Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

Abstract

Background: Adverse drug event (ADE) is said to be serious, when it is life-threatening, leads to hospitalization, disability, congenital anomaly, death or requires intervention to prevent permanent impairment or damage. The present study aimed to determine the pattern, causality, preventability of serious ADEs.Methods: This retrospective study was carried out to profile serious ADEs reported from Bangalore Medical College and Research Institute to Adverse Drug Reaction (ADR) Monitoring Centre, under Pharmacovigilance Programme of India from 2012 to 2016. Patient demographics, clinical and drug data, details of the ADE, onset time, causal drug details, outcome and severity were collected as per CDSCO form. Causality was assessed by WHO-ADR probability scale, preventability by modified Schumock and Thornton scale.Results: A total of 809 ADEs were reported, of which 50 (6.18%) were serious in nature. Male preponderance (74%) was observed, with 42% among patients aged 20-40 years. 56% of serious ADEs were reported from department of Dermatology. Steven Johnson Syndrome (SJS) (20%) contributed for most of the ADEs. Antiepileptics caused maximum number of serious ADEs (32%). 76% of the ADEs were found to be ‘probable’ and 4% were definitely preventable. 56% of them was life threatening and 86% required intensive interventions. 16% patients experienced serious ADEs during hospital stay.Conclusions: Serious ADEs constituted 6.18% of all ADEs reported. SJS was commonly seen with antimicrobials and hepatotoxicity with ATT. Antiepileptics and ATT contributed for majority of them. This study highlights the importance of monitoring and timely management of serious ADEs to commonly prescribed medications.