INTRODUCTION

Adverse drug reaction is a major health concern for patients across the world.
No medicine is devoid of any side effects. The reporting of adverse drug reactions is highly
essential as it helps in analyzing the various drug reactions by the regulatory concerns and
could help in preparing an effective patient safety profile. WHO defined Pharmacovigilance
as the science and activities relating to the detection, assessment, understanding, and
prevention of adverse effects or any other possible drugs-related problems. (1)
Since ancient times, Tuberculosis has been regarded as a highly contagious disease that
continues to dominate global health. Mycobacterium tuberculosis is the causative agent of
tuberculosis, which mostly affects the lungs and is referred to as pulmonary tuberculosis
(PTB). PTB primarily spreads through airborne transmission; when an infected individual
sneezes, a significant amount of bacteria are released into the surrounding area. The other
individual could get infected by the air droplets. The term "extra-pulmonary tuberculosis"
refers to tuberculosis that can develop in other bodily parts. An estimated 1.9 million new
cases of tuberculosis (TB) are reported to develop in India each year, indicating that TB
remains a public health concern there. (1)

All currently prescribed medications have some sort of side effect.

One definition of an adverse medication reaction is a noticeably unpleasant or dangerous side
effect. Reaction that follows a medication-related intervention, signals a risk with ongoing
use, and necessitates halting the product entirely, modifying the dosage, or implementing
targeted therapy. (2)

One of the main causes of morbidity and death is adverse drug reactions (ADRs), which
constitute a significant public health concern. (3)
A toxic, unintentional damage resulting from drug-related causes is called an adverse drug
response (ADR). ADRs cause a significant burden on healthcare facilities, lengthen hospital
stays, and occasionally necessitate additional investigations and drug therapies for the
treatment of symptoms and diseases caused to the patient. These findings are supported by
mounting evidence that links the increased frequency and severity of ADRs to a negative
impact on patients' health status. (3)
ADVERSE DRUG REACTION
An unpleasant, unintentional damage resulting from drug-related causes is called an adverse
drug reaction (ADR). (3)
Additional definition of ADR: "an intervention related to the use of a medicinal product that
results in an appreciably harmful or unpleasant reaction" which forecasts potential risks from
further administration and orders against prevention, particular treatment, changing the
dosage, or stopping the substance (3). ADR detection has grown in importance as a result of
the introduction of numerous strong hazardous substances as medications throughout the last
two or thirty years. Monitoring the recognized as well as unknown side effects of medications
became vital. (4)

ADR reporting initiatives support ADR reporting, enhance ADR surveillance, and advance
health professionals' knowledge of potential ADRs. (5)

An effective hospital-based reporting scheme can play a crucial role in offering important
insights into possible drug use issues within an organization. These initiatives identify and fix
issues, which leads to ongoing improvements in patient care. (5)

ADR REPORTING AND PHARMACOVIGILANCE

The World Health Organization defines pharmacovigilance as the science and activities
relating to the detection, assessment, understanding and prevention of adverse effects or any
other possible drug related problems (6)

Pharmacovigilance, the scientific study of medication safety, is one area in which

pharmacists are highly influential in the realm of medicinal pharmaceuticals. (7)

International Drug Monitoring Program of the World Health Organization is coordinated

from Geneva by the Quality Assurance and The Department of Essential Drugs and
Medicines Policy's Safety of Medicines Team (7)
A nationwide Pharmacovigilance Program of India (PvPI) is being run by the Central Drugs
Standard Control Organization (CDSCO), Directorate General of Health Services, under the
auspices of the Ministry of Health and Family Welfare, Government of India, in partnership
with the Indian Pharmacopeia Commission (IPC), Ghaziabad, to safeguard patient health
through ensuring drug safety. As a National Coordinating Center (NCC), the IPC oversees
the program. (8)
The goal of PvPI is to protect the health of the Indian populace by making sure that the
advantages of using pharmaceuticals exceed the hazards. The goal of PvPI is to decrease the
risk related to medication use by improving patient safety. (8)
Early ADR detection, risk factor identification, and comprehension of the mechanisms
underlying the ADR are all made possible with the aid of pharmacovigilance. (8)

The Government of India's Ministry of Health and Family Welfare introduced PvPI in 2010
with the goal of monitoring drug safety and lowering the risk that comes with using
medications among the populace of India. (9)
ADR Monitoring Centers (AMCs) have been put up throughout India to track ADRs and
report them to the NCC. These AMCs include medical colleges and hospitals,
medical/central/autonomous institutes, and public health
initiatives as well as corporate medical facilities. Qualified pharmacy degree holders, dentists,
and other professionals are assigned to each of these centers as Technical Associates (TAs).
(9)

TUBERCULOSIS
One of the biggest causes of sickness and death in the world's health is still tuberculosis (TB).
Mycobacterium tuberculosis (M. tuberculosis) is known to infect one in three people
worldwide, or 2.3 billion people, of whom 5–15% are expected to experience active TB
disease at some point in their lives. (10)
People who have pulmonary or laryngeal tuberculosis cough, sneeze, shout, or sing, releasing
droplet nuclei into the air that can infect others. Inhaling these droplet nuclei causes
transmission, which then proceeds through the upper respiratory tract, bronchi, mouth or
nasal cavities, and lung alveoli. (10)
PATHOGENESIS

Alveolar macrophages consume the tubercle bacilli when they enter the alveoli, which causes
the inhaled tubercle bacilli to be destroyed and inhibited. (11) Within macrophages, the small
unaffected proportion multiplies. Released tubercle bacilli can travel through lymphatic or
blood vessels to affect any region of the body, including the organs, tissues, and spine. Other
areas that are particularly vulnerable to tubercle bacilli infection include the kidney, larynx,
lymph nodes, spine, and lungs. The bulk of the tubercle bacilli can be encapsulated or
destroyed by white blood cells when an immunological response is triggered, which occurs in
roughly two to eight weeks. The tubercle bacilli are encapsulated by the white blood cells,
creating a barrier that surrounds them and forms a granuloma. The tubercle bacilli are
considered to be under control once they are inside the barrier shell. resulting in the
establishment of latent tuberculosis infection (LTBI). At this point, a person does not exhibit
any TB-related symptoms, is not spreading the infection, and is not regarded as a case of TB.
On the other hand, LTBI can develop into a case of tuberculosis (TB) if the immune system is
unable to suppress the tubercle bacilli and they multiply quickly. Patients with tuberculosis
are highly contagious and can infect others with the bacteria. (11)
DOTS REGIMEN

The RNTCP recommends Directly Observed Treatment Short Course (DOTS) chemotherapy
as the treatment for tuberculosis. This internationally accepted technique ensures cure by
prescribing the most effective medication and ensuring its use. (12)
The most successful way to encourage treatment adherence is to use DOT, which involves
seeing the patient swallow each prescribed dose at the appropriate times and amounts. This
not only provides each TB patient the best chance of recovery but also prevents the
development of drug resistance [11].

To ensure that patients are taking all of the recommended medications under DOT under this
new regimen, the entire course of treatment should be administered. This means that for the
full six months of treatment, patients should be monitored by TB Treatment Supporters (TTS)
while taking their medications on a daily basis. This is in contrast to the previous regimen,
which only monitored TB patients during the intensive phase of their treatment during the
first two months. This approach has not been tried before and may have some unintended
consequences because it may be challenging to monitor every TB patient while they are
taking their medications every day for the entirety of their treatment.
Thus, the purpose of this study was to investigate how patients and healthcare professionals
(HCPs) experienced using DOT during the entire course of tuberculosis therapy at a few
Addis public health institutions. (13)

Under the Revised National Tuberculosis Control Programme (RNTCP) in India, patients
with tuberculosis (TB) are treated with Directly Observed Treatment Short-course (DOTS)
regimens. The DOTS center is recommended for antituberculosis therapy (ATT), which
includes isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E). Pulmonary
tuberculosis treatment consists of a six-month course of treatment divided into two phases:
the 56-day Intensive Phase (IP) and the 112-day Continuous Phase (CP). Extrapulmonary TB,
including miliary TB, bone or joint TB, and tubercular meningitis, also has a 6-month
treatment plan, and can last up to 9–10 months, depending on the diagnosis. (1)
Intensive Phase (IP):

In a normal adult, the dose of HRZE is given daily in fixed-dose combination according to
the bodyweight of the patient for 56 days.

TABLE- INTENSIVE PHASE DRUGS

Weight category Number of tablets (in FDC)

HRZE (75/150/400/275 mg)
25-39 kg 2
40-54 kg 3
55-69 kg 4
>=70 kg 5

Table- continuous phase drugs

Weight category Number of tablets (in FDC)

HRE (75/150/400/275 mg)
25-39 kg 2
40-54 kg 3
55-69 kg 4
>=70 kg 5
LITERATURE REVIEW

 P. Bordoloi et al., (2022), reported that adverse drug reactions after taking any medicines is very
much essential to establish a safe patient profile for drugs. The co-infection of HIV and TB has
been a major concern for the healthcare system, and the various drugs interaction from taking
ART and ATT should be highlighted to avoid unwanted reactions. The study was conducted in a
hospital set up for a period of one year in the ART center, where the ADR cases were recorded
from the HIV patients suffering from tuberculosis. During the study, 135 patients co-infected with
HIV and TB were analyzed from which a total 135 adverse drug reactions were collected and
recorded. It was observed that rash, raised liver function, fever, peripheral neuropathy, and
anaemia are the most common adverse drug reactions from the concomitant therapy of ART and
ATT. From the study, 13 different types of ADRs were reported in patients on the ART and ATT
therapy. It was important to do the causality assessment according to the WHO-UMC scale of the
suspected drug reaction in order to determine whether drug discontinuation is needed or not, as
well as to put emphasis on patient education to avoid the same adverse events in the future. (1)
 Lakshyajeet Nath et al., (2022), performed a study to observe the pattern of adverse drug
reactions (ADRs) with the usage of various anti-cancer drugs in a tertiary care hospital of North
East India. The study was a prospective, observational evaluation of the ADRs which was
conducted over a period of 1 year. During the study period 59 cancer patients receiving
chemotherapy were analysed from which a total of 79 ADRs were identified and collected which
occurred during and after the cancer treatment. Maximum cases of ADR recorded in the study
were mucositis, respiratory disorder, neuropathy, constipation, itching etc. On causality
assessment, it was observed that nearly 92% ADRs are considered as possible, 6% are probable
and 2% are unlikely. Although, the reporting of ADR was very minimal by the healthcare
professionals, this study focused on the various common ADR associated with the use of anti-
cancer agents in the treatment of cancer. The information from the study might be helpful in
identifying and minimizing preventable ADRs, while enhancing the knowledge of the healthcare
professionals to deal with them more efficiently. Hence the study was done to record and
analyze the pattern of adverse drug reaction from oncology drugs. (6)
 Tesemma Sileshi et al., (2021), studied that Tuberculosis remains the major public health
problem. Most tuberculosis patients are treated with a standard dose of first-line anti-TB drugs.
 The cure rate, however, varies from patient to patient. Various factors have been related to anti-
TB treatment failure. In recent years, studies associating lower plasma concentrations of anti-TB
drugs with poor treatment outcomes are emerging although the results are inconclusive. Thus
the study investigated the impact of first-line anti-tubercular drugs pharmacokinetics on
treatment outcome. (14)
 Ajay K. Shukla et.al., (2021), evaluated that the Pharmacovigilance Program of India recommends
the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while
many clinicians prefer the Naranjo algorithm for its simplicity. This study assessed agreement
between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the
Naranjo algorithm. In this study, 842 individual case safety reports were randomly selected from
1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary
healthcare Institute in Central India between 2016 and 2018. Two well-trained independent
groups performed the causality assessment. One group performed a causality assessment of the
842 ADRs using the WHO-UMC criteria and the other group performed the same using the
Naranjo algorithm. The agreement between two ADR causality scales was assessed using the
weighted kappa (κ) test. (15)
 Gashaw workalemahu et al., (2020), studied and evaluated adverse drug reactions associated
with chemotherapy and related factors in hospitalized paediatric cancer patients in Ethiopia’s
north-west hospitals. Adverse drug reactions were developed in a significant proportion of
the study patients (2 out of 5 patients). Therefore, for paediatric cancer patients on
concomitant medications and for patients on etoposide, mercaptopurine and doxorubicin
drug regimens, efficient prevention and management of adverse drug reactions was
sighted (16)

 Tarun Bhatnagar et al., (2019), studied and evaluated the structural and individual level factors in
prisons create challenges towards detection and management of HIV/tuberculosis. WHO and
India’s HIV/tuberculosis control programs recommend intensified case finding in prisons. Low HIV
and tuberculosis detection rates suggest poor implementation of existing surveillance strategies
within the prison healthcare system in Mizoram’s capital city of Aizawl. This study explored the
operational feasibility of implementing the intensified case finding strategy in Aizawl central
prison. It also implemented the intensified screening through entry screening of new inmates,
mass screening of resident inmates and exit screening at release. It followed digital chest
radiography, sputum smear microscopy and HIV testing facilities within the prison and referral to
external facility for Cartridge Based Nucleic Acid Amplification Test (CBNAAT). Thus , screened
 738 inmates (Male: 626; Female: 112). Of 53% inmates having presumptive tuberculosis
symptoms, 37% underwent sputum microscopy and detected 14 new tuberculosis cases; overall
tuberculosis positivity 1.9%. Moreover it tested 65% of 657 inmates for HIV, of which 41 new
cases were detected; overall HIV positivity 16.5%. Three male inmates had HIV-tuberculosis co-
infection. It is feasible to implement intensified case detection for tuberculosis/HIV in the prison
with inter-departmental coordination, albeit with certain challenges. (17)
 Manodeep Sen et.et., (2018), evaluated that Adverse drug reactions (ADRs) are a major cause of
morbidity and mortality in hospitals and pose great economic burden on the health care system.
This study was conducted with the aim of creating awareness and developing a culture for
proper communication and reporting of ADRs among health care professionals. Methods: This
study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital
during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the
pattern and type of reactions, body systems involved, causative drugs, and severity of reaction,
their outcome, management and causality assessment. (8)
 Claudia Giardina et al., (2018), studied Adverse drug reactions (ADRs) are an important public
health problem, representing a major cause of morbidity and mortality. However, several
countries have no recent studies available. Since 2014, a prospective active pharmacovigilance
project, aimed to improve ADRs monitoring in hospital wards (FORWARD) was performed in
Sicily. This study, as part of FORWARD project, was aimed to describe ADRs occurred during the
hospital stay in Internal Medicine wards. ADRs related to hospital admission, characteristics and
preventability of ADRs were also evaluated. (3)

• Muhammad Abdul Hadi et al., (2017), highlighted the role of pharmacists in

pharmacovigilance and identified barriers and facilitators toward ADR reporting
document in the literature. The perspective of pharmacy students on pharmacovigilance
and ADR reporting was discussed with an aim to highlight the need to improve content
related to ADR reporting and pharmacovigilance in undergraduate pharmacy curriculum.
(18)

 Lakshman Das et al., (2017), studied that Adverse drug reactions (ADRs) are important causes of
morbidity and mortality worldwide. Spontaneous reporting of ADRs is the cornerstone of
 pharmacovigilance (PV) and is important in maintaining patient safety. The study was conducted
to assess the knowledge, attitude, and practice (KAP) of PV among doctors of a medical college
hospital. (2)

 Ratan J. Lihite et al., (2017), monitored adverse drug reactions reported from various
departments of a tertiary care hospital in Northeast India. Adverse drug reactions were analysed
for causality and severity assessment. This cross-sectional study was conducted in a tertiary care
hospital at Guwahati, Northeast India, for 7months. Patients of all age and either sex were
included. This cross-sectional study was conducted in a tertiary care hospital at Guwahati,
Northeast India, for 7months. Patients of all age and either sex were included. The topical steroid
(betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority
of the patients. The commonly reported reaction was acne. (4)
 Borah Ajoy et al., (2016), determined the level of awareness amongst the junior doctors about
the necessity of ADR reporting. 167 junior doctors responded in this study. 46.10% of the
responders were found to be aware of pharmacovigilance. 65.86% of the responders in this
study considered pharmacovigilance to be essential and only 19.16% were in favour of making
ADR reporting mandatory. 19.76% of the responders had reported an ADR before. (19)
 Anuradha Joshi et.al., (2015), studied and evaluated Adverse drug reactions (ADRs) constitute
important cause of morbidity and mortality affecting all age groups. Most of the studies in past
have explored and reported knowledge and perception toward ADRs among health-care
professionals, pharmacists, and medical students. But studies on awareness among patients are
limited. To improve understanding of ADR and its reporting, it is important to find out the same
among patients. This study aimed to assess knowledge and perception toward ADR among
patients visiting tertiary-care rural hospital, and to sensitize patients on ADR reporting system.
(20)

 Kaur I et al., (2015), analysed the reporting by pharmacist in Pharmacovigilance Programme of

India (PvPI) Individual Case Safety Reports (ICSRs) submitted by pharmacists spontaneously to
the NCC-PvPI were extracted from the data base of July 2011 to December 2014. He analysed
these reports for patients Sex, Age and Seriousness of the reactions, etc. resulted as out of
1,10,000 ICSRs in the database 16646 ICSRs were reported by Pharmacists. 3782 reports were
serious and 9601 reports were non serious and 1979 reports were of unknown criteria, and
concluded that the pharmacist can help in buildup of an effective Pharmacovigilance system not
only in India but throughout the world. (9)
 Rituparna Das et.al., (2015), studied the noncompliance to the DOTS regimen that leads to
treatment failure, relapse, MDR tuberculosis, XDR tuberculosis etc. requiring more prolonged &
expensive therapy. This study aimed to assess the adherence rate among pulmonary tuberculosis
patients in west Tripura district and studied the factors affecting adherence to DOTS regimen
among pulmonary tuberculosis patients. (12)

 Daniel Fiseha et.al., (2015), evaluated that Tuberculosis remains a major public health problem in
Ethiopia. In 2010 the TB treatment regimen was shortened from 8 to 6-months treatment. With
this new regimen, the full course of treatment should be taken under Directly Observed Therapy
(DOT) unlike the 8-month regimen where TB patients were only observed during the intensive
phase, this has not been tried before and may be difficult to implement. Therefore this study
aimed to investigate the experiences from both TB patients and health care providers’
perspective of implementing DOT for the full course of TB treatment. (13)
 Mahesh N. Belhekar et.al., (2014), evaluated the reliability and usefulness of various adverse
drug reaction (ADR) causality assessment scales have not been fully explored. There is no
universally accepted method for causality grading of ADRs. The study assessed agreement
between the two widely used causality assessment scales, that is, the World Health Organization
Uppsala Monitoring Center (WHO-UMC) criteria and the Naranjo algorithm. This study showed
that there is a poor agreement between the WHO-UMC criteria and Naranjo algorithm with the
former being less time-consuming. (21)
 Hardeep et.al., (2013), aimed to assess the pharmacovigilance awareness among the healthcare
professionals in a teaching hospital in Northern India and concluded that there is a need for a
regular training and the re enforcement for the ADR reporting among the health care personnel.
The perception of the reporting process being tedious, the lack of time, a poor knowledge on the
reporting mechanism and inadequate expertise seemed to be the main reasons for not reporting
the ADRs. A majority of the respondents suggested regular training sessions on a priority basis
for the success of the pharmacovigilance program and for the better clinical management of the
patients in general. (22)
 Lisha Joshua et.al., (2009), examined that patients in the intensive care unit (ICU) have
multiorgan dysfunction as well as altered pharmacokinetic parameters. Hence, they are
susceptible to adverse drug reactions (ADRs). The objective of the study was to assess the
characteristics of ADRs among inpatients in the medical ICU and to compare the same with
patients who have not experienced ADRs. (23)
 Mohammad Reza Javadi et.al., (2007), evaluated that Tuberculosis (TB) has been a common
chronic infectious disease in human communities. Besides disease-related complications, there
could be serious adverse reactions due to anti-tuberculosis (anti-TB) drug therapy. The objectives
was to assess the incidence and severity of adverse drug reactions (ADRs) induced by anti-TB
drugs and to determine possible covariates associated with detected ADRs. (24)

AIM-

OBJECTIVE-
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%

DISCUSSION