VigiFlow - advanced concepts · Advanced concepts • To build on yesterdays country presentations I would like to mention some core features of VigiFlow, which if used can: – Improve

Magnus Wallberg

Dar Es Salaam, Tanzania November 25th, 2009

[email protected]

VigiFlow -advanced concepts

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


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


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


• VigiFlow is a web based report management toolthat 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

Recommended usage

VigiFlow

VigiBaseAutomatic extractionManual entry

VigiFlow database

Report Handling -advanced



Main parts: report handling

• This is what we went through in previous module…


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


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


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


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)


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


Only the send option, not commit!

No filter!

List with reports under NC assessment from the RC!

Report list at Regional Centre


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



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


Admin chapter

This button open up the “Admin chapter”



Search and Statistics


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


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



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




Search and Statistics• Search on “own” reports

– Reports must be committed to beavailable 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


Query interface

• Select profile• Add search parameters• Run query!

Magnus Wallberg, UMCRun the query Save the query

Name and description only needed if the query is saved


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

An example

Ingredient/Base

Salt/Ester Brand name Medicinal product

Paracetamol - Alvedon 500 mg Tablets

Paracetamol - Alvedon Fluid

Paracetamol - Acetamol Tablets

Paracetamol Paracetamol sodium

Acetasod Intravenous

Paracetamol Paracetamol hydrocloride

Acecloride Unspecified


12 3

4

1 – Search on medicinal product level2 – Search on brand name level3 – Search on Salt/Ester level4 – Search on base ingredient level


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


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


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


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


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



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



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



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



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




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



Use the tabs to see different statistical numbers

Expand and hide the tree with the “+” and “-” signs


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




Excel output


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


Excel - structure

• All generated Excel files stores data in different sheets:– One query sheet– Multiple data sheets

• With detailsOr• With other views of the data


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


The content is located on different sheets


Each report is listed only once


On the drug and reaction page there is one row per drug/reaction


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


Each summary is located on a separate sheet


Usage example

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

Documents

VigiFlow - advanced concepts · Advanced concepts • To build on yesterdays country presentations I would like to mention some core features of VigiFlow, which if used can: – Improve