Monesh Likhitkar

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. Keywords: Adverse drug reaction, Antibiotics, ICSR, IPC, PvPI.

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