Pharmacovigilance Workshop 2728 May 2002 Madrid, Spain

1
Pharmacovigilance Workshop27-28 May 2002
(Madrid, Spain)

• Breakout Session 1
• Ideal Reporting Scheme
• Chair E. De Ridder
• Rapporteur D. Murphy

2
1. Routes of reporting (1)

• Advantages and disadvantages
• MAH only
• Reg. Authority only
• Both routes
• Option of both routes preferred
• Facilitate submission of reports
• More cooperation, collaboration rapid transfer
  of information
• should be working on the same information
• Increased confidence in system
• Remove duplicates
• Should not be a legal obligation to the vet (Nat.
  leg.)
• All reports should not go just via the EMEA

3
1. Routes of reporting (2)

• Anonymous reports NO
• No follow-up, no validation or causality check
• Of low value
• Open to abuse
• Quality of reports
• companion animal owners
• Farmers (more experienced)
• Vets (more knowledgeable)
• Reporting forms
• Need standardised approach to allow comparisons
• Use different forms at different levels
• Simplicity easy to fill in, easy to assess
• But simple forms less data more follow-up
  needed

4
1. Routes of reporting (3)

• Feedback
• Immediate feedback to vet/reporter
• Strong need for this to encourage reporting
• Must be more than just acknowledgement of receipt
• How the case will be handled
• Cannot give too much info, e.g. causality
  assessment or whether there will be an
  investigation
• Regular reports of analysis of data
• Increase awareness of the whole PHV process

5
2. Third country reporting

• How do Reg Auth use them
• Report to a single site (only to EMEA?)
• Expected ADR from the perspective of the local
  SPC
• Only to EMEA different national SPCs cannot
  classify
• VICH recognised 3rd country reporting required
  in EU
• 15 day deadline from the date MAH is informed

6
3. Electronic reporting

• Paper option will be kept
• Web based system should be developed
• Validation, electronic signature, registered
  users
• Down loading forms an asset
• Should increase the level of reporting
• Cost implications must be investigated
• Need to improve implementation of basic system
  across all MSs first

7
4. Timing and frequency

• How can we meet 15 days for SAEs?
• MAH should try to meet the 15 days
• Send a follow-up report
• If 15 is not possible give an explanation
• Reg. auth. prefer to be informed immediately
• e.g. send immediate notification with existing
  information, and follow-up with a full report
• E.g. send information as soon as it is checked,
  but do not wait for lab analysis report
• Reg. auth. will not be inflexible partnership

8
4. Timing and frequency

• 6 month reporting
• Authorities want this
• Industry perception
• Often of no value no market penetration
• Should be first 6 months from start of marketing?
• Could be mis-leading, 1st 12 months could be
  better
• First 6 months stocking the chain, hi sales,
  low use very low incidence
• Second 6 months, distribution chain stocked, low
  sales, but now high use high incidence
• This should be explained in the 6 month report
• Different marketing dates in other MSs

9
4. Timing and frequency

• 5 year reporting
• 3 years proposed in the Review, in conjunction
  with deletion of 5-year renewal
• If 5-year renewal retained, keep 5-year PSURs
• International birth date
• This is needed for national authorisations
• All parties agreed this is preferred