AN OBSERVATIONAL PHARMACOVIGILANCE STUDY OF PATIENTS RECEIVING DOTS AT ASHOK NAGAR DISTRICT HOSPITAL OF MADHYA PRADESH, INDIA

Sarita Shrivastava; Dr. Balvir Singh; Dr. Rajkumari Bansal

Volume : V, Issue : X, October - 2016

AN OBSERVATIONAL PHARMACOVIGILANCE STUDY OF PATIENTS RECEIVING DOTS AT ASHOK NAGAR DISTRICT HOSPITAL OF MADHYA PRADESH, INDIA

Sarita Shrivastava, Dr. Balvir Singh, Dr. Rajkumari Bansal

Abstract :

Vigilant assessment of the risks and benefits of medicines applies throughout the life cycle of a medicine. India had a National TB Programme to combat the problem of TB. India�s National Tuberculosis Programme (NTP) was initiated as a truly integrated Programme , instigated through District Tuberculosis Centers (DTCs). It was a hospital based prospective observational study. A total of 47 patients were registered. Among these, 38 (80.85%) patients were showed adverse drug reaction due to any therapeutic agent. Twenty six (68.42%) patients were male and 12 (31.57%) were female. Most common age group affected, was between 10– 30 years (55.26%). Most common adverse drug reaction experienced was nausea and vomiting (developed among 27 patients). Chest pain was present in 10 persons. Loss of appetite in 9, Loss of communication in five patients, 5 patients experienced cough, three patients experienced constipation, two patients had restlessness, another two patients suffered from fever, headache. Only one patient had skin rashes. Metallic taste was seen in one patient. Drowsiness was experienced by one patient. Causality assessments by Naranjo�s causality assessment scale showed, possible causality in 28 patients (73.68%), probable in 7 patients (18.42%), definite in 2 patients (5.26%) while doubtful in 1 patient (2.63%).