title: Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India.
abstract: OBJECTIVE
  The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.
  
  
  METHODS
  A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.
  
  
  RESULTS
  At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students.
  
  
  CONCLUSIONS
  UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.
authors.affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.
authors.forename: Vishal R
authors.initials: VR
authors.lastname: Tandon
authors.affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.
authors.forename: Vivek
authors.initials: V
authors.lastname: Mahajan
authors.affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.
authors.forename: Vijay
authors.initials: V
authors.lastname: Khajuria
authors.affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.
authors.forename: Zahid
authors.initials: Z
authors.lastname: Gillani
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends*; D001291:Attitude of Health Personnel; D002983:Clinical Competence; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000639:trends*; D006801:Humans; D007194:India / Q000453:epidemiology; D060735:Pharmacovigilance; D057184:Practice Patterns, Nurses' / Q000639:trends; D010818:Practice Patterns, Physicians' / Q000639:trends; D011446:Prospective Studies; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Adverse drug reaction; pharmacovigilance; spontaneous reporting; under reporting
references.citation: Eur J Clin Pharmacol. 2013 Jan;69(1):75-85
references.pmid: 22673927
references.citation: Int J Risk Saf Med. 2013 Jan 1;25(1):1-16
references.pmid: 23442293
references.citation: Pharmacoepidemiol Drug Saf. 2011 Dec;20(12):1287-94
references.pmid: 21702073
references.citation: Drug Saf. 2012 Aug 1;35(8):655-65
references.pmid: 22788235
references.citation: Soc Sci Med. 2012 Jul;75(1):165-70
references.pmid: 22521677
references.citation: J Nat Sci Biol Med. 2013 Jan;4(1):191-6
references.pmid: 23633861
references.citation: Drug Saf. 2009;32(1):19-31
references.pmid: 19132802
references.citation: Drug Saf. 2006;29(5):385-96
references.pmid: 16689555
references.citation: Eur J Clin Pharmacol. 2013 Feb;69(2):237-44
references.pmid: 22706618
references.citation: Drug Saf. 2007;30(11):1073-82
references.pmid: 17973543
references.citation: Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):223-8
references.pmid: 22745046
references.citation: Pharmacoepidemiol Drug Saf. 2006 Mar;15(3):179-84
references.pmid: 16184621
references.citation: Saudi Pharm J. 2013 Jul;21(3):261-6
references.pmid: 23960842
references.citation: IEEE Trans Inf Technol Biomed. 2010 May;14(3):826-37
references.pmid: 20007038
references.citation: Stud Health Technol Inform. 2013;194:63-8
references.pmid: 23941932
references.citation: Drug Saf. 2013 Mar;36(3):199-206
references.pmid: 23444232
references.citation: Drug Saf. 2012 Dec 1;35(12):1171-82
references.pmid: 23072620
references.citation: Br J Nurs. 2013 Apr 25-May 8;22(8):484-5
references.pmid: 23905231
references.citation: Drug Saf. 2006;29(4):331-40
references.pmid: 16569082
references.citation: Postgrad Med. 2010 Nov;122(6):154-64
references.pmid: 21084792
references.citation: Drug Saf. 2012 Oct 1;35(10):807-18
references.pmid: 22928729
references.citation: Drug Saf. 2013 Feb;36(2):75-81
references.pmid: 23329541
references.citation: J Clin Pharmacol. 2013 Nov;53(11):1220-5
references.pmid: 23852627
references.citation: Pharmacoepidemiol Drug Saf. 2011 Dec;20(12):1295-302
references.pmid: 21793098
references.citation: Drug Saf. 2013 Apr;36(4):267-76
references.pmid: 23475583