1) The document discusses adverse drug reactions (ADRs), the Pharmacovigilance Programme of India (PvPI), and how to recognize and report ADRs. 2) It explains what an ADR is according to WHO, how the PvPI is organized in India with a national coordination center and regional centers, and the process for reporting suspected ADRs using the individual case safety report form. 3) Examples of completed ADR reporting forms are provided showing real cases involving suspected ADRs like postural hypotension from prazosin and Steven Johnson Syndrome from phenytoin.

1. Pharmacovigilance Orientation
Class
Anindya Banerjee
Sr. Pharmacovigilance Associate
Nilratan Sircar Medical College, Kolkata
And
National Coordination Centre-Pharmacovigilance Programme of
India
Indian Pharmacopoeia Commission, Ghaziabad

2. Content
• Adverse Drug Reaction
• Pharmacovigilance Programme of India (PvPI)
• Reporting of ADR

3. Introduction
Adverse Drug Reaction
use to take because of
many reasons.
- Self Medication
- Over the Counter Drug
- Medication Error
- Race and Ethnicity

4. Side Effect & Adverse Drug
Reaction
• Side Effect: Any unintended effect of a pharmaceutical
product occurring at doses normally used in man
which is related to the pharmacological properties of
the drug.
• Adverse Drug Reaction according to WHO: “Any
response to a drug which is noxious and unintended,
and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease, or for
the modification of physiological function.”

6. Adverse Event
Medication
Errors
(preventable)
Adverse Drug Event:
preventable or unpredicted
medication event---with harm
to patient
Adverse Drug
Events

7. How to Recognize ADR in Patients
Following approach is helpful in assessing possible drug-related
ADRs:
1. Ensure that the medicine ordered is the medicine received
and actually taken by the patient at the dose advised.
2. Take a proper history and do a proper examination of patient
3. Establish time relationships
4. Carry out a thorough physical examination with
appropriate laboratory investigations
5. Effect of Dechallenge and Rechallenge should be determined
6. Check the known pharmacology of the medicine

8. Pharmacovigilance
Pharmacovigilance: It is a science and activity related
to
 Detection
 Assessment
 Understanding
&
 Prevention
of adverse drug reactions or any other drug related
problems
WHO 2002

9. Importance of Pharmacovigilance
•Thalidomide tragedy (1961-62): The
greatest of all drug disasters.
Thalidomide had been introduced and
welcomed as a safe and effective
hypnotic and antiemetic. It rapidly
became popular for the treatment of
nausea and vomiting in early pregnancy.
•Tragically the drug proved to be a
potent human teratogen that caused
major birth defects in an estimated
10,000 children
•Phocomelia was a characteristic feature

10. PvPI Organogram

11. Communication under PvPI
Uppsala Monitoring
Centre, Sweden
National Coordination
Centre, IPC, Ghaziabad
ADRs Monitoring
Centre
Healthcare
Professionals
CDSCO Zonal Offices
South Zone, Chennai
West Zone, Mumbai
East Zone, Kolkata
North Zone, Ghaziabad
CDSCO
Headquarter,
New Delhi

12. Regional Centres under PvPI
These regional centres are recognized as
Regional Resource Centre.
Eastern Region: IPGMER, Kolkata
Western Region: KEM Hospital, Mumbai
Northern Region: PGIMER, Chandigarh
Southern Region: JSS Hospital, Mysore

13. How to report & Whom to Report?
 Use the ‘Suspected Adverse Drug
Reaction Reporting (SADRR)
Form’ to report any ADR
 Form available in all AMCs or
download from www.ipc.gov.in
 The filled-in SADRR form can be
submitted to the ADR Monitoring
Centre (AMC) or directly to the
National Coordination Centre-
Pharmacovigigilance Programme
of India (NCC-PvPI), Indian
Pharmacopoeia Commission (IPC)
 A reporter can also mail the form at
pvpi.ipcindia@gmail.com
 Dial Toll free number 1800-180-
3024 for reporting ADR from
Monday to Friday (9am – 5:30pm)

14. NRSMC as an AMC – Whom and/or
Where to report?
• Red colored Suspected Adverse Drug Reaction Reporting
Form is available at the website of NCC-PvPI, IPC –
Download and fill up, and send the filled in Form at
pvpi.ipcindia@gmail.com
or
• You may dial the mobile number: 8670117829
or
• Drop Email: anindyabanerjee1988@gmail.com
or
• Contact at: Pharmacovigilance Centre, Dept of
Pharmacology, 4th Floor, Academy Building, NRS
Medical College, 138, AJC Bose Road, Kolkata - 14

15. Fundamentals of ADR Reporting

16. Suspected Adverse Drug Reaction Form – How it’s Look like?

17. Suspected Adverse Drug Reaction
Reporting Form
• Currently NCC-PvPI, IPC
is using Suspected
Adverse Drug Reaction
Reporting Form version
1.4

18. Completeness Criteria of Suspected Adverse Drug
Reaction Reporting Form
1. An Identifiable
Patient
2. An Identifiable
Suspected Adverse
Reaction
3. An Identifiable
Suspected
Medicine
4. An Identifiable
Reporter

19. Turning up of Suspected Adverse Drug Reaction Reporting
Form into Individual Case Safety Report (ICSR)

20. Important parts of Individual Case Safety
Report (ICSR)
• Reg No./OPD No./IPD No.:
RG XXXXXXXXXX
• AMC Report No.:
• Worldwide Unique No.:

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

22. Contd..
• Suspected Medication(s)
• Reporter Details

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

24. Seriousness criteria and Outcome
• Seriousness of Report – if the report
is serious then the report has to be
sent within 14 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.
• If the Death Occurs then it has to be
reported within 24 hours
• Outcome

25. Contd..
• Challenge – First time administration of a medicine
• De-Challenge – Drug withdrawal/stoppage of Medicine
• Re-Challenge – readministration of drug after
dechallenge
• Concomitant Medication

26. What Happens to the Submitted Reports??
“Confidentiality”

27. Causality Assessment
≥9 = Definite, 5-8 = Probable, 1-4 = Possible, ≤0 = Doubtful
World Health Organization-Uppsala Monitoring
Centre (WHO-UMC) Scale

28. Hands on - Suspected Adverse
Drug Reaction Form Fill Up

29. Tulsi Chakroborty, 79 years old Male patient came to Cardiology Dept., with
complaint of Hypertension, Blood Pressure = 164/92 mm Hg, Pulse = 98/min.
Tab. Prazosin 2 mg 1tab ODAC x cont given on 06/07/2021, on next day, i.e.,
on 07/07/2021 the patient came to Cardiology Dept., and informed that he had
been feeling light headedness 3 hours after taking Tab. Prazosin 2 mg, while he
is standing up from sitting or lying down position, which has been diagnosed
as Postural Hypotension following taking Prazosin 2 mg once daily before
meal.
As an Action Taken - Dose not changed, Outcome - Recovering
Name of Reporter: Mr. S. Manna, OPD Pharmacist, NRSMC&H
Date of Report: 15/07/2021
Report has been considered and Seriousness of the Suspected Medicine
induced Adverse Drug Reaction was found to be Non-Serious, Causality
Assessment has been performed, and found to be Possible
Case 1

31. Case 2
Ashwini Ghatak, A 37 years old male ambulatory patient came to Neuro Medicine
Dept., with the complaint of Head Injury due to fall from bike on 10/06/2021, The
patient has been given Tab. Phenytoin 100 mg TDS x 7 days.
4 days after consumption of the prescribed medicine, the patient got exfoliation of skin,
fever. On 14/06/2021 the patient got admitted at Dermatology Dept, on diagnosis it was
found that the Patient has Developed Steven Johnson Syndrome, having positive
Nikolsky Sign. Suspected Medicine has been withdrawn and medical treatment has
been provided. On 09/07/2021 patient recovered from Steven Johnson Syndrome and
discharged.
Medicine Details: Tab. Phenytoin, Manufacturer Name: Abott Pvt Ltd., Batch No. AK-
1409, Mfg Date: March, 2020, Exp Date: Feb, 2022
Lab Details: Hb = 12.8 g/dl, TC = 7300/cu.mm, Platelet= 2.9 L/cu.mm, SGOT= 75
U/L, SGPT= 79 U/L
Seriousness criteria: Yes, Hospitalization/Prolonged
Action Taken: Drug Withdrawn, Outcome: Recovered
Name of the Reporter: Dr. Ananya Mandal, AMC Coordinator, NRSMC, Kolkata
Date of Report: 19/07/2021
Name of Receiver: Anindya Banerjee

33. Case 3
Ayan Chatterjee, 51 years old Male patient has been prescribed with Ibuprofen 400 mg
BDPC x 3 days for toothache from 14/07/2021.
On 15/07/2021, patient complaint that, 1 hour after consumption of Ibuprofen patient was
feeling Nausea followed by Vomiting from yesterday only, he also informed that, he has
taken only 2 tablets of the prescribed medicine at the time of lunch and dinner on
14/07/2021, Ibuprofen has been stopped.
On 16/07/2021 patient said that he is not feeling nausea and vomiting anymore, after
discontinuation of Ibuprofen 400 mg from 15/07/2021.
Lab Report – Not Available
Medical History – Toothache.
Date of Report – 16/07/2021
Name of the Reporter – Mr. Anindya Banerjee, Sr. Pharmacovigilance Associate, Dept of
Pharmacology, NRSMC, Kolkata

35. Acknowledgement
• Dr. Ananya Mandal, Associate Professor, Dept of
Pharmacology and AMC Coordinator under National
Coordination Centre - Pharmacovigilance Programme
of India (NCC-PvPI), Indian Pharmacopoeia
Commission (IPC)
• Dr. Suman Chattopadhyay, Assistant Professor Dept of
Pharmacology and CAC Member under NCC-PvPI,
IPC
• Prof & Head, Dept of Pharmacology, Nilratan Sircar
Medical College, Kolkata
• Dr. Jai Prakash, Sr. Principal Scientific Officer, NCC-
PvPI, IPC

36. Questions???

37. Thank You