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Serious Adverse Events and Reactions (SAEARs) management

Serious Adverse Events and Reactions (SAEARs) management. 21 October 2010 Dr Christiane Niederlaender. Overview. SAEARs systems required at TEs reporting to the HTA an introduction to the severity grading tools internal investigation assessing cases. Definitions - summary. Reactions :

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Serious Adverse Events and Reactions (SAEARs) management

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  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!

  9. 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

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

  11. 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

  12. 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

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

  14. Reportable? YES NO YES YES YES

  15. 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

  16. 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.

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