Vigi flow -_data_entry

1. VigiFlow –
Introduction and data
entry
Somnath Mondal
Technical Associate (PvPI)
STM-AMC
Dept. of Clinical & Experimental Pharmacology
Kolkata, India
June,14, 2013

2. Agenda
•Module I
–VigiBase –recapture
–VigiFlow
•General information and background
•Data entry
•Hands on…
•Module II
–VigiFlow –advanced concepts
•Advanced report handling
•Search and Statistics Somnath Mondal, STM-AMC Kolkata, India

3. What is VigiFlow?
Awebbasedreportmanagementtoolthat
simplifiesreportmanagement.
Complete ICSR Management System
ICSR(Individual Case Safety Report) –
A synonym for ADR report.
VigiFlowcanbeusedbyanyauthorityorcompanyas
acompletedatabaseforreportmanagementand
storage.

4. Complete ICSR Management System
–Dataentry
–Assessment
–Storage
–Retreival(e.g.forfollow-ups)
–Communication with other
parties
•Itisweb-based
•ItisE2Bcompatible
Somnath Mondal, STM-AMC Kolkata, India

5. VigiFlowisnotprimarilyatoolfor
reportingtotheUMC,butreportscan
easilybesentthroughthesystem.
Somnath Mondal, STM-AMC Kolkata, India

6. 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
•(Predefined values in drop-down boxes)
•Outputs in several formats
–E2B, PDF, Excel
All factors that increase the report quality.
Somnath Mondal, STM-AMC Kolkata, India

7. 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

8. History
•2001 –Swissmedic needed a new
pharmacovigilance system
–Support for primary notifier reporting
–7 regional centres
–4 languages
•A project was started –“ADR Pilot”:
–Version 0.1 –Summer 2003
–Version 1 –Autumn 2003
•E2B compatible version complying with international
standards
•With this version the first report was entered –by
Alexin Ghana
Somnath Mondal, STM-AMC Kolkata, India

9. Success Story: Swissmedic usage
•As mentioned Swissmedic has been using
VigiFlow for all their report management
since summer 2004.
–They have connected 7 regional centres,
including one specialized centre
–There is no more paper based reporting from
physicians directly to Swissmedic
•But companies are still sending reports on paper…
–They are today managing twice the amount of
reports compared to 2004 without increase in
staff
Somnath Mondal, STM-AMC Kolkata, India

10. VigiFlow
NC
NC
NC
Company
RC
RC
RC
RC Flexibility of VigiFlowExample 1 Example 3
Example 2
NCRC
Two strong centres in a country,
on set up as NC, one as RC.
Both the RC and the NC enters
and assesses their own reports.
The RC sends its reports to the
NC for committment into the
database of finialized reports.
NC
One NC (regional PV centres not
connected to VigiFlow
Only the National PV Centre is
connected to VigiFlow. All
reports are entered and
assessed by NC personnel.
(Not necessarily at the same
location.)
VigiFlow
VigiFlow
NC
RC
RC
RC
A strong NC with several RC
sharing the work of data entry.
The RCs enter the primary data
and sends the report to the NC.
The NC performs all
assessments and supports the
RCs in their work.
VigiFlow
Example 4
Companies with a need for ICSR
management can also use
VigiFlow.
CompanyVigiFlow
Magnus Wallberg, UMC
PvPI

11. Magnus Wallberg, UMC
Flow of reports in VigiFlowReport
repository Regulatory Authority Regional Centre 1 Regional Centre 2 External
organizations
E2B
(XML) PDF WHO
database -
VigiBaseE2B
(XML)

12. Magnus Wallberg, UMC
Pros and cons with VigiFlow
Pros
•Combination of structured and
free-text fields to encourage
complete data entry
•Integrated dictionaries and
terminologies ensures correct
coding
•Easy communication between
national and regional centres
•No need for local server upkeep
and back-ups
•Seamless transmission of
reports to WHO/UMC
Cons
•Server (with national data) in
another country might be
against national regulations
•Needs Internet access -at
least 0.5 Mbit/s for a good
experience
•Not 100% adaptable to local
ideas of how it “should work”

13. Magnus Wallberg, UMC
Terminologies used
•Terminology for coding reactions and indications
–WHO-ART / ICD
•Easy reporting and analysis
•Dictionary for coding drugs
–WHO Drug Dictionary
•Products from many countries as well as herbal products

14. Report
input module

15. Main parts
Report handlingsearch and statisticsexit
new reportSend reportlist reports
Somnath Mondal, STM-AMC Kolkata, India

17. Main parts: report handling
Withthisbuttonyou
createanewreport
Thisbuttonlistsall
reportsthatare“under
assessment”
Somnath Mondal, STM-AMC Kolkata, India

18. Create a new report
Click this button to
create a new report
Standard case:
–A normal report with one patient taking a
drug and suffering from an ADR
Parent-child case:
–A report where a parent has taken a
medicine and the child is suffering from the
ADR
Somnath Mondal, STM-AMC Kolkata, India

19. Sections of the report input module
0. Report Information
1.Patient
2.Tests and procedures
3. Relevant Medical Histories
4.Past drug therapy
5.Reactions
6. Drugs
7. Assessment
8. Overview
9. Save
A. Print Report
0. Report Information
1.Patient
5.Reactions
6. Drugs
Somnath Mondal, STM-AMC Kolkata, India
Mandatory

20. General report information
•The first section of the report
•Collects information about
–General report data
–Sender of the report
–Primary source(s)
Somnath Mondal, STM-AMC Kolkata, India

21. General report data
Date received at Regional Center
ddmm ccyy
Date received at National Center
Report Title
Type of Report
Spontaneous
Study
Literature
Seriousness criteria
Country of occurrence
Somnath Mondal, STM-AMC Kolkata, India

22. Warning
Mandatory field
Tab. Metronidazole-Pancreatitis
Thistextwillappearin
thereportlistingand
enableyoutoidentify
yourreport,Fluoxetine-
SerotininSyndrome or
Suppose
Serious
Ifcaseisserious,reason
forseriousnessmustbe
given
ReasonforSeriousness
Allthecriteriaapplyas
thecaseasawhole
andshouldnotbe
confusedoutcome(s)of
individualreaction(s)/
event(s)
Medicallyconfirmedif
notinitiallyfromhealth
professional.
Onlytobecompletedif
theprimaryreporter
was a lawyer,
consumer,orother
non-health
professional.
Somnath Mondal, STM-AMC Kolkata, India

24. Somnath Mondal, STM-AMC Kolkata, India

26. General report information –sender details
•Information about the organization sending the report to
–Type of organization (Sender)
Pharmaceutical Company
Regional Pharmacovigilance Center
Health professional
Regulatory Authority
other
Regional Pharmacovigilance Center
–Nameofsenderandsendersreportnumbertobeenteredinadmin
chapter
Somnath Mondal, STM-AMC Kolkata, India

27. •World wide unique number
–If you are the first receiver of the report this should be left blank. It will be
automatically filled with your report number.
–If you are notthe first receiver, fill in the report number of the original sender
of the case
Ifthereporthasnoworldwide
uniquereportnumberboththe
fieldsshouldleftempty.The
worldwideuniquenumberthenbe
automaticallyassignedwhena
reportIdisgenerated.
Thisnumberwillberemain
unchangedinallsubsequent
transmissions.
Ifthereporthasworldwide
uniquenumber,enteraseither
authorityreportnumberor
companyreportnumber.This
numbershouldremainunchanged
forsubsequenttransmission.
Somnath Mondal, STM-AMC Kolkata, India

28. Somnath Mondal, STM-AMC Kolkata, India

29. General report information –primary source(s)
•Information about primary source
–Name and details of for example physician
–Literature reference
•To be filled in if a literature case
–Information about study details
•To be filled in if report from study
•The entire section is repeatable if there
are more than one primary source
•Possibility to save a reporter for later
re-use
Somnath Mondal, STM-AMC Kolkata, India

30. Somnath Mondal, STM-AMC Kolkata, India
Patient information
•Birth date, age or age group
•Initials
•Weight
•Height
•Sex
•Information on patient death
–Death date
–Death cause
–Autopsy information

31. Thisfiledwillbecalculated
automaticallyifageofonsetis
present.
Theagegroupdefinitionsusedin
thisapplicationare
Neonate <= 1 month
infant <= 4 years
child <= 11 years
adolescent <=16 years
adult <= 69 years
elderly > 69 years
Onsetage
Thisfiledwillbeautomatically
becalculatedfrom„onsetdate
ofreaction‟and„dateofbirth‟
ifboththosedatesare
completelyentered&differ.
If„onsetdateofreaction‟and
„dateofbirth‟isidenticalor
incomplete,anonsetdatemay
beentered.
Populate“unknown”ifthe
initialoftheinitialsof
thepatientisunknown.
(Newamendmentin4.3
versionofvigiflow)
Verify content
Move to next
section
decade
Year
month
week
day
hour
Search for ICD-10 term
Somnath Mondal, STM-AMC Kolkata, India

32. Tests and procedures
•Allows for entry of test data
•Free text field
•Structured information
–The preferred option
–Test type entered as free text or by selection
from a drop down.
Inappearancethetestsectionsdiffers
somewhatfromtherestofthetoolsince
therehasbeenawishtoalwaysseeall
informationforcomparisonreasons.

33. Free text entry
Add another “coded” test
Add test type as free text
or from drop down
(Only MedDRA term if MedDRA is
used as terminology)
Add another test result,
more than one can be
added at the same time
Copy dates if several tests
have been done at the
same date(s)
Passive
Active

34. Relevant medical history
•In this section medical history that might
be of importance is recorded
•Free text field
•Structured information
–Medical history term (ICD-10)
–Start and stop date
–Comment

35. Free text entry
3 medical history entries
added
Active entry
Details about
active entry

36. Past drug therapy
•In the past drug therapy section
information about previous
medications is recorded
–Drug name
–Indication (if available)
–Reaction (if applicable)

37. 2 past drug therapies
entered
Name of drug
(free text)
Indication (coded
with term lookup)
Reaction (coded
with term lookup)

38. Free text entry
3 medical history entries
added
Details about
active entry

39. Reactions
•Reporter’s comments
•List of coded reactions
•Details about each individual reaction
•Causality assessment

41. List of reactions
5 reactions added
Use the up arrow to move
the most important
reaction to the top

42. Reaction entry
Use the reaction lookup
tool to add the correct
term (described later)
Enter a new term onlyif
you could not find an
appropriate term in the
term lookup tool

43. Comments provided from
primary source (in free
text)
Coded reactions
The reaction in bold is the
“active” reaction below
Details about “active”
reaction
Relatedness assessment –
entered for each
drug/reaction combination
Thisfieldshouldbeusedto
includetheprimaryreporter‟s
commentsondiagnosisCausality
assessmentorotherissues
consideringrelevant.
Error
Maximum500characters
Thisfieldshouldreflectthe
wordingabouttheeventas
receivedfromtheprimarimary
reporter.(Originaltextunlessto
avoidmisunderstandings.)
Error
Maximum200characters

44. Drugs
•List of coded drugs
•Details about each individual drug
•Causality assessment

45. List of drugs
Use the up arrow to move
the most important drug to
the top
Add one more drug to the
report
3 suspected and 1
concomitant drug added

46. Drug entry
Use the drug lookup tool to
add the correct drug

47. Coded drugs
The drug in bold is the
“active” drug below
Details about “active” drug
Relatedness assessment –
entered for each
drug/reaction combination

48. Drug reaction relatedness (Relatedness
assessment)
•Information on the relatedness of the
drugs and reactions coded on a report
–Relatedness information
•In VigiFlow –WHO Causality
–Information on recurrence
•Information entered in a“simple” matrix
Remove a relatedness with
the trash if NO relatedness
at all

50. Assessment
•A number of “mainly” free text
fields
–Case narrative
–Sender’s comments
•Your comments
–Sender’s diagnosis
•Coded in ICD10 or MedDRA with the term lookup tool
–References
•Any references to other sources, like literature

51. Overview
•Shows a summary of the report
–All filled in fields
–All fields with errors or warnings
–Only to be used for a quick overview not
“print or read friendly”!
If you are about to finalize/commit a
report and it is reporting that it has
errors… this is the place where to go!

53. Reaction lookup tool
•The reaction lookup tool has been rebuilt
in version 4.1 and further of VigiFlow.
New features are:
–The lookup is done without leaving the page
where the term shall be added
–The entire search tree is displayed in the
result
–Searches can be done with
•Begins with, equals and contains
–Searches can be done on specific levels
–Result tree can be expanded

54. Reaction lookup tool

55. Drug lookup tool
•With version 4.1 of VigiFlow one of the
major changes is the tool to pick drugs
from WHO-DD
•The aim is to:
–Make it easier to find the appropriate drug
and drug level
–Make it more difficultto suggest new
drugs!

56. Enter a new drug onlyif
you could not find an
appropriate drug in the
drug lookup tool
Select appropriate level
depending on available
information on report and
details available in WHO-
DD.

57. Comment on report entry
•VigiFlowcontainalargenumberofdata
fields,fillingthemallinmaybeverytime
consuming
But…
•There are only 5 mandatory fields
–Header,initials(recentlymodified),Age
attheonsetofADR,drug,reaction
andonsetdate(Year)
Ontheotherhand…
•Moredatawillimprovetheoverallqualityandsimplifythe
causalityassessment

58. VigiFlow –hands on
•Form groups of three or four
•One in the group mustbe a ”experienced” VigiFlow
user
–But –someone else should do the hands on!
•Create one ”made up” report with your ”group
name” in the report header and a smallamount of
data
–Add at least two reaction
•Save and committ the report
–Write down the report number
•Search for the report in the search and statistics
tool and export the result set on excel format

59. Vigiflow Without Mouse
AccessKeystofacilitateswitchingbetween
differentpageswithoutpressingmouse.
Toswitchtoaspecificpagestheaccesskeys
areAlt+[keys]
Afteropeningthereporthandlingpageifwe
wanttogodirectlytodrugentrypage..Alt+
[6]{Becauseintheleftpagemenuparticular
sectiondenotedbyaspecificnumberor[Letter].

60. The access keys for buttom Entry
Alt+[c] andAlt+[n]
Variability based on Web Browser:
For Internet Explore: Alt+[1]+ Enter
For Mozilla Fire Fox: Shift + Alt+ [1]
Pressing back function in the secure web
browser is generally discouraged.

61. Thank you

62. Next Discussion will be on
Advanced usage of vigiflow