magnus wallberg senior systems architect m sc engineering ... · magnus wallberg senior systems...
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Magnus WallbergSenior Systems ArchitectM Sc Engineering Physics
November 24th 2009Dar Es Salaam, Tanzania
VigiBase
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
Magnus Wallberg, UMC
VigiBase(WHO ICSR database)
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
Magnus Wallberg, UMC
National Centre
E2b
National Centre
Intdis
Home-built tools
Eudra-vigilance
VigiFlow
MedDRA WHO database
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
Report (ICSR) Patient
Background 1Background 2
Background 3
Drug 1Drug 2
ADR 1ADR 2
ADR 3
Relationship(s) (Possibly nine different)
Test 1 Result 1Result 2
Test 2 Result 1Result 2
…
Parent?Drug 3
Magnus Wallberg, UMC
Cumulative number of correct reports processed per year
Reporting formatsMagnus Wallberg, UMC
Magnus Wallberg, UMC
Reporting formats
INTDIS – (International Drug Information System)• 41 countries
E2B – (ICH standard)• 53 countries
So – what’s all this about formats?
WHO Format
Paper formats
• ’Yellow cards’
• CIOMS forms
• MedWatch
Electronic media
• INTDIS format (text files)
None of those are accepted by the UMC
E2B-format
• 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
ICH ;International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Magnus Wallberg, UMC
WHO- versus E2B-format
WHO
Outcome – case levelCausality assessment on case levelLimited data on a case
All ICSRs are convertedinto E2B format duringimport to VigiBase!
E2B
Outcome – ADR levelCausality assessment on ADR/drug levelParent child / fetus reportsLinked reportsLiterature casesSuspected duplicateReport nullificationLab valuesFree text fields: Patient medical history, case narrative, labelling info, reporter’s comment, sender’s diagnosis, sender’s comment
What to Report to the UMC?
• Serious and Non-serious cases• Conventional medicines
PrescriptionOTC
• Traditional medicines• Biologicals including vaccines
Do NOT report:• Veterinary medicines• Cosmetic/hygiene products
• Foreign cases
Brand name!
Reporting of Brand Names
Fluoxetine (Eli Lilly)
• FDA - USA Prozac®
• MPA - Sweden Fontex®
Flow of ICSRs
Magnus Wallberg, UMC
WHO database
VigiSearch/ VigiMine
Transmitting reports to the UMC is only one of the functions within the VigiFlow system
Magnus Wallberg, UMC
Data entry and assessment
Data entry and assessment
VigiFlowdatabase
Search and statistics
Search and statistics
Submission managementSubmission
management
Report import (E2b) Report export (E2b)
Capability of country wide reporting mechanismsCapability of country wide reporting mechanisms
In all a complete management system!In all a complete management system!
Some VigiBase statistics and comments
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 88E-mail: [email protected]
Website: www.who-umc.org