/L) 100 or greater 50-99 less than 50 Dose Modifications (carboplatin and paclitaxel) 100% Delay for 7 days. If the counts recover to at least 1x109/L within this time continue with the full dose. If the counts do not recover within 7 days or repeated delays are required then delay until recovery then reduce the dose by 20% Dose Modifications (carboplatin and paclitaxel) 100% Delay for 7 days. If the counts recover to at least 100x109/L within this time then continue with the full dose. If counts do not recover within 7 days or repeated delays are required then delay until recovery then reduce dose by 20% Delay until recovery then reduce dose by 50% There is little need to adjust the dose of atezolizumab or bevacizumab for haematological toxicity. Version 1.0 (November 2023) Page 2 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel Hepatic Impairment Drug Atezolizumab Bilirubin (μmol/L) AST/ALT units 1.5-3xULN OR 3-5xULN Dose Delay – see notes below Greater than 3xULN OR Greater than 3xULN Discontinue – see notes below Bevacizumab N/A N/A No information available Carboplatin N/A N/A No dose adjustment needed Paclitaxel less than 21 21-26 27-51 52-85 greater than 85 and less than 10xULN or greater than 10xULN 175mg/m2 135mg/m2 75mg/m2 50mg/m2 Contra indicated For patients with pre-existing mild hepatic impairment no dose adjustment is recommended. Atezolizumab has not been studied in patients with moderate or severe hepatic impairment. For NCI-CTC grade 2 hepatitis (ALT or AST between 3-5xULN or bilirubin between 1.53xULN) that persists for between 5-7 days then withhold the atezolizumab and consider treatment with a corticosteroid. The corticosteroid may be resumed when the event improves to grade 1 or below within 12 weeks and the corticosteroid dose has been reduced to the equivalent of oral prednisolone 10mg per day or less. For a grade 3 or above hepatitis (ALT or AST greater than 5xULN or bilirubin greater than 3xULN) permanently discontinue atezolizumab Renal Impairment Drug Atezolizumab Creatinine Clearance (ml/min) N/A Dose No dose adjustment needed Bevacizumab N/A No information available Carboplatin* less than 20 Omit Paclitaxel N/A No dose adjustment needed Version 1.0 (November 2023) Page 3 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel * Significant changes in GFR of more than 10% may require dose adjustment. 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. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent should then be reduced to 75% of the original dose or discontinued as appropriate. Atezolizumab Atezolizumab belongs to the immunotherapy class of cancer treatments. Autoimmune toxicities are most frequently noted and can be life threatening. If autoimmune toxicities occur delaying treatment should be considered while investigations or treatments are organised. Some, but not all, toxicities mandate cessation of treatment. Please seek guidance from relevant site-specific specialist teams or oncologists / haematologists with experience of prescribing these agents. Clinicians should be aware that the current funding approval precludes further treatment after an interruption of 12 weeks or longer; this situation may change. Refer to the latest version of the European Society of Medical Oncology guidelines; Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(3). 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. Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Most occur during treatment, however, onset months after the last dose has been reported. Unless an alternate aetiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and atezolizumabrelated. Early diagnosis and appropriate management are essential to minimise lifethreatening complications. Atezolizumab should be permanently discontinued for: any NCI-CTC grade 3 or 4 pneumonitis or hepatitis; any other life-threatening NCI-CTC grade 4 reaction (including colitis and renal impairment); any recurrence of a severe or NCI-CTC grade 3 reaction; any persistent NCI-CTC grade 2 or 3 treatment-related adverse reaction that does not recover to grade 1 or resolve within 12 weeks after the last dose. Version 1.0 (November 2023) Page 4 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel Immune-related adverse reaction Severity Pneumonitis Grade 2 pneumonitis Treatment modification Withhold until symptoms resolve and radiographic abnormalities improve. Consider treatment with oral prednisolone 1-2mg/kg/day or equivalent. Treatment may be resumed if the event improves to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to 10mg or less oral prednisolone equivalent per day. Colitis Pancreatitis Grade 3 or 4 pneumonitis Grade 2 or 3 diarrhoea or symptomatic colitis Permanently discontinue atezolizumab. Consider treatment with corticosteroids. Withhold the atezolizumab initially. For a grade 2 diarrhoea or colitis, if the symptoms persist for more than 5 days or recur, start treatment with 1-2mg/kg/day oral prednisolone or equivalent. For a grade 3 diarrhoea or colitis treatment with intravenous corticosteroids should be started, this may be converted to oral treatment as symptoms improve. If the symptoms improve to grade 1 or less taper the corticosteroids over one month Grade 4 diarrhoea or colitis Grade 3 or 4 serum amylase or lipase levels increased (more than 2xULN) or grade 2 or 3 pancreatitis Treatment may be resumed if the event improves to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to 10mg or less oral prednisolone equivalent per day Permanently discontinue atezolizumab. Consider treatment with corticosteroids. Withhold atezolizumab. Treatment with atezolizumab may be resumed if serum amylase and lipase levels improve to grade 0 or grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to 10mg or less oral prednisolone or equivalent per day Grade 4 or any grade of recurrent Permanently discontinue atezolizumab. pancreatitis Consider treatment with corticosteroids. Thyroid disorders Symptomatic Withhold atezolizumab Version 1.0 (November 2023) Page 5 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel Adrenal insufficiency Symptomatic Nephritis Grade 2 Hypophysitis Grade 3 or 4 Grade 2 or 3 Hypothyroidism Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing. Hyperthyroidism Treatment may be resumed when symptoms are controlled by carbimazole or equivalent and thyroid function is improving Withhold atezolizumab Treatment may be resumed if the symptoms improve to grade 0 or grade 1 within 12 weeks and corticosteroids have been reduced to the equivalent of 10mg or less of oral prednisone or equivalent per day and patient is stable on replacement therapy Withhold atezolizumab Start treatment with prednisolone 12mg/kg/day or equivalent. Treatment with atezolizumab may be resumed if the symptoms improve to grade 0-1 within 12 weeks and corticosteroids have been reduced to ≤ 10mg prednisolone or equivalent per day. Permanently discontinue atezolizumab Withhold atezolizumab Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisolone or equivalent per day and patient is stable on replacement therapy. Type I diabetes mellitus Grade 4 Permanently discontinue atezolizumab. Grade 3 or 4 hyperglycaemia Withhold atezolizumab (fasting glucose more than 250- 500mg/dL or 13.9mmol/L) Treatment may be resumed if metabolic Version 1.0 (November 2023) Page 6 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel control is achieved on insulin replacement therapy Myasthenic Facial paresis Grade 1 or 2 syndrome / myasthenia gravis, Guillain-Barre syndrome and meningoencephalitis and facial paresis All Grades Myasthenic syndrome/myasthenia gravis, Guillain Barré syndrome and Meningoencephalitis or Facial paresis Grade 3 or 4 Withhold atezolizumab Treatment may be resumed if the event fully resolves. If the event does not fully resolve while withholding atezolizumab, permanently discontinue. Permanently discontinue atezolizumab Myositis Grade 2-3 Withhold atezolizumab Grade 4 or recurrent grade 3 Permanently discontinue atezolizumab Infusion related reactions Grade 1 or 2 Reduce injection rate or pause injection. Treatment may be resumed when the event has resolved. Grade 3 or 4 Permanently discontinue atezolizumab Rash/severe Grade 3 rash cutaneous reactions or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) Withhold atezolizumab Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to 10mg or less oral prednisolone or equivalent per day Grade 4 rash Permanently discontinue atezolizumab. Consider treatment with corticosteroids or confirmed Stevens-Johnson syndrome (SJS) r toxic epidermal necrolysis (TEN) Bevacizumab Bevacizumab doses should be omitted and not reduced for adverse reactions. If more than two doses are missed due to adverse events treatment should be stopped. It should be noted that the half life of bevacizumab is approximately twenty days. Discontinuation of treatment in response to adverse effects is not expected to influence the short-term clinical evolution of the event, symptomatic treatment is often necessary. Bevacizumab should be stopped if the individual develops; • Gastrointestinal perforation • Arterial thromboembolic events Version 1.0 (November 2023) Page 7 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel • NCI-CTC grade 3 and above haemorrhagic events (requiring a blood transfusion or a major non-elective intervention) • NCI-CTC grade 3 and above congestive heart failure or left ventricular dysfunction. • NCI-CTC grade 4 fistula If an NCI-CTC symptomatic grade 4 venous thromboembolic event occurs bevacizumab should be stopped. However, if this is a pulmonary embolism bevacizumab may be restarted once a full recovery has been made and the individual is anti-coagulated with a subcutaneous low molecular weight heparin. An oral anticoagulant must not be used. Hypertension is a common consequence of bevacizumab therapy. For an NCI-CTC grade 1 hypertension no treatment is necessary. NCI-CTC grade 2 hypertension, consider antihypertensive therapy. For an NCI-CTC grade 3 and above hypertension that is persistent consider stopping treatment. Bevacizumab may be continued for an NCI-CTC grade 1 proteinuria or the first occurrence of a grade 2 proteinuria. For the second occurrence of an NCI-CTC grade 2 proteinuria or any NCI-CTC grade 3 proteinuria give the bevacizumab as scheduled. A 24-hour urine collection or UPCR should be conducted at most three days before the next dose. If there is less than 2g protein per 24 hours or a UPCR 0-1 administer the bevacizumab and return to dipstick monitoring. If there is more than 2g protein per 24 hours omit the bevacizumab. Repeat the 24-hour urine collection prior to the next scheduled dose. If this is less than 2g per 24 hours administer the bevacizumab and continue 24-hour urine collection until the protein is 1g per 24 hours or less. Regimen Induction - 21 day cycle for 4 cycles The starting dose of carboplatin AUC6 is used with calculated GFR. AUC5 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 AUC6 is 900mg this is set at 890mg in ARIA to comply with national dose bands). 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. Drug Atezolizumab Bevacizumab Carboplatin Paclitaxel Dose 1875mg 15mg/kg AUC 6 (maximum dose) 200mg/m2 Days 1 1 1 1 Administration Subcutaneous injection Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes (see administration information) Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 500ml sodium chloride 0.9% over 180 minutes. Followed by: Maintenance – 21 day cycle for a further 31 cycles (35 cycles in total) Version 1.0 (November 2023) Page 8 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel Atezolizumab is continued until loss of clinical benefit or unmanageable toxicity Bevacizumab is continued until disease progression or unacceptable toxicity. Drug Atezolizumab Bevacizumab Dose 1875mg 15mg/kg Days 1 1 Administration Subcutaneous injection Intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes (see administration information) Dose Information • Bevacizumab will be dose banded in accordance with the national dose bands (bevacizumab) • The recommended maximum dose when using a calculated creatinine clearance at AUC 6 is 900mg (this will be set at 890mg in ARIA to comply with national dose bands). 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. • Carboplatin will be dose banded in accordance with the national dose bands. • Paclitaxel will be dose banded in accordance with the national dose bands (6mg/ml) • A lower starting dose of paclitaxel 175mg/m² should be used in patients of Asian origin as per the SPC Administration Information Extravasation • Atezolizumab – neutral • Bevacizumab – neutral • Carboplatin – irritant • Paclitaxel - vesicant Other • The atezolizumab injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5 cm from the old site and never into areas where the skin is red, bruised, tender, or hard. During the treatment course with Atezolizumab SC formulation other medicinal Version 1.0 (November 2023) Page 9 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel products for subcutaneous administration should preferably be injected at different sites. • The first infusion of bevacizumab will be over 90 minutes. If this is well tolerated the second infusion may be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes • Hypersensitivity reactions tend to occur with the first or second infusion of paclitaxel. Paclitaxel infusion 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 inline 0.22 micron filter. Additional Therapy • Premedication to reduce of risk of hypersensitivity reaction 30 minutes before paclitaxel - chlorphenamine 10mg intravenous - dexamethasone 20mg oral or intravenous - H2 antagonist according to local formulary choice and availability • Antiemetics 15-30 minutes prior to chemotherapy (cycles 1-6 only) - ondansetron 8mg oral or intravenous As take home medication (cycles 1-4 only) - dexamethasone 4mg oral twice a day for 3 days - metoclopramide 10mg oral three times a day as required • As required for the treatment of infusion related reactions; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • Loperamide 4mg oral initially followed by 2mg after each loose stool when required for the relief of diarrhoea (maximum 16mg/24 hours). • Gastric protection with a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information Version 1.0 (November 2023) Page 10 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel • The use of systemic corticosteroids, before starting treatment with atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of the agent. However, systemic corticosteroids can be used after starting atezolizumab to treat immune-related adverse reactions. The use of systemic corticosteroids after starting treatment does not appear to impair the efficacy of atezolizumab. • Patients must be given an atezolizumab Patient Alert Card. References 1. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC, MA Socinski, RM Jotte, F Cappuzzo et al. N Engl J Med 2018; 378:2288-2301 2. National Institute for Health and Care Excellence (2019). Atezolizumab in combination for treating metastatic non- squamous non-small-cell lung cancer. NICE technology appraisal guidance 584 3. Haanen J, Carbonnel F, Robert C, Kerr K.M , Peters S, Larkin J, Jordan J on behalf of the ESMO Guidelines Committee. Management of toxicities from immunotherapy. ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 2017; 28 (suppl 4): 119-142. 4. Roche Products Ltd (2023). Tecentriq 1875mg solution for injection Summary of Product Characateristics. Online at https://www.medicines.org.uk/emc/product/15037/smpc last accessed 25/03/2024. Version 1.0 (November 2023) Page 11 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel REGIMEN SUMMARY Atezolizumab-Bevacizumab-Carboplatin (AUC6)-Paclitaxel Cycle 1, 2, 3, 4 1. Atezolizumab 1875mg subcutaneous injection Administration Instructions Administer 15 mL of atezolizumab solution for injection subcutaneously into the thigh over approximately 7 minutes. Use of a SC infusion set (e.g. winged/butterfly) is recommended. DO NOT administer the remaining residual hold-up volume in the tubing to the patient. Ensure the patient has been given an atezolizumab patient alert card. 2. Bevacizumab 15mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of bevacizumab will be over 90 minutes. If this is well tolerated the second infusion may be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 3. Chlorphenamine 10mg intravenous 4. Dexamethasone 20mg intravenous 5. 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 three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 6. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes before SACT. This may be administered as ondansetron 8mg intravenous if required 7. Warning - Check paclitaxel dose Administration Instructions A lower starting dose of paclitaxel 175mg/m² should be used in patients of Asian origin as per the SPC 8. Paclitaxel 200mg/m2 in 500ml sodium chloride 0.9% intravenous infusion over 180 minutes. Administration Instructions A lower starting dose of paclitaxel 175mg/m² should be used in patients of Asian origin as per the SPC Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter 9. Carboplatin AUC 6 (maximum dose) intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions The maximum dose of carboplatin at AUC 6 is 900mg (creatinine clearance 125ml/min). This has been set at 890mg in ARIA to comply with national dose bands 10. Chlorphenamine 10mg intravenous injection when required for infusion related reactions 11. Hydrocortisone 100mg intravenous injection when required for infusion related reactions Version 1.0 (November 2023) Page 12 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel 12. 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 Take Home Medicines 13. Dexamethasone 4mg oral twice a day for 3 days starting on day 2 of the cycle 14. Metoclopramide 10mg oral three times a day for three days then 10mg three times a day when required for nausea Administration Instructions When required for the relief of nausea. Please supply five days or an original pack as appropriate 15. Loperamide as directed (cycle 1 only) Administration Instructions Take 4mg after the first loose stool then 2mg after each subsequent loose stool to a maximum dose of 16mg / 24 hours Cycle 5-35 16. Atezolizumab 1875mg subcutaneous injection Administration Instructions Administer 15 mL of atezolizumab solution for injection subcutaneously into the thigh over approximately 7 minutes. Use of a SC infusion set (e.g. winged/butterfly) is recommended. DO NOT administer the remaining residual hold-up volume in the tubing to the patient. Ensure the patient has been given an atezolizumab patient alert card. 17. Bevacizumab 15mg/kg intravenous infusion in 100ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of bevacizumab will be over 90 minutes. If this is well tolerated the second infusion may be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 18. Chlorphenamine 10mg intravenous injection when required for infusion related reactions 19. Hydrocortisone 100mg intravenous injection 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 Version 1.0 (November 2023) Page 13 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel DOCUMENT CONTROL Version Date Amendment 1.0 March 2024 None Written By Eleanor Taylor Oncology Pharmacist Approved By Judith Cave 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 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 1.0 (November 2023) Page 14 of 14 NSCLC-AtezolizumabSC-Bevacizumab-Carboplatin(AUC6)-Paclitaxel
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/AtezolizumabSC-Bevacizumab-Carboplatin-Paclitaxel-Ver1.0.pdf

Atezolizumab SC-Carboplatin(AUC5)-Etoposide (IV/PO)

Description: Chemotherapy Protocol LUNG CANCER– SMALL CELL (SCLC) ATEZOLIZUMAB-SC-CARBOPLATIN (AUC5)-ETOPOSIDE(IV/PO) Regimen • Lung - AtezolizumabSC-Car
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-small-cellSCLC/Atezolizumab-SC-CarboplatinAUC5-Etoposide-IVPO.pdf

Atezolizumab-Bevacizumab-Carboplatin(AUC6)-Paclitaxel

Description: Chemotherapy Protocol LUNG CANCER ATEZOLIZUMAB-BEVACIZUMAB-CARBOPLATIN (AUC6)-PACLITAXEL Regimen  Lung-Atezolizumab-Bevacizumab-Carboplatin
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Atezolizumab-Bevacizumab-CarboplatinAUC6-Paclitaxel.pdf

Papers Trust Board 28 March 2019

Description: Agenda Group Name: Date of Meeting: Venue: Time: Apologies to: Trust Board – Open Session 28 March 2019 Conference Room, Heartbeat Education Centre, F Level, North Wing, SGH 9.00am Sue Diduch, Corporate Affairs Administrator 9.00 1. Chair’s Welcome, Apologies and Declarations of Interest 2. Minutes of Previous Meeting held on 28 February 2019 3. Matters Arising/Summary of Agreed Actions 9.15 9.30 9.35 9.40 9.45 10.30 10.40 10.50 4. Quality, Performance and Finance 4.1 Patient Story (Derek Sandeman, Medical Director) 4.2 Briefing from Chair of Audit & Risk Committee for review (Simon Porter, Chair, A&RC) 4.3 Briefing from Chair of Quality Committee for review (Mike Sadler, Chair, QC) 4.4 Briefing from Chair of Strategy & Finance Committee for review (Jane Bailey, Chair, S&FC) 4.5 Integrated Performance Report for Month 11 including Quarterly Patient Experience Report (QIF) for review 4.6 Informatics Update for review (Jane Hayward, Director of Transformation & Improvement/ Adrian Byrne, Director of Informatics) 4.7 2018 NHS National Staff Survey Results for review (Paula Head, Chief Executive/Steve Harris, Director of Human Resources) 4.8 Finance Report for Month 11 for review (David French, Chief Financial Officer) Oral Oral Oral Oral 11.00 5. Chair’s and Chief Executive’s Reports 5.1 Chief Executive’s Report for review and Chair’s Actions for ratification (Paula Head, Chief Executive/Peter Hollins, Trust Chair) 11.05 6. Corporate Governance, Risk and Internal Control 6.1 Feedback from Council of Governors’ Meeting 12 March Oral 2019 to note (Peter Hollins, Trust Chair) 11.15 7. Any other business 8. To note the date of the next meeting: Tuesday, 30 April 2019 in the Conference Room, Heartbeat Education Centre, F Level, North Wing, SGH In Attendance: Adrian Byrne, Director of Informatics Steve Harris, Director of Human Resources Vicki Havercroft-Dixon, Head of Patient Relations (shadowing Gail Byrne) EXCLUSION OF PRESS, PUBLIC AND OTHERS The public and representatives of the press may attend all meetings of the Trust, but shall be required to withdraw upon the Board of Directors resolving as follows “that representatives of the press, and other members of the public, be excluded from the remainder of this meeting as publicity would be prejudicial to the public interest by reason of the confidential nature of the business to be transacted” 11.30-11.45 Follow-up discussion with governors Items Circulated: The following items have been circulated to the Board since the last meeting. Executive directors are happy to take questions from individual members, before the meeting, by e-mail or telephone, or to meet separately to discuss in more detail. 25 February 2019 Press Release: Hospital first to offer all patients chance to manage healthcare online 7 March 2019 Press Release: Eight-week breastfeeding supplement prevents weight loss in premature babies after discharge 12 March 2019 Press Release: Leading doctor warns use of blood test to diagnose heart attacks is “flawed” 15 March 2019 Press Release: Healthcare scientists “hamstrung” by lack of awareness and investment Trust Board Minutes – Open Session Minutes of the Open Trust Board meeting held on Thursday 28 February 2019, in the Conference Room, Heartbeat Education Centre, North Wing, University Hospital Southampton, commencing at 0900 and concluding at 1100. Present: Mr P Hollins, Trust Chair Mrs P Head, Chief Executive Mr D French, Chief Financial Officer & Deputy Chief Executive Mrs G Byrne, Director of Nursing & Organisational Development Ms J Hayward, Director of Transformation & Improvement Dr C Marshall, Chief Operating Officer Dr D Sandeman, Medical Director Mr S Porter, Senior Independent Director/Deputy Chair Ms J Bailey, Non-Executive Director Prof C Cooper, Non-Executive Director Ms J Douglas-Todd, Non-Executive Director Ms C Mason, Non-Executive Director Dr M Sadler, Non-Executive Director PTH PHe DAF GB JH CM DS SP JB CC JD-T CMa MS In Attendance: Mr C Helps, Interim Associate Director Corporate Affairs CH Mr N Pearce, Associate Medical Director for Patient Safety NP Mr M Green, Head of Bereavement Care MG Ms V Boland, Corporate Affairs Manager (minutes) VB Ms S Herbert, DHN/P, Division A (shadowing Mrs G Byrne) SH 1 member of staff 2 governors 19/19 20/19 Apologies Apologies were received from Jenni Douglas-Todd, Non-Executive Director. Chair’s Welcome, Opening Comments and Declarations of Interest The Chair welcomed everyone to the meeting, specifically welcoming back VB. The chair congratulated CMa for her successful appointment as Chair at Solent NHS Trust. Action By There were no declarations of a conflict of interest with any items on the agenda. 21/19 Minutes of Previous Meeting (Agenda item 2) The minutes of the meeting held on 31 January 2019 were AGREED as an accurate record subject to amendments to: 6/19c) the last sentence of the second paragraph was deemed inaccurate and should state that the key performance indicator (KPI) for emergency readmissions be reviewed for next year. 6/19g) date of the major incident that occurred on 30th November 2018 to be provided in full. 22/19 22/19 a) Matters Arising/Summary of Agreed Actions (Agenda item 3) Minute Ref 143/18a) Complexity of Employee Relations Cases and Minute Ref 159/18a) Integrated Performance Report (specifically relating to Diabetes) – It was agreed that the Trust Board Study Session forward plan would be discussed during the closed Board session, to include these items. Page 1 of 6 22/19 b) Minute Ref 6/19j) Staffing – GB confirmed that a more detailed update in relation to the appraisal target would be included in the next Human Resources Report. 22/19 c) The Board noted the latest position on the actions in summary of actions. 23/19 Quality, Performance and Finance Patient Story (agenda item 4.1) DS introduced the patient to the Board. The Board heard a first-hand account of their experience of the Trust’s services. It was noted that the patient felt their experience fell short of their expectations and provided specific examples where the standard of care was disappointing. The patient reported a high standard of care from medical staff. The importance of listening to patients and responding appropriately, and ensuring patients basic needs as well as medical needs were met was emphasised. The Board thanked the patient for attending and providing an overview of their experience noting the value of this. It was confirmed that this information would be used to improve the care provided by UHS. 24/19 Integrated Performance Report for Month 10 including Quarterly Infection Prevention & Control Report (Agenda item 4.2) a) Safe GB advised that there was nothing specific to highlight from the report. There were no further comments or questions. 24/19 b) Caring GB provided an update noting the initiatives being introduced to improve the quality of response to patient complaints and concerns. A patient panel has now been introduced to assist in collecting and understanding patient feedback. It was confirmed that this would be discussed in more detail at the March Quality Committee. The decrease in the percentage of patients with a nutrition care plan was noted. GB will be working with the matrons and ward leaders for areas that are not achieving the expected standard. 24/19 c) Effective DS advised that there was nothing specific to highlight from the report. MS sought additional detail in relation to the four national reports with areas of concern within section E1.2. DS gave a brief overview of these reports noting that diabetes will be scheduled for discussion at a future Trust Board Study Session. 24/19 d) Activity CM highlighted the increase in Emergency Department (ED) attendances compared to the previous January, the significant reduction in non-elective length of stay and the reduction in the percentage of elective operations cancelled as a result of this. The increase in ED attendances was attributed to the opening of the Paediatric ED. An increase had been anticipated however data was being reviewed to confirm the cause as increased paediatric attendances. PHe emphasised the importance of ensuring that the increased attendances do not adversely affect the patient experience. MS congratulated those involved in reducing non-elective length of stay. Page 2 of 6 24/19 e) Emergency Access CM provided an overview noting that ED performance was the average of our local peer group despite the significant increase in attendances. The time to initial assessment metric is currently under development following the introduction of a new triage process within ED. JB drew attention to the continued reduction in eye casualty performance noting the difficulties already within Ophthalmology. CM confirmed that this was being addressed and more detail could be provided if required. PHe introduced the “Best March Ever” concept. CM provided an overview of the steps being taken to achieve this including working with community providers to reduce delayed transfers of care and patients referred to ED, for example, by GPs. PHe added that ED targets were being reviewed and new targets were expected. 24/19 f) Referral to Treatment Time (RTT) CM summarised RTT performance noting improvements in the number of patients waiting over 18 weeks and the number of patients on an incomplete pathway. Patients waiting longer than 52 weeks had been reviewed; patient choice was the reason for delay and there were no clinical concerns due to delayed treatment. 24/19 g) Cancer CM provided an overview of Cancer performance noting a number of measures had not been achieved. CM outlined a recent visit to the Imperial group of hospitals to learn about data analysis that enables better forward prediction and therefore providing more insightful information for the organisation/Board. MS noted the 6-8% increase in cancer activity year on year and suggested that the executive team consider a more a transformational change to address this to ensure this does not have an adverse effect on patients. JH emphasised the increased pressure on services due to identification of cancer at an earlier stage and new initiatives such as lung cancer screening. This would provide better outcomes for patients however would increase the number of patients being treated; this therefore needs to be planned for as part of the Trust’s strategy. PHe summarised the work that is ongoing with commissioners and the Cancer alliance to enable providers to achieve the cancer targets with the increased activity. It was agreed that further information be provided to the Board in relation to this. Action: Update in relation to planning for cancer targets to be provided to the PHe Board. GB noted that a process for reviewing harm as a result of patients waiting longer than 104 days for cancer treatment was being agreed with commissioners. CC queried whether there was any data providing a longer term perspective i.e. over the past five years. JH confirmed this could be made available if requested. 24/19 h) Infection Prevention Report GB provided an update noting that there would be a hand hygiene campaign in March/April 2019 which should have a direct impact on infection control. 24/19 i) Staffing GB summarised the challenges currently being experienced with nurse staffing particularly due to vacancy levels and the steps taken to address this on a daily basis. Page 3 of 6 24/19 j) RESOLVED That the Board NOTE the Month 10 Integrated Performance Report including the Quarterly Infection Prevention & Control Report. 25/19 Learning from Deaths Quarter 3 Report (Agenda item 4.3) a) DS and NP introduced the report. MS thanked NP for a clear report and the reassurance provided by the small number of avoidable cases. MS sought clarification of the personnel involved in reviewing cases and whether any audits were undertaken to ensure the process was working effectively. NP described the process in use. A new medical examiner service would commence in April. PTH queried whether the process identified the consequences for patients who had experienced repeated delays in treatment. NP advised that previous admissions were reviewed however a more formal process would be instigated once the medical examiner service was in place. CC asked whether there was potential for external validation and comparison of availability. NP has been working with other Trusts to ensure their processes mirror UHS’ to allow a comparison between organisations. JH informed the Board that the Hospital Standardised Mortality Ratio (HSMR) is expected to change from April once Countess Mountbatten Hospital becomes independent from the Trust. 25/19 b) RESOLVED That the Board NOTE the Learning from Deaths Quarter 3 Report. 26/19 Freedom to Speak Up Report (Agenda item 4.4) a) GB presented the report summarising the work undertaken and cases received to date. CC confirmed that all cases appeared to have been dealt with appropriately and had not required his involvement. CMa queried whether any trends had been identified so far. GB advised that some cases were protracted Human Resource cases where action had previously been slow. Learning points were being shared when possible, given the need for confidentiality, and this was encouraging others to speak out. 26/19 b) RESOLVED That the Board NOTE the Freedom to Speak Up Report. 27/19 CRN: Wessex 2018/19 Quarter 3 Performance Report (Agenda item 4.5) a) DS provided an overview of the report noting the good performance of the network. MS asked when the last review by the National Institute for Health Research (NIHR) had taken place and the outcome of this. DS confirmed that this took place 6 to 8 weeks ago and positive feedback had been received. MS asked that this information be included in future reports. Action: Future reports to include the outcome of NIHR reviews. DS 27/19 b) RESOLVED That the Board Page 4 of 6 28/19 Briefing from Chair of Strategy & Finance Committee (Agenda item 4.6) a) JB provided an overview of items discussed at the February meeting: • Outcome of 2017/18 reference cost index submission. • Review of latest financial position. • Operational plan 2019/20 update. 28/19 b) RESOLVED That the Board NOTE the update. 29/19 Finance Report for Month 10 (Agenda item 4.7) a) DAF presented the month 10 Finance report, noting for January: • The Trust delivered a control total surplus excluding Provider Sustainability Fund (PSF) of £2.8m. Year to date the Trust is on plan. • In month once non-recurrent items were excluded was break-even, against a Plan target of £2.8m surplus. • Under the single oversight framework the Trust delivered a score for Finance and Use of Resource of a ’1’. • Cost Improvement Plan (CIP) delivery in the month was £2.5m against a target of £2.8m. • Pay has increased by £1m since month 9 due to an increase in substantive, bank and agency costs month-on-month. A proportion related to December pay enhancements for bank holidays. PTH highlighted elective income as £2.9m behind plan year to date. This was attributed to gaps in spinal and cardiac surgery; these tend to be high value cases. PHe noted that whilst the Trust performed well against the NHS Improvement temporary staff pay ceiling, the total head count had increased. DAF confirmed that the data will be reviewed to better present the overall position. CMa asked whether the invest-to-save negative variance related to delays in the replacement of Princess Anne Hospital (PAH) windows. DAF advised that this related to delays in some estates projects such as PAH windows and theatre modernisation due to the requirement to close services to enable work to be undertaken. 29/19 b) RESOLVED That the Board NOTE the month 10 Finance Report. Chair’s and Chief Executive’s Reports 30/19 Chief Executive’s Report (Agenda item 5.1) a) PHe provided an overview of the requirement for the Trust to formally report progress with the flu vaccination programme and approve the achievement of 7 day services standards self-assessment. MS drew the Board’s attention to the percentage of staff concerned about possible side effects from the flu vaccine despite the evidence available to support that they are limited and manageable. PHe highlighted the importance of influencing perceptions of the vaccine and the need for the Trust to target its messages. DS plans to target messages by staff group. 30/19 b) RESOLVED That the Board NOTE the Staff Flu Vaccinations Update and APPROVE the Achievement of 7 day Services Standards Self-Assessment. Page 5 of 6 30/19 c) Items for Ratification Actions taken by the Chair as set out in paragraphs 3.1 – 3.2 were ratified. Strategy and Business Planning 31/19 Revised Equality, Diversity and Inclusion (EDI) Strategy (agenda item 6.1) a) GB presented the updated strategy which has been consulted upon and comments considered and included where appropriate. MS supported the amended strategy. CMa identified that the ‘white other’ group was classified differently within different sections of the strategy. Action: Ethnic group classifications to be consistent within the Strategy. GB The Board discussed the difference between reducing equality and reducing inequity and how this can be addressed alongside the wider health system. 31/19 b) RESOLVED That the Board APPROVE the Equality, Diversity and Inclusion Strategy subject to one minor amendment as outlined above. 32/19 32/19 a) Any Other Business MS provided an update on the recent Diabetes screening event held at the Southampton FC v Cardiff FC football match. 103 people were tested and 2 cases of undiagnosed diabetes identified. The event raised awareness as well as highlighted the value of co-operation between the organisations involved. PHe thanked those involved for their hard work in organising this event. 33/19 Date and Time of Next Meeting Thursday, 28 March 2019 commencing at 0900 in the Conference Room, Heartbeat Education Centre, F Level, North Wing, SGH. Page 6 of 6 UHSFT – Directors’ Actions Summary for 28 March 2019 Trust Board – Open Session ___________________________________________________________________________________________________________________________________________ Action & Minute Reference By whom Target Date Current Status Trust Board 28 February 2019 Integrated Performance Report for Month 10 (Minute Ref 24/19 g) Cancer - Update in relation to planning for cancer targets to be PHe provided to the Board. CRN: Wessex 2018/19 Quarter 3 Performance Report (Minute Ref 27/19 a) Future reports to include the outcome of NIHR reviews. DS Revised Equality, Diversity and Inclusion (EDI) Strategy (Minute Ref 31/19 a) Ethnic group classifications to be consistent within the Strategy. GB as at 18/3/19 Page 1 of 1 Cover sheet for a report to the Trust Board of Directors dated Thursday, 28 March 2019 Title: Integrated Performance Report Month 11 Category Quality, Performance, and Finance Agenda item 4.5 Sponsor Director of Transformation and Improvement Author Trust Performance Manager Provenance Report to the Board provided by the Trust Executive. Purpose The paper is presented for the Board for Review The Board is requested to consider the performance metrics provided, identify any elements, trends or emerging themes it wishes to pursue further. Relevant to Board  Goal 1 – Trusted on  Goal 2 – Delivering for  Goal 3 – Excellence in goals Quality Taxpayers Healthcare Board Assurance This report relates to all of the aims and objectives contained in the Board Framework links Assurance Framework. Equality Impact Assessment The Trust aims to ensure that any change in performance does not affect one or more cohorts of people with specific protected characteristics. This equality monitoring is conducted operationally. Other standards affected NHS Provider Licence and Constitutional standards. Integrated KPI Board Report covering up to Feb 2019 Executive Sponsor - Jane Hayward, Director of Transformation Jane.Hayward@uhs.nhs.uk March 2019 Overview Safe Amber Caring Green Safe remains amber this month as UHS has failed some KPI's yet we have seen continued good performance in other areas. There were no never events reported in February. There were no avoidable high harm falls or MRSA infections/contaminants in February. C.Diff performance remains better than year to date target. In 18/19 the Trust planned to reduce pressure ulcers by 20% compared to last year, this trajectory has not be met in 18/19, however to date the number of pressure ulcers is very similar year on year. The themes are being collated and the learning is being shared through Pressure Ulcer Panel. VTE risk assessments remain an area of focus for the Trust with the new IT solution being piloted in AMU, Surgery and T&O in January 2019. A decision will be made in March by the Thrombosis committee to roll out trust wide. Complaints were low during November, December and January and increased slightly to levels seen previously in February. The rate of complaints against activity level remains consistent and within target range. Negative ratings through the FFT are under the trust threshold with patients continuing to rate their experience positively. Same Sex Accommodation breaches have fallen to under the trust target. Effective Green There were four national reports published and reviewed in Feburary, of these reports one raised an area of concern (National prostate Cancer Audit Annual Report 2018). There are now 218 outcomes being reported to TEC from 46 specialities. Of these the majority are green (78%) and only 7% graded red. Emergency readmissions was at 10.8% in December which is just below the average of last 2 years (11%). HSMR remained stable in November well below the national benchmark and crude mortality dropped slightly to 3.7% Activity Red Flow Amber New referrals recieved are following expected seasonal variation but continue to be higher than 18/19 in the month, quarter and year to date. New urgent cancer referrals in January did not decrease as seen last year instead are showing a 16% increase in the month. Main ED attendances remain exceptionally high in February compared to previous years. This is contrary to the normal seasonal trend which sees a reduction in the volume but not complexity of attendances, paediatric attendances have increased the most, but other streams also have increased compared to 17/18. There have been a number of changes year on year in services provided and how services are recorded that make year on year comparison difficult, this includes the Lymington surgical services and outpatients (up from August 17, impacts electives and outpatients), the change in TrehceoardveinrgagCeDnUucmhbaeirrso(df oDwelnayfreodmTrSaenpstfeemrsboefrC1a7r,eiminptahcetsTrounstnoinnFeelbercutiavreys)r,etmheairneecdoradti9n4g.oTfhtehenuremsbpeirraotofrpyacteiennttrsew(Ahporihla1v8e, dbaeyecnaisnehs otospoituatlpfaotriegnrtesa)t.er than or equal to 7 days / 21 days also increased yet remained lower than February 2018 by 2% and 4% respectively. Emergency Access Main ED (Type 1) performance reduced in February to 71.4%, compared to UHS February 2018 77.2%, and were 4.8% below the average of our local peer group. This performance was impacted by ED attendances significantly exceeding volumes in previous years and the onset of winter pressures in the inpatient service. Red RTT & Diagnostics Both RTT and diagnostic performance improved again in February. The trend of patients waiting greater than 52 weeks continues downwards and the patients waiting at the end of February have now been treated. Amber Diagnostic performance also improved and achieved the target in February. Pleasing to see Average weeks waited for first outpatient appointment continues to reduce. Cancer Red Cancer performance is currently rated red as we are not achieving a number of measures. Recovery of the Treatment started within 62 days of urgent GP referral wait, is likely to be slow and significant challenges are being experienced linked to significant growth in referrals and the number of additional cancers being treated (192 year to date). Improving trends in waiting times for initial appointment, waiting times for radiology and patients waiting for treatment are encouraging. Research & Dev Research and Development has been rated Amber this month. October recruitment benefitted from activity on a high recruiting meningitis prevention study. Whilst recruitment to this study has ended recruitment Amber projections to year end are satisfactory. Complexity (weighted) performance is also satisfactory with UHS ranked 2nd in the UK for a number of consecutive months. Staffing Amber Staffing remains amber overall because some key targets have been missed including those for turnover, non-medical appraisal completion, total nursing and registered nurse vacancy rates. However, UHS has seen improvements in the following: sickness absence (which has never been lower), turnover (the lowest rate since November 2017), decreases in total nursing and registered nurse vacancy rates and percentage of BME staff at Band 7+ (the highest rate it has been). CHPPD is within normal range this month as expected, after seasonal effects in January and it reflects high patient numbers. Estates Green Estates has been rated green this month as we are meeting all targets in February. The target missed on a 3 month rolling average is for percentage of help desk requests completed on time. Digital Green DigiRounds has demonstrated both time saving in reviewing the patient record during ward rounds, but also the quality of the review that is carried out, as clinicians are able to easily see all the significant elements of the record. It saves junior doctors time in preparing information for consultants (transcribing relevant results etc) prior to the ward round. Records accessed using Digirounds increased to 98,573 in February. Also in February the number of alerts sent using Medxnote increased again to 4079. 1 Chart Type Cumulative Column Example Cumulative Column Year on Year Line Benchmarked Line Percentiles Control Chart Variance from Target Report Guide Explanation A cumulative column chart is used to represent a total count of the variable and shows how the total count increases over time. This example shows quarterly updates. A cumulative year on year column chart is used to represent a total count of the variable throughout the year. The variable value is reset to zero at the start of the year because the target for the metric is yearly. The line benchmarked chart shows our performance compared to the average performance of a peer group. The number at the bottom of the chart shows where we are ranked in the group (1 would mean ranked 1st that month). A line percentiles chart is used to represent the distribution of a variable. The 50th percentile shows the median value, we also show the 5th, 25th (lower quartile), 75th (upper quartile) and 95th centiles. A control chart shows movement of a variable in relation to it's control limits (the 3 lines = Upper control limit, Mean and Lower control limit). When the value shows special variation (not expected) then it is highlighted green (leading to a good outcome) or red (leading to a bad outcome). Values are considered to show special variation if they -Go outside control limits -Have 6 points in a row above or below the mean, -Trend for 6 points, -Have 2 out of 3 points past 2/3 of the control limit, -Show a significant movement (greater than the average moving range). Variance from target charts are used to show how far away a variable is from it's target each month. Green bars represent the value the metric is achieving better than target and the red bars represent the distance a metric is away from achieving it's target. 2 March 2019 Safe Safe remains amber this month as UHS has failed some KPI's yet we have seen continued good performance in other areas. There were no never events reported in February. There were no avoidable high harm falls or MRSA infections/contaminants in February. C.Diff performance remains better than year to Amber date target. In 18/19 the Trust planned to reduce pressure ulcers by 20% compared to last year, this trajectory has not be met in 18/19, however to date the number of pressure ulcers is very similar year on year. The themes are being collated and the learning is being shared through Pressure Ulcer Panel. VTE risk assessments remain an area of focus for the Trust with the new IT solution being piloted in AMU, Surgery and T&O in January 2019. A decision will be made in March by the Thrombosis committee to roll out trust wide. MMoonntthhllyy Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Target YTD YTD Target S1.1 Never Events 1 1 1 - 3 0 1 S1.2 Avoidable High Harm Falls =95% 98% > =95% S1.12 % Thromboprophylaxis . Patients Assessed 95% 93.3% 92.8% > =95% 93% > =95% S1.12 - The IT solution within e prescribing was piloted from 24th January. This has demonstrated improvements in compliance particularly in AMU. This will be seen in April's report containing Feb data. There will be a discussion at thrombosis committee on 21st march about whether we can roll out the IT solution trust wide to increase compliance further. 100% S1.13 Patients appropriately . screened for sepsis 76% 76% 85% 98% 98% 60% 90% S1.14 Sepsis Patients Treated in a . timely manner 82% 77% 86% 82% 85% 60% 90% - - 90% - - 4 March 2019 Caring Green Complaints were low during November, December and January and increased slightly to levels seen previously in February. The rate of complaints against activity level remains consistent and within target range. Negative ratings through the FFT are under the trust threshold with patients continuing to rate their experience positively. Same Sex Accommodation breaches have fallen to under the trust target. C1.1 FFT response rate - Inpatients Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb 27% 15% 9% Monthly Target > =20% 0% 0.9% C1.2 FFT Negative Score - Inpatients 5% 0.9% =20% 2.4% =95% 75% C1.6 Although we are maintaining above 90% we are still not reaching 95%. Therefore some focus work to drive this is being done with the ward areas that are consistently achieving below this requirement, as this is reflective of a small pocket of areas. C1.7 Total Complaints Received . 37 48 40 33 44 37 43 44 44 32 50 28 31 32 42 - C1.8 Complaints per 1000 units . 0.50 0.42 0.00 500 C1.9 Bereavement Survey Response Count 0 15% C1.10 Bereavement Survey Negative Score Core Questions - % 0% C1.9/C1.10 - Figures will be updated quarterly (next month) 0.42 =7days Census average 550 Extended LOS Census average 300 256 RF1.8 (Patients with LOS > =21days) 94 =30% 20.9% 66.2% > =80% 95.5% 90-95% 2 8 4 44 46 44 41 42 19 1 12 15 29 32 8 56 40 3 - 150 77 84 - 0 YTD 23.84% 63.17% - RF1.13 - currently undertaking investigation to understand cancelled operations figures 55 RF1.14 Last minute cancelled operations not 5 . readmitted within 28 days 0 2 - - RF1.15 % elective operations cancelled and not 5% 6.5% . readmitted within 28 days 2.4% 314445224641146 70% 100% 92.3% 94.9% RE1.2 Eye Casualty (Type 2) 90.4% - RE1.3 Lymington MIU (Type 3) 85% 100% 99.7% 99.4% 99.6% - 95% RE1.4 UHS Total 85% . . 70% 97% RE1.5 Local Delivery System . . 80% 82.1% 87.5% 90.0% 81.5% 77.9% > =90% 95.0% 83.3% 85.9% > =95% UHS Total (RE1.4) includes SGH all types and lymington. Local Delivery System (RE1.5) is UHS Total and Southampton Treatment Centre (RSH MIU). 14 March 2019 Emergency Access Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Target R-3M RE1.6 % patients who left the department 5% 4.7% . before being seen UHS Total 6.8% =92% 80% 4700 4111 3993 RR1.2 Total patients waiting over 18 weeks (in . backlog) - 1700 7 RR1.3 . Patients waiting > 52 weeks for treatment 2 0 RR1.4 Total number of patients on an . incomplete pathway RR1.5 Patients on a surgical waiting List 36000 26000 6900 5900 7,700 RR1.6 Patients waiting for diagnostics RR1.7 . RR1.8 . 5,500 4% % of Patients waiting over 6 weeks for diagnostics 0% Average weeks waited for first outpatient 9.5 appointment 6.5 30978 6541 6651 3.65% 8.44 30037 31297 6701 - 7700 - 0.71% 93% 41 of 1513 90% RC1.2 . Breast symptoms referral seen in 2 weeks 69.1% 25.9% 50.7% => 93% 32 of 75 51% RC1.1 & RC1.2 - Performance has improved significantly in January and February following commencement of a new Consultant Radiologist in post in January. RC1.3 Treatment started within 62 days of . urgent GP referral 89.4% 79.9% 70.5% => 85% 71.4% 18 of 134.5 71% RC1.4 Treatment started within 62 days of . referral (Breast, Cervical & Bowel . Screening) 87.8% 72.0% RC1.4 - All 5 January breaches related to breast surgery RC1.5 62 Day - Consultant Upgrades 86.00% 54.2% => 90% 3 of 24 79% 79.17% 85.71% => 86% 0 of 3.5 86% 17 March 2019 Cancer Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Target no. patients to recover target QTD RC1.6 Treatment started within 31 days of . decision to treat 98.7% 94.9% 91.1% RC1.6 Half of the 41 breaches in January related to either Urology (mainly Prostate) or Breast Surgery => 96% 27 of 341 88% 87.98% Second or subsequent treatment (surgery) RC1.7 started within 31 days of decision to treat 89.5% 76.0% RC1.7 - Approximately 2/3 of the breached pathways in January were for skin surgery, and the remaining pathways were for prostate surgery => 94% 16 of 118 81% 80.51% Second or subsequent treatment (anti 100% RC1.8 cancer drugs) started within 31 days of decision to treat 95% 100% Second or subsequent treatment RC1.9 (radiotherapy) started within 31 days of decision to treat 95% 100.00% 100.00% 100.00% => 98% 0 of 172 100% 99.05% => 98% 0 of 211 99% RC1.10 104 day waits (treated in month) 16 16 16 11 18 20 17 23 26 17 - - - Principal reasons impacting RC1.10 are prostate surgery (same as RC1.3 & RC1.7), also late referrals of patients referred from other trusts and extended waits due to patient choice. 18 March 2019 Research and Development Amber Research and Development has been rated Amber this month. October recruitment benefitted from activity on a high recruiting meningitis prevention study. Whilst recruitment to this study has ended recruitment projections to year end are satisfactory. Complexity (weighted) performance is also satisfactory with UHS ranked 2nd in the UK for a number of consecutive months. CRN Recruitment WR1.1 Participants Recruited WR1.2 Weighted Recruitment WR1.3 Weighted National Ranking - All Studies WR1.4 Specialties Recruiting Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb 3000 YTD YTD Target 1602 500 13,729 7,501 1,273 10842 1 1 1 1 2 2 3 4 4 4 5 6 57 1236 12073 14473 60396 60217 - Top 5 53 - tbc The number of research active UHS specialties has been introduced as a new metric this year in response to implementing the new research strategy and the aim for all specialties to be research active. Having identified whether a specialty is research active or not, we are now trying to understand levels of activity in relation to size of department for this to be more meaningful. BRC 200 WR1.5 Papers published in partnership with UOS 0 94 99 153 120 112 Number of BRC papers published are in line with expectations and more detailed analysis is informing the next BRC bid preparations. Activity/Staffing Balance £8,000 6531 WR1.6 Income per WTE £4,000 385 400 4878 - - 19 March 2019 Staffing Amber Staffing remains amber overall because some key targets have been missed including those for turnover, non-medical appraisal completion, total nursing and registered nurse vacancy rates. However, UHS has seen improvements in the following: sickness absence (which has never been lower), turnover (the lowest rate since November 2017), decreases in total nursing and registered nurse vacancy rates and percentage of BME staff at Band 7+ (the highest rate it has been). CHPPD is within normal range this month as expected, after seasonal effects in January and it reflects high patient numbers. WS1.1 HR - Turnover - Rolling 12-months Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Monthly Target 13.67% 13.17% 13.1% 13.0% 92% WS1.4 . Nursing Vacancies (Total Clinical Wards) 11% 13.04% =76% WS1.7 Statutory & Mandatory Training . Achieving Target - 5 5 7 6 7 7 7 7 7 7 8 9 8 8 8 9.5 7 7 5 6 5 5 5 5 5 5 4 3 4 4 4 WS1.8 Total nursing staff all inpatient areas - 8.4 . Care hours per patient day (CHPPD) 8.0 8.3 - WS1.8 The CHPPD for ward based areas in the Trust has decreased from last month to RN 3.7 (previously 3.8) HCA 3.3 (previously 3.3) overall 7.0 (previously 7.2). 6.0 WS1.9 Registered nursing staff all inpatient . areas - CHPPD 5.1 5.0 3.5 3.3 WS1.10 Unregistered nursing staff all inpatient . areas - CHPPD 2.5 5.1 - 3.2 - 9% WS1.11 Black & Minority Ethnic Band 7+ . Percentage 7.5% 7% WS1.11 UHS has a target of 15% Band 7+ BME staff by 2023. WS1.12 Quality of practice experience for doctors . in training (annual report with quarterly . qualitative updates) Minor Risk Minor Risk Minor Risk Minor Risk 8.3% - Minor Risk No risk 21 March 2019 Estates Green Estates has been rated green this month as we are meeting all targets in February. The target missed on a 3 month rolling average is for percentage of help desk requests completed on time. Reactive Maintenance Monthly Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Target 2500 R-3M PE1.1 Number of defect work orders and 1300 2197 - - 2078 percentage completed on time 86.2% 86.7% > 85% 89.2% Preventative Maintenance 74.42% 200 PE1.2 Number of statutory maintenance jobs planned and percentage 50 69 - - 131 completed on time 98.6% 94.09% > 95% 98.3% 98.5% 600 308 PE1.3 Number of mandatory maintenance jobs planned and 250 percentage completed on time 98.8% 96.13% 419 - - 99.5% > 95% 99.5% PE1.4 Number of routine maintenance jobs planned and percentage completed on time 125 75 97.7% 92.29% 80 98.8% 88 - 100.0% > 85% 99.7% 2500 PE1.5 Number of Help desk requests and 1000 percentage completed on time 100% 85% Unresolved help desk requests PE1.6 Unresolved help desk requests PE1.7 (over 30 days old) 50% 1500 500 600 1000 200 0 1737 82.3% 1007 498 1640 - 86.6% > 85% 84.3% 569 =95% - - SD1.4 acknowledgment > =95% - - through eQUEST - rolling 3M 85% Release 29 of CHARTS goes live on 23rd January 2019. This includes enhancements to histopathology requesting from the Endoscopy Unit and should result in an increase in both requesting and acknowledgment - this will first appear in the April 2019 data extracts. SD1.5 digiRounds patient records accessed 200000 0 98573 eQuest Results Alerts Sent SD1.6 Decision support notifications (email alerts) 20,000 9345 0 5000 SD1.7 Medxnote 4079 0 SD1.8 InfoQlik (Daily) Activity 50 20.1 35.4 0 100 SD1.9 Sap BI (Daily) Activity 40.0 0 500 351 SD1.10 My Medical Record - UHS patient registrations 0 2,000 SD1.11 My Medical Record - UHS patient logins 968 0 23 March 2019 Changes and Corrections Page Staffing KPI WS1.11 KPI Name Type Black & Minority Ethnic Band 7+ Change - Display Percentage Detail Long term target added 24 • Improvements made to the processes for managing complaints have driven significantly better performance in the timeliness of responses. For January and February, the trust closed 82% of complaints within 35 working days, with an average response time of 30 working days. This is a significant improvement from Q3 where the trust closed just 42% of complaints in the timeframe, with an average response time of 38 working days. • The complaints quality improvement work continues to deliver benefits for patients. The trust has slightly increased the % of complaints being managed informally to 44% of the overall number received (compared to 42% this time last year). There is a plan to return to clearly distinguishing between the PALS function and formal complaints process, and this will likely improve this further and offer patients and families greater access to support in getting early resolution to their concerns. • Good progress is being made in improving how the trust supports patients and carers with disabilities through compliance with the Accessible Information Standard. A flag is now available in ECAMIS, which pulls through into other systems, to alert staff that a patient has information and / or communication support needs. There is also a Staffnet resource to guide staff in how to meet needs. The Experience of Care team are currently working on a number of projects to enable needs to be identified and recorded on the system, while project teams on E2 ward and Princess Anne Outpatients work on embedding and testing the processes and resources. • Patient feedback remains generally high, although with more local variation in FFT feedback scores. Response rates have declined generally, with a significant factor being survey fatigue experienced by both patients and staff. While the FFT remains mandatory, it is often too generic to gain a sense of local ownership. With a new survey contract, the FFT will be augmented with more locally-relevant questions to better empower staff to use feedback to identify improvements, and this sense of ownership will drive better staff engagement and improve responses. Low recommend scores in ED are due to extremely low response rates. • A review of the trust’s provision of interpreting services is underway, with the aim of ensuring that patient needs are being met effectively and that the trust is receiving value for money. Part of this work is looking at the variability of interpreting provision across the trust, identifying areas for piloting efficiency improvement projects. There is a lack of data on how the impact of poor provision of interpreters (as well as other communication support) affects attendance rates, involvement in care, and overall experience- and this review will look at capturing some of this information. • The number of people applying to volunteer increased in Q3 to 98 (from 57 in Q2). Overall for the year to date, the trust has had 242 applications with 115 of these starting and a number of applications still being processed. Retention of volunteers continues to be an issue, with too many new volunteers still leaving within the first 6 months. The team is reviewing its support and supervision processes, but with 824 active volunteers, it remains an ongoing challenge. • The trust successfully bid for funding from the Pears Foundation to develop and grow a youth volunteering programme. The funding will be for two years and will pay for a project worker to lead on collaboration with local schools and colleges to provide short to medium term placements for young volunteers (16-18). • The trust welcomed the first cohort of employee volunteers from the local NHS England team in March. NHSE staff are able to take up to five days each year in order to volunteer within their local community and the trust has agreed a pilot with NHSE to test out new volunteer roles with the group to assess feasibility and value. This includes getting qualitative feedback from patients and carers, a new role in AMU, and supporting the pharmacy team. 25 Complaints PALS Friends & Family Test Volunteers Indicator Complaints received Complex concerns received Complaints closed within 35 days Average working day to close PALS contacts Inpatient positive score Outpatient positive score Maternity positive score ED positive score Applications received New starters Target Q1 Q2 Q3 Q4* n/a 124 120 109 74 n/a 88 91 110 42 = > 66% 64% 59% 42% 82% 95% 97% 97% 96% 97% = > 95% 95% 96% 96% 93% = > 95% 99% 97% 90% NA = > 95% 94% 96% 85% 71% n/a 87 57 98 NA n/a 57 28 30 NA * Data is provisional and for the quarter to date. NA denotes data not yet available. Jan 32 24 81% 31 324 Feb 42 19 78% 30 275 26 Nursing and midwifery staffing hours - February 2019 Report notes Our staffing levels are monitored daily and we will risk assess and fill any gaps to ensure that safe staffing levels are always maintained The total hours planned is our planned staffing levels to deliver care across all of our areas but does not represent a baseline safe staffing level. We plan for an average of one registered nurse to every five or seven patients in most of our areas but this can change as we regularly review the care requirements of our patients and adjust our staffing accordingly. Staffing on intensive care and high dependency units is always adjusted depending on the number of patients being cared for and the level of support they require. Therefore the numbers will fluctuate considerably across the month when compared against our planned numbers. Enhanced Care (also known as Specialling) Occurs when patients in an area require more focused care than we would normally expect. In these cases extra, unplanned staff are assigned to support a ward. If enhanced care is required the ward may show as being over filled. If a ward has an unplanned increase or decrease in bed availability the ward may show as being under or over filled, even though it remains safely and appropriately staffed. CHPPD (Care Hours Per Patient Day) is a measure which shows on average how many hours of care time each patient receives on a ward /department during a 24 hour period - this will vary across wards and departments based on the specialty, interventions, acuity and dependency levels of the patients being cared for. The maternity workforce consists of teams of midwives who work both within the hospital and in the community offering an integrated service and are able to respond to women wherever they choose to give birth. This means that our ward staffing and hospital birth environments have a core group of staff but the numbers of actual midwives caring for women increases responsively during a 24 hour period depending on the number of women requiring care. WARD C4 (Solent ward) C4 (Solent ward) C6 C6 C6 (Teenage Cancer Trust unit) C6 (Teenage Cancer Trust unit) D2 D2 D3 D3 Surgical high dependency unit Surgical high dependency unit Registered nurses Total hours planned Registered nurses Total hours worked Unregistered staff Total hours planned Unregistered staff Total hours worked Registered nurses % Filled Day Night Day Night Day Night Day Night Day Night 1303.5 975.5 2572.1 1850.0 645.0 610.8 1196.0 943.0 1507.9 944.8 1230.8 910.8 2267.3 1740.5 661.3 513.0 1184.8 943.8 1325.9 932.4 915.0 644.0 174.5 0.0 332.2 0.0 1055.5 770.5 731.5 641.3 1281.3 829.0 209.5 99.5 166.2 79.0 1136.4 816.5 799.0 798.8 94.4% 93.4% 88.1% 94.1% 102.5% 84.0% 99.1% 100.1% 87.9% 98.7% Day Night 1962.1 1843.2 1865.4 1831.7 312.4 322.0 374.7 321.0 95.1% 99.4% Unregistered staff % Filled t Comments 140.0% Safe staffing levels maintained; Support workers used to maintain staffing numbers. 128.7% Safe staffing levels maintained; Support workers used to maintain staffing numbers. 120.1% Support workers used to maintain staffing numbers. Shift N/A Safe staffing levels maintained. 50.0% Safe staffing levels maintained; Staffing appropriate for number of patients. Shift N/A Staffing appropriate for number of patients; Staff moved to support other wards. 107.7% Safe staffing levels maintained. 106.0% 109.2% Safe staffing levels maintained. Safe staffing levels maintained. 124.6% Safe staffing levels maintained. 119.9% 99.7% Safe staffing levels maintained. Safe staffing levels maintained. Page 1 of 5 Cardiac intensive care unit Cardiac intensive care unit General intensive care unit A General intensive care unit A General intensive care unit B General intensive care unit B Neuro intensive care unit Neuro intensive care unit E5A E5A E5B E5B E8 E8 F11 F11 F6 F6 F5 F5 Acute medical unit Acute medical unit D5 D5 D6 D6 D7 D7 Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night Day Night 4911.3 4752.0 4116.4 3848.5 3657.1 3526.0 4334.7 3836.5 1151.2 645.0 1274.0 639.0 1961.3 961.0 1914.6 966.0 2016.5 966.5 1821.0 966.0 3826.1 3202.5 1621.6 972.6 1079.3 667.3 841.7 645.0 4309.8 3986.0 3757.0 3793.5 3438.1 3140.0 4218.1 3649.5 904.2 587.0 1117.0 622.5 1356.9 978.3 1236.9 814.0 1535.9 887.0 1172.9 828.0 3750.9 2871.3 1027.5 794.5 987.0 668.8 816.7 634.0 1123.8 794.3 890.5 644.0 507.8 322.0 694.3 587.0 615.4 322.0 727.5 322.0 1496.0 860.0 726.2 322.0 620.9 644.0 876.4 644.0 3032.7 1808.5 957.0 524.0 1451.7 690.5 949.3 300.0 607.8 472.5 722.9 453.5 373.6 274.5 510.0 545.0 707.0 472.5 724.0 398.2 1592.6 1208.4 629.6 587.5 962.5 736.5 1415.2 1068.0 3772.3 2468.3 1250.1 1077.0 1373.0 777.0 1030.3 323.0 87.8% 83.9% 91.3% 98.6% 94.0% 89.1% 97.3% 95.1% 78.5% 91.0% 87.7% 97.4% 69.2% 101.8% 64.6% 84.3% 76.2% 91.8% 64.4% 85.7% 98.0% 89.7% 63.4% 81.7% 91.5% 100.2% 97.0% 98.3% 54.1% 59.5% 81.2% 70.4% 73.6% 85.2% 73.5% 92.8% 114.9% 146.7% 99.5% 123.7% 106.5% 140.5% 86.7% 182.4% 155.0% 114.4% 161.5% 165.8% 124.4% 136.5% 130.6% 205.5% 94.6% 112.5% 108.5% 107.7% Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers. Safe staffing levels maintained;Additional staff used for enhanced care - Support workers. Support workers used to maintain staffing numbers; Band 4 staff working to support registered nurse numbers. Safe staffing levels maintained; Additional staff used for enhanced care - Support workers. Support workers used to maintain staffing numbers; Band 4 staff working to support registered nurse numbers. Safe s
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Description: Chemotherapy Protocol LYMPHOMA VINBLASTINE Regimen Lymphoma – Vinblastine Indication Non-Hodgkin’s Lymphoma H
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