Serious Adverse Events and Reactions (SAEARs) management

1. Serious Adverse Events and Reactions (SAEARs) management 21 October 2010 Dr Christiane Niederlaender

2. Overview • SAEARs systems required at TEs • reporting to the HTA • an introduction to the severity grading tools • internal investigation • assessing cases

3. Definitions - summary Reactions: • Recipient: death, life-threatening disease, communicable disease, prolonged hospitalisation • Donor: impact on quality and safety, or supply chain, or harm to the donor due to donation Events: • any event associated with licensable activities that could lead to the above

4. What systems should be in place? • SOP covering the reporting of SAEARs - plans for the DI’s absence? • two parties licensed: communications plan - responsibilities • systems to work with third parties • written agreements with end users • end user vigilance !!

5. What systems should be in place? • establishment should be able to manage SAEARs • Verification of report • Record keeping • Internal investigation • Communication with other organisations • Recall • part of internal adverse events management

6. SAEARSReporting Obligations • DI responsible (but can delegate) • includes third party or end user SAEARs • via the HTA website (user name, password) • all notifications followed up by the HTA’s SAEARs team

7. without delay – currently... Report within 24 hours from discovery !

8. The SAEARs team We’re here out-of hours!

10. What should be contained in the report? • initial reports: • as much detail as possible • be as accurate as possible (medical conditions, bacterial strains) • outline follow-up if possible but don’t delay reporting for the sake of gathering additional information! • follow-up: • the results of internal investigation • CAPAs

11. Follow-up why? why? RootCAUSEANALYSIS ? SAEARs why? why? why?

12. RCA and CAPA • define the problem. • gather data/evidence. • ask why • identify corrective action(s) • identify effective solutions that prevent recurrence, • are within your control • do not cause other problems • implement the recommendations • observe to ensure effectiveness

13. What does the HTA do with the information submitted? • follow up each SAE/SAR • initiate proportionate follow up response • issue regulatory alerts and inform other CA if necessary • analyse the information for internal and external use • feedback via the HTA’s annual Summary of Compliance Report • annual report of SAE / SARs to the European Commission • participation in EUSTITE pilot project

14. What the future holds • increase reporting for all sectors and activities • SOHO V&S • looking to build closer ties with professional bodies

15. Reportable? YES NO YES YES YES

17. Triggers for reporting SARs • examples: • transmitted infections - donor to recipient • transmitted infection – contaminated materials • hypersensitivity reactions • malignant disease transferred by material • immunological reaction due to tissue / cell mismatch • aborted procedure involving unnecessary exposure to risk

18. An SAE should be reported to the HTA if: • inappropriate material has been distributed for clinical use • implications for other patients /donors • loss of a significant quantity of unmatched allogeneic tissues or cells • loss of irreplaceable autologous tissues or any highly matched (i.e. recipient specific) allogeneic tissues or cells.