Pharmacovigilance study of spontaneous adverse drug reaction in a tertiary care centre

Background: Adverse drug reactions (ADRs) are a rapidly growing universal problem that has a significant impact on users worldwide. They are the cause of significant disability and mortality and are expected to be associated with an economic burden on the health-care system. Aims: To promote patient safety from pharmaceutical products. Materials and Methods: A prospective, observational evaluation of the ADRs collected during spontaneous pharmacovigilance reporting over a period of 18 months in various hospital departments. During the study period, 214 individual case safety reports (ICSR) were reported. Results: The 214 reports that were identified, a slightly higher percentage of ADRs in females 105 (50.93%) was observed as compared to males 109 (49.07%), 73 (34.1%) serious and 141 (65.9%) non serious ADRs. In serious ADRs, the male patients were 35 (33.3%) and females were 38 (34.9%) including 6 (2.8%) deaths. The largest number of reports was associated with antimicrobials 41% followed by non-steroidal anti-inflammatory drugs − 21.1%, antidiabetic − 10.9%. The most commonly implicated organ system was skin − 46.62% followed by gastrointestinal reactions − 18.05%, blood and metabolic disorder − 11.65%, central nervous system − 6.77%, liver − 6.02% and cardiovascular system (3.38%). The outcomes were recorded as recovering (45.8%), recovered (26.2%), continuing (19.2%) and unknown (6.1%) at the time of processing ICSR through vigiflow database. The causality of more than half of ADRs were recorded as possible (59.8%) followed by probable (24.8%), certain (15%) and unlikely (0.5%). Conclusion: Limited ADR is permissible in normal clinical trials setting; hence, spontaneous adverse reaction reporting systems need to be developed, which may improve rational drug prescribing habits to obtain maximum benefits meanwhile minimizing the risk of health from undesirable effects of drugs.