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Daratumumab SC Ver1

Description: Chemotherapy Protocol Myeloma Daratumumab Subcutaneous Regimen • Myeloma – Daratumumab (SC) Indication • Daratumumab monotherapy is recommended as an option for treating relapsed and refractory multiple myeloma in adults whose previous therapy included a proteasome inhibitor and an immunomodulator (‘imid”) as a fourth line of treatment, that is, after 3 previous treatments. Toxicity Drug Daratumumab Adverse Effect Infusion related reactions, hypotension, headache, rash, urticaria, pruritus, nausea, vomiting, respiratory tract infections (including pneumonia), neutropenia, thrombocytopenia, anaemia, lymphopenia, peripheral neuropathy, diarrhoea, muscle spasms, fatigue, pyrexia and peripheral oedema, blood transfusion related events The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, U&Es, Ca2+ and LFTs prior to day one of each cycle of treatment. • Paraprotein and / or light chains prior to each cycle. • All patients should be tested for hepatitis B virus (HBV) before initiating treatment with daratumumab. Those patients who test positive for HBV infection should be discussed with a consultation specialist in HBV prior to initiating treatment with daratumumab to plan monitoring requirements whilst on treatment. Patients should also be tested for hepatitis C, CMV and HIV at the same time. • Send a blood sample to transfusion and inform patient and transfusion laboratory that patient is due to commence daratumumab. Patient will require red cell phenotyping as cross match fails due to binding of daratumumab to red cells. • Regular monitoring of blood glucose is considered good practice due to dexamethasone use. Version 1 (November 2020) Page 1 of 14 Myeloma – Daratumumab SC Dose Modifications There are no dose modifications for subcutaneous daratumumab, rather doses are delayed. Haematological No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of a NCI grade 4 haematological toxicity or grade 3 or higher thrombocytopenia with bleeding. Always refer to the responsible consultant, as any dose 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 or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). Consider growth factor support as an alternative to the options below, particularly where there is evidence of bone marrow suppression. To initiate a new cycle of daratumumab, the neutrophil count should be 1x109/L or greater and the platelet count should be 50x109/L or greater, unless the low counts are due to bone marrow infiltration with myeloma. In this situation the daratumumab may be administered at the discretion of the treating consultant haematologist with the appropriate blood product and growth factor support. Neutrophils (x109/L) Less than 0.5x109/L or febrile neutropenia (fever greater than or equal to 38.5°C and neutrophils less than 1) Platelets (x109/L) Less than 50x109/L Dose Modifications Interrupt daratumumab treatment and monitor FBC weekly. Once neutrophils recover to 1x109/L, resume daratumumab Dose Modifications Interrupt daratumumab treatment and monitor FBC weekly. Once platelets recover to 50x109/L or greater resume daratumumab. Hepatic Impairment No formal studies of daratumumab in patients with hepatic impairment have been conducted. Based on population pharmacokinetic analysis no dosage adjustments are necessary for patients with hepatic impairment Renal Impairment No dosage adjustment is necessary for patients with pre-existing renal impairment For patients that are over 120kg in weight it may be worthwhile considering the intravenous preparation to ensure efficacy. Infusion related reactions (IRR) Daratumumab solution for subcutaneous injection can cause severe and/or serious IRRs, including anaphylactic reactions. In clinical studies, approximately 11% (52/490) of patients Version 1 (November 2020) Page 2 of 14 Myeloma – Daratumumab SC experienced an IRR. Most IRRs occurred following the first injection and were Grade 1-2. IRRs occurring with subsequent injections were seen in less than 1% of patients The median time to onset of IRRs following daratumumab injection was 3.7 hours (range 0.15-83 hours). The majority of IRRs occurred on the day of treatment. Delayed IRRs have occurred in less than 1% of patients. Signs and symptoms of IRRs may include respiratory symptoms, such as nasal congestion, cough, throat irritation, allergic rhinitis, wheezing as well as pyrexia, chest pain, pruritus, chills, vomiting, nausea, and hypotension. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension and tachycardia Patients should be pre-medicated with antihistamines, antipyretics, and corticosteroids as well as monitored and counselled regarding IRRs, especially during and following the first and second injections. If an anaphylactic reaction or life-threatening (Grade 4) reactions occur, appropriate emergency care should be initiated immediately. Daratumumab therapy should be discontinued immediately and permanently To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following daratumumab injection. Patients with a history of chronic obstructive pulmonary disease may require additional post-injection medicinal products to manage respiratory complications. The use of post-injection medicinal products (e.g. short- and longacting bronchodilators and inhaled corticosteroids) should be considered for patients with chronic obstructive pulmonary disease Interference with Serological Testing Daratumumab binds to CD38 in red blood cells and results in a positive indirect antiglobulin test (Coombs test). Daratumumab mediated positive indirect antiglobulin test may persist for up to six months after the last daratumumab infusion. Daratumumab bound red blood cells masks detection of antibodies to minor antigens in the patients serum. The determination of a patients ABO and Rh blood type are not impacted. Blood transfusion must be informed that a patient is receiving daratumumab. Patients must be typed and screened prior to daratumumab. All patients must be given an identification card that should be carried for six months after stopping therapy and agree to inform all healthcare professionals who treat them that they have received daratumumab. Daratumumab is a human IgG kappa monoclonal antibody detectable on both the serum electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in all patients with IgG kappa myeloma. Reactivation of Hepatitis B Virus Hepatitis B virus reactivation has been reported in patients treated with daratumumab. All patients must be screened for hepatitis B before initiation of treatment. This includes all patients with unknown serology who are on treatment already. Monitoring is required for patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment and for at least six months after completion of daratumumab. Those with positive serology must seek medical help immediately if they experience symptoms of hepatitis B. Daratumumab must be stopped if hepatitis B reactivation occurs during treatment. Version 1 (November 2020) Page 3 of 14 Myeloma – Daratumumab SC Regimen 28 day cycle until disease progression or intolerance (12 cycles will be set in Aria) Cycles 1 and 2 Drug Daratumumab Dose 1800mg Days 1,8,15,22 Administration Subcutaneous Injection Cycles 3 to 6 Drug Daratumumab Dose 1800mg Days 1 and 15 Administration Subcutaneous Injection Cycles 7 onwards Drug Daratumumab Dose 1800mg Day Administration 1 Subcutaneous Injection Administration Information • If the patient experiences no major IRRs after the first four injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued. • Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-injection medicinal products including short and long acting bronchodilators, and inhaled corticosteroids should be considered. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-injection medicinal products may be discontinued at the discretion of the physician. • For first dose a cannula should be inserted to allow emergency treatment of anaphylaxis • First dose daratumumab that the patient should be observed for 4 hours following subcutaneous administration. If no infusion-related reactions following the first dose then neither cannulation nor additional post injection observations are needed with subsequent doses. If IRR with first dose then continue to observe for 4 hours following subsequent doses until IRRs subside. • Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the umbilicus over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. • Injection sites should be rotated for successive injections • Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Version 1 (November 2020) Page 4 of 14 Myeloma – Daratumumab SC • Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. • During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. Additional therapy • Consider allopurinol 300mg once a day for seven days for the first cycle only oral • No anti-emetics are required • Premedication required 1 to 3 hours before every injection; - Antihistamine oral as per local formulary choice - dexamethasone 20mg oral cycle 1 and cycle 2. This can be reduced to 10mg oral from the third cycle onwards. - paracetamol 1000mg oral - montelukast 10mg oral for the first cycle • Dexamethasone 4mg oral each morning for 2 days starting the day after each injection • Consider anti-infective prophylaxis including; - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only - fluconazole 100mg once a day oral only if recurrent oral candidiasis • Bisphosphonates in accordance with local policies. • Mouthwashes according to local or national policy on the treatment of mucositis. • Gastric protection with a proton pump inhibitor or an H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. • As required for the treatment of infusion related reactions for patients at high risk of respiratory complications; - sodium chloride 0.9% 500ml intravenous - salbutamol 2.5mg nebulised - hydrocortisone sodium succinate 100mg intravenous - chlorphenamine 10mg intravenous - paracetamol 1000mg oral - oxygen as required Additional Information • All instances of infusion related reaction must be recorded on ARIA. • Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red Version 1 (November 2020) Page 5 of 14 Myeloma – Daratumumab SC blood carpusles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. • Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response. References 1. Janssen-Cilag Limited (16 Aug 2017). Darzalex 20mg/ml Summary of Product Characteristics. Electronic Medicines Compendium. Online at https://www.medicines.org.uk/emc/product/7250 , accessed 18 January 2018. 2. National Institute for Health and Care Excellence (2018). Daratumumab for multiple myeloma [TA10076]. London: National Institute for Health and Care Excellence. 3. Thames Valley Strategic Cancer Network Myeloma Group MM32 Daratumumab (Darzalex TM) Monotherapy Protocol version 1.3 July 2017. 4. 90 minute daratumumab infusion is safe in multiple myeloma. Leukemia. Hallie Barr et al. Accessed 27/11/18 https://doi.org/10.1038/s41375-018-0120-2. Version 1 (November 2020) Page 6 of 14 Myeloma – Daratumumab SC REGIMEN SUMMARY Daratumumab (SC) Cycle 1 Day 1 1. Warning – Inform blood transfusion Administration Instructions Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response Please inform blood transfusion when a patient is prescribed daratumumab 2. Antihistamine oral Administration Instructions Oral antihistamine according to local formulary choices. To be taken 1 -3 hours prior to daratumumab infusion For example; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 3. Dexamethasone 20mg oral Administration Instructions Administer 20mg intravenous or equivalent dose if the patient is unable to tolerate the oral dose. To be taken 1 -3 hours prior to daratumumab infusion 4. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours. To be taken 1 -3 hours prior to daratumumab infusion 5. Montelukast 10mg oral 6. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 7. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions Version 1 (November 2020) Page 7 of 14 Myeloma – Daratumumab SC 8. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 9. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 10. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions 11. Sodium chloride 0.9% 500ml intravenous infusion when required for the relief of infusion related reactions Cycle 1 Days 8, 15, 22 12. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; To be taken 1 -3 hours prior to daratumumab infusion Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 13. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 14. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 15. Montelukast 10mg oral 16. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 17. 18.17. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 19.18. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 20.19. Paracetamol 1000mg oral when required for the relief of infusion related reactions Version 1 (November 2020) Page 8 of 14 Myeloma – Daratumumab SC Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 21.20. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions 22.21. Sodium chloride 0.9% 500ml intravenous infusion when required for the relief of infusion related reactions Take home medicines (day 1 only) 23.22. Dexamethasone 4mg on days 2, 3, 9, 10, 16, 17, 23 and 24 oral Administration Information Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. Supply 8 doses. 24.23. Dexamethasone 20mg on day 8,15 and 22 of cycle 1 and day 1 of cycle 2 Administration Information Take in the morning prior to daratumumab injection Note to pharmacy – Please dispense 4 doses of 20mg dexamethasone to be taken on days 8,15,22 of cycle 1 and day 1 of cycle 2 25.24. Allopurinol 300mg once a day for 7 days oral Administration information Take in the morning with food and plenty of water. This should be supplied for the first cycle only. 26.25. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 27.26. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 28.27. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 29.28. Anthistamine on the days of daratumumab administration Administration Instructions Take on the day of daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x OP. This is to cover all cycles. To be supplied as per local formulary choice Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 30.29. Paracetamol 1000mg oral on the days of daratumumab administration Administration Instructions Version 1 (November 2020) Page 9 of 14 Myeloma – Daratumumab SC Take 1000mg prior to daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x 100 x 500mg. This is to cover all cycles Cycle 2 days 1, 8, 15, 22 31.30. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 32.31. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 33.32. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 34.33. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 35.34. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 36.35. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 37.36. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 38.37. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take home medicines (day 1 only) 39.38. Dexamethasone 4mg on days 2, 3, 9, 10, 16, 17, 23 and 24 oral Administration Information Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. Supply 8 doses. 40.39. Dexamethasone 20mg on day 8,15 and 22 of cycle 2 and on day 1 of cycle 3 Administration Information Version 1 (November 2020) Page 10 of 14 Myeloma – Daratumumab SC Take in the morning of daratumumab injection Note to pharmacy – Please dispense 4 doses of 20mg dexamethasone to be taken on days 8,15,22 of cycle 2 and day 1 of cycle 3 . 41.40. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 42.41. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 43.42. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. Cycle 3, 4, 5, 6 days 1, 15 44.43. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 45.44. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 46.45. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 47.46. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. Version 1 (November 2020) Page 11 of 14 Myeloma – Daratumumab SC During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 48.47. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 49.48. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 50.49. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 51.50. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take home medicines (day 1 only) 52.51. Dexamethasone 4mg on days 2, 3, 16 and 17 oral Administration Information Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. Supply 4 doses. 53.52. Dexamethasone 20mg on day 15 of the current cycle and day 1 of the next cycle Administration Information Take in the morning of daratumumab injection Note to pharmacy – please dispense 2 doses of dexamethasone 20mg to be taken on day 15 of the current cycle and day 1 of the following cycle of daratumumab 54.53. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 55.54. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 56.55. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. Cycle 7 day 1 onwards 57.56. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Version 1 (November 2020) Page 12 of 14 Myeloma – Daratumumab SC Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 58.57. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 59.58. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 60.59. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 61.60. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 62.61. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 63.62. Paracetamol 1000mg oral when required for the relief of infusion related reactions 64.63. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take home medicines (day 1 only) 65.64. Dexamethasone 4mg on days 2, 3 oral Administration Information Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. Supply 2 doses. 66.65. Dexamethasone 20mg on day 1 of next cycle Administration Information Take in the morning of Daratumumab injection Note to pharmacy – please dispense as a separate supply to the dexamethasone due to be given during current cycle (days 2 and 3). Supply 1 dose. 67.66. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. Version 1 (November 2020) Page 13 of 14 Myeloma – Daratumumab SC 68.67. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 69.68. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 October 2021 None Nanda Basker Pharmacist Dr Mathew Jenner Dr Noel Ryman Dr Ed Belsham 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 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 (November 2020) Page 14 of 14 Myeloma – Daratumumab SC
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DRD Daratumumab-Lenalidomide-Dexamethasone

Description: Chemotherapy Protocol Myeloma DRD Daratumumab-Lenalidomide-Dexamethasone Regimen • Myeloma – DRD Daratumumab-Lenalidomide-Dexamethasone Indication • Daratumumab in combination with lenalidomide and dexamethasone is recommended for use within the Cancer Drugs Fund as an option for treating untreated multiple myeloma patients who are ineligible for an autologous stem cell transplant. • This regimen was based on MAIA trial and has been slightly modified to simplify the schedule (i.e. SC instead of IV Daratumumab and two divided doses of dexamethasone instead of once weekly dosing). • Cancer Drug Fund approval – BLUETEQ is required prior to treatment. • The Cancer Drug Fund stipulates that the patient is contraindicated for thalidomide containing chemotherapy or intolerant to thalidomide. Toxicity Drug Daratumumab Dexamethasone Lenalidomide Adverse Effect Infusion related reactions, hypotension, headache, rash, urticaria, pruritus, nausea, vomiting, respiratory tract infections (including pneumonia), neutropenia, thrombocytopenia, anaemia, lymphopenia, peripheral neuropathy, diarrhoea, muscle spasms, fatigue, pyrexia and peripheral oedema, blood transfusion related events Weight gain, gastrointestinal disturbances, hyperglycaemia, CNS disturbances, Cushingoid changes, glucose intolerance. Peripheral neuropathy, bone marrow suppression, pneumonia, infection, venous thrombotic events, respiratory dysfunction, rashes, hypokalaemia, hypomagnesaemia, hypocalcaemia, teratogenic risk, GI disturbances, flu-like symptoms. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Bloods • FBC, U&Es, Ca2+ and LFTs prior to day one of each cycle of treatment. Version 1 (October 2023) Page 1 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone • Paraprotein and / or light chains prior to each cycle. • All patients should be tested for hepatitis B virus (HBV) before initiating treatment with daratumumab. Those patients who test positive for HBV infection should be discussed with a consultant specialising in HBV prior to initiating treatment with daratumumab to plan monitoring requirements whilst on treatment. Patients may also be tested for hepatitis C, CMV and HIV at the same time if clinically appropriate. • Send a blood sample to transfusion and inform patient and transfusion laboratory that patient is due to commence daratumumab. Patient will require red cell phenotyping as cross match fails due to binding of daratumumab to red cells. • Regular monitoring of blood glucose is considered good practice due to dexamethasone use. • Pregnancy testing in women of childbearing potential. A negative pregnancy test must be obtained within 3 days of starting lenalidomide the test must be repeated every 4 weeks (every 2 weeks in women with irregular menstrual cycles) with the final test 4 weeks after the last dose of lenalidomide. 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 No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity. Always refer to the responsible consultant, as any dose 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 or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). Consider growth factor support as an alternative to the options below, particularly where there is evidence of bone marrow suppression. To initiate a new cycle of daratumumab, the neutrophil count should be 1x109/L or greater and the platelet count should be 50x109/L or greater, unless the low counts are due to bone marrow infiltration with myeloma. In this situation the daratumumab may be administered at the discretion of the treating consultant haematologist with the appropriate blood product and growth factor support. Version 1 (October 2023) Page 2 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Dose Reduction Steps Starting Dose Dose Level -1 Dose Level -2 Dose Level -3 Dose Level -4 Dose Level -5 Lenalidomide 25 mg 20 mg 15 mg 10 mg 5 mg 2.5 mg Neutrophils (x109/L) Dose Modifications (Lenalidomide) Fall to less than 1.0 First Occurrence Interrupt lenalidomide treatment and monitor FBC weekly. Consider G-CSF treatment. Return to 1.0 with no other observed toxicity Return to 1.0 or greater and dosedependent haematological toxicities other than neutropenia are observed Resume at 25 mg daily Resume at the next lower dose Subsequent Occurrence Fall to less than 1.0 Interrupt lenalidomide treatment and monitor FBC weekly. Consider G-CSF treatment. Return to 1.0 or greater Resume at the next lower dose Platelets (x109/L) Fall to less than 30 Returns to 30 or greater Dose Modifications First Occurrence Interrupt lenalidomide treatment and monitor FBC weekly. Consider transfusion. Resume at the next lower dose Version 1 (October 2023) Page 3 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Fall to less than 30 Returns to 30 or greater Subsequent Occurrence Interrupt lenalidomide treatment and monitor FBC weekly. Consider transfusion. Resume at the next lower dose Hepatic Impairment Drug Lenalidomide Daratumumab Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No formal studies conducted. No specific dose recommendations. No formal studies of daratumumab in patients with hepatic impairment have been conducted. Based on population pharmacokinetic analysis no dosage adjustments are necessary for patients with hepatic impairment Renal Impairment Drug Lenalidomide Daratumumab Creatinine Clearance Dose (ml/min) (% of original dose) 10 mg daily 30 and 50 The dose may be escalated to 15 mg after 2 cycles if patient is not responding to treatment and tolerates the dose Less than 30 7.5 mg daily or 15 mg every other day Less than 30 with Dialysis 5 mg daily Administer after dialysis No formal studies of daratumumab in patients with renal impairment have been conducted. Based on population pharmacokinetic analysis no dosage adjustments are necessary for patients with renal impairment 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. Lenalidomide In general, lenalidomide treatment should be stopped when the patient develops NCI-CTC grade 3 or 4 toxicities. Restart at next lower dose level when toxicity has resolved to grade 2 or lower depending on the physician’s discretion. Allergic or hypersensitivity reactions that occur at NCI-CTC grade 2, withhold treatment until the symptoms have resolved to NCI-CTC grade 1 or below. Treatment may be cautiously Version 1 (October 2023) Page 4 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone restarted at a daily dose of 15mg. For NCI-CTC grade 3 or above reactions discontinue the lenalidomide. Thromboembolism The combination of lenalidomide with dexamethasone is associated with an increased risk of venous thromboembolism. Appropriate thromboprophylaxis is recommended, especially in patients with additional thrombotic risk factors. Patients and their carers should be made aware of the symptoms of thromboembolism and advised to seek a medical advice if they develop shortness of breath, chest pain or swelling of a limb. If the patient develops thromboembolic events, treatment must be discontinued. Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the lenalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment. Skin Rash Lenalidomide should be interrupted or discontinued for NCI-CTC grade 2 or 3 skin rash. Allergic or Hypersensitivity Reactions Cases of allergic reactions including angioedema, anaphylactic reaction and severe cutaneous reactions including SJS, TEN and DRESS have been reported in patients treated with lenalidomide (see section 4.8). Patients should be advised of the signs and symptoms of allergic and hypersensitivity reactions and should be instructed to seek medical attention immediately if they develop these symptoms. Lenalidomide must be discontinued for angioedema, anaphylactic reaction, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected and should not be resumed following discontinuation for these reactions. Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity. Patients who had previous allergic reactions while treated with thalidomide should be monitored closely, as a possible cross-reaction between lenalidomide and thalidomide has been reported in the literature. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported with lenalidomide. Patients should be monitored for new or worsening neurological symptoms, cognitive or behavioural signs and symptoms. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed, lenalidomide must be permanently discontinued. Version 1 (October 2023) Page 5 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Teratogenicity Lenalidomide is highly teratogenic. All prescribers, patients and pharmacy staff must comply with the manufacturer’s Pregnancy Prevention Programme. Women of child-bearing potential taking thalidomide must use one agreed effective method of contraception for at least 4 weeks before starting thalidomide, while on Lenalidomide and for one month after. They must have a negative pregnancy test within 3 days prior to starting treatment. Pregnancy testing should be repeated monthly thereafter until one month after stopping Lenalidomide (or every 2 weeks in women with irregular menstrual cycles). If a woman taking Lenalidomide thinks she may be pregnant she must stop the drug immediately and seek medical advice. Men taking Lenalidomide must use a barrier method of contraception throughout treatment and for one week after stopping, if their partner is capable of bearing children. Other Dexamethasone For patients who are elderly or unable to tolerate the standard dose of dexamethasone the dose given the day after bortezomib alone may be reduced. Please note the doses before and the day after each daratumumab are to reduce the risk of infusion related reactions and as a steroid component of the triple combination. Infusion related reactions (IRR) Daratumumab solution for subcutaneous injection can cause severe and/or serious IRRs, including anaphylactic reactions. In clinical studies, approximately 11% (52/490) of patients experienced an IRR. Most IRRs occurred following the first injection and were Grade 1-2. IRRs occurring with subsequent injections were seen in less than 1% of patients. The median time to onset of IRRs following daratumumab injection was 3.7 hours (range 0.15-83 hours). The majority of IRRs occurred on the day of treatment. Delayed IRRs have occurred in less than 1% of patients. Signs and symptoms of IRRs may include respiratory symptoms, such as nasal congestion, cough, throat irritation, allergic rhinitis, wheezing as well as pyrexia, chest pain, pruritus, chills, vomiting, nausea, and hypotension. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension and tachycardia. Patients should be pre-medicated with antihistamines, antipyretics, and corticosteroids as well as monitored and counselled regarding IRRs, especially during and following the first and second injections. If an anaphylactic reaction or life-threatening (Grade 4) reactions occur, appropriate emergency care should be initiated immediately. Daratumumab therapy should be discontinued immediately and permanently. To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following Daratumumab injection. Patients with a history of chronic obstructive pulmonary disease may require additional post-injection medicinal products to manage respiratory complications. The use of post-injection medicinal products (e.g. short- and long- Version 1 (October 2023) Page 6 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone acting bronchodilators and inhaled corticosteroids) should be considered for patients with chronic obstructive pulmonary disease. Interference with Serological Testing Daratumumab binds to CD38 in red blood cells and results in a positive indirect antiglobulin test (Coombs test). Daratumumab mediated positive indirect antiglobulin test may persist for up to six months after the last daratumumab infusion. Daratumumab bound red blood cells masks detection of antibodies to minor antigens in the patient serum. The determination of a patient ABO and Rh blood type are not impacted. Blood transfusion must be informed that a patient is receiving daratumumab. Patients must be typed and screened prior to daratumumab. All patients must be given an identification card that should be carried for six months after stopping therapy and agree to inform all healthcare professionals who treat them that they have received daratumumab. Daratumumab is a human IgG kappa monoclonal antibody detectable on both the serum electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in all patients with IgG kappa myeloma. Reactivation of Hepatitis B Virus Hepatitis B virus reactivation has been reported in patients treated with daratumumab and lenalidomide. All patients must be screened for hepatitis B before initiation of treatment. This includes all patients with unknown serology who are on treatment already. Monitoring is required for patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment and for at least six months after completion of daratumumab. Those with positive serology must seek medical help immediately if they experience symptoms of hepatitis B. Daratumumab and lenalidomide must be stopped if hepatitis B reactivation occurs during treatment. Regimen Cycles 1 to 2 Drug Dose Daratumumab 1800mg Dexamethasone 20mg PO (this includes dexamethasone pre-meds) i.e. on daratumumab days, the premed dose of dexamethasone is sufficient. On nondaratumumab days, 20mg is Days Days 1, 8, 15 and 22 Days 1, 2, 8, 9, 15, 16, 22 and 23 Administration Subcutaneous 20mg Oral 10mg oral (or iv dose equivalent) for over 75yrs and less than BMI 18.5 Version 1 (October 2023) Page 7 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone to be administered. Lenalidomide 25mg PO Days 1 to 21 (NOCTE) Oral Cycles 3 to 6 Drug Daratumumab Dexamethasone Lenalidomide Dose 1800mg 20mg PO (this includes dexamethasone pre-meds) i.e. on daratumumab days, the premed dose of dexamethasone is sufficient. On nondaratumumab days, 20mg is to be administered. 25mg PO Days Days 1, and 15 Days 1, 2, 15 and 16 Days 1 to 21 (NOCTE) Administration Subcutaneous 20mg Oral 10mg oral (or iv dose equivalent) for over 75yrs and less than BMI 18.5 Oral Cycles 7 and further cycles Drug Daratumumab Dexamethasone Lenalidomide Dose 1800mg 20mg PO (this includes dexamethasone pre-meds) i.e. on daratumumab days, the premed dose of dexamethasone is sufficient. On nondaratumumab days, 20mg is to be administered. 25mg PO Days Day 1 Days 1 and 2 Days 1 to 21 (NOCTE) Administration Subcutaneous 20mg Oral 10mg oral (or iv dose equivalent) for over 75yrs and less than BMI 18.5 Oral Cycle Frequency Version 1 (October 2023) Page 8 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone 28-day cycle until disease progression or intolerance Dose Information • Dexamethasone is available as 2mg and 500microgram tablets and 3.3mg in 1ml injection (equivalent to 4mg orally) • Lenalidomide is available as 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg, and 25mg capsules Administration Information • The first dose of daratumumab should be administered in an environment where resuscitation facilities are available. • For first dose a cannula should be inserted to allow emergency treatment of anaphylaxis • Pre-medications (oral or intravenous) should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every administration of Daratumumab. • For patients with a history of chronic obstructive pulmonary disease, the use of postinjection medicinal products including short and long-acting bronchodilators, and inhaled corticosteroids should be considered. • Inject 15 mL daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the umbilicus over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. • First dose daratumumab that the patient should be observed with hourly observations for 4 hours following subcutaneous administration. If no infusion-related reactions following the first dose then neither cannulation nor additional post injection observations are needed with subsequent doses. If IRR with first dose then continue to observe for 4 hours following subsequent doses until IRRs subside. Following the first four injections, if the patient experiences no major IRRs, inhaled postinjection medicinal products may be discontinued at the discretion of the physician. • If the patient experiences no major IRRs after the first three injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued. • No modification to rate or dose of daratumumab administration was required to manage IRRs in clinical studies. • Injection sites should be rotated for successive injections. • Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. • Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. Version 1 (October 2023) Page 9 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone • During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as Daratumumab. • Lenalidomide should be taken at night to avoid daytime drowsiness • Lenalidomide prescriptions must be accompanied by a completed Prescription Authorisation Form Additional therapy • Consider allopurinol 300mg once a day for seven days for the first cycle only oral • Anti-emetics - Metoclopramide 10mg three times a day when required oral (this is not included in the regimen on ARIA but can be added from favourites if required) • Premedication required 1 to 3 hours before every daratumumab infusion: - Dexamethasone – see regimen for dose details - Chlorphenamine 4mg oral - Paracetamol 1000mg oral - Montelukast 10mg oral for the first four doses only • Thromboprophylaxis according to local formulary choice. For example; - Dalteparin 5000units once a day subcutaneous injection - Enoxaparin 40mg once a day subcutaneous injection - Heparin 5000units twice a day subcutaneous injection - Apixaban 2.5mg twice a day oral (unlicensed use) - Aspirin 75mg once daily (patients with no or one risk factor) • Bisphosphonates in accordance with local policies. • Mouthwashes according to local or national policy on the treatment of mucositis. • Laxatives as required for Lenalidomide-induced constipation. • Gastric protection with a proton pump inhibitor or an H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. • As required for the treatment of infusion related reactions for patients at high risk of respiratory complications: - Salbutamol 2.5mg nebulised - Hydrocortisone sodium succinate 100mg intravenous - Chlorphenamine 10mg intravenous - Paracetamol 1000mg oral - Oxygen as required Version 1 (October 2023) Page 10 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Additional Information • All instances of infusion related reaction must be recorded on ARIA. • Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. • Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response. • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • For all patients taking lenalidomide; the patient, prescriber and supplying pharmacy must comply with an appropriate pregnancy prevention programme. Reference 1. eMC (2023). Apixaban 2.5mg film-coated tablets. Available at: https://www.medicines.org.uk/emc/product/14534. Accessed [15/10/2023]. 2. eMC (2023). Darzalex 1800mg solution for injection. Available at: https://www.medicines.org.uk/emc/search?q=daratumumab. Accessed [15/10/2023]. 3. eMC (2023). Revlimid 25mg Hard Capsules. Available at: https://www.medicines.org.uk/emc/product/10047/smpc Accessed [15/10/2023]. 4. Facon, T., Kumar, S. et al (2019). Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. Available at: https://www.nejm.org/doi/full/10.1056/nejmoa1817249. Accessed [15/10/2023]. 5. IMWG Guidelines (2023). IMWG Guidelines for the Prevention of Thalidomide and Lenalidomide-Associated Thrombosis in Myeloma. Available at: https://www.myeloma.org/resource-library/imwg-guidelines-preventionthalidomide-lenalidomide-associated-thrombosis-myeloma. Accessed [15/10/2023]. 6. Moik, F., et al (2020). Direct oral anticoagulants compared to low‐molecular‐weight heparin for the treatment of cancer‐associated thrombosis: Updated systematic review and meta‐analysis of randomized controlled trials. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7292654/ [Accessed 15/10/2023] REGIMEN SUMMARY Myeloma – DRD Daratumumab-Lenalidomide-Dexamethasone Version 1 (October 2023) Page 11 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Cycle 1 Day 1 1.Warning – Inform blood transfusion Administration Instructions Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response Please inform blood transfusion when a patient is prescribed daratumumab 2.Antihistamine oral Administration Instructions Oral antihistamine according to local formulary choices. To be taken 1 -3 hours prior to daratumumab infusion For example; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 3.Dexamethasone 20mg oral Administration Instructions To be taken 1 -3 hours prior to daratumumab infusion. Can be administered as 20mg intravenous. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old. 4.Paracetamol 1000mg oral Administration Instructions To be taken 1 -3 hours prior to daratumumab infusion Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 5.Montelukast 10mg oral Administration Instructions To be taken 1-3 hours prior to daratumumab 6.Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 7.Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions Version 1 (October 2023) Page 12 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone 8.Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 9.Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 10.Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Days 8, 15, 22 11.Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; To be taken 1 -3 hours prior to daratumumab infusion Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 12.Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old. 13.Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 14.Montelukast 10mg oral Administration Instructions To be taken 1-3 hours prior to daratumumab 15.Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 16.Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 17.Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 18.Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Version 1 (October 2023) Page 13 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 19.Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Take home medicines (day 1 only) 20.Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients 21.Dexamethasone 20mg on days 2, 8, 9, 15, 16, 22 and 23 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 22.Dexamethasone 20mg on day 1 of the next cycle Take in the morning prior to daratumumab injection Note to pharmacy; dispense for day 1 of the next cycle 23.Lenalidomide 25mg once a day for 21 days from Day 1 to 21 of cycle oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Take at night to avoid daytime drowsiness. To start at 25mg and adjust the dose according to toxicity and patient’s tolerance 24.Allopurinol 300mg once a day for 7 days oral Administration information Take in the morning with food and plenty of water. This should be supplied for the first cycle only. 25.Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 26.Levofloxacin 500mg once a day for 84 days oral Administration Instructions Please supply 12 weeks on cycle 1 only 27.Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice 28.Fluconazole 100mg once a day oral Administration information Prescribe if recurrent oral candidiasis. 29.Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - Esomeprazole 20mg once a day oral - Omeprazole 20mg once a day oral - Lansoprazole 15mg once a day oral - Pantoprazole 20mg once a day oral - Rabeprazole 20mg once a day oral - Cimetidine 400mg twice a day oral - Famotidine 20mg once a day oral - Nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 30.Anthistamine on the days of daratumumab administration Administration Instructions Version 1 (October 2023) Page 14 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Take on the day of daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x OP. This is to cover all cycles. To be supplied as per local formulary choice - Chlorphenamine 4mg Oral - Loratadine 10mg Oral - Cetirizine 10mg Oral - Fexofenadine 120mg Oral - Acrivastine 8mg Oral 31.Paracetamol 1000mg oral on the days of daratumumab administration Administration Instructions Take 1000mg prior to daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x 100 x 500mg. This is to cover all cycles 32.Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - Dalteparin 5000units once a day subcutaneous injection - Enoxaparin 40mg once a day subcutaneous injection - Heparin 5000units twice a day subcutaneous injection - Apixaban 2.5mg twice a day oral (unlicensed use) - Aspirin 75mg once daily (patients with no or one risk factor) Please supply 28 days or nearest original pack size. Cycles 2 days 1, 8, 15, 22 33.Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; - Chlorphenamine 4mg Oral - Loratadine 10mg Oral - Cetirizine 10mg Oral - Fexofenadine 120mg Oral - Acrivastine 8mg Oral 34.Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old. 35.Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 36.Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 37.Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions Version 1 (October 2023) Page 15 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone 38.Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 39.Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 40.Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions. Cycles 2 Take home medicines (day 1 only) 41.Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 42.Dexamethasone 20mg on days 2, 8, 9, 15, 16, 22 and 23 oral Administration Information Reduce dose to 10mg in patients over 75 years old. Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 43.Dexamethasone 20mg on day 1 of the next cycle Take in the morning prior to daratumumab injection. Reduce dose to 10mg in patients over 75 years old. Note to pharmacy; dispense for day 1 of the next cycle. 44.Lenalidomide 25mg once a day for 21 days from Day 1 to 21 of cycle oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Take at night to avoid daytime drowsiness. To start at 25mg and adjust the dose according to toxicity and patient’s tolerance. 45.Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 46.Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 47.Fluconazole 100mg once a day for 28 days oral Administration Instructions 48.Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - Esomeprazole 20mg once a day oral - Omeprazole 20mg once a day oral - Lansoprazole 15mg once a day oral - Pantoprazole 20mg once a day oral - Rabeprazole 20mg once a day oral - Cimetidine 400mg twice a day oral - Famotidine 20mg once a day oral - Nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 49.Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - Dalteparin 5000units once a day subcutaneous injection - Enoxaparin 40mg once a day subcutaneous injection Version 1 (October 2023) Page 16 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone - Heparin 5000units twice a day subcutaneous injection - Apixaban 2.5mg twice a day oral (unlicensed use) - Aspirin 75mg once daily (patients with no or one risk factor) Please supply 28 days or nearest original pack size. Cycles 3 to 6 day 1 and 15 50.Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 51.Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old. 52.Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 53.Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections. Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 54.Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 55.Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 56.Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 57.Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycles 3,4,5 Take home medicines (day 1 only) 58.Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients Version 1 (October 2023) Page 17 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone 59.Dexamethasone 20mg on days 2, 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 60.Dexamethasone 20mg on day 1 of the next cycle Take in the morning prior to daratumumab injection. Reduce dose to 10mg in patients over 75 years old. Note to pharmacy; dispense for day 1 of the next cycle 61.Lenalidomide 25mg once a day for 21 days from Day 1 to 21 of cycle oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Take at night to avoid daytime drowsiness. To start at 25mg and adjust the dose according to toxicity and patient’s tolerance. 62.Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 63.Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 64.Fluconazole 100mg once a day for 28 days oral Administration Instructions 65.Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 66.Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection - Apixaban 2.5mg twice a day oral (unlicensed use) - Aspirin 75mg once daily (patients with no or one risk factor) Please supply 28 days or nearest original pack size. Cycle 6 Take home medicines (day 1 only) 67.Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients 68.Dexamethasone 20mg on days 2, 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Version 1 (October 2023) Page 18 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 69.Dexamethasone 20mg on day 1 of the next cycle Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 70.Lenalidomide 25mg once a day for 21 days from Day 1 to 21 of cycle oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Take at night to avoid daytime drowsiness. To start at 25mg and adjust the dose according to toxicity and patient’s tolerance. 71.Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 72.Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 73.Fluconazole 100mg once a day for 28 days oral Administration Instructions 74.Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 75.Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formulary choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection - Apixaban 2.5mg twice a day oral (unlicensed use) - Aspirin 75mg once daily (patients with no or one risk factor) Please supply 28 days or nearest original pack size. Cycles 7 and further cycles day 1 76.Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Version 1 (October 2023) Page 19 of 22 Myeloma –DRD-Daratumumab-Lenalidomide-Dexamethasone Acrivastine 8mg Oral 77.Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old. 78.Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 79.Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections. Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 80.Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 81.Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 82.Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is
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DVdSC (weekly cycles1-8) Bortezomib-Daratumumab-Dexamethasone Ver1

Description: Chemotherapy Protocol Myeloma DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Regimen • Myeloma – DVd SC (weekly cycles 1-8) bortezomib-daratumumab-dexamethasone Indication • Daratumumab in combination with bortezomib and dexamethasone is recommended for use within the Cancer Drugs Fund as an option for treating relapsed multiple myeloma in people who have had 1 previous treatment. • This weekly bortezomib regimen is for patients who experience neuropathy or those with pre-existing neuropathy. Note both the twice weekly and weekly bortezomib regimens include 32 doses of bortezomib; therefore bortezomib continues to the end of cycle 10 in the weekly regimen. Ensure the correct regimen selected. Toxicity Drug Bortezomib Daratumumab Dexamethasone Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Infusion related reactions, hypotension, headache, rash, urticaria, pruritus, nausea, vomiting, respiratory tract infections (including pneumonia), neutropenia, thrombocytopenia, anaemia, lymphopenia, peripheral neuropathy, diarrhoea, muscle spasms, fatigue, pyrexia and peripheral oedema, blood transfusion related events Weight gain, gastrointestinal disturbances, hyperglycaemia, CNS disturbances, Cushingoid changes, glucose intolerance. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Bloods • FBC, U&Es, Ca2+ and LFTs prior to day one of each cycle of treatment. • Paraprotein and / or light chains prior to each cycle. • All patients should be tested for hepatitis B virus (HBV) before initiating treatment with daratumumab. Those patients who test positive for HBV infection should be discussed with a consultant specialising in HBV prior to initiating treatment with daratumumab to plan monitoring requirements whilst on treatment. Patients may also be tested for hepatitis C, CMV and HIV at the same time if clinically appropriate. Version 1 (Nov 2019) Page 1 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone • Send a blood sample to transfusion and inform patient and transfusion laboratory that patient is due to commence daratumumab. Patient will require red cell phenotyping as cross match fails due to binding of daratumumab to red cells. • Regular monitoring of blood glucose is considered good practice due to dexamethasone use. 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 No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity. Always refer to the responsible consultant, as any dose 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 or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). Consider growth factor support as an alternative to the options below, particularly where there is evidence of bone marrow suppression. To initiate a new cycle of daratumumab, the neutrophil count should be 1x109/L or greater and the platelet count should be 50x109/L or greater, unless the low counts are due to bone marrow infiltration with myeloma. In this situation the daratumumab may be administered at the discretion of the treating consultant haematologist with the appropriate blood product and growth factor support. Neutrophils (x109/L) Less than 0.5x109/L or febrile neutropenia (fever greater than or equal to 38.5°C and neutrophils less than 1) Platelets (x109/L) Daratumumab Less than 50x109/L Dose Modifications (Daratumumab and Bortezomib) Interrupt daratumumab treatment and monitor FBC weekly. Once neutrophils recover to 1x109/L, resume daratumumab Bortezomib - Consider treatment delay or dose reduction or growth factor support. Seek consultant advice. Dose Modifications Interrupt daratumumab treatment and monitor FBC weekly. Once platelets recover to 50x109/L or greater resume daratumumab Bortezomib Less than 25x109/L Consider treatment delay or dose reduction or platelet transfusion. Seek consultant advice. Version 1 (Nov 2019) Page 2 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bortezomib Daratumumab Bilirubin μmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. No formal studies of daratumumab in patients with hepatic impairment have been conducted. Based on population pharmacokinetic analysis no dosage adjustments are necessary for patients with hepatic impairment Renal Impairment Drug Bortezomib Creatinine Clearance (ml/min) greater than 20 Dose (% of original dose) 100% 20 and below Clinical decision Daratumumab No adjustments necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes Bortezomib For patients experiencing NCI-CTC grade 1 neuropathy without loss of function or pain continue with full dose bortezomib. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2. For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. Version 1 (Nov 2019) Page 3 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Dexamethasone For patients who are elderly or unable to tolerate the standard dose of dexamethasone the dose given the day after bortezomib alone (days 8 and 15 from cycle 4 onwards) may be reduced. Please note the doses before and the day after each daratumumab are to reduce the risk of infusion related reactions and as a steroid component of the triple combination. Infusion related reactions (IRR) Daratumumab solution for subcutaneous injection can cause severe and/or serious IRRs, including anaphylactic reactions. In clinical studies, approximately 11% (52/490) of patients experienced an IRR. Most IRRs occurred following the first injection and were Grade 1-2. IRRs occurring with subsequent injections were seen in less than 1% of patients. The median time to onset of IRRs following daratumumab injection was 3.7 hours (range 0.15-83 hours). The majority of IRRs occurred on the day of treatment. Delayed IRRs have occurred in less than 1% of patients. Signs and symptoms of IRRs may include respiratory symptoms, such as nasal congestion, cough, throat irritation, allergic rhinitis, wheezing as well as pyrexia, chest pain, pruritus, chills, vomiting, nausea, and hypotension. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension and tachycardia. Patients should be pre-medicated with antihistamines, antipyretics, and corticosteroids as well as monitored and counselled regarding IRRs, especially during and following the first and second injections. If an anaphylactic reaction or life-threatening (Grade 4) reactions occur, appropriate emergency care should be initiated immediately. Daratumumab therapy should be discontinued immediately and permanently. To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following Daratumumab injection. Patients with a history of chronic obstructive pulmonary disease may require additional post-injection medicinal products to manage respiratory complications. The use of post-injection medicinal products (e.g. short- and longacting bronchodilators and inhaled corticosteroids) should be considered for patients with chronic obstructive pulmonary disease. Interference with Serological Testing Daratumumab binds to CD38 in red blood cells and results in a positive indirect antiglobulin test (Coombs test). Daratumumab mediated positive indirect antiglobulin test may persist for up to six months after the last daratumumab infusion. Daratumumab bound red blood cells masks detection of antibodies to minor antigens in the patients serum. The determination of a patients ABO and Rh blood type are not impacted. Blood transfusion must be informed that a patient is receiving daratumumab. Patients must be typed and screened prior to daratumumab. All patients must be given an identification card that should be carried for six months after stopping therapy and agree to inform all healthcare professionals who treat them that they have received daratumumab. Daratumumab is a human IgG kappa monoclonal antibody detectable on both the serum electrophoresis and immunofixation assays used for the clinical monitoring of endogenous Version 1 (Nov 2019) Page 4 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone M-protein. This interference can impact the determination of complete response and of disease progression in all patients with IgG kappa myeloma. Reactivation of Hepatitis B Virus Hepatitis B virus reactivation has been reported in patients treated with daratumumab. All patients must be screened for hepatitis B before initiation of treatment. This includes all patients with unknown serology who are on treatment already. Monitoring is required for patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment and for at least six months after completion of daratumumab. Those with positive serology must seek medical help immediately if they experience symptoms of hepatitis B. Daratumumab must be stopped if hepatitis B reactivation occurs during treatment. Regimen 21 day cycle If prescribing the DVd regimen the bortezomib is given cycle 1 to 8 only, then continue daratumumab until disease progression. Note that cycle length changes from 21 days to 28 days from cycle 9 onwards hence the need for a separate protocol. Cycles 1 to 3 Drug Bortezomib Dose 1.3mg/m2 Days 1,8,15 Administration Subcutaneous Daratumumab 1800mg 1,8,15 Subcutaneous 20mg Oral Dexamethasone 20mg once a day Dexamethasone 20mg once a day 1, 8, 15 2, 9, 16 Reduce dose to 10mg orally (or iv dose equivalent) in over 75yrs Oral Reduce dose to 10mg in over 75yrs Version 1 (Nov 2019) Page 5 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Cycles 4 to 8 Drug Bortezomib Daratumumab Dose 1.3mg/m2 1800mg Dexamethasone 20mg once a day Dexamethasone 20mg once a day Days 1,8,15 1 1 2, 8, 9, 15, 16 Administration Subcutaneous Subcutaneous Orally Can be given as 20mg intravenous equivalent. Reduce dose to 10mg in over 75yrs Oral Reduce dose to 10mg in over 75yrs Cycles 9 onwards – see separate protocol Dose Information • Bortezomib dose will be dose banded in accordance with the national dose bands (2.5). • Dexamethasone is available as 2mg and 500microgram tablets and 3.3mg in 1ml injection (equivalent to 4mg orally) Administration Information • If the patient experiences no major IRRs after the first three injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued. • Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-injection medicinal products including short and long acting bronchodilators, and inhaled corticosteroids should be considered. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-injection medicinal products may be discontinued at the discretion of the physician. • For first dose a cannula should be inserted to allow emergency treatment of anaphylaxis • First dose daratumumab that the patient should be observed with hourly observations for 4 hours following subcutaneous administration. If no infusion-related reactions following the first dose then neither cannulation nor additional post injection observations are needed with subsequent doses. If IRR with first dose then continue to observe for 4 hours following subsequent doses until IRRs subside. • Inject 15 mL daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the umbilicus over Version 1 (Nov 2019) Page 6 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. • Injection sites should be rotated for successive injections • Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. • Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. • During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as Daratumumab. Additional therapy • Consider allopurinol 300mg once a day for seven days for the first cycle only oral • No anti-emetics are required • Premedication required 1 to 3 hours before every daratumumab infusion: - dexamethasone – see regimen for dose details - chlorphenamine 4mg oral - paracetamol 1000mg oral - montelukast 10mg oral for the first two cycles only • Consider anti-infective prophylaxis including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only - fluconazole 100mg once a day oral if recurrent oral candidiasis • Bisphosphonates in accordance with local policies. • Mouthwashes according to local or national policy on the treatment of mucositis. • Gastric protection with a proton pump inhibitor or an H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. • As required for the treatment of infusion related reactions for patients at high risk of respiratory complications: - salbutamol 2.5mg nebulised - hydrocortisone sodium succinate 100mg intravenous - chlorphenamine 10mg intravenous - paracetamol 1000mg oral - oxygen as required Version 1 (Nov 2019) Page 7 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Additional Information • All instances of infusion related reaction must be recorded on ARIA. • Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. • Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response. References 1. Janssen-Cilag Limited (18 Dec 2018). Darzalex 20mg/ml Summary of Product Characteristics. Electronic Medicines Compendium. Online at https://www.medicines.org.uk/emc/product/7250 , accessed 01 July 2019. 2. National Institute for Health and Care Excellence (2019). Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma. [TA573]. London: National Institute for Health and Care Excellence. 3. Thames Valley Strategic Cancer Network Myeloma Group MM47 DaraVelDex Protocol version 2.0 April 2019. 4. 90 minute daratumumab infusion is safe in multiple myeloma. Leukemia. Hallie Barr et al. Accessed 27/11/18 https://doi.org/10.1038/s41375-018-0120-2. Version 1 (Nov 2019) Page 8 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone REGIMEN SUMMARY Myeloma – DVd SC (Weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Cycle 1 Day 1 1. Warning – Inform blood transfusion Administration Instructions Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response Please inform blood transfusion when a patient is prescribed daratumumab 2. Antihistamine oral Administration Instructions Oral antihistamine according to local formulary choices. To be taken 1 -3 hours prior to daratumumab infusion For example; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 3. Dexamethasone 20mg oral Administration Instructions Can be administered as 20mg intravenous. Reduce dose to 10mg intravenous equivalent or 10mg orally in patients over 75 years old.. 4. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 5. Montelukast 10mg oral 6. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 7. Bortezomib 1.3mg/m2 subcutaneous injection Version 1 (Nov 2019) Page 9 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone 8. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 9. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 10. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 11. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 1 Days 8, 15 12. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; To be taken 1 -3 hours prior to daratumumab infusion Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 13. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 14. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 15. Montelukast 10mg oral 16. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 17. Bortezomib 1.3mg/m2 subcutaneous injection 18. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 19. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions Version 1 (Nov 2019) Page 10 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone 20. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 21. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycles 1 Take home medicines (day 1 only) 22. Dexamethasone 20mg on days 2, 8, 9 and 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 23. Dexamethasone 20mg on day 1 of cycle 2 Take in the morning prior to daratumumab injection Note to pharmacy; dispense for day 1 of cycle 2 24. Allopurinol 300mg once a day for 7 days oral Administration information Take in the morning with food and plenty of water. This should be supplied for the first cycle only. 25. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 26. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 27. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 21 days or the nearest original pack size. 28. Anthistamine on the days of daratumumab administration Administration Instructions Take on the day of daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x OP. This is to cover all cycles. To be supplied as per local formulary choice Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 29. Paracetamol 1000mg oral on the days of daratumumab administration Administration Instructions Take 1000mg prior to daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x 100 x 500mg. This is to cover all cycles Cycles 2 days 1, 8, 15 Version 1 (Nov 2019) Page 11 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone 30. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 31. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 32. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 33. Montelukast 10mg oral 34. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. 35. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 36. Bortezomib 1.3mg/m2 subcutaneous injection 37. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 38. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 39. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 40. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 2 and 3 Take home medicines (day 1 only) 41. Dexamethasone 20mg on days 2, 8, 9, 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 42. Dexamethasone 20mg on day 1 of the next cycle Version 1 (Nov 2019) Page 12 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Administration Information Take in the morning of daratumumab injection Note to pharmacy – please dispense 1 doses of dexamethasone 20mg to be taken on day 1 of the following cycle prior to daratumumab 43. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 44. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 45. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 21 days or the nearest original pack size. Cycle 3 Day 1, 8 and 15 46. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 47. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose. 48. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 49. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. Version 1 (Nov 2019) Page 13 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 50. Bortezomib 1.3mg/m2 subcutaneous injection 51. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 52. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 53. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 54. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 3 Take home medicines (day 1 only) 55. Dexamethasone 20mg on days 2, 8, 9, 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 56. Dexamethasone 20mg on day 1 of the next cycle Administration Information Take in the morning of daratumumab injection Note to pharmacy – please dispense 1 doses of dexamethasone 20mg to be taken on day 1 of the following cycle prior to daratumumab 57. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 58. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 59. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 21 days or the nearest original pack size. Cycles 4 to 8 day 1 60. Warning – Check if Antihistamine Taken Version 1 (Nov 2019) Page 14 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 61. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose 62. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 63. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject the daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available. Injection sites should be rotated for successive injections Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 64. Bortezomib 1.3mg/m2 subcutaneous injection 65. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 66. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 67. Paracetamol 1000mg oral when required for the relief of infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 68. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycles 4 to 8 days 8 and 15 69. Bortezomib 1.3mg/m2 subcutaneous injection Cycles 4 to 8 Take home medicines (day 1 only) 70. Dexamethasone 20mg on days 2, 8, 9, 15 and 16 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle, or individual bottles according to local practice. 71. Dexamethasone 20mg on day 1 of the next cycle Administration Information Version 1 (Nov 2019) Page 15 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone Take in the morning of daratumumab injection Note to pharmacy – please dispense 1 doses of dexamethasone 20mg to be taken on day 1 of the following cycle prior to daratumumab 72. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 73. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 74. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 21 days or the nearest original pack size. Version 1 (Nov 2019) Page 16 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Oct 2020 None Nanda Basker Pharmacist Dr Mathew Jenner 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 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 (Nov 2019) Page 17 of 17 Myeloma –DVd SC (weekly cycles 1-8) Bortezomib-Daratumumab-Dexamethasone
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Myeloma/DVdSC-weekly-cycles1-8-Bortezomib-Daratumumab-Dexamethasone-Ver1.pdf

DVd-T SC Bortezomib-Daratumumab-Dexamethasone-Thalidomide v1

Description: Details of the Chemotherapy Protocol for Myeloma.
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Myeloma/DVd-T-SC-Bortezomib-Daratumumab-Dexamethasone-Thalidomide.pdf

Total knee replacement HHFT - patient information

Description: Welcome to your guide to total knee replacement (TKR) surgery.
Url: /Media/UHS-website-2019/Patientinformation/Muscles,jointsandbones/Total-knee-replacement-HHFT-4037-PIL.pdf

Annual report 2021-2022

Description: 2021/22 Incorporating the quality report University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2021/22 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2022 University Hospital Southampton NHS Foundation Trust Table of contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 36 Directors’ report 37 Remuneration report 59 Staff report 72 Annual governance statement 94 Quality report 105 Statement on quality from the chief executive 106 Priorities for improvement and statements of assurance from the board 109 Other information 182 Annual accounts 210 Statement from the chief financial officer 211 Auditor’s report 212 Auditor’s report including audit certificate 218 Foreword to the accounts 220 Statement of Comprehensive Income 221 Statement of Financial Position 222 Statement of Changes in Taxpayers’ Equity 223 Statement of Cash Flows 224 Notes to the accounts 225 5 Welcome from our chair and chief executive As we emerged from the most severe phase of the COVID-19 pandemic, 2021/22 was another challenging year for everyone at University Hospital Southampton NHS Foundation Trust (UHS). It was also a year on which we can look back with pride at what we achieved together in unprecedented circumstances. Amongst many notable achievements over the past twelve months, we have: • Led on globally ground-breaking research trials to inform the country’s COVID-19 vaccine booster strategy, including the world’s first COVID-19 vaccine booster study of mixed schedules. • Successfully managed infection prevention and control, putting us amongst the best in the country for minimising nosocomial spread. This was against a backdrop of, at times, R-rates in our local community that were amongst the highest in the country. • Published new strategies for digital and sustainability, which respectively set out how we are revolutionising our technical capability to meet changing patient needs and responding to the growing threat posed by climate change as part of the NHS-wide commitment to reaching carbon net zero by 2045. The pandemic also highlighted the vital importance of our staff’s wellbeing so we could continue to meet the needs of the most vulnerable and sick within our community and beyond. In response, we launched and have sustained a comprehensive programme of support to help our staff recognise and address the physical and emotional burden of the last two years. In financial terms, the Trust achieved its forecast breakeven position in 2021/22 on a turnover of £1.15 billion. Our strong, long-term financial performance meant we could continue investing in the capacity and condition of our estate. During the last year we have welcomed patients into our new ophthalmology outpatients area, expanded the majors area of our emergency department, built Hamwic House for treating cancer patients and opened four new operating theatres. Our ambition remains to increase capacity and improve facilities so that we can meet rising demand for our services, treating more people in improved settings than ever before. The momentum we are building is informed and driven by our five-year strategic plan, which describes our collective ambitions on our journey to becoming a world-class organisation. Our successes over the last twelve months were set against a backdrop of exceptional pressure on our services, unlike anything we have seen before. Like most hospital trusts, the lifting of COVID-19 restrictions in the wider community saw significant increases in attendances at our emergency department and increased referrals for treatments including surgery and cancer care. Everyone at UHS is working hard to restore services and bring waiting times down, although there are headwinds impacting our elective recovery. As we write this report, we have more than 200 patients in the hospital who no longer need our care but are waiting for discharge, either to a care home or to their own home with domiciliary care packages. Like many sectors, our local authority partners are struggling to buy or directly provide the capacity that is needed due primarily to workforce shortages. On occasion, the number of patients stranded in our hospitals means we have had to cancel scheduled surgery patients due to a lack of beds. Despite this, we are making good progress on recovering our elective performance, for example the number of elective surgery procedures in May 2022 was over 8% higher than in May 2019, prior to the COVID-19 pandemic. 6 Looking back over the year, our achievements would not have been possible without every single one of our 13,000 staff, who have gone above and beyond to put patients first. As a Trust Board we recognise that our people are our greatest asset. The results of this year’s NHS annual staff survey are encouraging, with the percentage of staff recommending UHS as a place to work being the sixth highest across all NHS trusts in England. However, we know we can do even better and our new people strategy will help us achieve this by introducing programmes which enable our people to thrive, excel and belong in a diverse and inclusive environment. We ended the year by saying farewell to Peter Hollins, who completed his second and final term as chair on 31 March 2022. In the six years of his leadership, the Trust has undergone a huge transformation to the benefit of both patients and staff. Peter has been a trusted and respected colleague whose outstanding leadership has set UHS on course to be a world-class organisation with world-class people delivering worldclass care. We welcome the formation of the Hampshire and Isle of Wight integrated care system on 1 July 2022, which will facilitate increased integration and collaboration across health and social care partners. We look forward to continuing strong relationships with all our partners as we work to develop an NHS of which all the communities we serve can be proud. Jane Bailey Interim Chair June 2022 David French Chief Executive Officer June 2022 7 OVERVIEW AND PERFORMANCE Performance report Introduction from our chief executive 2021/22 is the second year that the ways in which the Trust has worked, and the performance it has achieved, have been strongly influenced the COVID-19 pandemic. Our circumstances varied significantly through the year, however, by March 2022: • COVID-19 related restrictions had been removed across the wider community, but remained necessary within healthcare settings; • a combination of partial immunity and improved treatments had reduced the numbers of patients experiencing the most severe symptoms of COVID-19, but the total numbers of people being infected remained very high; and • the numbers of patients attending, or being referred to, healthcare services for other conditions had returned to pre-pandemic levels or higher. Our challenges and priorities have varied through the year in a similar manner, and have included: • providing sufficient urgent care capacity for patients with COVID-19 alongside those with other illnesses or injuries; • running our services with significantly increased levels of COVID-19 related absence amongst our staff, as infection rates have increased in the wider community; and • increasing the numbers of elective treatments provided, back to pre-pandemic levels and higher, to start to reduce patient waiting times and reverse the increases in waiting list sizes caused by COVID-19. Our performance this year has often been impacted by the adversity of the circumstances. We have not always been able to achieve the targets established prior to the pandemic, nor to deliver the standard of service that we would aspire to for our patients. The Trust is proud to have performed well in comparison to other hospital trusts across many performance measures, however, I would like to thank our patients for their understanding and patience, and all our staff for their resilience, commitment and dedication to care for patients and their colleagues. As we begin to emerge from the pandemic, and consider the year ahead, we look forward to working with patients, hospital colleagues, and partners across health and social care to: • continue the recovery from the impacts of the COVID-19 pandemic; • improve our performance against key measures, continuing to perform well in comparison with other hospitals and moving closer to the national targets; and • continue to adapt and improve services such that the outcomes and results achieved for patients will be better than ever before. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2021/22. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volumes as ranked by the NIHR Clinical Research Network. 12,000 Every year over staff at UHS: treat around 160,000 inpatients and day patients, including about 75,000 emergency admissions see over 650,000 people at outpatient appointments deal with around 150,000 cases in our emergency department deliver more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it offers a safe, ‘home away from home’ environment for women having a healthy pregnancy and expecting a straightforward birth. The NHS patient services provided by the Trust are commissioned and paid for by local clinical commissioning groups (CCGs) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Just under half of the Trust’s NHS patient services are paid for by CCGs and just over half are paid for by NHS England. We provide these under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by Monitor (the independent regulator, now part of NHS England and NHS Improvement) and the healthcare services we provide are regulated by the Care Quality Commission. Being a foundation trust has enabled greater local accountability and greater financial freedom and has supported the delivery of the Trust’s mission and strategy over a number of years. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Public and foundation trust members Council of Governors Board of Directors Executive Directors Division B Division C Division D Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology 11 Trust Headquarters Division Always Improving Central Operations Clinical Outcomes Commercial Development Communications Contracting Corporate Affairs Data and Analytics Education and Workforce Estates, Facilities and Capital Development Finance Health and Safety Human Resources Informatics Medical Examinerss Service Occupational Health Organisational Development Quality Patient Safety Planning and Productivity Procurement and Supply Research and Development Safeguarding Strategy and Partnerships The Trust is also part of an integrated care system in Hampshire and the Isle of Wight, which is a partnership of NHS and local government organisations working together to improve the health and wellbeing of the population across Hampshire and the Isle of Wight. Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to continue on its journey to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these it describes a number of ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the tax payer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2021/22 these objectives included: • Recovery restoration and improvement of clinical services • Introducing a robust and proactive safety culture • Empowering and developing staff to improve services for patients • Implementing the ‘Always Improving’ strategy • Delivering the first year of the research and investment plan • Restoring a full research portfolio and preparing for future growth • Delivering joint research and innovation infrastructure with UoS and Wessex partners • Increasing our people capacity (recruitment, retention, education) • Great place to work including focus on wellbeing • Building an inclusive and compassionate culture • Working in partnership with the integrated care system and primary care networks • Integrated networks and collaboration • Creating a sustainable financial infrastructure • Making our corporate infrastructure (digital, estate) fit for the future to support a leading university teaching hospital in the 21st century • Recognising our responsibility as a major employer in the community of Southampton and our role in delivering a greener NHS. Performance against these objectives will be monitored and reported to the Trust’s board of directors on a quarterly basis. Principal risks to our strategy and objectives The board of directors has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2021/22 were that: • It would have insufficient capacity to respond to emergency demand, reduce waiting lists for planned activity and provide diagnostics results in avoidable harm to patients • It would not be able to provide service users with a safe, high quality experience of care and positive patient outcomes • It would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection • It would not secure the required ongoing investment to support our pioneering research and innovation, driving clinical services of the future 14 • It would not realise the full benefits of being a University teaching hospital through working with regional partners to accelerate research, innovation and adoption; increasing the number of studies initiated and the patients recruited to participate in these studies and the delivery of new treatments and treatments that would not otherwise be available to patients • It would not be able to increase the UHS workforce to meet current and planned service requirements through recruitment to vacancies and maintaining annual staff turnover below 12% and develop a longerterm workforce plan linked to the delivery of the Trust’s corporate strategy • It would not develop a diverse, compassionate and inclusive workforce, providing a more positive staff experience for all staff • It would not create a sustainable and innovative education and development response to meet the current and future workforce needs • It would not implement effective models to deliver integrated and networked care, resulting in suboptimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • It would be unable to deliver a financial breakeven position and support prioritised investment as identified in the Trust’s capital plan within locally available limits (CDEL). • It would not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. • It would fail to introduce and implement new technology and expand the use of existing technology to transform our delivery of care through the funding and delivery of the digital strategy. • It would fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045 While the COVID-19 pandemic presented the Trust with new risks as it introduced more stringent infection control processes, stopped certain types of activity and responded quickly to care for large numbers of seriously ill patients who had tested positive for COVID-19, it also prompted innovation across a wide range of areas. However the ongoing impact of the pandemic on both our staff, patients who have had COVID-19 and patients who have waited longer than expected for treatment as a result, have added to the risks facing the Trust. This risk has continued into 2021/22 and has been coupled with increases in referrals for cancer and increased attendances to our emergency department and non-elective activity. National targets for performance have not been amended as a result of the pandemic, although the national plan has focussed on the recovery of activity levels as the first stage in a restoration of elective services. Capacity – The initial and subsequent waves of the COVID-19 pandemic have led to increases in the waiting times for patients and the number of patients waiting more than 52, 78 and 104 weeks has increased significantly. While there was a significant reduction in the number of patients waiting over 104 weeks in 2021/22, with the Trust expecting that no patients will be waiting more than 104 weeks by July 2022, its ability to reduce the overall waiting list and the length of time patients are waiting for treatment remains one of the key risks for the Trust. This may be compounded by future waves of the COVID-19, a continuation of the sustained demand for urgent non-elective activity and an ongoing number of referrals, often requiring more complex treatment due to delays in people visiting their GPs for the first time and presenting with more advanced disease. The Trust utilised the support available from the independent sector to continue cancer treatment and surgery for those patients at highest risk and continues to make use of independent capacity for cardiac surgery. It also increased the number of outpatient attendances which took place by telephone or video call. The Trust developed a clinical assurance framework during the year to better assess the risk of harm to patients as a result of delays in treatment and this has been utilised in decision-making around the allocation of resources to those areas where there is the greatest risk of potential harm to patients. In addition to opening additional capacity during 2021/22 (described in the Estates section below), the Trust also committed expenditure in 2021/22 to open further wards and operating theatres during 2022/23 and 2023/24. These initiatives will contribute to further improvements in elective waiting times in coming years. 15 Quality and compliance – The Trust continued to monitor the quality of care delivered throughout 2021/22. During the COVID-19 pandemic the primary focus became infection prevention and control, with the launch of an award-winning COVID ZERO campaign that saw the Trust reduce the transmission of the virus in hospital (nosocomial transmission). While the Trust continued to perform well overall, the Trust exceeded its annual threshold for Clostridium difficile infections and there was one MRSA bacteraemia during March 2022, the only such event in 2021/22. The Trust continued to develop its proactive patient safety culture during 2021/22 with changes to the way in which patient safety incidents are investigated and the launch of its Always Improving strategy and transformation initiatives in theatre efficiency, patient flow and outpatients. Reporting and investigation of incidents continued during 2021/22. The Trust continues to prepare for the implementation of the new patient safety incident response framework in June 2022/23. Partnerships – During 2021/22, the Trust and its partners continued to work together to discharge patients safely, to ensure patients requiring urgent cancer treatment and surgery were able to continue their treatment in the independent sector and to develop the regional COVID-19 saliva testing programme for local schools, hospitals and other employers. The new arrangements for integrated care systems will be implemented in July 2022. This is expected to reinvigorate work with partners at a system, place and provider level in Hampshire and Isle of Wight. The Trust is already part of an acute provider collaborative with other acute trusts in Hampshire and the Isle of Wight and is progressing a number of projects including the development of an elective hub at Winchester Hospital, diagnostics, pathology, endoscopy and imaging networks. The Trust also continued to progress research activity and opportunities with the University of Southampton and Wessex health partners. Workforce – The Trust continued to recruit nurses from overseas and through targeted recruitment campaigns during 2021/22 meaning that the number of nursing vacancies has remained relatively stable. Vacancies in other areas have increased reflecting a more competitive job market, particularly for lower band roles. The Trust also continued to work with its staff networks and specific focus groups to increase diversity in leadership roles. Staff turnover remained above the 12% target during 2021/22 and retention is a key element of the people strategy. While workforce capacity continues to be one of the biggest challenges faced by the Trust, during 2021/22 we have also focused on supporting our staff to respond to the COVID-19 pandemic and operational pressures by providing both the tools and time to help staff recovery. We are incredibly proud of the way that staff responded to the pandemic and continue to recognise this in whatever ways we can, however, we also want to ensure that staff continue to be able to contribute to patient care at their best and want to stay and develop with the Trust. Technology was also used at levels not previously achieved to continue to deliver training to staff and enable staff to work from home where possible, ensuring a safer environment for patients and staff in the hospitals. Estate – The Trust continued to invest in and develop its estate during 2021/22 including opening a new ophthalmology outpatient area, expansion of the majors area of the emergency department and four new operating theatres. These were part of £65 million of capital expenditure in 2021/22 that also included equipment, digital and the backlog maintenance programme. Innovation and technology – There have been exceptional levels of achievement in relation to COVID-19 related research activity, including in partnership with the universities. You can read more about these in part three of the quality account. The board of directors has also supported the funding of an expansion of research and innovation activity to allow the continued delivery of the Trust’s ambitions to innovate and improve and transform its services. 16 The Trust and its partners also been successful in securing external funding including one of only four successful NHSX awards to test the concept of federated trusted research environments with its Wessex health partners and core funding of £10.5 million for the National Institute for Health and Care Research (NIHR) Southampton Clinical Research Facility (CRF) for the period between September 2022 and August 2027. Sustainable financial model –The Trust achieved its forecast breakeven position in 2021/22. Income was more predictable in 2021/22 as block contract arrangements remained in place in response to the COVID-19 pandemic and ensured that costs were covered, however, funding from the elective recovery fund, particularly, in the first half of 2021/22 introduced a degree of income volatility as did changes to the framework for the elective recovery fund half way through the year. The Trust continues to maintain a strong cash position and to implement improvements and efficiency savings, allowing it to continue to invest in its services. The financial outlook across the NHS looks extremely challenging going into 2022/23 due to the reductions in non-recurrent funding and efficiency targets. The Trust currently has an underlying deficit, with pressures on energy prices and drugs cost growth within block contract arrangements, which had been supported with non-recurrent funding in previous years. While specific funding has been provided to address inflationary pressures there is a risk that inflation could exceed this funding and raw material and supply shortages could also impact on costs. Performance overview The Trust monitors a very wide range of key performance indicators within its departments, divisions, directorates and executive committee. Assurance for our board of directors and executive committee includes an integrated performance report which is reviewed monthly and contains a variety of indicators intended to provide assurance regarding implementation of our strategy and that the care we provide is safe, caring, effective, responsive and wellled. The integrated performance report also includes a monthly ‘spotlight’ section, to enable more detailed consideration of any topics that are of particular interest or concern. The selection of topics is informed by a rolling schedule, any performance concerns and requests from the board of directors. Assurance for our council of governors includes a quarterly Chief executive’s performance report, which includes a range of non-financial and financial performance information. 17 Performance analysis COVID-19 Impacts In 2021/22, the most prominent impacts of COVID-19 have been in relation to occupancy of inpatient beds by patients with a COVID-19 diagnosis and increased levels of staff sickness absence associated with COVID-19, in addition to normal levels of absence due to other causes. The impact of COVID-19 has varied significantly through the year, linked primarily to the prevalence of the disease within the wider community. In comparison to 2020/21: • bed occupancy (all types) did not reach the same exceptional peaks, however, it exceeded 50 patients between August 2021 and March 2022 and reached an average of 83 in March 2022; • the number of patients requiring treatment in intensive care and high care were much reduced, though still significant; • fewer patients were admitted requiring hospital treatment for COVID-19 alone, and greater numbers were admitted requiring treatment for other medical conditions who were also infected with COVID-19 at the same time; • staff sickness absence levels were typically higher, particularly in the second half of the year when national restrictions had been removed and COVID-19 infections in the community increased – the sickness absence rate (from all causes) peaked at 6% in March 2022 All bed types Intensive care/higher care beds 18 Staff sickness absence Emergency access through our emergency department Following a reduction during the first year of the pandemic, the numbers of patients who presented to receive care at our emergency department increased exponentially in 2021/22. Attendance levels exceeded the higher levels seen prior to the pandemic by approximately 10%. All patients presenting to the emergency department This exceptional increase in the clinical demand upon our department has had a significant adverse impact upon the timeliness of care, particularly for those patients who have a less urgent condition. The department has also continued to deliver services separately for those patients who have respiratory symptoms and those who do not, and to implement additional infection control measures. Emergency access performance is measured as the percentage of patients discharged from emergency department care or admitted to a hospital bed within four hours of arrival to the department. The national target of 95% was not achieved and the Trust experienced a large deterioration in our own performance to 64% (main ED/Type 1 attendances) by March 2022. Our performance compared favourably with other acute trusts in England despite this, however. 19 Emergency access four hour performance The number and duration of any ambulance handover delays are another important performance indicator. Ensuring that ambulance staff can ‘hand over’ the patients they convey to our emergency department without delay is important because this releases the staff and their vehicle to meet the needs of other medical emergencies in the community. We are very proud to have an exceptionally good record in this regard, working with colleagues in ambulance services to transfer arriving patients into our emergency department and the care of our staff even when the hospital is already fully occupied. 20 Elective Waiting times Demand 2021/22 has seen a continuation of the trend of increasing elective referrals, following a major reduction which occurred at the start of the COVID-19 pandemic. Referral rates to our services are now typically at, or above, the levels seen before the pandemic. Feedback from clinicians is that they are also seeing more patients with advanced disease than they would normally, because of delays in referral to the service/diagnosis. Accepted referrals The number of patients referred to hospital with suspected cancer increased exceptionally during 2021/22; the number of patients seen for a first consultant-led appointment was 27% higher than in 2020/21 and 18% higher than in 2019/20. Performance remained below the national target of 93% throughout the year, with a deterioration to 74% in December 2021 prior to a recovery to 90% in March 2022. Our performance also declined in comparison with other acute trusts in England. Most of the patients who waited longer than two weeks for their first appointment were within our breast service, which sees a very large number of referrals for suspected cancer and experienced a 22% increase in the number of patients seen compared to 2019/20. Additional consultants who specialise in breast cancer have now been recruited and performance in this service returned to target in April 2022. 21 Performance following ‘Two week wait’ urgent referral for suspected cancer 22 Activity The number of UHS hospital appointments, diagnostic tests and elective admissions all increased significantly during 2021/22. The number of appointments undertaken, and diagnostic tests performed, exceeded activity levels in both 2019/20 and 2020/21. The number of elective and day case admissions increased significantly compared to 2020/21 (the first year of the pandemic) yet remained approximately 10% below the levels achieved between April 2019 and February 2020 (prior to COVID-19). There were a wide range of factors influencing these activity levels, and the lower levels of admitted activity specifically, including: • the availability of beds for the admission of elective patients after emergency patients with COVID-19 and other conditions had been accommodated; • the availability of staff to deliver elective care, during periods of increased COVID-19 bed occupancy, and during periods of increased staff absence related to COVID-19; • additional infection prevention measures which were maintained, particularly within inpatient treatment settings where risks of COVID-19 transmission are otherwise increased. Most of the activity has been delivered within NHS hospitals in 2021/22 (local independent sector hospitals were used to replace NHS elective capacity in 2020/21), and we have recruited additional staff and invested in an additional ward, theatres and outpatient rooms in order to be able increase our treatment activity. The graphs below show 2021/22 activity levels as a percentage of those achieved prior to the COVID-19 pandemic. Elective admissions (including day case) 23 Outpatient attendances Diagnostics Our performance measures for diagnostics report on a total of 15 different frequently used tests. At the end of March 2022, 20% of patients were waiting more than six weeks to receive their investigation. This is a significant improvement compared to 28% of patients waiting more than six weeks at the end of March 2021, yet still significantly worse than the national target (1%) and UHS performance prior to pandemic. At the end of March 2022, the total waiting list size (including patients waiting less than six weeks) had increased by 14% compared to March 2021 and was 34% larger than before the pandemic. These trends reflect a combination of large reductions in diagnostic activity in the first year of the pandemic, followed by record levels of diagnostic tests being performed during 2021/22 (7% higher than before the pandemic) combined with very high levels of referrals for diagnostic testing over the same period. 24 The tests with largest numbers of longer waiting patients are non-obstetric ultrasound, peripheral neurophysiology, MRI and CT. Initiatives to improve performance include the recruitment of additional staff in the relevant professions and investment in additional equipment, in the context of NHS forecasts that diagnostic demand will continue to increase over the longer term. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) Percentage of patients waiting over 6 weeks for a diagnostic test to be performed 25 Referral to Treatment Our waiting list from referral to treatment increased in size by 27% (9,768 patients) during 2021/22 and is now 36% larger than before the pandemic. Both referrals and hospital activity declined steeply at the start of the pandemic, but referral levels increased more quickly than hospital activity following this. The rate at which the waiting list is increasing has however reduced in the most recent six months. Number of patients waiting between referral and commencement of a treatment for their condition The national target is that at least 92% of patients should be waiting for treatment no more than 18 weeks from their referral to hospital. Our performance has deteriorated from 80% immediately before the pandemic, to 68% at the end of March 2022. Our performance continues to be typical of the major teaching hospital trusts that we benchmark with, and the trend has been similar to that experienced across trusts in England. Percentage of patients waiting up to 18 weeks between referral and treatment 26 The fact that some patients wait significantly longer than the 18 week target is a particular concern. In 2020/21 NHS England targeted the stabilisation of the numbers of patients waiting more than 52 weeks and the elimination of waiting times more than 104 weeks (except when patients choose to wait longer). The percentage of patients waiting more than 52 weeks at UHS reduced from 9% to 4%. The number of patients waiting more than 104 weeks reduced, from a maximum of 171, to 59 at the end of March 2022 (of whom only five were wishing to proceed with treatment at that time). The patients who typically wait longest for treatment continue to be those who require admission for surgical procedures in specialities such as ear nose and throat, orthopaedics and oral surgery. The Trust opened four additional operating theatres during 2020/21 and is working in collaboration with partners in the Hampshire and Isle of Wight integrated care system to implement further elective recovery plans. Percentage of patients waiting more than 52 weeks, between referral and commencement of a treatment for their condition 27 Cancer Waiting Times The timeliness of urgent services for patients with suspected cancer has unfortunately declined during 2021/22. The Trust continues to perform well in comparison with the teaching hospitals that we benchmark with and deliver a similar range of services, however. We have faced a range of challenges including: • a large increase in the number of new patients referred for investigation; • delays in the onward referral (for specialist investigation or treatment) of patients from other trusts which have also experienced increases in referrals; • the need to provide capacity to investigate and treat the full range of other conditions, alongside those patients with suspected cancer; and • an increase in the complexity of treatment required by new and existing patients, potentially because of delays in referral or treatment during the first year of the pandemic The national target is to provide the first definitive treatment to at least 85% of patients with cancer with 62 days of referral to hospital. UHS exceeded this level of performance in April 2021 but has not done so since then, performance deteriorated to 66% in January 2022 before recovering somewhat to 72% by March 2022. Treatment for Cancer within 62 days of an urgent GP referral to hospital The national target is to provide the first definitive treatment to at least 96% of patients within 31 days of a decision to treat being made and agreed with the patients. Trust performance has been very variable in 2021/22, ranging from 89% to 98% in individual months. Likewise, performance has ranged from below average in some months, to amongst the best in the group of teaching hospitals that we benchmark with. 28 First definitive treatment for cancer within 31 days of a decision to treat A range of initiatives are being pursued to maintain and improve the timeliness of our cancer services including: • changes to some of the processes for the referral and initial assessment of patients with suspected cancer, for example the inclusion of high quality photographs within referrals for suspected skin cancer; • projects to refine processes and procedures for the investigation of suspected gynaecological and urological cancers; • an operating services improvement programme designed to improve the flow of patients, and the numbers of patients treated, through our existing theatre facilities; and • staffing level increases and recruitment to clinical roles in specialities where the increases in demand require this. Quality priorities The Trust set four quality priorities in 2021/22, which were aimed at ensuring we continued to deliver the highest quality of care. The quality priorities were shaped by a range of national and regional factors as well as local and Trust‐wide considerations. We recognised the overriding issues of significant operational pressures being felt right across the health and social care system, including those associated with the second year of the COVID-19 pandemic, by limiting the number of priorities to four. We also acknowledged the risk that the delivery of our priorities could be disrupted by the ongoing pandemic and that we needed to be flexible in adapting the priorities to changing circumstances. The Trust set the following four priorities: 1. Introduction of midwifery continuity of carer for women at risk of complications in pregnancy. 2. To support staff wellbeing and recovery. 3. Managing risks to patients delayed for treatment and restoring elective programmes. 4. Reducing healthcare associated infection (HCAI) 29 The Trust achieved three of the quality priorities and partially achieved one priority. In relation to midwifery continuity of carer, the Trust’s performance exceeded the ambition that had been set by NHS England in 2020/21 following its national review of maternity services in 2015 as shown below. NHS England ambition set in 2020/21 35% of women will be booked to receive care in a continuity of carer team 35% of black and minority ethnic women booked to receive care in a continuity of carer team 35% of women living in an IMD-1 area (most deprived areas measured using indices of deprivation) Percentage achieved 41.7% 75% 80% The Trust continued to introduce programmes, interventions and wider support offerings to promote staff wellbeing and recovery in 2021/22. Our 2021/22 annual NHS staff survey results are positive with our scores relating to wellbeing above the benchmark average. Contributing factors to wellbeing such as staff engagement, morale, staff experience in areas such as kindness and respect, feeling valued and trusted to do their job were all above the benchmark average. More information about staff health and wellbeing is included in the staff report below. The Trust only partially achieved the priority relating to managing the risks to patients delayed for treatment and restoring elective programmes. The Trust’s performance against elective waiting time standards are described in more detail above. While the Trust focused on prioritising all patients waiting for surgery to ensure we continued to treat people based on need and urgency, we continue to recognise the impact of delays on people’s quality of life and, at times, outcomes. COVID-19 remained a key area of focus for the Trust in 2021/22 in terms of infection prevention. The Trust implemented a number of awareness campaigns, including its award-winning COVID ZERO campaign, and strategies to reduce in-hospital transmission of COVID-19 and kept these under review throughout the year. The chart below shows the trend of hospital-onset cases of COVID-19, which has broadly followed local and national prevalence of the virus, and the Trust’s performance compared very favourably with its local and national peers. 30 The table below provides an overview of the Trust’s performance against national and other infection prevention standards and limits to minimise infections, the majority of which have been achieved by the Trust. Category National Objectives: MRSA bacteraemia Clostridium difficile infection E coli Bacteraemia End of year RAG Action /Comment R One MRSA bloodstream infection attributable to UHS 2021/22 in March 2022. R 74 cases against a threshold of 64 for the year. G 138 cases in 2021/22 against a threshold of 151. Klebsiella Bacteraemia A 64 cases in 2021/22 against a threshold of 64. Pseudomonas Bacteraemia MSSA G 30 cases in 2021/22 against a threshold of 34. 43 cases in 2021/22 after 48 hours in hospital. Other: Hospital onset, healthcare associated COVID-19 103 hospital-onset probable healthcareassociated cases in 2021/22. 125 hospital onset definite healthcare associated cases in 2021/22. Prudent antibiotic Antimicrobial prescribing Stewardship G The standard contract requirement for reduction in antibiotic usage for 2021/22 was waived, as in 2020/21. Had it been applied as anticipated, the Trust would very likely have met this. Provide Assurance of Infection G The annual infection prevention audit assurance of Prevention Practice programme was reinstated in April 2021 for basic infection Standards the monitoring and assurance of infection prevention prevention and control practices but practice: subsequently suspended in September 2021. You can find more information about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2022/23, in the Trust’s quality account for 2021/22, incorporated in the Trust’s annual report and accounts. 31 Financial performance The Trust delivered a surplus of £0.048 million from a revenue position of over £1.2 billion, once items deemed as “below the line” by NHS England and NHS Improvement, su
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/Annual-report-2021-2022.pdf

Having a total hip replacement - patient information

Description: This leaflet contains important information about having a total hip replacement.
Url: /Media/UHS-website-2019/Patientinformation/Muscles,jointsandbones/Having-a-total-hip-replacement-4038-PIL.pdf

Papers Sept 2020 held in closed session due to Covid-19

Description: Date Time Location Chair Agenda - Trust Board Meeting 29/09/2020 9:00 - 16:00 Microsoft Teams Peter Hollins 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 To note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. Minutes of Previous Closed Meeting held on 27 August 2020 (Not for publication) Matters Arising and Summary of Agreed Actions (Not for publication) OPEN ITEMS (For publication) 2 QUALITY, PERFORMANCE and FINANCE 2.1 Patient Story To receive feedback from patients, carers, or other stakeholders about their experience of the Trust's services. 2.2 Briefing from Chair of Charitable Funds Committee for review (Oral) 9:15 Dave Bennett, Chair 2.3 Briefing from Chair of Finance & Investment Committee for review (Oral) 9:20 Jane Bailey, Chair 2.4 Briefing from Chair of People & OD Committee for review (Oral) 9:25 Jenni Douglas-Todd, Chair 2.5 Integrated Performance Report for Month 5 for assurance 9:30 To review the Trust's performance as reported in the Integrated Performance Report Sponsor: Paula Head, Chief Executive 2.5.1 10:15 Access Targets: Cancer Trajectory Update for review Sponsor: Joe Teape, Chief Operating Officer 2.5.2 10:25 ED Performance & Recovery Plan Update for review Sponsor: Joe Teape, Chief Operating Officer 2.6 Violence and Aggression Progression Report for review 10:40 Sponsor: Joe Teape, Chief Operating Officer Attendee: Sandra Hodgkyns, Head of Security/Emergency Planning (LSMS) 2.7 Workforce Race Equality Standard (WRES) and Workforce Disability 10:50 Equality Standard (WDES) Annual Reports 2019/20 for review and Action Plans 2020/21 for review Sponsor: Steve Harris, Chief People Officer Attendee: Gemma Genco, Head of Equality, Diversity and Inclusivity 2.8 Black, Asian and Minority Ethnic (BAME) Experience Improvement Plan 11:05 for approval Sponsor: Steve Harris, Chief People Officer Attendees: Gemma Genco, Head of Equality, Diversity and Inclusivity/ John Norton, Chair, BAME One Voice Network 2.9 Finance Report for Month 5 for review 11:20 Sponsor: David French, Chief Financial Officer 3 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 3.1 Feedback from Council of Governors' meeting 1 September 2020 (Oral) 11:35 Sponsor: Peter Hollins, Trust Chair 3.2 Register of Seals, and Chair's Actions for ratification 11:45 In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Peter Hollins, Trust Chair 4 Follow-up Discussion with Governors 11:50 5 To note the date of the next meeting: 29 October 2020 in the Conference Room, Heartbeat/Microsoft Teams (Closed meeting only) 6 Items Circulated to the Board for reading 6.1 CRN: Wessex 2020/21 Quarter 1 Performance Report Sponsor: Derek Sandeman, Chief Medical Officer Page 2 2.5 Integrated Performance Report for Month 5 for assurance 1 Integrated Performance Report 2020-21 Month 5 Report to the Trust Board of Directors dated Tuesday 29 September 2020 Title: Agenda item: Sponsor: Date: Purpose Issue to be addressed: Integrated Performance Report 2020/21 Month 5 2.5 Chief Executive 22 September 2020 Assurance Approval or reassurance Y Ratification Information This report is intended to support the Trust Board in assuring that: • the care we provide is safe, caring, effective, responsive and well led in the context of the Covid 19 pandemic • at the same time we continue our journey toward our vision of World Class Care for Everyone. Response to the issue: For the year 2020/21 the Integrated Performance Report has adapted to reflect the current operating environment. In particular we have aligned it with the Care Quality Commission Key Lines of Enquiry and then cut it again to reflect delivery of our Strategic Goals and annual corporate objectives. Implications: This report covers a broad range of trust services and activities. It is (Clinical, Organisational, intended to assist the Board in assuring that the Trust meets regulatory Governance, Legal?) requirements and corporate objectives. Risks: (Top 3) of carrying This report is provided for the purpose of assurance. out the change / or not: Summary: Conclusion This report is provided for the purpose of assurance. and/or recommendation Page 1 of 24 Integrated KPI Board Report covering up to Aug 2020 Sponsor - Andrew Asquith, Director of Financial and Productivity Improvement, andrew.asquith@uhs.nhs.uk Page 2 of 24 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 Page 3 of 24 Report to Trust Board in September 2020 Introduction The Trust Integrated Performance Report is presented to the Trust Board each month. For the year 2020/21 the Integrated Performance Report has adapted to reflect the current operating environment. In particular we have aligned it with the Care Quality Commission Key Lines of Enquiry and then cut it again to reflect delivery of our Strategic Goals and annual corporate objectives in order to: • Demonstrate that we can assure ourselves that the care we provide is safe, caring, effective, responsive and well led in the context of the Covid 19 pandemic • Ensure that at the same time we continue our journey toward our vision of World Class Care for Everyone. We might adjust/ or add to these indicators – informing the Board and keeping a comparative narrative – if the situation changes as we work through these unusual circumstances. An example of this might be measuring vulnerable groups as the evidence around COVID emerges. The monthly Trust Integrated Performance Report is currently complemented by a ‘Covid-19 Balanced Scorecard’ which is considered by the UHS Integrated Assurance Group, and also available to Board Members, on alternate weeks. August 2020 Summary During August the direct impact of Covid 19 infections upon the Trust continued to reduce. The number of beds occupied by patients with Covid 19 remained in low single figures and at times there were 0 Covid 19 inpatients. Over a 2 week period we tested 0 positive staff or patients. Covid 19 in the local community also remained low, with infection rates estimated at 4-7 per 100,000. Non-elective admission volumes in total remained at approximately 90% of their normal levels. Elective spells increased to approximately 72% of their normal levels. Elective activity continued to be adversely affected by the need to socially distance, particularly in outpatients, infection control guidance (which was relaxed for some cases in the middle of August) and the inability to fill theatre lists when patients cancelled at the last minute because of the need to isolate for 14 days. The trust has sought to prioritise the reduced elective capacity available towards those patients requiring assessment or treatment more urgently, and to provide assessments by telephone or video whenever appropriate. The trust started to develop detailed speciality specific recovery plans in August, in line with the Wave 3 letter, as well as each service 3 Page 4 of 24 Report to Trust Board in September 2020 RESPONSIVE • Emergency Department timeliness deteriorated in August, reaching 85.9% across the month (RE 10). Other Trusts have also seen similar deterioration, though UHS had the fourth best performance out of 8 ‘peer’ Major Trauma Centres (RE9). Attendance numbers increased to approximately 85% of the normal level (RE 8), whilst enhanced infection control precautions remained in place. • The percentage of patients waiting up to 18 weeks from referral to treatment improved marginally to 55% (RE 14). The total number of patients waiting is now above pre-Covid levels, at 34,900 patients (RE 15), and is expected to increase further, due to the recovery in the number of referrals being made to hospital (RE 12). The percentage of patients waiting more than 6 weeks for a diagnostic test (RE 20) improved from 35% to 40%, though the total number of patients waiting continued to increase and is now above pre-Covid levels (RE 19). The average waiting time for new outpatient appointments further reduced in August and is now at 8.8 weeks (RE 18). • Cancer performance measures for July indicate that UHS 62 day performance (RE 21) improved and is now the best amongst our 10 ‘peer’ teaching hospitals, and that 31 day performance (RE 22) further improved to 98.2% and achieved the national standard. The number of patients still waiting with pathways greater than 104 days (RE 23) reduced from 36 to 17. There remain challenges particularly in the head and neck tumour site. 4 Page 5 of 24 Report to Trust Board in September 2020 RESPONSIVE Jun Jul Aug Sep Oct Nov Dec Jan 6,800 6,533 RE1 Non-elective Spells (including CDU) Feb Mar Apr May Jun Jul Aug Monthly Target 6,058 - 4,000 7.5 RE2-L Non Elective LOS Rolling 12 months 6.42 6.0 250 RE3 Number of patients medically optimised for discharge Longer LOS Census average RE4-N (Patients with LOS > =21days) 0 211 227.34 180.19 133.04 - 6.10 123 - 137 - RE5-l Adult midday bed occupancy 95.2% 72.4% 90-95% RE6 Last minute cancelled operations not readmitted within 28 days 3 150 78 RE7 Hospital initiated cancelled ops 91% 80.3% 81% 85.04% 90.7% 71% 766545365325334 Patients spending less than 4hrs in ED RE10-N UHS Total (includes SGH all types and lymington until Jul 19) 91.51% 83.3% 75.05% 82.2% 85.9% 91.27% Q Target - 95% 95% RE11-N Total time spent in ED Total Percentiles UHS Mean, 3:16 50th, 3:06 90th, 4:07 Mean, 2:50 - - 50th, 2:47 RE12 Accepted Referrals 25000 22249 14883 - - RE13 Elective spells 0 2,000 0 1,453 1,191 - - 6 Page 7 of 24 Report to Trust Board in September 2020 RESPONSIVE RE14-N % Patients on an open 18 week pathway (within 18 weeks ) Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug 83% 84.0% 78% 72% 54.75% Target > =92% 35000 Total number of patients on a waiting RE15-N list (18 week referral to treatment pathway) RE16 Face to face outpatient attendances 28000 50,000 52,480 33746 34903 24,043 - RE17 Non-face to face outpatient attendances 0 50,000 7,948 0 RE17 - Latest month is awaiting approx ~3k outpatient attendances to be reported 12,900 - RE18 Average weeks waited for first outpatient appointment 9,000 RE19 Patients waiting for diagnostics 4,000 RE20-N % of Patients waiting over 6 weeks for diagnostics 19% 121%% 7.5 7004 2.8% 8.8 - 8794 - 39.61% RE22-N 31 day cancer wait performance (latest data held by UHS) no.patients Target to recover QTD Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul /July 1 94.5% 78.4% N=> N = 12 90% L=> L= 17 of 84% 76.5% 72.6% 95% 111.5 36578645655121 0.5 96.2% 92.4% 88.5% 98.22% N=> 96% N=0 of 805 0.9665821 RE23 Snapshot of waits > 104 days (from referral on a 62 day pathway) 33 38 41 55 52 41 29 35 27 29 11 25 36 17 - - 100% RE24-N 28 Day Faster Diagnosis 70% 10,000 RE25 My Medical Record - UHS patient logins 5,000 0 2500 RE26 Number of Estates Help desk requests and percentage completed on time 900 100% 85% 75% 4,634 1620 81.0% 85% => 75 % - 7,132 - 1516 - 89.6% > 85% 50% 79.80% 89.0% 8 Page 9 of 24 Report to Trust Board in September 2020 RESPONSIVE 50% Monthly Target Target QTD /July - Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Elective inpatient activity - % of same time last year 60.00% 50.19% RE27 UHS Corporate peer average ------------------------------Rank--> 48.32% 000000000047330 0.00% Non-elective inpatient activity - % of same time last year RE28 UHS 110.00% 108.41% 100.61% Corporate peer average ------------------------------Rank--> 000000000046650 0.00% 1st outpatient attendances - % of same time last year 100.00% 96.80% RE29 UHS Corporate peer average ------------------------------Rank--> 70.70% 000000000065570 0.00% 9 Page 10 of 24 Report to Trust Board in September 2020 SAFE • The majority of measures indicate that safety has been maintained during August. • New Covid-19 diagnoses amongst hospital inpatients (SA5, SA6) have reduced significantly, and there were no cases of ‘probable’ transmission or ‘healthcare-acquired’ Covid-19 in UHS inpatient services in August. The Covid 0 campaign continued to be rolled out, focusing on the absolute importance of stopping nosocomial COVID infection. The campaign encourages all people to follow government guidance when walking apart, wear a mask where you can’t, and continue to wash your hands as often as possible. • Statutory and mandatory training compliance further reduced in August. • Both clinical and Serco cleaning scores showed an improvement in August; with both meeting 100. • As expected CHPPD for all areas this month is still elevated at 11.0 (RN 6.7, HCA 4.3) with ward only areas also elevated at 9.4 (RN 5.0, HCA 4.4). This is reflective of new ward configurations, roster changes, additional staff deployments and reduced patient numbers in some areas. • In UHS ward-based areas, the data shows that total nursing staff vacancies have increased to 9.63%. Registered nurse vacancies in ward-based areas have decreased this month to 15.52%. This position is being continuously validated as data, sourced from rosters, has been affected by the significant ward changes in size and specialty focus that have occurred as a result of the COVID-19 restart plan. Annual ward staffing reviews are currently taking place to confirm required levels against the changed configurations. Monthly Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Target YTD YTD Target SA1-N Cumulative Clostridium difficile 2 SA2 MRSA bacterium 0 100 SA3 Clinical cleaning scores for very high risk areas 99 95 SA4 Serco cleaning scores for very high risk areas 100 99 95 27 5 32 32 0 0 100 98 - 14days after admission 00 0 0 0 0 0 0 0 0 20 30 14 1 0 0 Probable hospital-associated 50 SA6 COVID infection: COVID-positive sample taken > 7 days and 95% - 96.3% YTD Target - - > 95% 12 Page 13 of 24 Report to Trust Board in September 2020 CARING • The majority of measures indicate that UHS has continued to provide caring services during August. • Friends and family negative scores remained below target, at 3.7% (CA1), although maternity saw an increase for the second month, rising to 8.3% (CA2). • Complaints per 1,000 units remained significantly below the target, at 0.27 (CA4). The number of complaints closed on time continues to make a slow recovery following the pausing of complaints investigation at the height of Covid 19. In August the Trust achieved 46%, compared to 41% in July (CA5) • The percentage of women receiving ‘Continuity of Care’ within the Maternity service remained static at 11% and remains well below the target of 35%. A plan has been developed to drive improvements in this aspect of care. • The number of non-clinically justified overnight ward moves rose slightly in August, to 68 (CA9). An action plan is being developed to reduce these. Monthly Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Target 0.6% CA1-N FFT Negative Score - Inpatients 5% =35% 1.30 CA4-L Complaints per 1000 units 0.00 CA5-L % Complaints closed within 35 days 80% 0% 0.38 81% Page 14 of 24 =70% 13 Report to Trust Board in September 2020 0% Jun Jul Aug Sep 100% % Patients reporting being CA6 involved in decisions about care and treatment 50% 100% % Patients reporting finding CA7 somebody to talk to about worries and fears 50% 100% % Patients with a CA8 disability/additional needs reporting those needs/adjustments were met 50% CA9 Overnight ward moves with a reason marked as non-clinical Jun Jul Aug Sep 135.76 99 76.96 18.16 18.0 Total nursing staff all inpatient CA10 areas - Care hours per patient day13.0 (CHPPD) 8.0 40.0 Same Sex Accommodation CA11 (Non Clinically Justified Breaches) 20.0 2 0.0 9.0 11 4 4 CARING Oct Nov Dec Jan Feb Mar Apr May Jun Oct Nov Dec Jan Feb Mar Apr May Jun 32 12 1 1 0 15 0 0 0 Monthly Target Jul Aug 84% > =90% 91% > =90% 94% > =90% Monthly Jul Aug Target 68 - 11.0 - - 0 0 14 Page 15 of 24 Report to Trust Board in September 2020 EFFECTIVE • The number of patients screened for alcohol and smoking continued to significantly exceed the 80% target, at 97% (EF5) • The number of patients found to have either a moderate or high dependence on alcohol (EF6), or to smoke (EF7) who were given advice or an onward referral continued to exceed the targets, at 80% and 94% respectively. EF1-L Cumulative Specialities with Outcome Measures Developed Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug 47 52 52 53 54 223 234 250 255 260 Monthly Target +1 100% EF2 Developed Outcomes RAG ratings 75% 78% 77% 79% 80% 81% 50% 100 EF3-N HSMR - UHS HSMR - SGH 81 75 4.5% EF4 HSMR - Crude Mortality Rate 2.9% 80% 15 Page 16 of 24 Report to Trust Board in September 2020 EFFECTIVE 80% Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug % patients screened & found to EF6-N have either moderate or high alcohol dependence given advice 90% 87% 80% or referral 70% % patients screened & found to 100% 83% 94% EF7-N smoke given brief advice or a medication offer 60% Monthly Target > 90% > 90% 16 Page 17 of 24 Report to Trust Board in September 2020 WELL LED • Turnover this month has increased due to the student nurses who joined the trust to support for covid have started to return to their University courses and this has strongly affected the turnover % this month, and is likely to continue next month as these students are leaving UHS. • In clinical ward areas there are 163 registered nurses and 153 healthcare assistants in the covid ‘at risk’ categories who are unable to be deployed to some patient-facing activities. The majority of these staff have now been deployed to low risk areas, as risk levels are continuously reviewed. All nursing staff have been flexibly deployed to manage this deployment safely. A review is ongoing with covid assessments to move our system to be covid age instead of risk level 1 – 3. • This month staffing remains amber overall because some key targets have been missed for staff turnover, sickness and appraisals. The in-month sickness absence rate has seen a decrease and is below its normal position, but the 12 month figure is elevated due to the spoke during the pandemic. • Statutory and mandatory training compliance has seen some slippage (with 6 of 12 measures meeting target) due to COVID-19 and the reductions in training release during that time. • Recognising the pause in appraisals during COVID efforts are now being focused on improving quantity undertaken whilst retaining the important focus on quality of discussion as reflected in our staff survey. • UHS has seen an increase in rates of employment for BAME Band 7+ to 9.37%, but is still on an upwards trend. UHS is now monitoring BAME individual occupying 35 key medical leadership positions. This will be reported on a quarterly basis. WL1-L Substantive Staff - Turnover Monthly Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Target 13.90% 13.18% 12.46% 12.8% 13.3% 92% 77.24% 17 Page 18 of 24 Report to Trust Board in September 2020 WELL LED Monthly Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Target WL3-L 100.00% Staff - Medical appraisals completed - Rolling 12-months 50.00% 0.00% 60.00% WL4-L Staff vacancies 10.00% 5.00% 0.00% 4.09% WL5-L Staff - Sickness absence 4.43% 3.7% 2.99% 3.31% 2.91% =76% 30% 20% WL9-L Black & Minority Ethnic Band 7+ Percentage 9% 8.8% 9.4% 15% by 2023 7% WL10 Cumulative Number of staff trained in QI 1001 1064 1171 WL10 - QI training programme, and reporting, is currently temporarily suspended as team members support urgent change programmes as part of our Covid 19 response and recovery WL11 Statutory & Mandatory Training Achieving Target 8 8 8 8 7 7 7 7 7 7 7 6 6 6 6 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 - 100 WL12 Number of Apprenticeship Starts 53 - 50 29 28 23 0 19 Page 20 of 24 Report to Trust Board in September 2020 WELL LED 0 Monthly Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Target WL13-L Comparative CRN Recruitment Performance by clinical specialty 44% 44% 52% 56% 52% > =50% 2 WL14-L Comparative CRN Recruitment Performance - weighted 4 5 5 6 Top 5 WL15-L Comparative CRN Recruitment - contract commercial 15 15 13 13 13 Proportion of studies closing in FY on 88% WL16-L time and to recruitment target - 59% 65% 65% 50% non-commercial 452 WL17 NIHR CRF & BRC publications Year on year growth 329 246 137 Top 10 > =80% 20 Page 21 of 24 Report to Trust Board in September 20C20hanges and Corrections Section Responsive Responsive Responsive KPI KPI Name Type Elective inpatient activity - % RE26 of same time last year Addition Non-elective inpatient RE27 activity - % of same time last Addition year 1st outpatient attendances - RE28 % of same time last year Addition Detail Addition of benchmark position - % activity compared to same time last year, with rank and average of corporate peer group CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST 21 Page 22 of 24 Nursing and midwifery staffing hours - Aug 2020 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) This 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 from registered nurses and support staff - 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. During the last 2 weeks in March and beyond a number of our clinical areas started to change specialty and size to respond to the COVID-19 situation (e.g G5-G9, Critical Care and RHDU). Repurposing of wards to respond to the COVID-19 social distancing recommendations and to enable the separation and restart of services continues with changes sometimes being swift in nature. The data may in some cases not be fully reflective of these changes. WARD C4 (Solent ward) C4 (Solent ward) C6 C6 C6 (Teenage Cancer Trust unit) C6 (Teenage Cancer Trust unit) D2 D2 D3 D3 Critical Care Critical Care E5A E5A E5B E5B F10 E F10 E F11 F11 ASU ASU F6 F6 F5 F5 Acute medical unit Acute medical unit D5 D5 D6 D6 D8 D8 D9 D9 E7 E7 Respiratory high dependency unit Respiratory high dependency unit C5 C5 D10 D10 f7 f7 G5 G5 G6 G6 G7 G7 G8 G8 G9 G9 Registered nurses Total hours planned Registered nurses Total hours worked Unregistered staff Total hours planned Unregistered staff Total hours worked Registered nurses % Filled Day 1383.7 1370.1 1048.9 1253.3 99.0% Night 1069.3 1011.8 713.0 1176.8 94.6% Day 2791.3 2783.6 183.5 414.7 99.7% Night 2049.3 2097.4 102.4% 0.0 320.0 Day 727.5 564.5 331.9 334.8 77.6% Night 674.0 597.0 88.6% 0.0 96.7 Day 1303.0 1671.0 1108.0 909.8 128.2% Night 1057.5 1058.3 713.0 759.0 100.1% Day 1685.5 1641.7 689.2 1157.0 97.4% Night 1046.3 1083.5 686.3 812.5 103.6% Day 21459.4 18076.5 4440.8 2978.6 84.2% Night 20549.2 17565.5 2736.5 2251.8 85.5% Day 1339.7 1171.4 723.4 1019.4 87.4% Night 714.0 679.5 356.5 701.5 95.2% Day 1413.6 1190.3 811.5 1112.0 84.2% Night 713.0 713.0 356.5 597.8 100.0% Day 2313.5 1483.1 623.0 1277.7 64.1% Night 1069.5 1001.5 713.0 793.5 93.6% Day 1953.9 1405.9 774.8 1011.3 72.0% Night 713.0 713.8 713.0 885.5 100.1% Day 1480.3 1056.8 417.5 589.0 71.4% Night 695.0 718.0 356.5 327.5 103.3% Day 2306.0 1384.7 576.8 1345.9 60.0% Night 1069.5 1030.8 701.5 850.0 96.4% Day 1969.1 1534.2 1322.9 1268.3 77.9% Night 1069.5 991.5 712.5 873.5 92.7% Day 3572.8 4020.6 3294.5 3737.1 112.5% Night 3548.8 4008.4 2495.5 3893.3 113.0% Day 1255.0 1313.0 1668.0 1572.3 104.6% Night 1046.5 993.0 934.5 858.0 94.9% Day 1120.5 1061.3 1522.0 1441.5 94.7% Night 713.0 750.5 945.5 820.5 105.3% Day 1134.0 1009.5 1467.5 1700.0 89.0% Night 713.0 794.5 945.5 954.0 111.4% Day 1247.0 1350.7 1711.0 1590.8 108.3% Night 1069.5 978.0 945.5 980.5 91.4% Day 1080.5 1102.5 1232.0 1466.2 102.0% Night 713.0 681.5 713.0 702.5 95.6% Day 1256.3 992.0 521.0 346.5 79.0% Night 1143.0 1037.3 356.5 164.5 90.7% Day 860.0 1037.7 1285.0 602.0 120.7% Night 701.5 678.5 437.0 352.0 96.7% Day 1122.5 995.2 1301.0 1377.0 88.7% Night 702.0 656.5 713.0 552.0 93.5% Day 1083.7 980.4 1749.5 1649.0 90.5% Night 977.5 805.5 713.0 724.5 82.4% Day 1021.0 1277.2 1799.3 1700.8 125.1% Night 1058.8 932.3 701.5 839.5 88.1% Day 1061.9 1049.9 1782.5 1866.0 98.9% Night 1046.5 943.0 713.0 782.0 90.1% Day 742.5 742.5 1354.5 1679.5 100.0% Night 701.5 708.5 1069.5 1092.5 101.0% Day 1079.7 1041.6 1841.2 1829.0 96.5% Night 1069.5 874.0 713.0 805.0 81.7% Day 1080.8 1063.0 1768.8 1910.3 98.4% Night 1070.5 932.5 713.0 736.0 87.1% Unregistered staff % Filled 119.5% 165.0% 226.0% Shift N/A 100.9% Shift N/A 82.1% 106.5% 167.9% 118.4% 67.1% 82.3% 140.9% 196.8% 137.0% 167.7% 205.1% 111.3% 130.5% 124.2% 141.1% 91.9% 233.4% 121.2% 95.9% 122.6% 113.4% 156.0% 94.3% 91.8% 94.7% 86.8% 115.8% 100.9% 93.0% 103.7% 119.0% 98.5% 66.5% 46.1% 46.8% 80.5% 105.8% 77.4% 94.3% 101.6% 94.5% 119.7% 104.7% 109.7% 124.0% 102.2% 99.3% 112.9% 108.0% 103.2% CHPPD Registered midwives/ nurses CHPPD Care Staff 5.0 5.1 8.0 1.2 10.4 3.9 6.2 3.8 5.0 3.6 26.3 3.9 3.7 3.5 3.8 3.4 4.8 4.0 4.1 3.6 8.1 4.2 3.5 3.2 4.1 3.4 7.9 7.5 3.2 3.4 3.4 4.3 2.7 3.9 2.8 3.1 3.1 3.8 16.6 4.2 9.8 5.4 3.3 3.9 3.5 4.6 2.9 3.3 2.9 3.9 3.5 6.6 2.6 3.5 2.9 3.8 CHPPD Overall 10.0 9.2 14.2 10.0 8.6 30.1 7.2 7.2 8.8 7.7 12.3 6.6 7.5 15.5 6.6 7.7 6.6 5.9 7.0 20.8 15.2 7.2 8.1 6.2 6.9 10.1 6.1 6.7 Comments Safe staffing levels maintained. Safe staffing levels maintained. Safe staffing levels maintained; additional staff used for enhanced care - Support workers. Safe staffing levels maintained. Staff moved to support other wards; Staffing appropriate for number of patients. Staff moved to support other wards; Staffing appropriate for number of patients. Safe staffing levels maintained. Safe staffing levels maintained. Safe staffing levels maintained; additional staff used for enhanced care - Support workers. Safe staffing levels maintained. Beds flexed to match staffing. Beds flexed to match staffing. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care Support workers. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care Support workers. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care Support workers; Additional staff working in this area due to covid restrictions. Safe staffing levels maintained. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care Support workers. Safe staffing levels maintained; Additional staff used for enhanced care - Support workers. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers. Safe staffing levels maintained. Safe staffing levels maintained; Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care Support workers. Safe staffing levels maintained. Safe staffing levels maintained by sharing staff resource; Staffing appropriate for number of patients. Safe staffing levels maintained by sharing staff resource; Staffing appropriate for number of patients. Band 4 staff working to support registered nurse numbers; Beds flexed to match staffing; Safe staffing levels maintained; Covid testing zone requiring additional staffing. Band 4 staff working to support registered nurse numbers; Beds flexed to match staffing; Safe staffing levels maintained; Covid testing zone requiring additional staffing. Safe staffing levels maintained. Safe staffing levels maintained. Safe staffing levels maintained. Skill mix swaps undertaken to support safe staffing across the Unit; 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. Additional staff used for enhanced care - RNs; Safe staffing levels maintained. Additional staff used for enhanced care - RNs; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Safe staffing levels maintained. Beds flexed to match staffing; Staff moved to support other wards; Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Beds flexed to match staffing; Staff moved to support other wards; Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Skill mix swaps undertaken to support safe staffing across the Unit; Beds flexed to match staffing; Safe staffing levels maintained. Beds flexed to match staffing; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained; Beds flexed to match staffing. Staff moved to support other wards; Safe staffing levels maintained; Beds flexed to match staffing. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care - Support workers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Additional staff used for enhanced care - Support workers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. Page 23 of 24 Nursing and midwifery staffing hours - Aug 2020 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) This 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 from registered nurses and support staff - 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. During the last 2 weeks in March and beyond a number of our clinical areas started to change specialty and size to respond to the COVID-19 situation (e.g G5-G9, Critical Care and RHDU). Repurposing of wards to respond to the COVID-19 social distancing recommendations and to enable the separation and restart of services continues with changes sometimes being swift in nature. The data may in some cases not be fully reflective of these changes. Paediatric high dependency unit Paediatric high dependency unit Paediatric medical unit Paediatric medical unit Paediatric intensive care unit Paediatric intensive care unit Piam Brown ward Piam Brown ward E1 E1 G2 G2 G3 G3 G4 G4 Bramshaw women's unit Bramshaw women's unit Neonatal unit Neonatal unit Maternity service Maternity service Cardiac high dependency unit Cardiac high dependency unit Coronary care unit Coronary care unit D4 D4 E2 E2 E3 Green E3 Green E3 Blue E3 Blue E4 E4 Acute stroke unit Acute stroke unit Regional transfer unit Regional transfer unit E Neuro E Neuro Hyper acute stroke unit Hyper acute stroke unit D neuro D neuro SPI F4 Neuro SPI F4 Neuro Brooke ward Brooke ward Trauma Assessment Unit Trauma Assessment Unit F1 F1 F2 F2 F3 F3 F4 F4 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 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 Day Night Day Night 1627.5 1069.5 1835.4 1707.5 6762.1 5697.8 3695.9 1415.1 2068.0 1380.0 759.3 744.0 2410.6 1705.0 2429.0 1705.0 1120.0 713.0 6894.9 5439.5 8456.9 5383.8 4548.2 3653.1 1412.2 1331.8 1756.2 820.0 1721.2 704.0 1574.8 704.0 1181.7 665.0 1652.1 1100.5 1518.5 1023.0 773.0 682.0 1975.5 1364.0 1564.0 1358.0 1941.0 1364.5 1817.4 1089.0 1171.2 1069.5 535.5 341.0 2428.4 1781.8 1655.7 1023.0 1606.3 1023.3 1470.0 1023.0 1320.0 1162.5 2753.9 2438.4 4695.4 4443.2 2723.0 1178.6 1523.8 1193.8 780.1 793.0 1683.9 1350.8 1994.5 1324.5 1047.3 712.5 4472.4 3814.3 7597.2 4577.8 3991.0 3358.8 1864.8 1613.0 1425.2 780.3 1057.2 706.0 1394.2 682.0 975.7 621.0 1320.7 1069.0 1520.0 880.0 729.5 506.0 1719.0 1265.0 1181.5 924.0 1831.8 1310.0 1254.7 924.0 917.5 736.0 648.7 617.3 1980.8 1736.9 1455.8 803.0 1320.0 869.3 1364.2 860.3 0.0 0.0 352.2 680.5 726.2 587.8 93.0 0.0 620.0 371.3 0.0 0.0 1691.0 1023.0 1188.0 682.0 656.5 345.0 1551.0 1353.0 3137.4 2046.0 2233.7 1366.0 1089.0 968.0 1057.5 1012.0 866.4 341.0 1398.5 788.3 1150.5 682.0 1285.9 396.0 2674.5 1705.0 387.5 330.0 1031.0 1021.5 397.5 319.0 2033.5 1715.0 1143.0 1043.0 600.3 356.5 313.6 341.0 1936.3 1755.3 2000.5 1375.3 1791.2 1364.3 1217.2 693.8 81.1% Shift N/A 92.0 15.6 0.6 Non-ward based staff supporting areas; Safe staffing levels maintained. 16.2 108.7% 0.0 Shift N/A Safe staffing levels maintained. 150.0% 182.0% Additional beds open in the month; Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained. 640.9 21.0 5.5 26.5 713.5 142.8% 104.8% Additional beds open in the month; Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained. 269.0 472.8 69.4% 78.0% 37.0% 80.4% Beds flexed to match staffing. 39.1 3.2 42.2 Beds flexed to match staffing. 158.5 73.7% 170.4% 12.4 0.5 Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. 12.9 83.3% 0.0 Shift N/A Beds flexed to match staffing; Safe staffing levels maintained. 641.0 73.7% 103.4% 7.8 Band 4 staff working to support registered nurse numbers; Non-ward based staff supporting areas; Safe staffing levels maintained. 3.6 11.4 614.8 86.5% 165.6% Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. 102.7% Shift N/A 0.0 12.0 0.0 Safe staffing levels maintained. 12.0 106.6% 0.0 Shift N/A Safe staffing levels maintained. 791.0 69.9% 46.8% 8.4 Non-ward based staff supporting areas; Safe staffing levels maintained; Beds flexed to match staffing. 3.6 12.0 532.5 79.2% 52.1% Beds flexed to match staffing; Safe staffing levels maintained. 885.5 82.1% 74.5% 8.4 Non-ward based staff supporting areas; Safe staffing levels maintained; Beds flexed to match staffing. 3.7 12.1 583.0 77.7% 85.5% Beds flexed to match staffing; Safe staffing levels maintained. 609.0 93.5% 92.8% Safe staffing levels maintained. 8.1 4.4 12.6 345.0 99.9% 100.0% Safe staffing levels maintained. 1605.5 64.9% 103.5% 10.7 3.3 Staffing flexed to match bed numbers. 14.0 946.0 70.1% 69.9% Staffing flexed to match bed numbers. 2498.7 89.8% 79.6% Safe staffing levels maintained. 5.3 1.9 7.2 1770.8 85.0% 86.5% Safe staffing levels maintained. 1394.4 803.0 87.7% 91.9% 62.4% 58.8% Staff moved to support other wards; Skill mix swaps undertaken to support safe staffing across the Unit; Band 4 staff working to support 19.0 5.7 24.7 registered nurse numbers. Staff moved to support other wards; Skill mix swaps undertaken to support safe staffing across the Unit; Band 4 staff working to support registered nurse numbers. 132.0% 81.1% Additional beds open in the month; Staff moved to support other wards; Skill mix swaps undertaken to support safe staffing across the 883.5 9.5 4.6 14.1 Unit. 814.0 121.1% 84.1% Additional beds open in the month; Staff moved to support other wards; Skill mix swaps undertaken to support safe staffing across the Unit. 81.2% 139.7% Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained; Support workers used to maintain staffing 1477.8 4.4 4.9 9.3 numbers. 95.2% 92.9% Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained; Support workers used to maintain staffing 940.0 numbers. 61.4% 163.7% Staffing appropriate for number of patients; Staff moved to support other wards; Band 4 staff working to support registered nurse 1418.5 3.9 4.7 8.6 numbers. 687.4 100.3% 201.6% Staffing appropriate for number of patients; Staff moved to support other wards; Increased night staffing to support raised acuity. 1381.3 88.5% 98.8% 3.8 Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. 4.0 7.8 801.3 96.9% 101.6% Band 4 staff working to support registered nurse numbers; Safe staffing levels maintained. 1119.0 781.0 1192.9 748.0 2645.5 1815.0 234.5 396.0 1594.5 1439.5 495.0 427.8 1668.0 1550.5 1435.5 1197.0 585.8 563.5 827.6 660.0 2307.9 1852.0 2242.3 1572.3 2170.0 1486.0 1033.7 915.5 82.6% 93.4% 79.9% 97.1% 100.1% 86.0% 94.4% 74.2% 87.0% 92.7% 75.5% 68.0% 94.4% 96.0% 69.0% 84.8% 78.3% 68.8% 121.1% 181.0% 81.6% 97.5% 87.9% 78.5% 82.2% 84.9% 92.8% 84.1% 97.3% 114.5% 92.8% 188.9% 98.9% 106.5% 60.5% 120.0% 154.7% 140.9% 124.5% 134.1% 82.0% 90.4% 125.6% 114.8% 97.6% 158.1% 263.9% 193.5% 119.2% 105.5% 112.1% 114.3% 121.1% 108.9% 84.9% 132.0% Band 4 staff working to support registered nurse numbers; Patient requiring 24 hour 1:1 nursing in the month. 4.1 4.8 8.9 Band 4 staff working to support registered nurse numbers; Patient requiring 24 hour 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Staffing appropriate for number of patients; Support workers used to maintain 5.8 4.7 10.6 staffing numbers. Additional staff used for enhanced care - Support workers; Skill mix swaps undertaken to support safe staffing across the Unit; Support workers used to maintain staffing numbers. Patient requiring 24 hour 1:1 nursing in the month; Band 4 staff working to support registered nurse numbers; Support workers used to 3.1 5.7 8.7 maintain staffing numbers. Patient requiring 24 hour 1:1 nursing in the month; Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 1:1 nursing in the month; Low bed numbers but staff on roster being used in neuro swabbing hub making it look like working on ward in 18.2 9.3 27.4 report. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 5.9 6.0 11.8 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 14.0 6.2 20.2 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 1:1 nursing in the month. Patient requiring 24 hour 1:1 nursing in the month; Band 4 staff working to support registered nurse numbers; Support workers used to 5.8 5.9 11.8 maintain staffing numbers. Patient requiring 24 hour 1:1 nursing in the month; Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 5.3 6.4 11.6 1:1 nursing in the month. Band 4 staff working to support registered nurse numbers; Support workers used to maintain staffing numbers; Patient requiring 24 hour 1:1 nursing in the month. Safe staffing levels maintained by sharing staff resource; Staff moved to support other wards; Skill mix swaps undertaken to support safe 5.2 3.6 8.8 staffing across the Unit. Safe staffing levels maintained by sharing staff resource; Staff moved to support other wards; Skill mix swaps undertaken to support safe staffing across the Unit. Safe staffing levels maintained by sharing staff resource; This ward has a high number of admissions and acuity/dependency of patients 8.7 10.3 19.0 which means more Registered nurse and support workers are required. Safe staffing levels maintained by sharing staff resource; This ward has a high number of admissions and acuity/dependency of patients which means more Registered nurse and support workers are required. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to 4.5 5.1 9.6 support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to 3.2 5.3 8.5 support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to 3.9 6.5 10.3 support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to 4.5 3.9 8.4 support safe staffing across the Unit; Staff moved to support other wards. Patient requiring 24 hour 1:1 nursing in the month; Safe staffing levels maintained by sharing staff resource; Skill mix swaps undertaken to support safe staffing across the Unit; Staff moved to support other wards. Page 24 of 24 2.5.1 Access Targets: Cancer Trajectory Update for review 1 Access Targets: Cancer Trajectory Update Report to the Trust Board of Directors dated 29 September 2020 Title: Agenda item: Sponsor: Date: Purpose Issue to be addressed: Response to the issue: Access Targets: Cancer Trajectory Update 2.5.1 Joe Teape, Chief Operating Officer 16 September 2020 Assurance Approval or reassurance Ratification Information Yes To provide an update to Trust Board on cancer performance following the last report that went to Trust Board in March 2020 and the impact of Covid19 on performance. The report provides an update on UHS cancer performance and covers the following; • Current performance against the key cancer metrics • Challenges faced during Covid-19 and impact on demand • Changes made in managing patients on a cancer pathway Implications: (Clinical, Organisational, Governance, Legal?) Clinical Organisational Governance and risk Risks: (Top 3) of carrying out the change / or not: The top 3 risks are: • Inability to meet required cancer standard targets • Inability to manage cancer patients during a Covid-19 pandemic • Risk of increase in cancer referrals of patients whose cancer may have spread so that the cancer will be harder to treat or no longer be curative Summary: Conclusion and/or recommendation The Trust Board is asked to consider the recent cancer performance and note the impact of COVID 19 has had on activity/demand and performance. The Board is asked to note whilst we have seen improvements in performance since April 2020 there remain significant risks to achievement and further work is being undertaken to develop mitigations & assess the impact of improving referral times from other organizations which impact on UHS. Page 1 of 7 1. Introduction/Background In March 2020 Trust Board was provided with an update on cancer performance and plans on acti
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DVdSC (weekly cycles 9 onwards) DaratumumabSC-Bortezomib-Dexamethasone Ver1

Description: Chemotherapy Protocol Myeloma DVd SC (weekly) Bortezomib Daratumumab Dexamethasone Cycles 9 onwards Regimen • Myeloma – Bortezomib with daratumumab and dexamethasone Indication • Daratumumab in combination with bortezomib and dexamethasone is recommended for use as an option for treating relapsed multiple myeloma in people who have had 1 previous treatment. • This weekly bortezomib regimen is for patients who experience neuropathy or those with pre-existing neuropathy. Note both the twice weekly and weekly bortezomib regimens include 32 doses of bortezomib; therefore bortezomib continues to the end of cycle 10 in the weekly regimen. Ensure the correct daratumumab cycle 9 onwards is selected. Toxicity Drug Daratumumab Dexamethasone Adverse Effect Infusion related reactions, hypotension, headache, rash, urticaria, pruritus, nausea, vomiting, respiratory tract infections (including pneumonia), neutropenia, thrombocytopenia, anaemia, lymphopenia, peripheral neuropathy, diarrhoea, muscle spasms, fatigue, pyrexia and peripheral oedema, blood transfusion related events. Weight gain, gastrointestinal disturbances, hyperglycaemia, CNS disturbances, Cushingoid changes, glucose intolerance. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, U&Es, Ca2+ and LFTs prior to day one of each cycle of treatment. • Paraprotein and / or light chains prior to each cycle. • All patients should be tested for hepatitis B virus (HBV) before initiating treatment with daratumumab. Those patients who test positive for HBV infection should be discussed with a consultant specialising in HBV prior to initiating treatment with daratumumab to plan monitoring requirements whilst on treatment. Patients may also be tested for hepatitis C, CMV and HIV at the same time if clinically appropriate. • Send a blood sample to transfusion and inform patient and transfusion laboratory that patient is due to commence daratumumab. Patient will require red cell phenotyping as cross match fails due to binding of daratumumab to red cells. Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 1 of 11 • Regular monitoring of blood glucose is considered good practice due to dexamethasone use. 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 No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity. Always refer to the responsible consultant, as any dose 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 or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). Consider growth factor support as an alternative to the options below, particularly where there is evidence of bone marrow suppression. To initiate a new cycle of daratumumab, the neutrophil count should be 1x109/L or greater and the platelet count should be 50x109/L or greater, unless the low counts are due to bone marrow infiltration with myeloma. In this situation the daratumumab may be administered at the discretion of the treating consultant haematologist with the appropriate blood product and growth factor support. Neutrophils (x109/L) Dose Modifications Daratumumab Less than 0.5x109/L or febrile neutropenia (fever greater than or equal to 38.5°C and neutrophils less than 1) Interrupt daratumumab treatment and monitor FBC weekly. Bortezomib - Consider treatment delay or dose reduction or growth factor support. Seek consultant advice. Platelets (x109/L) Dose Modifications Daratumumab Less than 50x109/L Bortezomib Less than 25x109/L Interrupt daratumumab treatment and monitor FBC weekly. Once platelets recover to 50x109/L or greater resume Consider treatment delay or dose reduction or platelet transfusion. Seek consultant advice. Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 2 of 11 Drug Bortezomib Daratumumab Bilirubin μmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. No formal studies of daratumumab in patients with hepatic impairment have been conducted. Based on population pharmacokinetic analysis no dosage adjustments are necessary for patients with hepatic impairment Renal Impairment Drug Bortezomib Daratumumab Creatinine Clearance (ml/min) greater than 20 Dose (% of original dose) 100% 20 and below Clinical decision No adjustments necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes Infusion related reactions (IRR) DARZALEX solution for subcutaneous injection can cause severe and/or serious IRRs, including anaphylactic reactions. In clinical studies, approximately 11% (52/490) of patients experienced an IRR. Most IRRs occurred following the first injection and were Grade 1-2. IRRs occurring with subsequent injections were seen in less than 1% of patients. The median time to onset of IRRs following DARZALEX injection was 3.7 hours (range 0.1583 hours). The majority of IRRs occurred on the day of treatment. Delayed IRRs have occurred in less than 1% of patients. Signs and symptoms of IRRs may include respiratory symptoms, such as nasal congestion, cough, throat irritation, allergic rhinitis, wheezing as well as pyrexia, chest pain, pruritis, chills, vomiting, nausea, and hypotension. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension and tachycardia. Patients should be pre-medicated with antihistamines, antipyretics, and corticosteroids as well as monitored and counselled regarding IRRs, especially during and following the first and second injections. If an anaphylactic reaction or life-threatening (Grade 4) reactions Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 3 of 11 occur, appropriate emergency care should be initiated immediately. DARZALEX therapy should be discontinued immediately and permanently. To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following DARZALEX injection. Patients with a history of chronic obstructive pulmonary disease may require additional post-injection medicinal products to manage respiratory complications. The use of post-injection medicinal products (e.g. short- and longacting bronchodilators and inhaled corticosteroids) should be considered for patients with chronic obstructive pulmonary disease. Interference with Serlogical Testing Daratumumab binds to CD38 in red blood cells and results in a positive indirect antiglobulin test (Coombs test). Daratumumab mediated positive indirect antiglobulin test may persist for up to six months after the last daratumumab infusion. Daratumumab bound red blood cells masks detection of antibodies to minor antigens in the patients serum. The determination of a patients ABO and Rh blood type are not impacted. Blood transfusion must be informed that a patient is receiving daratumumab. Patients must be typed and screened prior to daratumumab. All patient must be given an identification card that should be carried for six months after stopping therapy and agree to inform all healthcare professionals who treat them that they have received daratumumab. Daratumumab is a human IgG kappa monoclonal antibody detectable on both the serum electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impoact the determination of complete response and of disease progression in all patients with IgG kappa myeloma. Reactivation of Hepatitis B Virus Hepatitis B virus reactivation has been reported in patients treated with daratumumab. All patients must be screened for hepatitis B before initiation of treatment. This includes all patients with unknown serology who are on treatment already. Monitoring is required for patients with positive serology for clinical and laboratory signs of hepatitis B reactivation during treatment and for at least six months after completion of datatumumab. Those with positive serology must seek medical help immediately if they experience symptoms of hepatitis B. Daratumumab must be stopped if hepatitis B reactivation occurs during treatment. Regimen 28 day cycle. Continue daratumumab until disease progression. Note that cycle length changes from 21 days to 28 days from cycle 9 onwards. Cycle 9 and 10 Drug Bortezomib Dose 1.3mg/m2 Days 1,8,15, 22 Administration Subcutaneous Daratumumab 1800mg 1 Dexamethasone 20mg once a day 1 Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Subcutaneous Oral Can be given as dose Page 4 of 11 Dexamethasone 20mg once a day 2, 8, 9, 15, 16, 22, 23 equivalent as iv bolus Reduce dose to 10mg (or iv dose equivalent) in over 75yrs Oral Reduce dose to 10mg in over 75yrs Cycle 11 onwards Drug Daratumumab Dexamethasone Dose 1800mg 20mg Dexamethasone 4mg Days 1 1 2 and 3 Administration Subcutaneous Oral Can be given as dose equivalent as IV bolus To reduce the risk of delayed infusion reactions Dose Information • Dexamethasone is available as 4mg, 2mg and 500microgram tablets and 3.3mg in 1ml injection (equivalent to 4mg orally) Administration Information • Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-injection medicinal products including short and long-acting bronchodilators, and inhaled corticosteroids should be considered. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-injection medicinal products may be discontinued at the discretion of the physician. • Inject 15 mL Daratumumab solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject Daratumumab solution for subcutaneous injection at other sites of the body as no data are available. • Injection sites should be rotated for successive injections • Daratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars. • Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 5 of 11 • During treatment with Daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as Daratumumab. Additional therapy • No anti-emetics are required • Premedication required 1 to 3 hours before every daratumumab infusion: - dexamethasone – see regimen for dose details - chlorphenamine 4mg oral - paracetamol 1000mg oral • Consider anti-infective prophylaxis including; - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only - fluconazole 100mg once a day oral if recurrent oral candidiasis • Bisphosphonates in accordance with local policies. • Mouthwashes according to local or national policy on the treatment of mucositis. • Gastric protection with a proton pump inhibitor or an H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. • As required for the treatment of infusion related reactions for patients at high risk of respiratory complications; - salbutamol 2.5mg nebulised - hydrocortisone sodium succinate 100mg intravenous - chlorphenamine 10mg intravenous - paracetamol 1000mg oral - oxygen as required Additional Information • All instances of infusion related reaction must be recorded on ARIA. Daratumumab will continue to be administered at the cycle one rate until a reaction free infusion is noted. • Daratumumab interferes with indirect antiglobulin tests as it binds to CD38 on red blood corpuscles (RBCs) and interferes with compatibility testing, including antibody screening and cross matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods. Since the Kell blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs. Alternatively, phenotyping or genotyping may also be considered. • Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 6 of 11 immunoglobulins (M protein). This can lead to false positive SPE and IFE assay results for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent very good partial response, consider other methods to evaluate the depth of response. Coding • Procurement –X71.5 • Delivery – X72.1 References 1. Janssen-Cilag Limited (18 Dec 2018). Darzalex 20mg/ml Summary of Product Characteristics. Electronic Medicines Compendium. Online at https://www.medicines.org.uk/emc/product/7250 , accessed 01 July 2019. 2. National Institute for Health and Care Excellence (2019). Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma. [TA573]. London: National Institute for Health and Care Excellence. 3. Thames Valley Strategic Cancer Network Myeloma Group MM47 DaraVelDex Protocol version 2.0 April 2019. 4. 90 minute daratumumab infusion is safe in multiple myeloma. Leukemia. Hallie Barr et al. Accessed 27/11/18 https://doi.org/10.1038/s41375-018-0120-2. Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 7 of 11 REGIMEN SUMMARY Myeloma DVd (weekly) Bortezomib Daratumumab SC Dexamethasone Cycles 9 onwards Cycle 9 and 10 Day 1 1. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 2. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose.. 3. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours 4. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject daratumumab 1800mg solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available.Injection sites should be rotated for successive injectionsDaratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 5. Bortezomib 1.3mg/m2 subcutaneous injection 6. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 7. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 8. Paracetamol 1000mg oral when required for the relief of infusion related reactions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 9. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Cycle 9 and 10 Day 8, 15 and 22 10. Bortezomib 1.3mg/m2 subcutaneous injection Cycle 9 and 10 Take home medicines 11. Dexamethasone 20mg on days 2, 8, 9, 15, 16, 22 and 23 oral Administration Information Reduce dose to 10mg in patients over 75 years old Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 8 of 11 bottle, or individual bottles according to local practice. 12. Dexamethasone 20mg on day 1 of the next cycle Take in the morning of daratumumab injection Note to pharmacy – please dispense 1 dose of dexamethasone 20mg to be taken on day 1 of the following cycle prior to daratumumab 13. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 14. Anthistamine on the days of daratumumab administration Administration Instructions Take on the day of daratumumab administration. To be taken 1 -3 hours prior to daratumumab infusion Please supply 1 x OP. This is to cover all cycles. To be supplied as per local formulary choice Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 15. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 16. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. Cycle 11 onwards day 1 17. Warning – Check if Antihistamine Taken Administration Instructions Ensure the patient has taken the antihistamine premedication. If not please administer one of the following according to local formulary choice; Chlorphenamine 4mg Oral Loratadine 10mg Oral Cetirizine 10mg Oral Fexofenadine 120mg Oral Acrivastine 8mg Oral 18. Warning – Check if the Dexamethasone Taken Administration Instructions Ensure the patient has taken the dexamethasone premedication. If not please administer dexamethasone 20mg oral or intravenous if the patient is unable to tolerate the oral dose 19. Warning – Check if the Paracetamol Taken Administration Instructions Please check if the patient has taken paracetamol. If not please administer paracetamol 1000mg. The maximum dose is 4000mg/24 hours Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 9 of 11 20. Daratumumab 1800mg subcutaneous injection over 3 – 5 minutes Administration Instructions Inject daratumumab 1800mg solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3-5 minutes. Do not inject daratumumab solution for subcutaneous injection at other sites of the body as no data are available.Injection sites should be rotated for successive injectionsDaratumumab solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.During treatment with daratumumab solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site as daratumumab. 21. Chlorphenamine 10mg intravenous when required for the relief of infusion related reactions 22. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions 23. Paracetamol 1000mg oral when required for the relief of infusion related reactions Please check if the patient has taken paracetamol. The maximum dose is 4000mg/24 hours 24. Salbutamol 2.5mg nebulised when required for the relief of infusion related reactions Take home medicines 25. Dexamethasone 4mg on days 2 and 3 oral Administration Information Take in the morning with or after food. Days 2 and 3 i.e. for two days starting the day after daratumumab administration to reduce the risk of delayed infusion reactions 26. Dexamethasone 20mg on day 1 of the next cycle Administration Information Take in the morning of daratumumab injection Note to pharmacy – please dispense 1 dose of dexamethasone 20mg to be taken on day 1 of the following cycle prior to daratumumab 27. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 28. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 29. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. Version 1(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 10 of 11 DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Oct 2020 None Nanda Basker Pharmacist Dr Mathew Jenner 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 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(July 2019) Myeloma –DVd (weekly) Bortezomib Daratumumab (S/C) Dexamethasone Cycles 9 onwards. Page 11 of 11
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UHS AR 23-24 Final

Description: 2023/24 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2023/24 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2024 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 37 Directors’ report 38 Remuneration report 62 Staff report 75 Annual governance statement 95 Quality account 111 Statement on quality from the chief executive 112 Priorities for improvement and statements of assurance from the board 115 Other information 180 Annual accounts 207 Statement from the chief financial officer 208 Auditor’s report 210 Foreword to the accounts 217 Statement of Comprehensive Income 218 Statement of Financial Position 219 Statement of Changes in Taxpayers’ Equity 220 Statement of Cash Flows 221 Notes to the accounts 222 5 Welcome from the Chair and Chief Executive Officer This has been another busy and undoubtedly challenging year across the NHS and UK health and social care system, and much of what has impacted the national picture has been reflected in the operational focuses and patient and people priorities for University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) over the last year. Meeting and continuing to overcome the challenges we have faced has required an organisation-wide team effort, and looking back at the successes we feel incredibly proud of the achievements of our 13,000 staff. Particular highlights include: • In the top ten in the country (7th) against government targets for elective recovery performance with 118% of activity compared with 2019. • Top-quartile performance against most performance metrics compared to similar sized teaching hospitals, including Emergency Department access, long-waiting patients on Referral to Treatment pathways, Diagnostics and Cancer performance. • Significant investment in new capacity through building new wards and theatres and refurbishing existing areas of the hospital. • Delivery of our highest ever Cost Improvement Programme saving. These achievements place us among the best performing trusts in England in several areas and are even more remarkable against a backdrop of continued periods of industrial action and increasing demand for our services, with many people coming to us with higher levels of acuity than ever before. The Trust’s performance in terms of elective recovery places it as one of the best-performing trusts in England and demonstrates the impact of the Trust’s decision to invest in additional capacity in prior years by building new wards and theatres. The Trust’s Emergency Department performance in respect of its four-hour waiting target at the end of March 2024 has attracted additional capital funding as part of an incentive scheme. Some of this funding will be used to increase the department’s same-day emergency care capacity during 2024/25. From a financial perspective, balancing the complexities of today’s challenges alongside the need to protect and ensure the long-term stability and quality of our service provision, has required the Board to take a number of considered and crucial efficiency improvement actions this year. Whilst challenging, the Trust has seen significant progress in delivering on both its forecasted finance position for 2023/24 and productivity targets. Achieving long-term financial stability is key to us continuing to invest in much needed upgrades and improvements to the parts of our estate that are ageing, and to developing new state-of-the-art facilities and infrastructure that increases our capabilities and capacity into the future. In the last year parts of the hospital have been transformed, with the opening of new wards, theatres and a skybridge to link the estate. Construction of a sterile services and aseptics facility has begun at Adanac Park and the expansion of our neonatal department, where we treat and care for some of our most vulnerable babies and their families, is underway. The development of a new aseptic facility at Adanac Park will have capacity to serve other hospitals within the region and is a significant opportunity for improved system-wide working. 6 We have also worked with our people to design spaces where they can rest, relax and recharge - including a new wellbeing hub and rooftop garden on the Princess Anne Hospital site. In addition, 40 staff rooms across the site have been refurbished thanks to funding from Southampton Hospitals Charity. During the year, the Trust worked to establish the Southampton Hospitals Charity as a separate charitable company to improve its ability to both raise and spend funds. This process completed on 1 April 2024. Work was carried out to refurbish a children’s ward during the year in partnership with the charity. Our people are our greatest asset, and we are pleased to see improvements from the annual staff survey in several areas - such as how people can work more flexibly, access to learning and development and improved satisfaction in support from line managers. We recognise the pressures and demands that come with working in this environment and will continue to ensure everyone working here feels heard, encouraged and supported when raising concerns. At UHS, every opportunity is taken to recognise and celebrate the incredible things our people do here every day, including the return of our in-person annual awards ceremony, monthly staff recognition events and the first ever ‘We Are UHS Week’. These occasions are an important reminder that, even when faced with challenges, there is so much to be proud of and celebrate across the whole Trust. Working together, both within the Trust and across organisational boundaries, remains one of our core values. The partnership between UHS and the University of Southampton is as strong as it has ever been, with more than 250,000 individuals having now taken part in research studies in Southampton. As the lead partner member for Acute Hospital Services on the Hampshire and Isle of Wight Integrated Care Board, we are proactively working with other trusts and healthcare providers in the region to improve the health of the community we serve. In addition, the Trust has continued to work in partnership with other providers across the system to build a shared elective orthopaedic hub in Winchester. It is anticipated that the health and social care system will continue to be a challenging environment in 2024/25. We recognise that many of the big challenges we face can only be solved in partnership with wider local partners, and we are committed to actively playing our part in delivering system-wide solutions. Equally, we will continue to focus on improving whatever is within our internal control, and to work collaboratively with our people to ensure our patients’ experience, safety and outcomes remain central to our decision-making and the actions of everyone at UHS. Jenni Douglas-Todd Chair 19 July 2024 David French Chief Executive Officer 19 July 2024 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer As with 2022/23, this was another challenging year with continued increasing demand for the Trust’s resources and the need to balance this with the need to deliver quality patient care and at the same time maintain a sustainable financial position. Demand for non-elective care continued to increase with an average of 375 attendances per day to our main Emergency Department. In addition, the number of patients on the 18-week Referral to Treatment pathway rose to 58,000. Patients having no clinical criteria to reside in hospital, but unable to be discharged due to the lack of funded care in a more suitable location, posed and continues to pose a significant challenge for the Trust. The number of patients within this category was as high as 270 at times and was consistently higher throughout the year when compared to 2022/23. Despite this the Trust continued to perform well when compared to other comparable organisations, achieving some of the best Emergency Department and elective recovery fund performance in England. The Trust’s financial position continued to be difficult, which required some difficult decisions in respect of spending controls and controls on recruitment. The Trust focused in particular on controlling spending on temporary and agency staff, but in view of the overall workforce numbers compared to the 2023/24 plan, further controls were implemented in respect of substantive recruitment. Due to the additional controls and the Trust’s best delivery to date on its Cost Improvement Programme (£63.4m), the Trust achieved an end of year deficit of £4.5m, compared to the deficit of £26m anticipated in its 2023/24 plan. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1.3 billion in 2023/24. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to nearly four million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 155,000 inpatients and day patients, including about 70,000 emergency admissions sees over 750,000 people at outpatient appointments deals with around 150,000 cases in our emergency department The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 54% is paid for by NHS England and 43% by integrated care boards, predominantly the Hampshire and Isle of Wight Integrated Care Board (ICB). These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board. The ICP is a statutory committee jointly formed between the NHS integrated care board and all upper-tier local authorities that fall within the ICS area. The ICP brings together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Division B Division C Division D Surgery Critical Care Opthalmology Theatres and Anaesthetics Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values The Trust’s values describe how things are done at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. These values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything its staff had experienced during the COVID-19 pandemic and what had been learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. The Trust’s strategy is organised around five themes and for each of these it describes a number of ambitions UHS aims to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2023/24 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Increasing the number of reported Shared Decision-Making conversations. • Increasing the number of specialities reporting outcomes that matter to patients. • Rolling out the Patient Safety Incident Reporting Framework across the Trust. • Working with patients as partners to improve patient satisfaction. • Treating patients according to need but aiming for no patient to wait, other than through patient choice, more than 65 weeks for treatment. • Delivering national metrics for site set-up time to target for clinical research studies. • Improving the Trust’s position against peers. • Delivering year three of the Trust’s research and innovation investment plan. • Developing the five-year research and development strategy implementation plan and delivery of the first year. • Strengthening and broadening the partnership between the Trust and the University of Southampton. • Supporting delivery of the Trust’s workforce plan for 2023/24. • Reducing turnover and sickness absence rates. • Increasing overall participation in the NHS staff survey and maintaining overall staff engagement score. • Increasing the proportion of appraisals completed. • Delivering the first year objectives of the Inclusion and Belonging strategy. • Working in partnership with acute trusts to agree and implement the acute services strategy. • Producing and embedding an internal framework for network development. • Working with the local delivery system on vertical integration to reduce the number of patients without criteria to reside. • Working with system partners to open a surgical elective hub. • For the Trust to be seen as an ‘anchor institution’ in the local area. • Delivering the Trust’s financial plan for 2023/24. • Engaging the organisation in the challenge to manage demand so that capacity and demand are in equilibrium. • Delivery of the Always Improving strategy priorities. • Delivering the Trust’s capital programme in full. • Entering into a new energy performance contract and delivering the first year of the Public Sector Decarbonisation Scheme. Performance against these objectives was monitored and reported to the Trust’s Board on a quarterly basis. 14 At the end of 2023/24, the Trust had met the objectives set as follows: Corporate Ambition Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future Totals Number of Objectives 5 5 5 5 5 25 Achieved in full 4 3 2 3 2 14 Partially achieved 1 2 2 1 3 9 Not achieved 0 0 1 1 0 2 Particular areas to highlight where the Trust has achieved strong delivery during the year include: • Delivery of quality priorities in Shared Decision-Making and the roll out of the Patient Safety Incident Response Framework. • Achieving the Trust’s 65-week waiter glide path. • Successful delivery of a number of research and development priorities, including work with the University of Southampton. • Maintaining sickness absence and turnover well below the targets set at the beginning of the year, and successfully delivering the first year of the Trust’s Inclusion and Belonging strategy. • Delivery of the Trust’s full available capital budget and completion of the first year of the Trust’s decarbonisation scheme. 15 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2023/24 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families or carers with a highquality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust does not take full advantage of its position as a leading university teaching hospital with a growing, reputable and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for its patients. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme; NHS England imposing additional controls/undertakings; and a reducing cash balance, impacting the Trust’s ability to invest in line with its capital plan, estates and digital strategies and in transformation initiatives. • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2023/24, the Trust saw continued increased demand for its services, particularly in the Emergency Department In addition, the number of patients having no clinical criteria to reside in hospital, but unable to be discharged due to a lack of appropriate care packages was higher than anticipated and spiked during winter, which significantly impacted patient flow through the hospital and required the Trust to engage additional temporary staff. The number of patients in this category peaked at 270 during the winter. There were particular challenges in respect of those patients with a primary mental health care need who would be better cared for in a more suitable alternative setting. 16 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The Trust continued to experience high demand for its services, especially in the Emergency Department, with average demand during the year being around 375 patients presenting per day in the main adult and children’s emergency department. In addition, the Trust experienced a significant impact on flow within the hospital due to a high number of patients having no clinical criteria to reside in hospital but unable to be discharged. This number was as high as 270 at times during winter: an increase of around 50 patients when compared to the prior year. The Trust also saw an increase in the number of referrals with the number of patients on a waiting list under the 18-week Referral to Treatment pathway rising from approximately 55,000 to 58,000 by the end of the year. In common with other trusts, the ongoing industrial action also impacted the Trust’s ability to provide urgent care and deliver on its elective recovery programme. Quality and compliance Despite the challenges, the Trust’s Emergency Department performance was one of the highest in England in March 2024, which resulted in additional capital funding being awarded. In addition, the Trust’s elective recovery performance was one of the best in England at 118% compared to 2019. The Trust continued to monitor the quality of care delivered throughout 2023/24 through a number of established quality assurance programmes. Clinical leaders monitored key quality, safety and patient experience indicators such as falls, pressure ulcers and venous thromboembolisms. Quality peer reviews were carried out, most significantly through Matron-led Quality Walkabouts every week in and out of hours focusing on the five key CQC questions – safe, effective, responsive, caring, and well-led. The Trust’s Clinical Accreditation Scheme builds on this intelligence, with clinical areas completing self-assessments of performance and review teams completing onsite visits. Patient representatives were included in these review teams. Learning was shared at the Clinical Leaders’ Group and via quarterly reports. The Trust was an active partner in a South-East accreditation network, offering advice and a steer to providers who are just setting up or looking to develop their own scheme, and extended that advice and support to other providers in England. 17 On 15 May 2023, the CQC inspected the maternity and midwifery service at Princess Anne Hospital as part of their national maternity inspection programme. The inspection report was published 11 August 2023, and the Trust retained its overall rating of ‘good’. This year UHS introduced its Fundamentals of Care (FOC) initiative. Whilst this is not a new concept, there were concerns that missed fundamental care had been amplified during the COVID- 19 pandemic. This initiative aims to empower and educate staff at all levels to ensure fundamental care is at the heart of what the Trust does. The Trust completed its transition to the Patient Safety Incident Response Framework (PSIRF) and collaborated with the ICB to develop a PSIRF plan and policy to underpin the change. The Trust implemented the requirements in respect of ‘Martha’s Rule’ where patients, relatives and carers have a legal right to a rapid review by a critical care outreach team during an acute deterioration episode in and out of hours. The Trust continued its focus on infection prevention and control, responding rapidly to rises in infection over the winter, and successfully flexing initiatives and innovations to achieve successful management in a responsive manner. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of further quality improvement projects. This included improvements across theatres, inpatient flow and outpatient programmes. During the year, average length of stay was reduced by 1.64%, day theatre cancellations were reduced by 200, and 42,350 patients were placed onto Patient Initiated Follow Up (PIFU) pathways. Further information can be found in the Quality Account. Partnerships The Trust works within the Hampshire and Isle of Wight Integrated Care System, and is an active member of a number of partner groups including the Acute Provider Collaborative Board and the Health and Wellbeing Board. The Trust develops and agrees its annual financial plans with the Integrated Care Board. The Trust is a member of a number of specific partnership groups for particular services, including the Central and South Genomics Medicine Service, the Children’s Hospital Alliance and the Southern Counties Pathology Network. The Trust works actively as a partner with other provider organisations around clinical networks, particularly with acute Trusts within the Integrated Care System and others closely located geographically. The Trust also links closely with the University of Southampton on a number of topics including research, commercial development and education and has a developed meeting structure to oversee this. 18 Workforce The Trust’s key areas of focus during 2023/24 were in respect of increasing the substantive workforce whilst also reducing reliance on bank and agency usage, and reducing staff turnover and sickness. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 331 whole-time equivalents above its plan for 2023/24. The Trust was successful in reducing staff turnover from 13.5% in 2022/23 to 11.4%, achieving the local target of . Cancer Waiting Times - 2 Week Wait Performance Cancer Waiting Times - 2 Week Wait Performance 100% 90% 80% 70% 60% 50% 40% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance % standard met The national target was for 96% of patients to commence treatment within 31 days of diagnosis. In March 2024, the Trust achieved 92% and performed in the range of 86%-94% throughout the year. The Trust has continued to make progress against the target for treatment of cancer within 62 days of an urgent GP referral, improving performance from 64% in April 2023 to 76% in March 2024 (NHS average: 69%). First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performanceUHS vs. NHSE average Cancer waiting times 31 day RTT performance UHS vs. NHSE average 96% 94% 92% 90% 88% 86% 84% 82% 80% 78% 76% Apr-23 May-23 Jun-2 3 Jul-2 3 Aug-23 Sep-2 3 Oct-23 Nov-2 3 Dec-23 Jan-24 Feb-2 4 Mar-24 Performance NHS Average 27 Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average % standard met 1 00% 80% 60% 40% 20% 0% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance NHS Average 28 Quality priorities Priorities for improvement 2023/24 Last year the Trust continued its ambition to deliver the highest quality care shaped by a range of national, regional, local, and Trust-wide factors. During the year the Trust continued to experience unprecedented demand on its services, with flow, capacity, infection prevention and safety all presenting challenges. However, the Trust was confident in its ability to keep a focus on its quality priorities, and its teams worked hard to achieve their goals even in these difficult circumstances. Priorities are aligned to the three core dimensions of quality: • Patient experience – how patients experience the care they receive. • Patient safety – keeping patients safe from harm. • Clinical effectiveness – how successful is the care provided? Out of the six priories set, the Trust achieved five and partially achieved one. Overview of success Quality Priority One Improving care for people with learning disabilities and autistic (LDA) people across the Trust. Supporting staff delivering this care. Outcome against goals: achieved Key achievements: • LDA working group reestablished. • Development of an improvement plan using the NHS Learning Disability Improvement standards. • The LDA team has moved to the virtual enhanced care group in Division B where operational and governance support, leadership, and peer support/learning opportunities has been strengthened. • Sensory Boxes have been introduced for all clinical areas, funded by the Hampshire and Isle of Wight (HIOW) Integrated care board (ICB). These boxes include noise cancelling headphones, fidget toys, communication books and visual cards to support patients and wards. • Recruited additional Learning Disability Champions. • Established links with the parent carer forum (PCF) for the local area and are now attending regular events. A representative from the PCF sits on the LDA working group. The LDA team are working with the Trust lead for patient experience to develop this aspect of the LDA workplan over the next year. Quality Priority Two Supporting patients, service users and staff to overcome their tobacco dependence via a smoking cessation programme. Outcome against goals: achieved Key achievements: • Package of support available to patients who may be smokers and who need to be supported not to smoke during their treatment. • Fully trained team of tobacco advisors working in the hospital and an advisor working in the outpatient setting supporting the patients once they have returned home. • Devised the IT changes the Trust would like to implement to improve its service and referral process. • Recruited 30 smoke-free champions. • Successfully supported 1,131 patients with a self-confirmed quit rate of 45.6% at 28 days. • Supported 109 outpatients who have successfully achieved a 60% quit rate. • On track to achieve the goal to go smoke-free by April 2024 including the removal of smoking shelters. 29 Quality Priority Three Ensure carers are fully supported, involved, and valued across all our services by developing the carers support service across the Trust in partnership with Southampton Hospitals. Outcome against goals: partially achieved Key achievements: • Carers now have a more comprehensive package of concessions and vouchers to help support their cared-for person (e.g. free parking available onsite for blue badge owners is now available). • Listening events were held to put patients at the centre of transforming the way we deliver care is delivered, enabling their voices to improve the quality of care and outcomes for all. • Developed joint working with local partners (e.g. Children’s Society and No Limits to support young carers). Not yet achieved: • The ‘pathway to support, has not yet been developed. Work is ongoing to develop a new strategy. • A charity-funded carers’ support worker has not yet been appointed. • The carers’ training package has not yet been relaunched. Quality Priority Four Put patients at the centre of transforming the way care is delivered, enabling their voices to improve the quality of care and outcomes for all. Outcome against goals: achieved Key achievements: • Work has continued to work across corporate and divisional services to embed patients and carers into quality and service improvement, creating new patient groups (e.g. Mesh Support Group). • Successfully developed our engagement with various local communities, working to ensure that a range of care experiences are considered ( e.g. there is now a Gypsy, Roma, and Irish Traveller community health liaison officer to ensure that these communities are engaged with and brought into work to improve the inclusivity of our services). • Attending multiple public engagement opportunities (Young Carers’ Festival, Mela, University Freshers’ Fayres, Carers’ Listening Lunch, Hoglands Park Play Day, visits to local temples and ‘Love Where You Live’). • Youth and Young Adult Ambassador involvement has increased, including attendance toat meetings of the Council of Governors, and supporting hospital projects. • A Celebration of Carers Week and Volunteers Week were run. • The Trust has analysed its reported outcome measures to identify health inequalities in its services. This information has been used to set a new quality priority for 2024/25. • An SMS friends and family test text survey has been introduced to improve the response rate on patient feedback from the Emergency Department. In the first three months following the survey launch, responses increased from 24 to 424. 30 Quality Priority Five To develop the Trust’s clinical effectiveness process, connecting to the Trust’s Always Improving approach to measuring, understanding, and using outcomes to improve patient care. Outcome against goals: achieved Key achievements: • The Trust has developed its clinical effectiveness process across the Trust with involvement of informatics, governance and management teams, clinical effectiveness leads as well as reporting committees. • Patient representation onhas been included in the clinical assurance meeting for effectiveness and outcomes (CAMEO) to ensure conversations focus on what matters to patients. • The CAMEO template has been changed to focus discussions on areas the specialty is proud of (strong or improving outcomes), areas for improvement (poorly benchmarked or worsening outcomes) and planned actions. • The Trust encourages the use of run and/or statistical process control charts along with benchmarking where available. • Details of NICE and quality standards and national and regional reviews are included to cover breadth of clinical effectiveness. • How the clinical effectiveness team works has been reorganised, aligning each of them to each division giving a named link which helps to deepen understanding and improve links with governance and improvement activities locally. • Working with informatics to establish a core set of clinical outcome measures which are meaningful to patients, which can be reported centrally (starting with surgical specialities). • Starting to develop an education strategy and platform to support staff with a number of tools used in clinical effectiveness as well as clarity on where and how to record and evidence audit and service improvement. • A revised strategy has been drafted. Quality Priority Six Developing a culture where all clinical staff have a basic knowledge of diabetes. Outcome against goals: achieved Key achievements: • Launch of the ‘Start with the Diabasics’ Initiative, designed to help give diabetes visibility across UHS. • Delivered an extensive education programme to clinical staff across the professions and bands, including the introduction of some e-learning and a Diabasics introductory video has been shown at all trust staff inductions since July 2023. • Supported the development of 45 diabetes link nurses, resulting in all ward areas now having a named diabetes link nurse. • Improved triage for referrals. • Established processes for ‘lessons learned’. • Developed IT solutions to improvingimprove alerts and guidance. • A ‘Ketone Wednesdays’ initiative has been created in response to overuse of blood ketone testing (estimated waste cost of £100,000 per year). • The Trust’s lead diabetes specialist nurse and the Diabasics Initiative were both shortlisted for National Quality in the Care Diabetes Awards (October 2023). • The Diabasics Initiative was mentioned as a case study on the Diabetes UK charity website as an example of good practice that could be reproduced elsewhere. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2024/25, in the Trust’s Quality Account for 2023/24. 31 Financial performance The Trust delivered a deficit of £4.5m from a revenue position of over £1.3bn, following receipt of £24.6m one-off cash support from NHS England. UHS started the year with an underlying deficit as a result of a number of cost pressures, notably demand for services being above block contract levels and the cost of national pay awards being above funded levels. The Trust has also continued to face a number of pressures, including high numbers of patients who no longer meet the criteria to reside in the hospital, and high demand for patients with a primary mental health need. In 2023/24, the Trust delivered a record savings level of £63.4m (5%) across a range of programmes. Trust operating income rose by £107m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Trust operating expenses rose by £89m, incorporating funded inflationary costs as well as costs relating to the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investment of over £75m, including investment in new wards, theatres, decarbonisation, digital infrastructure, neonatal expansion and backlog maintenance. Trust cash and cash equivalents finished the year at £79m, a reduction of £24m from the previous year due to the operating loss and capital investment outlined above. Whilst liquidity remained strong in 2023/24 supported by NHS England cash support, the underlying financial deficit means it is likely to decline further in 2024/25. The Trust is continuing to monitor its cash position closely and is considering whether additional cash support may be required in 2024/25. Sustainability The Trust recognises that everyone has a part to play in responding to the climate crisis. In March 2022, the Trust agreed its own green plan in response to the challenge of the NHS becoming the world’s first health service to reach carbon net zero. Now in its third year, the plan identifies the Trust’s key areas of focus and its ambitions and has seen progress across all areas of the plan. The plan sets out the scale of the challenge, the Trust’s commitment to reducing the impact on the environment and the steps to be taken across the following categories: • Estates and facilities • Clinical and medicines • Digital transformation • Supply chain and procurement • Travel and transport • Waste and resources • Food and nutrition • Adaptation • Biodiversity • Wider sustainability The Trust continues to progress through its green plan and has completed the ‘Greener NHS’ reporting tool for several quarters, which has demonstrated good progress. In addition, the Trust is planning to launch its ‘Our Sustainable UHS’ app for staff, which will give tips on sustainability and create personalised travel plans, including identifying potential contacts for car sharing. In addition, the Trust is considering proposals to implement additional solar power, smart metering and expanding the use of LED lighting. 32 In 2022/23, the Trust was successful in bidding for £29.4m of funding through the Public Sector DeCarbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. During the year the Trust successfully bid for £823k in National Energy Efficiency Funding which has been used to upgrade the lighting at Princess Anne Hospital. Social, community, anti-bribery and human rights issues The Trust recognises its responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK). These rights include: • right to life • right not to be subjected to inhuman or degrading treatment or punishment • right to liberty and freedom • right to respect for privacy and family life. These are reflected in the duty, set out in the NHS Constitution, to each and every individual that the NHS serves, to respect their human rights and the individual’s right to be treated with dignity and respect. The Trust is committed to ensuring it fully takes into account all aspects of human rights in its work. An equality impact assessment is completed for each Trust policy. For patients, the Trust’s safeguarding policies protect and support the right to live in safety, free from abuse and neglect and other policies and standards are designed to optimise privacy and dignity in all aspects of patient care. Feedback from patients and the review of complaints, concerns, claims, incidents and audit help to monitor how the Trust is achieving these objectives. The Trust’s green plan, approved by the board of directors in March 2022, recognises the Trust’s broader role and responsibility to address the issues of climate change, air pollution, waste and environmental decline present to the city of Southampton and the impact that these issues have on the health and wellbeing of the local population served. Although the Modern Slavery Act 2015 does not apply to the Trust, its green plan sets out an ambition to stop modern slavery. The Trust is also committed to maintaining an honest and open culture within the Trust; ensuring all concerns involving potential fraud, bribery and corruption are identified and rigorously investigated. The Trust has a Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Raising Concerns (Whistleblowing) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. Anti-bribery is part of the Trust’s work to counter fraud. This work is overseen by the Audit and Risk Committee, which receives regular reports from the local counter fraud specialist on the effectiveness of these policies through its monitoring and reviews, providing recommendations for improvement, as well as an annual report from the freedom to speak up guardian. You can read more about the work of the Audit and Risk Committee and the Trust’s approach to counter fraud in the Accountability Report. Events since the end of the financial year There have been no important events since the end of the financial year affecting the Trust. Overseas operations The Trust does not have any overseas operations. 33 Equality in service delivery NHS trusts have an essential role in tackling health inequalities, both as part of the services they provide, but also through work with the wider system. By working with those in integrated care systems, local authorities and third sector organisations, the Trust can have a significant impact on the health of the local population. The national focus on health inequalities is growing. This comes with new legal duties around reporting information and expectations to report on improvement programmes. In September 2023, a health inequalities steering group was initiated, under the leadership of the Chief Medical Officer, with representation from clinical, operational, transformation, patient experience, research, organisational development and culture, informatics, public health and the Integrated Care Board. The group focused on scoping future priorities aligned to national guidelines, contractual obligations and priorities, regional priorities, feedback from clinical teams and patients, understanding where action is already being taken, and what the data is showing. Overall, the group
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