Vigiflow

1. VIGIFLOW
Presented by :
Mr. Kajale Fulchand Vishwanath
M.Pharm first year 2ñd semester
Guided by:
Ms. Shagufta Farooqui
Assistant professor
Department of Pharmacology
Shri Sharda Bhavan Education Society’s
Nanded Pharmacy College Nanded
Presentation on

2. Content
• What is VigiFlow
• History
• Creating a new report
• General reporting
• Report information section
• Study information tab
• Advantages
• Disadvantages
• Reference
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3. What is VigiFlow ?
• VigiFlow is a web-based ICSR data management system
• It is complete easy management system of ICSR (individual
Case safety reporting ).
• Vigiflow can be used by any authority or company as a database
for report management and data analysis .
• Vigiflow is not primarily tool of UMC (Uppsala monitoring
center) but the data can be transferred to UMC.
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4. HISTORY:
• Vigiflow was initiated in the year 2001 when swiss medic
required a new pharmacovigilant body.
• Vigiflow was created with name ADR PLOT .
• It was supported with primary reporting facility 7 regional
centre in 4 languages.
• The first reporting was done in year 2003 at Ghana.
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5. CREATING A NEW REPORT:
• Once we load to new report option there are two sub option.
• Standard case:
In standard case, cases with ADR , ADE , side effect , drug
reaction or reaction due to possible drug administration etc.
• Parent child case :
A parent child case is filled when the child is suffering from an
ADE / ADR due to medication taken by parent.
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6. General reporting
• General reporting can be done by regional centre it consists
of various important section to be filled.
• Sender’s information
• In sender information various mandatory section like fillers
name, address, designation, date, time and location.
• Report information
• This contain details about event.
• Name/date of birth/age /age group, weight, gender
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7. • Current/ Past drug therapy
• This contain any drug treatment in the current or past time
section must be Filled with details like
• Drug name
• Indication
• Reaction observed
• Reaction observed
• Reaction list of code reaction causality assessment, onset of
reaction end time of reaction , duration of reaction outcome
of reaction details of any treatment given to counteract the
reaction drug dose.
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8. Drug consumed
• List of drug as treatment for the reaction, Drug name dose
• Assessment given
• Assessment can be either be physically or Therapeutically
• Overview of case
• This is a free text which includes case narrative, Sender’s
comments Sender’s diagnosis (MED DRA or ICD 10).
International Classification of Diseases –Medical Dictionary
for Regulatory Activities
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9. Image.no 1 Reporting of adverse drug reactions in VigiFlow
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10. Report information section
Spontaneous: For adverse events collected from the spontaneous
reporting system the report type
Spontaneous report applies
Study: For adverse event reports collected from studies Report
from study applies
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Image no 2 Report information section

11. Study Information Tab
Study type: select as applicable (e.g. Clinical trials)
Study name: enter as applicable according to study title (e.g. An
international randomized trial of additional treatments for COVID-
19 in hospitalized patients who are all receiving the local standard
of care)
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Image no 3 study information tab

12. Adverse reaction section
Reaction/event : Structure the Reaction/event using the appropriate
MedDRA term.
Use the +Sign to structure multiple reactions e.g. If Lack of
therapeutic efficacy
• Reaction/event as reported by initial reporter: enter the
Reaction/event as described by the initial reporter.
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Image no 4 Adverse reaction section

13. Suspected ingredient
• It is possible to indicate which component of the medicinal
product is the suspect of causing the events according to the
following list
• Active ingredient
• Preservative
• Antioxidant
• Stabilizer
• Colour
• Flavouring agent
• Solvent
• Constituent
• Excess percent
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Image no 5 suspected ingredients

14. • Advantages
• Free text providing complete data entry
• Easy and constant connection between regional and national
servers
• Integrated dictionaries which helps correct coding .
• Disadvantages
• Server of different country might have glitch in uploading.
• Need faster internet server.
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15. Conclusions
• VigiFlow is a web-based ICSR data management system that
is used reporting of adverse drug reactions.
• It is easy and constant connection between regional and
national servers.
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16. Reference
• https://who-umc.org/pv-products/vigiflow
• https://who-umc.org/media/165665/1-introduction-and-basic-
features-of-vigiflow.pdf
• https://www.mdpi.com/1660-4601/19/6/3264/htm
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