Transcript VigiBase Magnus Wallberg Senior Systems Architect M Sc Engineering Physics November 24th 2009 Dar Es Salaam, Tanzania [email protected].

VigiBase
Magnus Wallberg
Senior Systems Architect
M Sc Engineering Physics
November 24th 2009
Dar Es Salaam, Tanzania
[email protected]
Agenda of this block
• Who is that guy standing in front of you
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VigiBase
WHO-ART
WHO Drug dictionary
VigiSearch
• Live VigiSearch demo
Magnus Wallberg, UMC
09:00
09:40
10:45
11:30
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09:40
10:15
11:30
12:00
VigiBase
(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
VigiSearch/
VigiMine
MedDRA
Custom Searches
WHO database
VigiBase
WHO Drug
Dictionary
WHO-ART
E2b
Intdis
Eudravigilance
Home-built
tools
Home-built
tools
Win ADR
National Centre
VigiFlow
Magnus Wallberg, UMC
National Centre
(simple entry tool)
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
Parent?
Drug 1
Drug 2
Drug 3
Relationship(s)
(Possibly nine
different)
ADR 1
ADR 2
ADR 3
Test 1
Test 2
…
Magnus Wallberg, UMC
Result 1
Result 2
Result 1
Result 2
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’
• CIOMS forms
None of those are
accepted by the UMC
• MedWatch
Electronic media
• INTDIS format (text files)
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 level
 Causality assessment on case
level
 Limited data on a case
All ICSRs are converted
into E2B format during
import to VigiBase!
E2B
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Outcome – ADR level
Causality assessment on ADR/drug level
Parent child / fetus reports
Linked reports
Literature cases
Suspected duplicate
Report nullification
Lab values
Free 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
 Prescription
 OTC
• 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
WHO database
VigiBase
VigiFlow
VigiSearch/
VigiMine
E2b
Home-built
tools
Intdis
Magnus Wallberg, UMC
Transmitting reports to the
UMC is only one of the functions
within the VigiFlow system
Data entry and
assessment
Report import (E2b)
Search and
statistics
VigiFlow
database
Submission
management
Report export (E2b)
Capability of country wide reporting mechanisms
In all a complete management system!
Magnus Wallberg, UMC
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 88
E-mail: [email protected]
Website: www.who-umc.org