1) The presentation summarizes the pharmacovigilance activity at Nilratan Sircar Medical College and Hospital from December 2015 to November 2016 and compares it to the previous year. 2) General medicine reported the most adverse drug reactions at 21.27% and the skin was the most commonly involved system at 31.85%. 3) The number of adverse drug reaction reports sent to the national pharmacovigilance program increased from 160 in 2014-2015 to 221 in 2015-2016.

1. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Pharmacovigilance activity at Nilratan Sircar Medical College
and Hospital from December 2015 – November 2016 and a
retrospective comparative study with session 2014-2015
Presenter: Mr. Anindya Banerjee
Designation: Pharmacovigilance Associate
Affiliation: Dept of Pharmacology, NRSMCH,
Kolkata
And
NCC-PvPI, IPC, Ghaziabad

2. Contribution of various Disciplines to provide ADR(s)Contribution of various Disciplines to provide ADR(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
General Medicine 21.27%
Dermatology 14.02%
Psychiatry 9.04%
Orthopedic 9.04%
Neuro Medicine 8.59%
Paediatric Medicine 7.69%
Dental OPD 5.42%
Radiotherapy 4.52%
Haematology 4.07%
General OPD 3.62%
General Surgery 3.16%
Endocrinology 2.71%
Neuro Surgery 1.80%
Cardiothoracic and
Vascular Surgery (CTVS)
1.35%
Ophthalmology 1.35%
Chest 1.35%
ENT 0.9%

3. Demographic DistributionDemographic Distribution
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Male 43.89%
Female 56.1%

4. Demographic DistributionDemographic Distribution
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Neonate 1.80%
Infant 2.71%
Child 5.42%
Adolescent 5.88%
Adult 78.73%
Elderly 5.42%

5. Systems Involved in exposure to ADR(s)Systems Involved in exposure to ADR(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Skin 31.85%
GIT 19.32%
CNS 10.18%
Psychosomatic 7.57%
Metabolic 5.74%
Cardiovascular 5.48%
Muscular 5.48%
Endocrine 3.13%
Respiratory 2.61%
Haemopoetic 2.088%
Hepatic 1.82%
Urinary 0.78%
Others 3.91%

6. Drugs involved to produce ADR(s)Drugs involved to produce ADR(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Antimicrobial 19.57%
Antifungal 4.06%
Cardiovascular 6.92%
Antiasthmatic 3.61%
Steroid 1.35%
Antispasmodics 1.50%
Analgesics 16.57%
Antidiabetics 4.81%
Antiulcer 12.04%
Anticonvulsant 3.91%
CNS Stimulant 2.40%
Antipsychotic 10.99%
Antineoplastics 4.06%
Anticoagulants 0.9%
Antiemetic 2.40%
Antiparkinsonian 1.35%
Antihistamine 2.87%
Intra-articular 5.27%

7. OutcomeOutcome
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Recovered 57.47%
Recovering 41.62%
Fatal 0.9%
Recovered with sequel 0%
Not Recovered 0%
Unknown 0%

8. Seriousness Criteria of ADR(s)Seriousness Criteria of ADR(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Not Serious 66.5%
Serious 33.5%

9. Seriousness Criteria of ADR(s)Seriousness Criteria of ADR(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Death 2.70%
Life Threatening 2.70%
Hospitalization 52.7%
Disability 0%
Congenital Anomaly 0%
Required Intervention 5.4%
Other 36.5%

10. Polypharmacy VS MonopharmacyPolypharmacy VS Monopharmacy
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Polypharmacy 58.7%
Monopharmacy 41.3%

11. Medicines Prescribed in Generic Name Vs Brand NameMedicines Prescribed in Generic Name Vs Brand Name
(findings on the basis of 221 ICSRs)(findings on the basis of 221 ICSRs)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Generic 77.27%
Brand 22.73%

12. Single ADR vs Two ADR vs Three ADR vs Four ADR vs FiveSingle ADR vs Two ADR vs Three ADR vs Four ADR vs Five
ADR (findings on the basis of 221 ICSRs)ADR (findings on the basis of 221 ICSRs)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Single ADR 49.32%
Two ADR 32.58%
Three ADR 12.22%
Four ADR 4.52%
Five ADR 1.35%

13. Causality AssessmentCausality Assessment
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Certain 3.2%
Probable 44.3%
Possible 52.5%
Unlikely 0%

14. Month wise sent ADR reports to NCC-PvPI from DecemberMonth wise sent ADR reports to NCC-PvPI from December
2015 – November 20162015 – November 2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
December 2015 14
January 2016 23
February 2016 28
March 2016 18
April 2016 13
May 2016 17
June 2016 19
July 2016 21
August 2016 14
September 2016 18
October 2016 17
November 2016 19

15. Comparative study on Month wise sent ADR reporting inComparative study on Month wise sent ADR reporting in
session 2014-2015 & 2015-2016session 2014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Month 2014-2015 2015-2016
December 9 14
January 7 23
February 7 28
March 28 18
April 7 13
May 12 17
June 5 19
July 1 21
August 24 14
September 22 18
October 25 17
November 13 19

16. Comparative study on Yearly ADR reporting in sessionComparative study on Yearly ADR reporting in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 160
2015-2016 221

17. Comparative study on Departmental involvement in sessionComparative study on Departmental involvement in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

18. Comparative study on Gender Distribution in sessionComparative study on Gender Distribution in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 2015-2016
Male 53.8% 43.9%
Female 46.2% 56.1%

19. Comparative study on Age Distribution in sessionComparative study on Age Distribution in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 2015-2016
Neonate 3.75% 1.80%
Infant 6.875% 2.71%
Child 4.375% 5.42%
Adolescent 5.625% 5.88%
Adult 73.75% 78.73%
Elderly 5.625% 5.42%

20. Comparative study on Systems Involvement (SOC) in sessionComparative study on Systems Involvement (SOC) in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

21. Comparative study on Medicines Involvement to produce ADR(s) inComparative study on Medicines Involvement to produce ADR(s) in
session 2014-2015 & 2015-2016 (on the basis of ICSRs collectedsession 2014-2015 & 2015-2016 (on the basis of ICSRs collected
throughout the period)throughout the period)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

22. Comparative study on Outcome in sessionComparative study on Outcome in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 2015-2016
Recovered 56.9% 57.47%
Recovering 32.5% 41.62%
Recovered with sequel 8.1% 0%
Fatal 2.5% 0.9%

23. Comparative study on Seriousness of ADR(s) in sessionComparative study on Seriousness of ADR(s) in session
2014-2015 & 2015-20162014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 2015-2016
Not Serious 72.5% 66.5%
Serious 27.5% 33.5%

24. Comparative study on Seriousness Criteria of ADRs inComparative study on Seriousness Criteria of ADRs in
session 2014-2015 & 2015-2016session 2014-2015 & 2015-2016
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2014-2015 2015-2016
Death 9.76% 2.70%
Life Threatening 7.31% 2.70%
Hospitalization/Prolongation of Hospitalization 82.9% 52.7%
Disability 0% 0%
Congenital Anomaly 0% 0%
Required Intervention 0% 5.4%
Other 0% 36.5%

25. Some Photography of Serious Adverse Drug Reaction(s)Some Photography of Serious Adverse Drug Reaction(s)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

26. Other Co-curricular ActivitiesOther Co-curricular Activities
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
1. Attended and Worked
as resource person in
Pre-Conference
Workshop of 25th
Annual State
Conference of Indian
Pharmacological
Society on hands on
training of how to fill up
ICSR and to upload the
data on Vigiflow
software

27. Other Co-curricular ActivitiesOther Co-curricular Activities
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
2. Conducted training
program on
Pharmacovigilance of
3rd
Year B.Pharm
Students of Orissa
Pharmacy College
under guidance of AMC
Coordinator
3. Conducted training
program on
Pharmacovigilance of
M.Pharm in Clinical
Pharmacy Students of
Jadavpur University
under guidance of AMC
Coordinator Sample of Certificate Provided to
B.Pharm 3rd
Year Student
Sample of Certificate Provided to
M.Pharm in Clinical Pharmacy
Students of Jadavpur University

28. Questionnaire given for Test during training of M.Pharm inQuestionnaire given for Test during training of M.Pharm in
Clinical Pharmacy students of Jadavpur UniversityClinical Pharmacy students of Jadavpur University
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

29. Feedback From Students of B.Pharm 3Feedback From Students of B.Pharm 3rdrd
Yr StudentsYr Students
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

30. Feedback From Students of M.Pharm in Clinical PharmacyFeedback From Students of M.Pharm in Clinical Pharmacy
StudentsStudents
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

31. Attended SeminarsAttended Seminars
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Sr.
No
Date Title Venue
1. 20/02/2016 25th
Annual State Conference of
Indian Pharmacological Society
RG Kar Medical College
& Hospital
2. 21/03/2016 Symposium: Diabetes –
Individualized care to precision
medicine
Calcutta School of
Tropical Medicine,
Kolkata
3. 23/04/2016 National Workshop on
Pharmacovigilance
Chalapathi Institute of
Pharmaceutical
Technology, Guntur
4. 09/12/2016 Advance Level Training on
Pharmacovigilance
To be held at IPGMER,
Kolkata

32. Photography of Certificates of Attended SeminarsPhotography of Certificates of Attended Seminars
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

33. Presented PosterPresented Poster
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Presented Poster at
25th
Annual State
Conference of
Indian
Pharmacological
Society on 20th
February 2016,
Topic entitled as,
“Methotrexate
induced superficial
ulcer in an
undiagnosed
Arthritis: A Case
Study”

34. Other ActivityOther Activity
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
1. Send 84 pending ADR
reports of year 2013,
2014 which has been sent
by earlier Technical
Associates Ms. Soumita
Bag and Paramita
Chakraborty
2. Poster of ADR
Monitoring has been
stuck at Jadavpur
University to aware and
sensitizes students and
faculties of Jadavpur
University regarding
Pharmacovigilance.

35. Peripheral Sensitization Program at BurdwanPeripheral Sensitization Program at Burdwan
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

36. Conclusion & AcknowledgementConclusion & Acknowledgement
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
•Throughout December 2015 – November 2016 it was an immense
pleasure to work with all.
•Many of the Clinicians at NRSMCH are cooperative, specially General
Medicine, Dermatology, Psychiatry, Haematology, Paediatrics,
Endocrinology.
•In this session I got 221 no. of Suspected Adverse Drug Reaction
reporting Form.
•Scenario of NRSMCH as an AMC is changing in terms of betterment.
•Faculties of Dept of Pharmacology are also very cooperative. I use to
get critical guidance from Coordinator Madam and Dr. Tania Sur,
Associate Professor, Dept of Pharmacology, As she is also a Member of
Causality Assessment Committee.
•I am cordially thankful to Dr.V.Kalaiselvan ,Principal Scientific
Officer, NCC-PvPI for choosing me as Pharmacovigilance is my area of
Interest.

37. Thank YouThank You
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Anindya Banerjee
Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH
&
NCC-PvPI
Email: anindyabanerjee1988@gmail.com