Vigi flow -_data_entry

VigiFlow –Introduction and data

entry

Somnath Mondal Technical Associate (PvPI)

STM-AMCDept. of Clinical & Experimental Pharmacology

Kolkata, IndiaJune,14, 2013

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

What is VigiFlow?

A web based report management tool thatsimplifies report management.

Complete ICSR Management System

ICSR (Individual Case Safety Report) –A synonym for ADR report.

VigiFlow can be used by any authority or company asa complete database for report management andstorage.

Complete ICSR Management System

–Data entry–Assessment–Storage–Retreival (e.g. for follow-ups)–Communication with otherparties

• It is web-based• It is E2B compatible

Somnath Mondal, STM-AMC Kolkata, India

VigiFlow is not primarily a tool forreporting to the UMC, but reports caneasily be sent through the system.


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

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

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

Alex in GhanaSomnath Mondal, STM-AMC Kolkata, India

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


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


Flow of reports in VigiFlow

Report

repository

Regulatory Authority

Regional Centre 1 Regional Centre 2

External

organizationsE2B

(XML)

PDF

WHO

database -

VigiBaseE2B

(XML)


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”


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

Report input module

Main partsReport handling search and statistics exit

new report Send report list reports


Main parts: report handling

With this button youcreate a new report

This button lists allreports that are “underassessment”


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


Sections of the report input module0. 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


Mandatory

General report information

• The first section of the report

• Collects information about

–General report data

–Sender of the report

–Primary source(s)


General report data

Date received at Regional Center

dd mm ccyy

Date received at National Center

Report Title

Type of Report

Spontaneous

StudyLiterature

Seriousness criteria

Country of occurrence


WarningMandatory field

Tab. Metronidazole- PancreatitisThis text will appear inthe report listing andenable you to identifyyour report , Fluoxetine-Serotinin Syndrome orSuppose

SeriousIf case is serious, reasonfor seriousness must begiven

Reason for SeriousnessAll the criteria apply asthe case as a wholeand should not beconfused outcome (s) ofindividual reaction (s)/event (s)

Medically confirmed ifnot initially from healthprofessional.Only to be completed ifthe primary reporterwas a lawyer,consumer, or othernon-healthprofessional.



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

– Name of sender and senders report number to be entered in adminchapter


• 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 not the first receiver, fill in the report number of the original sender of the case

If the report has no worldwideunique report number both thefields should left empty. Theworldwide unique number then beautomatically assigned when areport Id is generated.

This number will be remainunchanged in all subsequenttransmissions.

If the report has worldwideunique number, enter as eitherauthority report number orcompany report number. Thisnumber should remain unchangedfor subsequent transmission.



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



Patient information

• Birth date, age or age group

• Initials

• Weight

• Height

• Sex

• Information on patient death– Death date

– Death cause

– Autopsy information

This filed will be calculatedautomatically if age of onset ispresent.

The age group definitions used inthis application areNeonate <= 1 monthinfant <= 4 yearschild <= 11 yearsadolescent <=16 yearsadult <= 69 yearselderly > 69 years

Onset ageThis filed will be automaticallybe calculated from „onset dateof reaction‟ and „date of birth‟if both those dates arecompletely entered & differ.

If „onset date of reaction‟ and„date of birth‟ is identical orincomplete, an onset date maybe entered.

Populate “unknown” if theinitial of the initials ofthe patient is unknown.(New amendment in 4.3version of vigiflow)

Verify content Move to next section

decade

Year

month

week

day

hour

Search for ICD-10 term


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.

In appearance the test sections differssomewhat from the rest of the tool sincethere has been a wish to always see allinformation for comparison reasons.

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)

Pass

ive

Act

ive

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

Free text entry

3 medical history entries added

Active entry

Details about active entry

Past drug therapy

• In the past drug therapy section information about previous medications is recorded–Drug name

–Indication (if available)

–Reaction (if applicable)

2 past drug therapies entered

Name of drug (free text)

Indication (coded with term lookup)Reaction (coded

with term lookup)

Free text entry

3 medical history entries added

Details about active entry

Reactions

• Reporter’s comments

• List of coded reactions

• Details about each individual reaction

• Causality assessment

List of reactions

5 reactions added

Use the up arrow to move the most important reaction to the top

Reaction entryUse the reaction lookup tool to add the correct term (described later)

Enter a new term only if you could not find an appropriate term in the term lookup tool

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

This field should be used toinclude the primary reporter‟scomments on diagnosis Causalityassessment or other issuesconsidering relevant.

ErrorMaximum 500 characters

This field should reflect thewording about the event asreceived from the primarimaryreporter. (Original text unless toavoid misunderstandings.)

ErrorMaximum 200 characters

Drugs

• List of coded drugs

• Details about each individual drug

• Causality assessment

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

Drug entryUse the drug lookup tool to add the correct drug

Coded drugs

The drug in bold is the “active” drug below

Details about “active” drug

Relatedness assessment –entered for each drug/reaction combination

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

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

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!

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

Reaction lookup tool

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 difficult to suggest new drugs!

Enter a new drug only if 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.

Comment on report entry• VigiFlow contain a large number of data

fields, filling them all in may be very timeconsuming

But…

• There are only 5 mandatory fields –Header, initials (recently modified), Age

at the onset of ADR, drug, reactionand onset date (Year)

On the other hand…• More data will improve the overall quality and simplify the

causality assessment

VigiFlow – hands on• Form groups of three or four

• One in the group must be 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 small amount 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

Vigiflow Without Mouse

Access Keys to facilitate switching betweendifferent pages without pressing mouse.

To switch to a specific pages the access keysare Alt + [keys]

After opening the report handling page if wewant to go directly to drug entry page.. Alt +[6] { Because in the left page menu particularsection denoted by a specific number or [Letter].

The access keys for buttom EntryAlt+[c] and Alt+[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.

Thank you

Next Discussion will be on Advanced usage of vigiflow

Business

Vigi flow -_data_entry