title: Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students.
abstract: OBJECTIVE
  Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated.
  
  
  METHODS
  The module consisted of (a) e-mailing an ADR narrative and online filling of the "suspected ADR reporting form" (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012-2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013-2014. The evaluation consisted of recording the number of students responding and the scores achieved.
  
  
  RESULTS
  A total of 171 students in 2012-2013 batch and 179 in 2013-2014 batch participated. In the 2012-2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013-2014 batch, the number (n= 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months.
  
  
  CONCLUSIONS
  This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.
authors.affiliation: Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Raakhi Kaliprasad
authors.initials: RK
authors.lastname: Tripathi
authors.affiliation: Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Sharmila Vinayak
authors.initials: SV
authors.lastname: Jalgaonkar
authors.affiliation: Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Pankaj V
authors.initials: PV
authors.lastname: Sarkate
authors.affiliation: Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Nirmala Narayan
authors.initials: NN
authors.lastname: Rege
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002983:Clinical Competence; D064420:Drug-Related Side Effects and Adverse Reactions; D004504:Education, Medical, Undergraduate / Q000379:methods*; D005180:Faculty, Medical; D006801:Humans; D010465:Perception; D013337:Students, Medical; D011795:Surveys and Questionnaires
keywords: Adverse drug reaction reporting; Use of an e-module for training students in ADR reporting skills was effective. The performance of students in filling ADR forms accurately increased, with a lesser number of students making mistakes. The module can be used to inculcate competency in ADR reporting in future health care professionals.; feedback; pharmacovigilance; teaching module; undergraduate medical education