Adverse Drug Reactions with Drugs used in Pulmonary Medicine:A Pharmacovigilance Study

World Health Organization defines Adverse Drug Reaction (ADR) as "Any response to a drug which is noxious and unintended, and which occurs at doses normally used in human beings for the prophylaxis, diagnosis or therapy for a disease, or for the modification of physiological functions".1 ADR is considered to be responsible for 2.9 to 5.6% of all hospital admissions, either directly or due to ADR related events. It is associated with significant morbidity, disability and it may cause financial burden on patients due to prolonged hospitalization. A hospital based pharmacovigilance study on ADR with drugs used in the Pulmonary Medicine Department of Gauhati Medical College Hospital was undertaken over a period of six months. Criteria for identifying ADR were based on spontaneous reporting by physicians in Pulmonary Medicine department. Case records having incomplete patient information were excluded from this study. The causality of the reported ADRs was carried out using Naranjo's scale, and the severity of ADR was assessed with Hartwig's scale. Hospital records of 214 consecutive patients admitted to the Pulmonary Medicine department were analyzed for the reports of ADR. A total of 44 patients (20.56%) were found to have some type of ADR. The highest incidence of ADR was reported in the age group of 50 - 69 years. Hepatitis, nausea, vomiting, chest pain, loss of appetite, vertigo, dryness of mouth and sore throat were the prominent manifestations of ADR in this study. The drugs causing ADRs were classified as (a) First line of anti-tubercular drugs, (b) Corticosteroids, and (c) Other drugs used as supportive therapy. Out of the 44 patients with ADR, 5 patients improved with change of drugs, 24 patients improved without any change of drugs, and 15 patients improved with addition of other drugs. Analysis of the causality using Naranjo's scale showed that 20 (45.4%) ADRs were "Definite", 16(36.4%) were "Possible", and 8(18.2%) were "Probable". In analysis of the severity using Hartwig's scale, 32 (72.8%) of ADRs were mild, 7(15.9%) were moderate, and only 5(11.3%) were severe. There was no patient with ADR resulting permanent disability or death.