This document provides an overview of pharmacovigilance and the Individual Case Safety Report (ICSR) process. It details the key components of an ICSR including patient information, suspected adverse reactions, suspected medications, and reporter details. It also discusses causality assessment, the process of evaluating whether a suspected adverse reaction is caused by a medication. Causality assessment algorithms like the WHO-UMC Scale are described. The document concludes with a case study example and demonstration of the Vigiflow software system used for ICSR reporting.

1. Fundamentals of Pharmacovigilance
Anindya Banerjee
Patient Safety – Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH, Kolkata
And
National Coordination Centre – Pharmacovigilance Program of India
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Govt of India
Ghaziabad - 201002

2. Content
• Detail of ICSR
• Causality Assessment
• Filling up of ICSR
• Vigiflow Demonstration

3. Individual Case Safety Report
• Currently NCC-PvPI is using ICSR version 1.3
• The Main Points are - 1. Patient Detail
- 2. Suspected Reaction
- 3. Suspected Medicine
- 4. Reporter Detail

4. Important Part of ICSR
• AMC Report No.:
Name of The AMC/Month-
YYYY/Serial No. Of the collected
ICSR
• Reg No./IPD No./IPD No.:
RG XXXXXXXXXX this no. Is
generated in Prescription of
OPD/IPD by the issuing
computer of AMC
• Worldwide Unique No.:
This no. Is generated by vigiflow
software after completion of
uploading and Saving individual
Case Safety Report.

5. Fundamentals of an ICSR
• Patient Information
• Suspected Adverse
Reaction

6. Contd..
• Suspected Medication(s)
• Reporter Detail

7. Contd..
• Laboratory Report
– This field is open
and manually can
be filled up.
• Relevant Medical/
medication History

8. Contd..
• Seriousness of Report – if the
report is serious then the
report has to be sent within 15
calendar days.
• If the Serious Adverse Event
(SAE) found to be as a
Suspected Unexpected Serious
Adverse Reaction (SUSAR) then
the report has to be sent
within 7 calendar days.
• Outcome

9. Contd..
• Challange – First time administration of a medicine
• De-Challange – Drug withdrawal/stoppage of
Medicine
• Re-Challange – readministration of drug after
dechallange
• Concomitant Medication

10. What Happens to the Submitted Reports??
Confidentiality

11. SOP of HOW to fill up Suspected
Adverse Drug Reaction Form

12. Causality Assessment
• how likely is it that this medication is the
cause of this problem in this particular
patient?
• Can the drug cause the adverse reaction?
• Has the drug caused the adverse reaction?
• Will the drug cause the adverse reaction?
Key Question(s)

13. Basic Criteria for Causality Assessment
• Pharmacology and Previous Knowledge of
ADRs
• Association (Time & Place) of AE and Drug
• Plausibility (Medical/Biological)
• Likelihood or Exclusion of Other Cause(s)
• Analyse everything in the report and do
Causality

14. Algorithms
• Imputability (France)
• Roussel-Uclaf (France)
• Venulet (Switzerland)
• Karsh-Lasagna (US)
• WHO (Sweden)
• Naranjo (Canada)

15. ≤9= Definite 5-8 = Probable/Likely 1-4 = Possible ≥0= Doubtful

16. WHO-UMC Scale

17. What Causality Assessment Can and
Can’t Do
Can Do: Can’t Do:
• Decrease disagreement
between assessors
• Classify relationship
likelihood (semi-
quantitative)
• Mark individual case reports
• Education / improvement of
scientific assessment
• Give accurate quantitative
measurement of
relationship likelihood
• Distinguish valid from invalid
cases
• Prove the connection
between drug and event
• Quantify the contribution of
a drug to the development
of an adverse event
• Change uncertainty into
certainty

18. Conclusion
• Causality Assessment is very Tricky!!

19. Case Study
A 19 years old male patient came to the hospital on 21/10/2015 with the following
complaints of fever, rash all over the body, lesions over front of neck, chest, palms and
soles since three days following the ingestion of Tab. Amoxicillin 500 mg BD for fever.
There is no history of similar episodes/allergies. On examination skin over the abdomen
shows lesions, Erythematous plaques on palms and soles, hemorrhagic crusting on lips,
peeling of skin on front of the chest, Magenta red colored tongue. Mucopurulent discharge
from eye lids, stickiness of eyelids, redness and watering of eyes were observed.
Dermatologists suspected this condition as Steven Johnson Syndrome due to drug
Amoxicillin. The administration of Amoxicillin was started on 18/10/2015 and stopped on
21/10/2015. For Medical Treatment he was on IV fluids and Inj.cefotaxime IV/1gm BD,
Inj. Dexamethasone IV/ 4mg BD. Chlorhexidine mouth gargles for oral ulcers,
Moxifloxacin and Tobramycin eyedrops along with Soframycin topical eye application.
Paracetamol, 500 mg SOS for fever. The patient recovered after 20 days.
Laboratory Report: Hb= 11.2 g/dl, TC= 7400/cu.mm, platelet= 1.7L/cu.mm, SGPT=
121U/L, SGOT= 101U/L, ALP= 106U/L, T.Bil= 0.9mg/dl, Albumin = 0.7mg/dl, Na+= 139
meq/dl, K+= 4.9meq/dl, Cl-= 0.7meq/dl
Additional information: Amoxicillin 500 mg, Batch no: MK-03, Expiry date: 10/2017,
Manufacturer: Hetero labs.
Name of the Reporter : Prof. Nina Das , H.O.D. Pharmacology, NRSMCH, Kolkata
Date of Report : 15/11/2015

20. Demonstration of Vigiflow Software

21. Thank You for Patience
Good Luck Ahead
Anindya Banerjee
Patient Safety – Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH, Kolkata
And
NCC-PvPI, IPC, Ghaziabad
Contact:[0]-9804561488
Email id: anindyabanerjee1988@gmail.com