title: A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey.
abstract: BACKGROUND
  Pharmacovigilance (PV) is related to detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs) which are incurred when drug is made available in the market and used in different physiological conditions. In many countries, ADRs ranks among the top ten leading cause of morbidity and mortality. There is a lack of formal culture for monitoring and reporting of ADRs in India, with ADR reporting rate being only 1% as compared to 5% in world. This type of academic detailing activity helps to create awareness of ADR reporting in the institutions.
  
  
  OBJECTIVE
  This study was planned to evaluate and analyse the incidence and patterns of ADRs in various inpatient and outpatient departments of hospital.
  
  
  METHODS
  This was an observational, retrospective and record based study conducted by analysing the spontaneous ADR forms, collected over a period of 12 months (September 2014 to August 2015) at Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India.
  
  
  RESULTS
  During the period of one year, 292 ADR forms were collected from 4,34,965 patients attending OPD and inpatients of the hospital. Incidence of ADR was 0.67 per thousand patients and average of around 24 ADR collected per month. Male:Female ratio was 1.30. Adolescent (16-30 yr) was the most common age group affected. Department of Skin and VD reported the maximum number of ADRs (33.22%), followed by the Departments of Oncology (18.84%). Antibiotics were the most common drug implicated followed by anticancer drugs.
  
  
  CONCLUSIONS
  ADR reporting is an ongoing and continuous process. Studies from the institute helps to identify and rectify the problems related to ADR reporting. Pitfalls can be addressed by creating awareness among physicians and the patients to achieve finally the goal of Pharmacovigilant India.
authors.affiliation: Senior Resident, Department of Pharmacology, IGIMS , Sheikhpura, Patna, Bihar, India .
authors.forename: Anuj Kumar
authors.initials: AK
authors.lastname: Pathak
authors.affiliation: Assistant Professor, Department of Pharmacology, IGIMS , Sheikhpura, Patna, Bihar, India .
authors.forename: Manish
authors.initials: M
authors.lastname: Kumar
authors.affiliation: Technical Associate, ADR Monitoring Centre, IGIMS , Patna, Pharmacovigilance Programme of India (PvPI), Patna, Bihar, India .
authors.forename: Shambhu
authors.initials: S
authors.lastname: Dokania
authors.affiliation: Associate Professor, Department of Pharmacology, IGIMS , Sheikhpura, Patna, Bihar, India .
authors.forename: Lalit
authors.initials: L
authors.lastname: Mohan
authors.affiliation: Professor, Department of Pharmacology, IGIMS , Sheikhpura, Patna, Bihar, India .
authors.forename: Harihar
authors.initials: H
authors.lastname: Dikshit
keywords: ADR reporting; Drugs; Pharmacovigilance; Pharmacovigilance program of India