The RSV season usually runs from October to March each year, whilst the pre-season is typically defined as the months between April and September.

Transcription

1 The RSV season usually runs from October to March each year, whilst the pre-season is typically defined as the months between April and September. A multi-disciplinary team (MDT) meeting at the end of the RSV season can be extremely helpful to evaluate the performance of the Synagis (palivizumab) immunisation programme. These questions will enable a MDT discussion about what worked well and can also identify areas of improvement for the following season, thereby facilitating continuous improvement. You might find it helpful to carry out a survey among the MDT to gain insight into how the pack ran. Alternatively you could use the following series of questions to facilitate a group discussion. Select questions that you feel your MDT would most benefit from or consider addressing themes of questions over a series of meetings. Questions to consider at the MDT meeting include (please tick as appropriate): Eligibility 1. Clear guidelines were available ahead of the RSV season to identify eligible babies for the RSV immunisation clinics 2. Did you have the right tools and support required to help identify eligible babies? 3. The funding process for Synagis (palivizumab) was easy to understand Clinic coverage 4. How many babies were immunised with Synagis (palivizumab) by the close of the RSV season at your clinic?

2 5. Of all the babies immunised with Synagis (palivizumab), how many were born pre-season versus in-season at your clinic? Pre-season In-season 6. Of the total number of appointments scheduled, how many were missed? Missed Total Percentage missed 7. What was the approximate coverage rate for Synagis (palivizumab) immunisation? (numbers immunised versus numbers logged as eligible for immunisation) 100% 90-99% 80-89% 70-79% 60-69% Less than 60% 8. Have you compared your Hospital Trust s coverage rate with that of other Hospital Trusts? Planning and implementation 9. Clinic rooms were booked in a timely manner ahead of the RSV season

3 10. The clinic location met the needs of the Synagis (palivizumab) immunisation programme (e.g. fridge is easily accessible) 11. There were adequate staffing levels for the Synagis (palivizumab) immunisation programme 12. The pharmacy team were notified in sufficient time to ensure availability of Synagis (palivizumab) stock ahead of the first clinic and throughout the RSV season 13. Reminders were sent to parents prior to clinic appointments 14. Follow-up plans were swiftly implemented for parents whose baby missed their appointment (e.g. home visit, scheduled into clinic the following week, etc)

4 15. There were sufficient processes in place to minimise the number of patients who do not attend their appointment (e.g. phone calls, text reminders, etc) 16. Was RSV testing used to confirm start and end of season? Resources and support 17. There were easily accessible tools (e.g. BadgerNet) and records (e.g. log book) to document which babies would be immunised and tracked for the duration of the RSV immunisation programme 18. The MDT meeting held prior to the start of the RSV season, to identify which babies were eligible for Synagis (palivizumab), was effective

5 19. There was adequate training of all staff involved in the Synagis (palivizumab) immunisation clinics 20. A review was conducted to assess RSV-related hospitalisation of high-risk babies who did not receive palivizumab versus those that did receive palivizumab 21. The clinic packs contained material that was applicable to running an effective RSV clinic HCP communication 22. Are you satisfied with the referral and transfer process of eligible babies from your hospital to another unit? 23. Are you satisfied with the referral and transfer process of eligible babies to your hospital from another unit? Date of preparation: June 2015 AXSYN150697g 24. The appropriate healthcare professionals/hospital Trusts were notified of the patients inclusions in the Synagis (palivizumab) clinic Always Most of the time Often Sometimes Rarely Never

6 Prescribing Information Synagis (palivizumab) 100 mg/ml solution for injection Refer to Summary of Product Characteristics (SmPC) for full information Presentation: Single use glass vial containing either 0.5 ml or 1 ml of solution for injection. Each 0.5 ml vial contains 50 mg of palivizumab. Each 1 ml vial contains 100 mg of palivizumab. Both vials also contain histidine, glycine and water. Indications: For prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease who are born at 35 weeks of gestation or less, and less than 6 months of age at the onset of the RSV season, or in children who are less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months, or children less than 2 years of age with haemodynamically significant congenital heart disease. Dose: 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community. Where possible, the first dose should be administered prior to the commencement of the RSV season. Children receiving palivizumab who are hospitalised with RSV should continue to receive monthly doses throughout the RSV season. For children undergoing cardiac bypass surgery, 15mg/kg should be administered as soon as stable after surgery, with subsequent monthly doses throughout the RSV season for those who continue to be at high risk of RSV disease. Refer to SmPC for further information. Administration: Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or 100mg respectively. Do not shake vial. Single-use vial. Do not dilute product. Administer immediately after drawing dose into syringe. Inject dose intramuscularly, using a standard aseptic injection technique, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely because of the risk of damage to the sciatic nerve. The volume (expressed in ml) of palivizumab to be administered at one monthly intervals = [patient weight in kg] multiplied by Injection volumes over 1 ml should be given as a divided dose. Contraindications: Hypersensitivity to the active substance or to any of the excipients, or other humanised monoclonal antibodies. Precautions and Warnings: Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration. In some cases, fatalities have been reported. A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab. A mild febrile illness is not usually a reason to defer administration. Palivizumab should be given with caution to patients with thrombocytopenia or any coagulation disorder. The efficacy of palivizumab as a second course of treatment during an ensuing RSV season has not been established. The possible risk of enhanced RSV infection in the season following treatment has not been ruled out. Assay interference following palivizumab could lead to false-negative RSV diagnostic test results. Do not mix the palivizumab solution and powder formulations. Side-Effects: In clinical studies and postmarketing reports in paediatric patients: Adverse Drug Reactions (ADRs) Very Common ( 1/10); rash, pyrexia. Common ( 1/100 to <1/10); injection site reaction, apnoea. Uncommon ( 1/1,000 to < 1/100); thrombocytopenia, convulsion, urticaria. Frequency not known; anaphylaxis, anaphylactic shock (in some cases fatal). In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain. Refer to the SmPC for further information on side effects. Anti-drug antibody (ADA) responses appear to be of no clinical relevance. Refer to SmPC for full list of side effects. Use in Pregnancy and Lactation: t for use in adults. Overdose: Overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose. Refer to SmPC for further information. Special Storage Conditions: Store in a refrigerator (2-8 C). Do not freeze. Keep the vial in the carton to protect from light. Legal Category: POM. Marketing Authorisation Number and basic NHS price: EU/1/99/117/003 (0.5 ml vial) EU/1/99/117/004 (1 ml vial) Further information is available on request from: AbbVie Ltd, Maidenhead, SL6 4UB, UK. Date of revision of PI: March PI/Synagis Liquid/03 Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to AbbVie Ltd. on ukadverseevents@abbvie.com For more information visit embraceonline.co.uk