Vigibase & VigiFlow by 99P9LdLD



   Magnus Wallberg
Senior Systems Architect
M Sc Engineering Physics
  November 24th 2009
Dar Es Salaam, Tanzania
   Agenda of this block
   • Who is that guy standing in front of you

   •   VigiBase              09:00   -   09:40
   •   WHO-ART               09:40   -   10:15
   •   WHO Drug dictionary   10:45   -   11:30
   •   VigiSearch            11:30   -   12:00

   • Live VigiSearch demo

Magnus Wallberg, UMC
            (WHO ICSR database)

Magnus Wallberg, UMC
   Agenda of this module
   • Generally about VigiBase

   • Different formats for reporting of ICSRs

   • Who reports to the UMC?
   • What to report to the UMC?

Magnus Wallberg, UMC
                                                              Custom Searches

                        MedDRA                 WHO database            WHO Drug
                                               VigiBase                Dictionary

                                               E2b        Intdis

             Eudra-                                                                    Home-built
            vigilance                                                                    tools

             Home-built                                                                 Win ADR
               tools                                               National Centre   (simple entry tool)
                           National Centre


Magnus Wallberg, UMC
   VigiBase – the database
   Core of the data collection done within the WHO Drug
     Monitoring Programme
   • in use for more than 30 years
         – Located in Uppsala since 1978
   • For spontaneous reports
   • maintained by the UMC
   • Relational database with tools for import,
     maintenance and analysis

Magnus Wallberg, UMC
                                 Background 1
                                   Background 2
                                     Background 3

 Report (ICSR)         Patient
                                  Drug 1
                       Parent?      Drug 2
                                      Drug 3             Relationship(s)
                                                         (Possibly nine
                                 ADR 1
                                  ADR 2
                                    ADR 3

                                 Test 1
                                                    Result 1
                                                     Result 2
                                 Test 2
                                                    Result 1
                                                     Result 2

Magnus Wallberg, UMC
   Cumulative number of correct
   reports processed per year

Magnus Wallberg, UMC
Reporting formats
Magnus Wallberg, UMC
   Reporting formats
   INTDIS – (International Drug Information System)
   • 41 countries

   E2B – (ICH standard)
   • 53 countries

   So – what’s all this about formats?

Magnus Wallberg, UMC
            WHO Format
Paper formats

• ’Yellow cards’
                        None of those are
• CIOMS forms           accepted by the UMC

• MedWatch

Electronic media

• INTDIS format (text files)
• ICH E2B standard (xml files)
   Format for transferring data between databases of
   different structure

• Guidelines (WHO, EMEA, ICH...)
   Description of content

• DTD (Document Type Definition)
   Description of file format
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
Magnus Wallberg, UMC
        WHO- versus E2B-format

WHO                              E2B

 Outcome – case level              Outcome – ADR level
 Causality assessment on case      Causality assessment on ADR/drug level
  level                             Parent child / fetus reports
 Limited data on a case            Linked reports
                                    Literature cases
                                    Suspected duplicate
                                    Report nullification
                                    Lab values
All ICSRs are converted             Free text fields:
into E2B format during               Patient medical history, case narrative,
import to VigiBase!                  labelling info, reporter’s comment,
                                     sender’s diagnosis, sender’s comment
 What to Report to the UMC?
• Serious and Non-serious cases
• Conventional medicines
    Prescription
    OTC                           Brand name!
• Traditional medicines
• Biologicals including vaccines

Do NOT report:
• Veterinary medicines
• Cosmetic/hygiene products

• Foreign cases
Reporting of Brand Names

Fluoxetine (Eli Lilly)


• MPA - Sweden
   Flow of ICSRs

                                      WHO database

                       E2b                            VigiMine


Magnus Wallberg, UMC
   Transmitting reports to the
   UMC is only one of the functions
   within the VigiFlow system
            Data entry and         Search and         Submission
             assessment             statistics        management

    Report import (E2b)                              Report export (E2b)

                 Capability of country wide reporting mechanisms

               In all a complete management system!

Magnus Wallberg, UMC
Some VigiBase
statistics and
Country Distribution in VigiBase
Correct and Active ICSRs in VigiBase
   - per million inhabitants and year
Search in VigiBase; November 2004 - November 2009
          - mean per 1,000,000 inhabitants
So why don’t we find all our cases in
VigiBase when using VigiSearch?

…the report is yet not processed into VigiBase

…the report is processed but not active in VigiBase

…the report was rejected due to incorrect format etc.
   The UMC Vigis...
   • VigiBase
         – The WHO ICSR database
         – What was presented here
   • VigiSearch
         – A web based tool to search VigiBase data
         – Separately presented later today
   • VigiFlow
         – A separate tool for National Centres to manage their ICSRs
         – Simplifies the process of sending ICSRs to VigiBase
         – Separately presented tomorrow

Magnus Wallberg, UMC
Magnus Wallberg, UMC
     WHO Collaborating Centre for
     International Drug Monitoring
    Box 1051, SE - 751 40 Uppsala
Sweden Tel +46 18 65 60 60, Fax +46
                        18 65 60 88

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