Pharmacovigilance Activity at NRS Medical College in 2017 and 3 Years of Comparative Study under NCC-PvPI,IPC

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Pharmacovigilance activity at
Nilratan Sircar Medical College
and Hospital from December
2016 – November 2017 and 3
years of comparative study
Presented by Mr. Anindya Banerjee
Designation: Patient Safety-Pharmacovigilance
Associate
Affiliation: Dept of Pharmacology, NRSMCH, Kolkata
And
NCC-PvPI, IPC, Ghaziabad

Content
• Detail Information of the
Parameters related to ADR of
December 2016 – November 2017
• Comparative Study
• Contribution for NCC-PvPI

Contribution of various DisciplinesContribution of various Disciplines
to provide ADR(s)to provide ADR(s)

Demographic DistributionDemographic Distribution

Systems Involved in exposure to ADR(s)Systems Involved in exposure to ADR(s)

Drugs involved to produce ADR(s)Drugs involved to produce ADR(s)

OutcomeOutcome

Seriousness Criteria of ADR(s)Seriousness Criteria of ADR(s)

Action TakenAction Taken

Lead Time IdentificationLead Time Identification

Polypharmacy VS MonopharmacyPolypharmacy VS Monopharmacy
Medicine usage Percentage
Monopharmacy 21.89%
Polypharmacy 78.11%

Distribution of Occurrences ofDistribution of Occurrences of
ADRs (findings on the basis of 297ADRs (findings on the basis of 297
ICSRs)ICSRs)

Distribution of Consumption ofDistribution of Consumption of
Medicines (findings on the basis ofMedicines (findings on the basis of
297 ICSRs)297 ICSRs)

Distribution of Consumption ofDistribution of Consumption of
Medicines vs Adverse Reaction (findingsMedicines vs Adverse Reaction (findings
on the basis of 297 ICSRs)on the basis of 297 ICSRs)
1 ADR 2 ADR 3 ADR 4 ADR 5 ADR Total (in
Percentage)
1 Med 48 13 5 1 0 21.89%
2 Med 50 29 13 1 1 31.64%
3 Med 42 30 12 3 6 31.31%
4 Med 17 16 7 3 2 15.2%
5 Med 0 0 0 0 0 0%
Total 52.2% 29.6% 12.46% 2.69% 3.03%

Causality AssessmentCausality Assessment

Severity on Hertwig’s ScaleSeverity on Hertwig’s Scale
Srinivasan et al., ADVERSE DRUG REACTION-CAUSALITY ASSESSMENT, INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND
CHEMISTRY;2011;1(3); 606-12

Month wise sent ADR reports to NCC-PvPI from DecemberMonth wise sent ADR reports to NCC-PvPI from December
2016 – November 20172016 – November 2017

Comparative study on Month wiseComparative study on Month wise
sent ADR reports in 3 sessionsent ADR reports in 3 session

Comparative study on Yearly ADRComparative study on Yearly ADR
reporting in 3 sessionsreporting in 3 sessions

Comparative study on DepartmentalComparative study on Departmental
involvement in 3 sessionsinvolvement in 3 sessions

Comparative study on GenderComparative study on Gender
Distribution in 3 sessionDistribution in 3 session

Comparative study on AgeComparative study on Age
Distribution in 3 sessionDistribution in 3 session

Comparative study on SystemsComparative study on Systems
Involvement (SOC) in 3 sessionsInvolvement (SOC) in 3 sessions

Comparative study on MedicinesComparative study on Medicines
Involvement to produce ADR(s) in 3 sessionsInvolvement to produce ADR(s) in 3 sessions
(on the basis of ICSRs collected throughout(on the basis of ICSRs collected throughout
the period)the period)

Comparative study on Outcome in 3Comparative study on Outcome in 3
sessionssessions

Comparative study on Seriousness ofComparative study on Seriousness of
ADR(s) in 3 sessionsADR(s) in 3 sessions

Comparative study on SeriousnessComparative study on Seriousness
Criteria of ADRs in 3 sessionCriteria of ADRs in 3 session

Comparative study on Skin &Comparative study on Skin &
Appendages Disorder in 3 sessionsAppendages Disorder in 3 sessions

Some Photography of SeriousSome Photography of Serious
Adverse ReactionsAdverse Reactions

Contribution for PvPIContribution for PvPI
1. Survey on Brand and Generic Medicine
2. Attended as Speaker to give talk on Pharmacovigilance
3. Training Provided to Students of GRD(PG)-IMT, KIT
Orissa, BCPSR Durgapur,WB
4. Inclusion of Doctors as Drug Alert Receiver
5. PvPI Promotional Activity – a) PvPI Poster given to
Bengal School of Technology (Pharmacy), Chunchura,
WB and b) Poster given to GRD(PG)-IMT (Pharmacy) and
c) Sent 1 student to attend 6th
Skill Development
Program on Pharmacovigilance held on and from
06/11/2017 – 15/11/2017
6. Attended Seminar
7. Achievement

1. Survey on Brand and Generic Medicine

a) Bengal School of
Technology (Pharmacy),
Chunchura

b) GRD(PG)-IMT
(Pharmacy), Dehradun

3. Training Provided to Students of GRD(PG)-IMT, KIT
Orissa, BCPSR Durgapur,WB

4. Inclusion of Doctors as Drug Alert Receiver

5. PvPI Promotional Activity – a) PvPI Poster given to
Bengal School of Technology (Pharmacy), Chunchura,
WB and b) Poster given to GRD(PG)-IMT (Pharmacy)

Cont..Cont..
5. c) Sent 1 student to attend 6th
Skill Development Program
on Pharmacovigilance held on and from 06/11/2017 –
15/11/2017
d) Tableau of Pharmacovigilance on Doctors’ Day

6. Attended Seminar:
a) Regional Symposium on Vector Borne Disease
b) CME at AIIMS, Rishikesh
c) East Zone Training Program on Pharmacovigilance

7. Achievement

Feedback Provided by StudentsFeedback Provided by Students
B.Pharm 3rd
Year Student - 01
M.Sc Biotech 1st
Yr, 2nd
Semester student - 03
B.Pharm 4th
Year, 1st
Semester student - 02

Other Contribution for PvPIOther Contribution for PvPI
Camp on Pharmacovigilance at Burdwan on 07/05/2017

Future PlanFuture Plan
• More Number of Reporting (≥35 or more per month)
• Conducting Awareness program for Pharmacist and
Nursing Professionals.
• Publication – We will do
• Interaction with Patient – In OPD, and IPD I meet Patient
and do the job properly, but now onward I will keep
documentation in terms of Photographs.
• Peripheral Sensitization is required.
• Department wise talk is necessary to include more no. of
Junior Doctors, but to do so some amount of fund is
required.

Take Home Message
To keep awake or alert, to keep watch.
45Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

Acknowledgement
• Prof (Dr.) Nina Das – AMC Coordinator, Prof & Head,
Dept of Pharmacology, Nilratan Sircar Medical
College & Hospital, Kolkata, WB
• Dr. Tania Sur (Kundu) – Causality Assessment
Committee Member, Dept of Pharmacology, Nilratan
Sircar Medical College & Hospital, Kolkata, WB
• Dr. V. Kalaiselvan, Principal Scientific Officer, NCC-
PvPI, IPC, Ghaziabad

Thank YouThank You
Anindya Banerjee
Patient Safety-Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH
&
NCC-PvPI
Email: anindyabanerjee1988@gmail.com

Pharmacovigilance Activity at NRS Medical College in 2017 and 3 Years of Comparative Study under NCC-PvPI,IPC

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Pharmacovigilance Activity at NRS Medical College in 2017 and 3 Years of Comparative Study under NCC-PvPI,IPC