Presented in NORC - Aug 2019 - National Original Research convention, discussion of Flu like illnesses and the Flu vaccination and drug utilization reviews and prescription audits and various other original research presented and published by Dr. Gaurav Gupta in his years of clinical practice, including yellow fever, Complementary medicines, drug costs and prescriptions analysis

1. Research out of
a Pediatrician's
office: My Story
Dr. Gaurav Gupta
Charak Clinics,
Mohali

2. Research out of
a Pediatrician's
office: My Story
Dr. Gaurav Gupta
Charak Clinics,
Mohali

3. Scope
• My interest in Research
• How did it ALL begin?
• Work on DUR, ILI
• Other studies
• Challenges
• The future ….

5. Pediatric research
BEFORE Office Practice !
RESEARCH PROJECTS
• Hair Iron Analysis In Normal And
Thalassemic Children And Correlation With
Serum Ferritin To Detect Iron Overload -
Dissertation

6. Pediatric Research
before Office Practice !
• Contributing Editor for CLIPPINGS in
INDIAN PEDIATRICS since July 2000 to
Dec 2015
• “Singhi S, Jain V, Gupta G. Pediatric
emergency admission profile in a
tertiary care center.” Journal of Tropical
Pediatrics Aug 2003

7. PEDIATRIC RESEARCH IN OFFICE PRACTICE
• PMS of Pentaxim (DTaP-IPV-Hib) vaccine
administered to healthy children in India.
(2009-2010)
• The PRIDE Study - Pedimune in Recurrent
Respiratory Infection and Diarrhoea - The
Indian Experience. Ind J Pediatrics 2006 (73); p
585.
www.medind.nic.in/icb/t06/i7/icbt06i7p585.p
df

8. How did it all begin?
• Dr. P Tiwari – comments by his ‘mentor’
• Start of something BIG

9. Study site:
Charak clinic, Mohali.
Supported by:
Dr. Gaurav Gupta
DRUG UTILIZATION IN AN OUTPATIENT
PRIVATE PEDIATRIC SETTING WITH SPECIAL
REFERENCE TO ANTIMICROBIAL DRUGS
Conducted by:
Ashutosh Gupta
Deptt. of Pharmacy Practice, NIPER, SAS Nagar.

10. Average number of drugs
 Average number of drugs per encounter was 2.95±0.03 (range 1-7)
10
R
E
S
U
L
T
S
0
8
0
9
 37% prescriptions had 3 drugs prescribed in it
117
284
456
278
73
5 19
34
72
105
47
3 0
0
50
100
150
200
250
300
350
400
450
500
1 2 3 4 5 6 7
No. of prescriptions
AMDs
Fig: Distribution of no. of drugs

11. AMD Utilization Pattern
 Azithromycin was the highest prescribed AMD (approx. 25%)
11
R
E
S
U
L
T
S
0
8
0
9
62
69
5
7
10
6
27
51
3
15
11
4
Amox. + Clav.
Azithromycin
Cefadroxime
Cefdinir
Cefixime
Cefodroxime
Cefodroxil
Cefpodoxime
Other
Norfloxacin
Ofloxacin
Clarithromycin
0 10 20 30 40 50 60 70 80
Fig: Prescribing pattern of AMDs
 The average duration of prescribed AMDs (without Azithro.)
was 3.84±1.44 days

12. Morbidity pattern
 RTI had max. no. of cases
12
R
E
S
U
L
T
S
0
8
0
9
 Infections contributed to approx. 60% of total cases
Respiratory
Tract
infections
29%
RAD
14%
Acute Otitis
Media
3%
AGE
9%Abdo. Pain
3%
Cough,Cold,
Fever
16%
Skin rashes
3%
Throat
congestion
3%
Others
20%
Fig: Morbidity pattern

13. Comparative depiction of studies
13
# Indicator 08-09 study Karande at al Bhartiy et al Dimri et al
1 Average no. of drugs per encounter 2.9 2.9 2.8 2.3
2 Medicines prescribed by generic name <1% 73.4% 48.5% 5.8%
3 Medicines from NLEM 13.5% 90.3% 66.9% 45%
4 Medicines from WHO EML for children 23.3%
5 Injections prescribed 0.16% 0.2% 13.6% 1.2%
6 Prescriptions with AMDs 22.1% 39.6% 60.9% 29.1%
7 Average duration of prescribed AMDs 3.7 days
8 Total cost of drugs prescribed (Rs.) 186198.6
9 Average drugs cost per encounter (Rs.) 152.4
10 Cost spent on AMDs (% of total) 9.5%
11 Cost spent on injections (% of total) 0.18%

14. CONCLUSIONS
1. Over 4000 prescriptions form the bases of results of this study.
2. The average number of drugs (2.86) prescribed was encouraging.
3. The use of antimicrobial drugs and injectables was rational.
4. Therefore, the drug costs were not very high (affordability).
5. This study has outlined the prescribing pattern in a private
outpatient pediatric setting. The results reflect rational prescribing.
14

15. Poster Presentation: 14th Annual meeting of ISPOR, Orlando, Florida, USA
15

16. Objective
Effectiveness of TIV in terms of clinical outcome among healthy
Indian children

17. • Design: Prospective cohort study (Vaccinated vs
Unvaccinated cohort)
• Site: Private outpatient pediatric setting
Site & Study Design
• Healthy child between the age of 6 months to 18 years
• Age & gender matched for Vaccinated & Unvaccinated cohort
Inclusion Criteria
• First call after 45 days of first dose of vaccine then every
month
Follow Up Protocol
Methodology_1

18. Results_(Comparing2008-09to2009-10)
Fully vaccinated (154) vs Unvaccinated Cohort (330) (2009-10)
# Parameter RR CI p value VE (%)
1 ILI 0.58 0.24-0.92 0.009 42
2 Unsch. Visit 0.71 0.33-1.09 0.039 29
Fully vaccinated (101) vs Unvaccinated Cohort (141) * (2008-09)
# Parameter RR CI p value VE (%)
1 ILI 0.57 0.32-0.09 0.05 43
2 Unsch. Visit 0.43 0.22-0.09 0.007 57
* Singh H, Gupta G, Tiwari P. Clinical effectiveness of the 2009-2010 seasonal
influenza vaccine among healthy Indian children. ISPOR 4th Asia Pacific
Conference, Phuket, Thailand.

19. Conclusion
• This study had shown that TIV is effective in
decreasing ILI and unscheduled visits in vaccinated
children
• Partially vaccinated children did NOT benefit from
TIV
• Sub-cohort of 3Y-9Y had shown 52% effectiveness
in reducing ILI events

20. Safety and Tolerability of Influenza Vaccine-1
18
11.3
8
5.5
2.2 2.6
5.5
2.9
1.1
4.7
10.2
0
0
2
4
6
8
10
12
14
16
18
20
P
e
r
c
e
n
t
a
g
e
Primary and secondary parameters
(N=272)
Percentage
*Singh H, Gupta G, Tiwari P. Safety and tolerability of trivalent inactivated influenza (TIV) vaccine in
healthy Indian children. 62nd Indian Pharmaceutical Congress, 2010. Manipal, India. (Poster No. L-6).

21. Safety and Tolerability of Influenza vaccine-2
*Singh H, Gupta G, Tiwari P. Safety and tolerability of trivalent inactivated influenza (TIV) vaccine in
healthy Indian children. 62nd Indian Pharmaceutical Congress, 2010. Manipal, India. (Poster No. L-6).
5.9
2.2
0
16.4
8.9
0
19.5
4
1.6
8.9
4.8 4
46.6
0 0
6.6
0
6.6
0
5
10
15
20
25
30
35
40
45
50
MILD MODERATE SEVERE MILD MODERATE SEVERE
Local reactions (Inj. site tenderness) Systemic reactions
P
e
r
c
e
n
t
a
g
e
Grading of the reactions after vaccination
N=272
> 6 to 35 Months
3Y to 9Y
> 9Y

22. 0
50
100
150
200
250
jan - mar
2008
apr-jun
2008
july-sept
2008
oct 2008-
dec 2008
jan to
march
2009
apr to
june 2009
july to
sept 2009
Oct 2009
to dec
2009
Jan to
march
2010
Apr to
june 2010
july to
sept 2010
Oct 2010
to dec
2010
Jan to
march
2011
Apr to
June
2011
Incidence of ILI from our center

23. Challenges
• Consent
• Establishing the clinical question
• Checking to ensure that the question(s)
were clearly understood by the student
and the parents
• Randomization
• Lack of placebo, blinding, case control
matching
• Biostats

24. Some publications
TIWARI P, AHLAWAT
R, GUPTA G. SAFETY
OF YELLOW FEVER
VACCINE IN INDIAN
TRAVELLERS: A
PROSPECTIVE
OBSERVATIONAL
STUDY. INDIAN J MED
RES 144, NOV 2016,
778-780 DOI:
10.4103/IJMR.IJMR_
1720_15
TIWARI P, AHLAWAT
R, GUPTA G.
ANTIBIOTIC USE FOR
RESPIRATORY TRACT
INFECTIONS IN
CHILDREN.
RESPIROLOGY.
2014;19:49.
AHLAWAT R, GUPTA
G, TIWARI P.
COMPLEMENTARY
MEDICINE CAUSING
SEVERE SIDE-EFFECTS
IN A CHILD - AN
OVERLOOKED CAUSE
OF WEIGHT LOSS?
INT J OF PHARM SCI
AND RES.
2014;5(8):478-9.
AHLAWAT R, TIWARI
P, GUPTA G.
ASSESSMENT OF
PRESCRIBING AT A
PRIVATE PEDIATRIC
OUTPATIENT SETTING
IN NORTHERN INDIA.
ASIAN J CLIN PEDIATR
NEONATOL.
2014;2(1):23-7.
AHLAWAT R, TIWARI
P, GUPTA G. DIRECT
COST INVOLVED IN
THE TREATMENT OF
MOST COMMONLY
OCCURRING ILLNESS
IN CHILDREN AT A
PEDIATRIC
OUTPATIENT CLINIC
IN NORTH INDIA.
JOURNAL OF ISPOR
2014; 17(3): A175.

25. Presentations
• ESPID 2016, Brighton UK
• CAPGAN 2015, New Delhi
• ASVAC 2015, Hanoi
• ISPOR 2014, Montreal, Canada
• WSPID 2013, Cape Town, South Africa
• ICP 2013, Melbourne, Australia
• ISPOR 2013, New Orleans, USA
• CISTM 2013, Maastricht, Netherland
• ACPID 2012, Colombo, Sri Lanka
• WSPID 2011, Melbourne, Australia
• ISPOR 2010, Phuket, Thailand

26. Long term
challenges
ETHICS
COMMITTEE
KITS FOR
INFLUENZA,
ROTAVIRUS ETC. –
FUNDS
MANPOWER,
TRAINED – RESEARCH
METHOD AND PAPER
WRITING
TIME

27. • Collaboration – Dr. Vipul Jain,
Use of Electronic S/w like Docon etc.
• Topics – PROS website
• Dr. Dighant Shastri

28. Missed something ?
Check www.slideshare.com/gauravg
docgaurav@gmail.com
www.youtube.com/charakclinics
Acknowledgements: My Wife ….