Serious Adverse Event and Reaction reporting

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Serious Adverse Event and Reaction reporting

• 25 March 2009
• Emyr Harries

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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?

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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)

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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

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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

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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

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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

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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

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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

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SAEARs should be reported via the HTA website
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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/

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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
  HTAs SAEARs team
• Contact us if you require any advice

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www.hta.gov.uk