Serious Adverse Event and Reaction reporting

1. Serious Adverse Event and Reaction reporting 25 March 2009 Emyr Harries

2. Aims and outcomes • Provide definitions of Serious Adverse Events and Reactions (SAEARs) • What are the criteria for reporting SAEARs? • When and how should the information be provided to the HTA? • What does the HTA do with the information?

3. Reporting of SAEARs • A statutory requirement of the European Tissues and Cells Directive (EUTCD) (Directive 2004/23/EC, Article 11) transposed into UK law via the • Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Part 4; 19 & 20)

4. What is a Serious Adverse Event (SAE)? • Defined as: “any serious untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissues and cells that may lead to transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which may result in or prolong hospitalisation or morbidity”

5. When should an SAE be reported? • An SAE should be reported to the HTA if: • inappropriate tissues/cells have been distributed for clinical use, even if not used • the event has implications for other patients /donors because of shared practices, services, supplies or donors • the event resulted in loss of irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells • the event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells

6. What is a Serious Adverse Reaction (SAR)? • Defined as: “an unintended response including a communicable disease in the donor or the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity”

7. When should a SAR be reported? • Triggers for reporting (examples, not exhaustive): • transmitted infections (viral, bacterial, parasitic, fungal, prion), donor to recipient • transmitted infection – contaminated materials • hypersensitivity reactions • malignant disease transferred by tissue / cells • unexpected delayed engraftment / graft failure • immunological reaction due to tissue / cell mismatch • aborted procedure involving unnecessary exposure to risk e.g. wrong tissue supplied, discovered after patient is anaesthetised and the surgical procedure has begun

8. Who should report any SAEARs to the licensed tissue establishment? • Licensed establishments should have an agreement in place with end users to ensure that any SAEARs are reported to the licensed establishment • Third party agreements should specify that any SAEARs are reported to the licensed establishment

9. Who should report to the HTA? • The DI has overall responsibility for notifying the HTA of any suspected SAEAR that occur at their licensed premises / premises under a third party agreement or end user establishments • The DI should have a username and password to login and report online • Persons Designated / others may register online for an account

10. SAEARs should be reported via the HTA website

11. What do the HTA do with the information? • The SAEARs team follow up each adverse event / reaction on a case-by-case basis, requiring a follow-up report detailing any corrective and preventative actions • Project in place to use information internally and externally • Feedback via the HTA annual Summary Inspection Reports • Annual report of SAEARs to the European Commission • Participation in EUSTITE pilot project • http://www.eustite.org/

12. Summary • The DI has a statutory responsibility to report any SAEARs to the HTA • This includes SAEARs that occurred at third party or end user premises • Notification should be done via the HTA website • All notifications will be followed up by the HTA’s SAEARs team • Contact us if you require any advice

13. www.hta.gov.uk