DOI: 10.21276/sajp.2016.5.6.5
251
Scholars Academic Journal of Pharmacy (SAJP) ISSN 2320-4206 (Online)
Sch. Acad. J. Pharm., 2016; 5(6): 251-255 ISSN 2347-9531 (Print)
©Scholars Academic and Scientific Publisher
(An International Publisher for Academic and Scientific Resources)
www.saspublisher.com
Research Article
Event Monitoring in Patients Prescribed with Anti-tubercular Therapy
Vaishnavi Prasannan*
1
, Dr. K.K Shyamala
2
, Binai K Sankar
3
, Saumya Sabu
1
, Khalid P K
4
. Legimol Sunny
4
1
Pharm. D Intern, Department of Pharmacy Practice, Acharya & B. M Reddy College of Pharmacy, Bangalore,
Karnataka, India
2
Assistant professor, Department of Pulmonology, Dr. B R Ambedkar Medical College and Hospital, Bangalore,
Karnataka, India
3
Assistant Professor, Department of Pharmacy Practice, Acharya & B. M Reddy College of Pharmacy, Bangalore,
Karnataka, India
4
Third year Pharm.D student, Department of Pharmacy Practice, Acharya & B. M Reddy College of Pharmacy,
Bangalore, Karnataka, India
*Corresponding author
Vaishnavi Prasannan
Email: girijatampi@gmail.com
Abstract: Tuberculosis is a chronic, granulomatous infectious disease caused by Mycobacterium tuberculosis. Multi-
drug resistance is a chronic problem associated with treatment of tuberculosis where a substantial proportion of
tuberculosis cases reported in India are multi-drug resistant. Poor patient compliance plays a major role in development
of resistance. The main objective of the study was to monitor the events associated with ATT in pulmonary and extra-
pulmonary tuberculosis patients and to achieve better patient outcomes by regular monitoring. This was a prospective
observational study which analysed patients diagnosed with pulmonary and extra-pulmonary kochs’, attending inpatient
and out-patient departments as well as registered under the RNTCP at Dr. B.R Ambedkar Medical College and Hospital
for a period of 1 year for any events associated with ATT. Routine investigations which are carried out by the patient at
the treatment initiation and whenever required were monitored. A total of 175 patients were monitored in the study out of
which majority were males. Most patients were category 1 patients. More than one-third of the patient population
reported an adverse event. Most ADRs were related to the GI system, followed by Skin Allergy. Most of the events
(72%) were patient reported during physician visit while 26% were reported on investigation. The study found that ADRs
has led to medication incompliance which leads them to discontinue the medication for a short duration. Close
monitoring of these events from the treatment initiation should be emphasized to prevent medication in adherence. It is
suggested that the establishment of pharmacovigilance programs in DOTS centres is essential.
Keywords: ATT, Anti-tubercular Therapy, Tuberculosis, Adverse Events.
INTRODUCTION
Tuberculosis is a chronic granulomatous
infectious disease caused by a bacterium,
Mycobacterium tuberculosis. India accounts for two-
third of the world tuberculosis burden. A percentage of
Indian population is diagnosed with tuberculosis in
which a substantial percentage is multi drug resistant
(MDR-TB) cases [1]. Tuberculosis (TB) remains a
leading infectious killer globally. Left untreated or
improperly treated, tuberculosis causes progressive
tissue destruction and eventually, death [2]. Active
disease is characterized by fever, chills, night sweats,
weight loss, and changes on chest radiography. Several
risk factors for tuberculosis have been identified,
including immune suppression, exposure to close
contacts, and smoking [3].
Drug treatment is the cornerstone for
management of tuberculosis patients. In a patient with
active tuberculosis, the overall treatment goals are to
cure the individual patient and to minimize the
transmission of M. Tuberculosis [2].The primary goals
of chemotherapy are rapid bacterial killing, prevention
of emergence of drug resistance, and elimination of
persistent tubercle bacilli to prevent relapse. Effective
treatment of tuberculosis requires a substantial period
(minimum 6 months) of intensive drug therapy with at
least two active bactericidal drugs [3].
The currently recommended anti-tuberculosis
regimen /DOTS (2H
3
R
3
Z3E
3
+4H
3
R
3
) is usually well
tolerated. However, some patients may experience
problems, usually due to the bulk of the medicines with
a single day’s dose consisting of 6-7 tablets [4].
Treatment-related side effects can be minor or major.