METHOD

Study design-

An observational, cross-sectional cohort study was carried out at DOTS centre located in
Guwahati medical College And Hospital, Guwahati.

The duration of the study followed a period from November 2023 to March 2024.

Patients-

Around 250 patients were selected including both male and female category. The patients
those who are undertaking the anti-tubercular drugs followed by DOTS were taken under
observation.

Data collection

The ADR reporting form from the PvPI utilized by the ADR monitoring centre of NETES
Institute of Pharmaceutical Science in Mirza, Guwahati Assam, helped the prime to tool for
data collection.

To facilitate ADR reporting, the study authors' contact information and email address were
shared with the physicians in their respective departments.

These cases were classified as ADRs and documented after being recognized and reported by
this hospital's doctors.

The gathered data encompassed the patient's first name, age, gender, hospital reporting
department, reaction description, reaction duration, name of probable medicine causing
reaction, and outcomes.
With the permission from the MRD department of the tertiary care hospital the ADR reports
were collected which was reported by the healthcare professionals.
All the TB causing ADR were noted and a follow-up to the patients was done which was
given according to the report.
Inclusion criteria
Eventually, a list of all suspected adverse drug reactions (ADRs) that could be caused by
prescription of Anti-tubercular drugs was noted.

Exclusive criteria
Patients taking more than ten prescription pharmaceuticals, overprescribing, overdosing, and
excessive consumption were not included, nor was the usage of other medical systems like
Ayurveda, Homeopathy, Unani, etc. The study also did not include any patients who were
unconscious, drug addicts, or intellectually retarded.

Interpretation of data
The collected ADR data were analyzed by taking the reference of the Causality Assessment
Category.
The WHO-UMC category which is taken into consideration for the study are as follows-
Probable
Possible
Unlikely
Unclassified
The severity of ADRs were analyzed by using the modified Hartwig and Siegel assessment
scale.
The Hartwig and Siegel assessment scale determines the severity into the following
categories as-
Mild
Moderate
Severe

Statistical analysis
All the data which were collected was analysed statistically.
The statistical analysis was done using a Microsoft excel sheet in MS office 2007.
Various statistical tools were used for presenting as well as plotting of the data.
The statistical tools which were used during the statistical analysis are bar graph, pie chart.
RESULT

Patient’s demographic pattern

A total of 250 no of patients (n=250) were screened during the 4months study duration.
Out of 250 number of patients there were 145 male (58%) and 105 female (42%) shown in
fig.
A standard WHO age scale was taken into consideration to check the prevalence of ADR
caused to different age groups. The age scale is shown in table
After the analysis it was seen that the prevalence of ADR caused during the DOTS therapy
was common the adult group i.e 19 to 64 years as compared to the other group shown in fig.

TABLE-

Sex n=250
Male 145
Female 105

TABLE- sex ratio

Table- age division

Period Age No. of patients

Child 0-12 3
Adolescence 13-18 16
Adult 19-64 221
Elder 65 and above 10

Chart Title
250

200
no. of patients

150

100

50

0
0-12 13-18 19-64 65 & above
age acale

Series1 Series2
Analysis of ADR

The medical data record (MRD) of 250 patients were analysed from which a total of 19 ADRs were
identified and recorded.

The table shows the types of ADR identified along with the total number of patients witnessed the
particular ADR.

The common ADRs identified in the study were fever (53.62%), abdominal pain (44.92) , general
weakness (44.92%), respiratory difficulty (36.23%), vomiting (31.88%).

Table- ADR TYPES

Type of ADR Total witnessed patients

fever 37
Abdominal pain 31
General weakness 31
Respiratory difficulty 25
Vomiting 22
Anorexia 19
Cough 16
Hemoptysis 15
Loss of appetite 13
Allergic reaction 13
Loose stool 12
Body pain 10
Joint pain 10
Giddiness 9
Cough bleeding 9
Leg pain 8
Headache 8
Chest pain 7
Sore throat 6
 ADR report
40
35
30
25
20
15
no. of patients

10
5
0
R IN SS TY G IA H SIS ITE ON OL IN IN SS NG IN HE IN AT
VE A E L IN EX G Y T I O A A E I A C A O
FE AL P AKN FICU MIT OR COU PT APE ACT ST DY P T P DIN EED G P ADA ST P HR
N E F O N O E S E O IN ID L LE E E T
M
I W DI
Y
V A
HE M O F IC R O O B JO G H B H CH RE
O
O S S G L G S
D OR LO LER
U
AB AT L CO
IR A
AP
RE

types of ADR caused

ANALYSIS Of DOTS CATEGORY

Patients following the DOTS regimen were taken for analysis.

It was seen that category 1 has highest number of patients when compared to other category
shown in fig.

Table- total number of patients with dot category and BDQ resistant

Category Total witnessed patient

Cat1 122
Cat2 72
Cat4 21
BDQ 35
 Chart Title

140
120
100
Axis Title

80
60
40
20
0
Cat1 Cat2 Cat4 BDQ
Axis Title

CAUSALITY ASSESSMENT

The WHO causality assessment was performed and it was analyzed that the category of possible
was seen with 60.40% cases as the highest amongst all.

The unclassified cases were the least with 1.2% cases and thus require additional data for
analysis.

The data is shown in table-

CA category Category report (%)

Probable 2%
Possible 60.40%
Unlikely 21.20%
Unclassified 1.20%
 WHO-UMC category caused

Unclassified
WHO- UMC category

Unlikely

Possible

Probable

0% 10% 20% 30% 40% 50% 60% 70%

category report (%)

SEVERITY ANALYSIS

The severity analysis was done with the help of Hartwig siegal scale

This includes the scale of mild, moderate and severe.

From the analysis it was seen that the mild scale had 60.40% of cases which is the highest one,
moderate with 24% and severe with 0.80% which was the least value.

The data is tabulated in the table-

Severity scale
1%

24%

60%

Mild Moderate Severe

Severity scale % cases analysed
Mild 60.40%
Moderate 24%
Severe 0.80%