vigiflow

Vigiflow

1. VIGIFLOW Presented by : Mr. Kajale Fulchand Vishwanath M.Pharm first year 2 ñd 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 2 11-07-2022

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 . 3 7/11/2022

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. 4 7/11/2022

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. 5 7/11/2022

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 6 7/11/2022

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. 7 7/11/2022

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 8 7/11/2022

9. Image.no 1 Reporting of adverse drug reactions in VigiFlow 9 7/11/2022

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 10 7/11/2022 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) 11 7/11/2022 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. 12 7/11/2022 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 13 7/11/2022 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. 14 7/11/2022

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. 7/11/2022 15

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 7/11/2022 16