title: A cross-sectional study of surveillance of adverse drug reactions in inpatient departments of a tertiary care hospital.
abstract: BACKGROUND
  Pharmacovigilance plays an imperative role in providing information about adverse drug reactions (ADRs) and drug safety in a hospital. Hence, it was considered worthwhile to study the surveillance of ADRs in inpatient departments (IPD). Our study aims to evaluate the frequency, type, characteristics, causality, and severity and avoidability of ADRs in the IPDs.
  
  
  METHODS
  This prospective observational study was done in the IPDs of a 550-bed tertiary care hospital in South India during the period April to September 2012. All the patients had experienced at least one suspected ADR after hospitalization and drug treatment; patients who are hospitalized due to suspected ADR(s) in the last 6 months were assessed after obtaining permission from the Institutional Research and Ethics Committee. All the ADRs were recorded on the appropriate, prescribed form for reporting ADRs designed by the Central Drugs Standard Control Organization.
  
  
  RESULTS
  A total of 147 ADRs were reported with the use of 96 drugs used by 91 IPD patients. The maximum number of ADRs reported in our study was with antipsychotic drugs and the maximum number of patients reported rashes (n=30) followed by extrapyramidal symptoms (n=17). Causality assessment by the WHO scale and Naranjo's algorithm showed 48 and 59 ADRs possibly related to drugs, respectively. Of this, 45 patients with ADR had moderate severity and 41 patients with ADRs were not preventable.
  
  
  CONCLUSIONS
  The maximum number of ADRs reported in our study was with antipsychotic drugs and the most common ADR reported was rashes. Most of the ADRs reported had a possible causality, were moderate in severity, and were not preventable. The majority of patients had recovered from the ADRs.
authors.forename: Ambili
authors.initials: A
authors.lastname: Remesh
authors.forename: Aswathy
authors.initials: A
authors.lastname: Balan
authors.forename: Angela
authors.initials: A
authors.lastname: Gnanadurai
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D003430:Cross-Sectional Studies; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D060735:Pharmacovigilance; D011446:Prospective Studies; D062606:Tertiary Care Centers