A Prospective Study of Adverse Drug Reactions at a Private Teritiary Care Teaching Hospital.

Abstract

Adverse drug reactions (ADRs) are responsible for approximately 5% of hospital admissions and they are potentially avoidable causes for seeking medical care. Most of the ADR are not reported. Hence this study was undertaken to emphasize the need to report ADRs. The study was carried out at Dr. B.R. Ambedkar Medical College and Hospital from July 2014 to July 2015. 40 cases were reported. Informed consent was obtained from each patient and thorough clinical examination was done. All the information was carefully recorded in a pre-designed proforma as per PVPI (Pharmacovigilance Programme Of India). To establish the etiologic agent for a particular type of reaction, attention was given to drug history, temporal correlation with the drug, duration of reaction, associated signs and symptoms, improvement of condition or lesion after withdrawal. Naranjo's Algorithm was used to determine the causality of ADRs. In the present study, most common age group reported with ADRs was between 25-40 years, with female predominance 26(65%). Type B ADRs 36(90%) were more common than Type A .The most commonly observed ADRs were with NSAIDS 27(67.5%) followed by anti-microbial9(22.5%) and anti-convulsants 4(10%). The most commonly observed reaction was Fixed drug eruption (FDE) 18(56.25%), followed by impairment of LFT (Liver Function Test) 2(0.8%). Study reveals that most of the reactions were cutaneous in nature. Systemic reactions were under reported. Causality assessment did not reveal strong association because of polypharmacy. So, ADRs are potentially avoidable causes for seeking medical care. ADRs can be prevented by avoiding polypharmacy, knowing previous history of ADR and reporting it for further concern and care of patients.