A retrospective study of Adverse Drug Reactions in a tertiary care centre
Keywords:Adverse Drug Reactions, Clinical trials, CDSCO, Pharmacovigilance
Background: Adverse drug reactions (ADRs) are a major concern in present day clinical practice. They are inevitable consequences of drug therapy; as no pharmacotherapeutic agent is completely free from noxious and unintended effects. They are major contributors for morbidity, mortality and hospitalization of the patients increasing the economic burden on the society and uncertainty in clinical outcomes.
Methods: This was a retrospective observational study, extending over 6 months (September 2016 to February 2017). A total of 290 cases were studied, excluding the geriatric age group. The data was collected using CDSCO ADR reporting form. A comparison of ADR between males and females was made; based on the organ system affected and the category of drug using “proportion test”.
Results: The study showed the ADR incidence was equal in both sexes (≈50%). It was observed that majority ADRs were from gastro intestinal system (39%) followed by CNS (20%) and skin and soft tissue (14%). Constipation was found to be the most common of the reported ADRs (18%) followed by vomiting (9%) and diarrhoea (8%).
Conclusions: ADRs are a major cause of morbidity worldwide. Several studies; including the present one, has shown GIT to be the most common system affected. Frequency of ADRs can be reduced by careful follow up and a robust hospital based pharmacovigilance setup.
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