Pharmacovigilance at NRSMC for last 2yrs and serial look since dec, 2014 june, 2019

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Comparison of ADR monitoring data over 2
consecutive years
&
A study of ADR monitoring data over 4.7
years in a tertiary care teaching hospital of
East India
Presented by Mr. Anindya Banerjee
Designation: Patient Safety-Pharmacovigilance
Associate
Affiliation: Dept of Pharmacology, NRSMCH, Kolkata
And
NCC-PvPI, IPC, Ghaziabad

• Comparative Study between December, 2017 – November,
2018 and December, 2018 – June, 2019
• Serial look at ADR monitoring data over 4.7 years
• Other contribution

Contribution of various Disciplines
29.30%
11.82% 11.30%
8.22% 7.71% 6.16% 5.14% 4.11% 3.34% 2.06% 1.79% 1.54% 1.02% 0.77% 0.51% 0.26%
December, 2017 – November, 2018
30.23%
13.95%
7.55% 9.30% 8.72% 9.30%
1.74% 3.48% 1.74% 0.58% 0.58% 1.74% 0.58% 0%
4.65% 2.32%
December, 2018 – June, 2019

Gender Distribution
Male Female
53.21%
46.78%
Male Female
58.13%
41.86%

Age Distribution (according to Vigiflow)
Adult (18 –
69 years)
Elderly (>
69years)
Adolescent
(≤ 16 years)
Child (≤11
years)
Infant (≤ 4
years)
Neonate (≤
1month)
90.23%
6.17% 2.06% 1.02% 0.51% 0%
Adult (18 –
69 years)
Elderly (>
69years)
Adolescent
(≤ 16 years)
Child (≤11
years)
Infant (≤ 4
years)
Neonate (≤
1month)
85.46%
5.81% 3.48% 4.65% 0.58% 0%

Systems Involved
Dec ‘17 – Nov ‘18
21.33%
65.03%
6.94%
2.57%
5.14%
0.51% 0.25%
14.91%
5.65%
14.90%
10.79%
8.74%

12.50%
42.27%
4.41%
0.73%
2.57%
0.36% 0%
5.88% 6.25%
7.72% 6.61% 5.51%
Systems Involved
Dec ‘18 – June ‘19

Drugs involved
Dec ‘17 – Nov ‘18
24.87%
14.97%
9.28%
5.44% 4.82% 4.33%
3.22% 2.72%
1.23% 1.11% 0.99% 0.62% 0.49% 0.37% 0.24% 0.12%

24.26% 24.63%
14.70%
2.91%
5.51%
4.41%
0.36%
1.83% 1.47%
0.73% 0.37% 0.24% 0.12%
1.83% 1.47%
Drugs involved
Dec ‘18 – June ‘19

Outcome
Recovered Recovering Recovered with
Sequele
Fatal
55.78%
42.93%
1.02% 0.26%
Recovered Recovering Recovered with
Sequele
Fatal
56.39%
40.11%
3.48% 0%

Seriousness Criteria of ADR(s)
Non-Serious Serious
76.35%
23.65%
Non-Serious Serious
76.74%
23.25%

Dec ‘ 2017 – Nov ‘ 2018
1.08% 0%
31.52%
0% 0% 1.08%
66.30%

0% 0%
35%
0% 0% 0%
65%
Dec ‘ 2018 – June ‘ 2019

Action Taken
Drug Withdrawn Dose Reduced Dose not changed
43.44%
7.17%
49.38%
Drug Withdrawn Dose Reduced Dose not changed
54.41%
5.88%
39.70%

Lead Time Identification
Dec ‘17 – Nov ‘18
0-3 days 4-7 days 8-14
days
15-21
days
22-28
days
≥1
month
≥2
month
≥4-6
month
≤1 year >1 year ≤2 year >2 year
26.47%
20.82% 21.33%
11.05%
8.48%
5.91%
3.08%
0.51% 0.51%
1.28%
0.25% 0.25%

0-3 days 4-7 days 8-14 days 15-21 days 22-28 days
19.18% 19.18%
20.93%
10.46%
3.48%
Lead Time Identification
Dec‘18 – June‘19

Fixed Dose Combination vs Single Medicine
Fixed Dose Combination Single Dose
20.37%
79.62%
Fixed Dose Combination Single Dose
20.37%
79.62%

Poly-Pharmacy vs Mono-Pharmacy
Mono-Pharmacy Poly-Pharmacy
28.80%
71.20%
Mono-Pharmacy Poly-Pharmacy
29.77%
70.22%

Generic Name Vs Brand Name
Generic Name Brand Name
74.10%
25.10%
Generic Name Brand Name
74.10%
25.10%

Ratio of Consumption of Medicines and ADRs Dec‘17 –
Nov‘18
18.25%
7.71%
1.28%
0.26%
22.36%
17.22%
4.11%
0.77% 0.51%
12.39%
8.48%
2.83%
0.77% 0.77% 0.77%
1.54%

12.40%
7.40%
0.70%
20.10%
17.20%
3.20%
12.10%
8.50%
Ratio of Consumption of Medicines and ADRs

Causality Assessment
Certain Probable Possible Unlikely
0%
28.28%
71.46%
0.26%
Certain Probable Possible Unlikely
0%
51.74%
48.25%
0%

Severity of ADR on Hartwig’s Scale
Dec‘17 – Nov‘18
Srinivasan et al., ADVERSE DRUG REACTION-CAUSALITY ASSESSMENT, INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY;2011;1(3); 606-12
Mild Moderate Severe
65.03%
34.70%
0.26%

Srinivasan et al., ADVERSE DRUG REACTION-CAUSALITY ASSESSMENT, INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY;2011;1(3); 606-12
Mild Moderate Severe
76.74%
23.25%
0%
Severity of ADR on Hartwig’s Scale

Month wise sent ADR reports to NCC-PvPI
December 2017 – November 2018
Dec, 2017 Jan, 2018 Feb, 2018 March,
2018
April,
2018
May,
2018
June,
2018
July, 2018 Aug, 2018 Sept,
2018
Oct, 2018 Nov, 2018
28
32
30 30
34
41
38
22
34
35
34 34

Month wise sent ADR reports to NCC-PvPI
December 2018 – June 2019
Dec, 2018 Jan, 2019 Feb, 2019 March, 2019 April, 2019 May, 2019 June, 2019
33
37
27
23
17
0
32

Month wise contribution of NSMC in West Bengal in
respect to other AMCs of WB in December, 2017 –
November, 2018
Dec, 2017 Jan, 2018 Feb, 2018 March,
2018
April,
2018
May,
2018
June,
2018
July, 2018 Aug,
2018
Sept,
2018
Oct, 2018 Nov,
2018
223 227
243
236
148
140 145
128
148
156
111
123
28
32 30 30
34
41 38
22
34 35 34 34
Total no. of reports of all AMCs in WB No. of Reports from NSMC

Dec, 2018 Jan, 2019 Feb, 2019 March, 2019 April, 2019 May, 2019 June, 2019
122
127 124
141
134
122
165
33 37
27 23
17
0
32
Total no. of reports of all AMCs in WB No. of Reports from NSMC
Month wise contribution of NSMC in West Bengal in
respect to other AMCs of WB in December, 2018 – June,
2019

Yearly contribution of NSMC in WB in comparison of
other AMCs of WB
Total No. of Reports in WB Total No. of report of NSMC
2028
392
Total No. of Reports in WB Total No. of report of NSMC
935
169

Study of ADR monitoring from our AMC over
4.7 years

Study on month wise sent ADR reports in
session December, 2014 - June, 2019
December January February March April May June July August September October November
9
7 7
28
7
12
5
1
24
22
25
13
14
23
28
18
13
17
19
21
14
18
17
19
10
19
21
20
15
20
26
17
38
36
38
35
28
32
30 30
34
41
38
22
34
35
34 34
33
37
27
23
17
0
32
0 0 0 0 0
2014-2015 2015-2016 2016-2017 2017 - 2018 2018 - 2019

Yearly ADR reporting
Dec, 2014 – Nov,
2015
Dec, 2015 – Nov,
2016
Dec, 2016 – Nov,
2017
Dec, 2017 – Nov,
2018
Dec, 2018 – June,
2019
160
221
297
389
172
December, 2014 - June, 2019

Departmental involvement
Dec‘ 2014 – June‘ 2019
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
Dec,14 – Nov,15
Dec,15 – Nov,16
Dec,16 – Nov,17
Dec,17 – Nov,18
Dec,18 – June,19

Gender Distribution
Dec‘ 2014 – June‘ 2019
Dec,14 – Nov,15 Dec,15 – Nov,16 Dec,16 – Nov,17 Dec,17 – Nov,18 Dec,18 – June,19
53%
43.89%
48.50%
53.21%
58.13%
46.20%
56.10%
51.50%
46.79%
41.86%
Male Female

Age Distribution
Dec‘2014 – June‘2019
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
100.00%
Neonate (≤
1month)
Infant (≤ 4
years)
Child (≤11
years)
Adolescent (≤
16 years)
Adult (18 – 69
years)
Elderly (>
69years)
According to Vigiflow
Dec,14 – Nov,15
Dec,15 – Nov,16
Dec,16 – Nov,17
Dec,17 – Nov,18
Dec,18 – June,19

Systems Involvement (SOC)
Dec‘2014 – June‘2019
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
2014-2015 2015-2016 2016-2017 2017-2018 2018-2019

Drugs involved in ADRs
Dec‘ 2014 – June‘2019
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
Dec,14 – Nov,15
Dec,15 – Nov,16
Dec,16 – Nov,17
Dec,17 – Nov,18
Dec,18 – June,19

Outcome
Dec‘2014 – June‘2019
2014-2015 2015-2016 2016-2017 2017-2018 2018-2019
56.90% 57.47%
46.50%
55.78% 56.39%
32.50%
41.62%
43%
42.93%
40.11%
8.10%
0%
10.40%
1.02%
3.48%
2.50%
0.90% 0% 0.26% 0%
Recovered Recovering Recovered with sequel Fatal

Seriousness of ADR(s)
Dec‘ 2014 – June‘ 2019
2014-2015 2015-2016 2016-2017 2017-2018 2018-2019
72.50%
66.50%
60.30%
76.35%
76.74%
27.50%
33.50%
39.70%
23.65% 23.25%
Not Serious Serious

Seriousness Criteria of ADRs
Dec‘2014 – June‘2019
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
Death Life
Threatening
Hospitalizati
on/Prolongat
ion of
Hospitalizati
on
Disability Congenital
Anomaly
Required
Intervention
Other
2014-2015 9.76% 7.31% 82.90% 0% 0% 0% 0%
2015-2016 2.70% 2.70% 52.70% 0% 0% 5.40% 36.50%
2016-2017 0% 0.85% 50% 0% 0% 8.47% 40.70%
2017-2018 1.08% 0% 31.52% 0% 0% 1.08% 66.30%
2018-2019 0% 0% 35% 0% 0% 0% 65%

SAE
Dec ‘2014 – June‘2019
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
14.00%
Death SJS SJS-
TEN
TEN FDE Maculo
papular
Bullous
Eruptio
n
Itching Papulop
ustular
Dec,14 – Nov,15 0.58% 1.18% 0% 0.44% 0.73% 4.19% 0.73% 5.01% 0%
Dec,15 – Nov,16 0.29% 1.47% 0% 0.59% 0.73% 2.50% 1.77% 5.01% 0%
Dec,16 – Nov,17 0% 1.47% 0.15% 0.15% 0.89% 1.77% 1.33% 9.14% 0%
Dec,17 – Nov,18 0.26% 1.70% 0.77% 1.02% 0.77% 3.59% 5.65% 13.11% 0%
Dec,18 – June,19 0% 2.50% 0% 0.58% 0% 4% 1.16% 14% 0.58%

Some Photographs of SAE

Contribution for PvPI
1. Training Provided to various Students of B.Pharm of Dr. B. C. Roy
College of Pharmacy and Allied Health Sciences during 12th June, 2018
– 12th July,2018, 2nd Jan,2019 – 11th Jan, 2019 and 19th June, 2019 – 29th
June, 2019
2. PvPI Promotional Activity –
a) PvPI Newsletter given to The Director of Dr. B. C. Roy College of
Pharmacy and Allied Health Sciences
b) Some of the trainee student will be attending Skill Development
Program on Pharmacovigilance for Medical Products (PvM) on and from
23/08/2019 – 27/08/2019
3. Attended Pharmacist Upgradation Training Program on and from 7th
April, 2018 – 8th April, 2018 and gave a talk on 8th April 2018, topic
was entitled as “Pharmacovigilance in Real Life”
4. Attended Seminar on Pharmacology and Pharmacovigilance

1. Training
12/06/2018 – 12/07/2018 02/01/2019 – 11/01/2019 19/06/2019 – 29/06/2019

Training Session
1. 12th June, 2018 – 12th July, 2018
2. 2nd Jan,19 – 11th Jan, 2019
3. 19th June, 2019 – 29th June, 2019

Certificates
12/06/2018 – 12/07/2018 19/06/2019 – 29/06/201902/01/2019 – 11/01/2019

Feedback Provided by Students
Feedback provided by Students of B.Pharm of Dr. B. C. Roy
College of Pharmacy and Allied Health Sciences undergone
Hospital Internship Training on Pharmacovigilance at NSMC,
Kolkata

2. PvPI Promotional Activity –
a) PvPI Newsletter given to The
Director of Dr. B. C. Roy College
of Pharmacy and Allied Health
Sciences, Durgapur
b) Some of the trainee students
will be attending Skill
Development Program on
Pharmacovigilance for Medical
Products (PvM) on and from
23/08/2019 – 27/08/2019

3. Attended Pharmacist Upgradation Training Program on and from
7th April, 2018 – 8th April, 2018 and gave a talk on 8th April 2018,
topic was entitled as “Pharmacovigilance in Real Life” at
BMCH, Burdwan

6. Attended Seminar:
Sr.
No
Date Title Venue
1. 20/03/2018 CME on Patient Safety and
Pharmacovigilance
Calcutta School of
Tropical Medicine,
Kolkata
2. 07/04/2018 –
08/04/2018
Up-gradation Training Program,
West Bengal Pharmacy Council
Burdwan Medical
College, Burdwan
3. 05/04/2019 Eastern & North-Eastern region
Colloquium on Pharmacovigilance
and Patient Safety in India
Calcutta School of
Tropical Medicine,
Kolkata
4. 22/04/2019 -
23/04/2019
28th Annual Conference of Indian
Pharmacological Society, West Bengal
Branch
Sinclairs Hotel,
Burdwan

Photography of Certificates of Attended Seminars

Future Plan
• More Reporting (target of ≥35 or more per month)
• Conducting Awareness program for Pharmacist and
Nursing Professionals.
• Publication of the gathered data in peer-reviewed
journals
• Peripheral Sensitization is required.

Thank You
Anindya Banerjee
Patient Safety-Pharmacovigilance Associate
NSMC, Kolkata
&
NCC-PvPI, IPC, Ghaziabad
Email: anindyabanerjee1988@gmail.com

Pharmacovigilance at NRSMC for last 2yrs and serial look since dec, 2014 june, 2019

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