Magnus Wallberg Dar Es Salaam, Tanzania November 25 th , 2009

1. VigiFlow - advanced concepts Magnus Wallberg Dar Es Salaam, Tanzania November 25th,2009 magnus.wallberg@who-umc.org

2. Agenda • VigiFlow – advanced concepts • General remarks • Report handling - advanced • Search and Statistics • This will not be presented but are left for reference … a live demo will be made instead

3. Advantages - (general aspects) • Less delay in ADR reporting • Sending a report is as fast as a mouse click • Improved report quality • Error checks and lexicons • Help texts • Mandatory fields • Outputs in several formats • E2B, PDF, Excel

4. Advantages - (technical) • Internationally recognised standards • E2B report format • WHO-ART and ICD or MedDRA • WHO Drug Dictionary • One server installation – maintained in Uppsala • No local installation needed • Immediate access to new versions of both VigiFlow and terminologies/dictionaries • Sharing of costs and ideas • Development and maintenance

5. Important points • VigiFlow is a web based report management tool that simplifies report management. • VigiFlow can be used by any authority or company as a complete database for report management and storage. • VigiFlow is not primarily a tool for reporting to the UMC, but reports can easily be sent through the system. • There is a Limited Access version that do not work as a complete report management tool, but it is free of charge for member countries for sending reports to the UMC.

6. Recommended usage

7. Report Handling - advanced

8. Main parts: report handling • This is what we went through in previous module…

9. Main parts: search & statistics • Advanced searches and statistical analyses of committed (finalized) reports • NB: only the organisations “own” reports • Management of committed reports • Only “closed” reports • Committed reports • Also nullified or history marked reports • Open a committed report for follow-up or amendment

10. Main parts: tools • Import and export of reports in E2B format • history of report imports • Keep track of contacts • organisations that you communicate with • Keep track of submissions • reports that will be sent • reports that have been sent

11. Advanced concepts • To build on yesterdays country presentations I would like to mention some core features of VigiFlow, which if used can: • Improve communication • Spread pharmacovigilance interest country wide • Change VigiFlow focus for the National Authority from data management to analysis

12. Use Regional Centres! • VigiFlow is, as already pointed out, built to facilitate the use of Regional Centres (RCs) • The users at the RC access VigiFlow and enter the reports • The report is sent (within VigiFlow) and appears in the “List of reports under assessment” at the National Centre (NC) • The NC assesses the report and commits it • The report will be searchable for both the NC and the users at the RC • Regional Centres is extensively used by the Swiss Medical Authority (Swissmedic)

13. Advantages of using Regional Centres with VigiFlow • The RCs will be more “involved” • The awareness and knowledge of PV is spread • Data entry is done at the RCs • Less need for data entry work at the NC • No handling of paper forms • Paper forms can be archived at the RC • Search and Statistics directly available for the RCs • Easy to send reports “back” to RC for follow up or corrections • Using the “send” function in VigiFlow

14. Report list at Regional Centre No filter! Only the send option, not commit! List with reports under NC assessment from the RC!

15. Report list at National Centre Tick one RC to see only reports from that RC Tick this to see the reports located at the RC

17. Admin chapter • Can be used to: • Add extra comments that do not belong on the report • Mark a report for close surveillance • Add sender information • Add receiver information • To facilitate submission management • Link reports • To indicate cases with some kind of relationship To add senders and receivers – those must first be added to the address book

18. Admin chapter This button open up the “Admin chapter”

20. Search and Statistics

21. Search and Statistics • Under the Search and Statistics menu all committed reports are found • there are two retrieval options for committed reports • List reports • Search and Statistics

22. List reports • Use “list reports” when you know what report to retrieve based on: • Receive date • Report Id or • Report title • Extended options described later • The reports will be presented in a list

24. List reports – expanded • The “list reports” tool can also be expanded to include • Reports under close surveillance • Sender • Sender must be added from contact list • Sender’s report number – exact match • World Wide Unique (WWU) number – like search • … and a number of new fields in v 4.1 • All the searchable fields except WWU number are entered in the administrative module

27. Search and Statistics • Search on “own” reports • Reports must be committed to be available in the Search and Statistics tool • Predefined output types (profiles) • Line listings • Statistics • Results can be exported to Excel for local analysis • Often used queries can be saved and reused

28. Query interface • Select profile • Add search parameters • Run query!

29. Name and description only needed if the query is saved Run the query Save the query

30. Search criteria - drug • Drugs added • List of drugs to search for • Drug level • Active substance – reports with any product with the same substance combination as the selected drug will be included in result • Trade name (excluding form/strength) – reports with any product with the same trade name (and substance combination) as the selected drug will be included in result • Medicinal product (including form/strength) – only reports with the same trade name form and strength as the selected drug will be included in result • Drug operator • or – one of the drugs must be present on the report • and – all drugs must be present on the report

31. An example 1 2 3 4 1 – Search on medicinal product level 2 – Search on brand name level 3 – Search on Salt/Ester level 4 – Search on base ingredient level

32. Search criteria - reaction • Reactions added • List of reactions to search for • Reaction level • SOC – reports with any reaction with the same SOC as the selected reaction will be included in result • Preferred – reports with any reaction with the same preferred term as the selected reaction will be included in result • Included – only reports with the same included term will be included in result • Reaction operator • or – one of the reactions must be present on the report • and – all reactions must be present on the report

33. Search criteria – other Other search criteria are: • Type of report • Country of primary source • Serious • Labeled • Sex In addition it is possible to specify whether or not to include concomitant drugs in the search

34. Profiles • Several statistical profiles easily accessible • Possible to look at a query result from different angles • Predefined by the needs of organizations and companies • If the profiles are not enough: • Possibility to add new profiles • A request must be made to the UMC for implementation • Build your own based on the Excel export

35. Profiles • The following profiles are currently available in VigiFlow • Report listing • CIOMS line listing • Summary tabulation • Drug reaction profile • Summary of products • Summary of reported ADRs • Summary of reported drugs

36. Profiles Report listing: • A detailed list of reports with • Report information • Drugs • Reactions • Access to a single report • Possibility to print selected reports • Possibility to export on Excel format

38. Profiles CIOMS line listing: • A detailed list of reports for a specified drug with • Report information • Reactions • Sorted by System Organ Class • Based on most important reaction • Access to a single report • Possibility to print selected reports

40. Profiles Summary tabulation: • A summary of reactions for a specified drug; the summaries are based on • System Organ Class and Preferred Term • Type of report • Possibility to export on Excel format

42. Profiles Drug reaction profile: • A summary for a specific drug containing: • Number of reports • Possibly related reactions • Unlikely reactions • Unclassified reactions • Fatal reports • Reported drugs • Generic drugs

44. Profiles Summary of products: • A summary of all reports (no search criteria necessary) grouped on substance combinations and drugs • In detailed view, all reports for each listed drug are shown with all drugs and reactions with relatedness and outcome • Access to each single report • Possibility to export on Excel format

46. Profiles Summary of reported ADRs: • Summary of all reactions grouped by System Organ Class, Preferred term and Included Term • Summary based on: • Year • Relatedness • Gender • Possibility to export on Excel format

47. Use the tabs to see different statistical numbers Expand and hide the tree with the “+” and “-” signs

48. Profiles Summary of reported drugs: • Summary of all reactions grouped by Substance combinations and Drug • Summary based on: • Relatedness • Gender • Summary of all reactions grouped by System Organ Class, Preferred term and Included Term • Summary based on • Drugs • Possibility to export on Excel format

50. Excel output