title: An analysis of serious adverse drug reactions at a tertiary care teaching hospital.
abstract: OBJECTIVE
  The objective of this study was to analyze the various aspects of serious adverse drug reactions (serious ADRs) such as clinical presentation, causality, severity, and preventability occurring in a hospital setting.
  
  
  METHODS
  All serious ADRs reported from January 2010 to May 2015 at ADR Monitoring Centre, Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, were selected as per the World health Organization -Uppsala Monitoring Center (WHO-UMC) criteria. A retrospective analysis was carried out for clinical presentation, causality (as per the WHO-UMC scale and Naranjo's algorithm), severity (Hartwig and Siegel scale), and preventability (Schumock and Thornton criteria).
  
  
  RESULTS
  Out of 2977 ADRs reported, 375 were serious in nature. The most common clinical presentation involved was skin and appendageal disorders (71, 18.9%). The common causal drug group was antitubercular (129, 34.4%) followed by antiretroviral (76, 20.3%) agents. The criteria for the majority of serious ADRs were intervention to prevent permanent impairment or damage (164, 43.7%) followed by hospitalization (158, 42.1%). Majority of the serious ADRs were continuing (191, 50.9%) at the time of reporting, few recovered (101, 26.9%), and two were fatal. The majority of serious ADRs were categorized as possible (182, 48.8%) followed by probable (173, 46.1%) in nature.
  
  
  CONCLUSIONS
  Antitubercular, antiretroviral, and antimicrobial drugs were the most common causal drug groups for serious ADRs. This calls for robust ADR monitoring system and education of patients and prescribers for identification and effective management.
authors.affiliation: Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
authors.forename: Kinjal
authors.initials: K
authors.lastname: Prajapati
authors.affiliation: Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
authors.forename: Mira
authors.initials: M
authors.lastname: Desai
authors.affiliation: Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
authors.forename: Samidh
authors.initials: S
authors.lastname: Shah
authors.affiliation: Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
authors.forename: Jigar
authors.initials: J
authors.lastname: Panchal
authors.affiliation: Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat, India.
authors.forename: Jigar
authors.initials: J
authors.lastname: Kapadia
authors.affiliation: Department of Pharmacology, GCS Medical College, Ahmedabad, Gujarat, India.
authors.forename: Ramkumar
authors.initials: R
authors.lastname: Dikshit
keywords: Causality; preventability; serious adverse drug reactions