STUDY TO EVALUATE SEVERE ADRS IN A TERTIARY CARE TEACHING HOSPITAL
Objective: This study attempts to analyze the severe ADRs in a tertiary care centre and assess their seriousness, outcome, causality and severity. We emphasize on the need for reporting of ADRs by all healthcare professionals as it will reduce the burden of morbidity due to drugs and ensure better and more efficient healthcare. To analyse and evaluate the severe ADVERSE DRUG REACTIONs reported from various departments in a Tertiary care Teaching hospital.
Methods: It is a prospective observational study that was carried out over a period of 6 mo (from July 2016 to December 2016) to assess the percentage of severe adverse drug reactions reported to the Pharmacovigilance cell of a tertiary care teaching hospital. The data collected included patient's demographic details, presenting complaints, clinical diagnosis and details of the drug(s) prescribed. The data was analysed for causality (as per the WHO-UMC scale) and severity (as per Hartwig and Siegel scale).
Results: Out of 64 ADRs reported, 17 were serious. The majority of serious ADRs were categorized as probable (82.35%), whilst 1(5.8%) was categorized as possible and 2(11.76%) as certain in nature. The criteria for the majority of serious ADRs were hospitalization (%) followed by intervention to prevent permanent impairment or damage (%).
Conclusion: The highest percentage of severe cases was reported with Antitubercular therapy (23.5%) followed by analgesics (23%) and anti epileptic agents (17.6%).
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