Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain

1
PharmacovigilanceWorkshop27-28 May 2002
(Madrid, Spain)

• Breakout Session 2
• Handling of Cases and Analysis
• Chair B. Freischem
• Rapporteur D. ORourke

2
1. Reporting of cases

• Motivation for vet to report
• Reasons for lack of reporting
• Culture/ Member States dependingfinancial
  interest (), scientific interest
• lack of education of vet. students/ vet
• lack of understanding of benefit
• Proposalsincrease awareness of system and its
  benefit to vets through authorities and industry
  to increase number and quality of reporting

3
2. Investigation / Data quality

• For successful investigation immediate
  information on ADR to the MAH is of major
  importance incl. (if possible) contact details of
  the reporter, however anonymous reporting should
  be possible, to a restricted degree
• Proposal Co-ordination of ADR reports between
  MAH and authorities (information flow) is
  important to allow for optimal investigation and
  causality assessment and to avoid duplicated
  reporting

4
3. Analysis of cases

• A need for better harmonisation of criteria for
  analysis and assessment of cases between Member
  States authorities has been identified
• CVMP is in process of discussing how analysis
  should be carried out and to come up with
  harmonised criteria
• CVMP is reviewing the PhV GL to clarify the
  requirements as toenvironmental safety, residue
  violation, lack of efficacy

5
3. Analysis of cases

• CVMP is in process of establishing guidance on
  definition of  signal, action triggers ,
• and on calculation of  incidence rate ,
  emphasising the need to include sales volumes per
  member state
• Early input into these discussions from industry
  experts at national and European level was
  stressed (e.g. joint discussion group meetings)

6
5. Feedback to veterinarian/owner

• Feedback to reporter (both vet and owner) is very
  important, and should be detailed
• MAH should acknowledge changes of the SPC as a
  result of the analysis and inform the vets
  accordingly
• Inform vet that the improved recommendations for
  the use of the product are due to the PhV system
  (benefit)
• To be done by both MAH and authorities