Analysis of reporting of adverse drug reactions in a tertiary care hospital: One year survey

Abstract

Introduction: Adverse drug reactions (ADRs) are inevitable component of drug therapy which negatively affects quality of life, increases physician visits, hospitalizations and even death. It also poses economic burden on health care system. Aim: To ascertain various ADRs occurring in our hospital; this can generate a notion to inculcate the culture of ADR reporting in view of improving the health safety of patients. Materials and Methods: A retrospective, record based study, conducted by analyzing ADR forms, reported over a period of 12 months and were further analyzed for demographic details, organ system involved, types of ADRs, suspected drugs, causality, severity, outcome and reporters qualification. Results: A total of 532 ADR reporting forms were studied in which 563 types of ADRs were seen. Male preponderance (57.1%) was seen with majority of ADRs between 40-59 yrs. of age (33.2%). Gastrointestinal tract (47.24%) was most commonly affected with abdominal pain, diarrhea and nausea. Antibiotics were the most common suspected group of drugs. Majority of ADRs were probable/likely (46.35%) and were of moderate category (56.12%). Most of the patients recovered/resolved (91.35%) from the reaction and majority of reports was from non-health professionals/consumers (53.19%). Conclusions: Results drawn from this study suggests reinforcing Pharmacovigilance Programme of India as it can help in minimization/prevention of ADRs through early detection. Also, it would be helpful if the system of ADR monitoring is designed in such a way that it encourages health care professionals to report ADRs spontaneously and intensively through a proper communication channel for ensuring patient safety.

Analysis of voluntary reported adverse drug reactions in a tertiary care hospital

“…3,4 The occurrence of ADR was more common in male patients 54%. In this study, males are more affected than females like study by Ali et al which are in concordance with several other studies by Giardini et al 4,5 No significant differences were found in occurrence of ADR among males (49.2%) and females (50%) in a study conducted by Medal et al 6 Our study results do not support that female gender is a risk factor for ADR for development of adverse drug reactions. Our results were contrast to study on gender related differences by Prasad et al 7 Comparing the route of administration, no of reactions occurred with the oral 62% followed by IV 31% and others (SC, IM, INH, SL, LA) 6.36%.…”