METHOD

Study design

An observational, cross-sectional cohort study was carried out at outpatient and inpatient
setting of a tertiary care hospital in Northeast India.

Ethical permission

Permission from Institutional Ethical Committee of the hospital was obtained prior to the
initiation of this study.

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

ADRs were reported from outpatient departments as well as from wards of cardiology,
dermatology, gynaecology, haematology, medicine, ophthalmology, paediatric, psychiatry, TB
and chest, and neurology department of the hospital.

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 and over-the-counter drugs taken by patients as inpatients or outpatients 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. Patients who were admitted because of
drug or alcohol misuse, attempted suicide, or admissions scheduled more than twenty-four
hours in advance were not documented.

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.

TABLE-
sex n=250
Male 145
Female 105
Table- age division
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
Table- total number of patients with dot category and BDQ resistant

Category Total witnessed patient

Cat1 122
Cat2 72
Cat3 0
Cat4 21
BDQ 35
Intensive Phase (IP):

In a normal adult, the dose of HRZE is given daily in fixed-dose combination

Table- 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