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

2. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Important points

6. Recommended usage

7. Report Handling - advanced Magnus Wallberg, UMC

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

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

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

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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. Magnus Wallberg, UMC Admin chapter This button open up the “Admin chapter”

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20. Search and Statistics

21. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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

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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

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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. Magnus Wallberg, UMC Query interface Select profile Add search parameters Run query!

29. Magnus Wallberg, UMC Run the querySave the query Name and description only needed if the query is saved

30. Magnus Wallberg, UMC 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 Ingredient /Base Salt/EsterBrand nameMedicinal product Paracetamol-Alvedon500 mg Tablets Paracetamol-AlvedonFluid Paracetamol-AcetamolTablets ParacetamolParacetamol sodium AcetasodIntravenous ParacetamolParacetamol hydrocloride AceclorideUnspecified Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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. Magnus Wallberg, UMC 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

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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

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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

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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

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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

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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. Magnus Wallberg, UMC Use the tabs to see different statistical numbers Expand and hide the tree with the “+” and “-” signs

48. Magnus Wallberg, UMC 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

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50. Excel output

51. Magnus Wallberg, UMC Excel output By clicking “generate Excel” an Excel file is created that can be downloaded locally The Excel file is generated on XML format Client requirements for Excel –Microsoft Office 2003

52. Magnus Wallberg, UMC Excel - structure All generated Excel files stores data in different sheets: –One query sheet –Multiple data sheets With details Or With other views of the data

53. Magnus Wallberg, UMC Excel – first example A query has been executed with the profile “Report listing” The excel file has the following content –One query sheet describing the query –One report sheet containing one row with information on every report in the result –One drug sheet with details of all drugs –One reaction sheet with details of each reaction Reactions and Drugs are linked to the report via the report number

54. Magnus Wallberg, UMC The content is located on different sheets

55. Magnus Wallberg, UMC Each report is listed only once

56. Magnus Wallberg, UMC On the drug and reaction page there is one row per drug/reaction

57. Magnus Wallberg, UMC Excel – second example A query has been executed with the profile “Summary of reported ADRs” The excel file has the following content –One query sheet describing the query –One sheet with reactions summarized by year –One sheet with reactions summarized by relatedness/causality –One sheet with reactions summarized by gender

58. Magnus Wallberg, UMC Each summary is located on a separate sheet

59. Magnus Wallberg, UMC Usage example

60. 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: info@who-umc.org Website: www.who-umc.org