Published: 2018-03-23

Effectiveness of a module to promote competency in adverse drug reaction reporting in undergraduate medical students

Nazuk Sharma, Taruna Sharma, Suman Bala


Background: Adverse drug reaction (ADR) under-reporting is a hindrance to the implementation of Pharmacovigilance Program of India. This is essentially due to lack of ADR reporting culture among healthcare professionals. Thus, study was conducted to assess and enhance awareness about ADRs and strengthen reporting among medical undergraduates.

Methods: This is an interventional crossover study. A total of 140 students of 2nd professional, MBBS were included and divided into two groups of 70 each. In phase 1, group A was given a didactic lecture (DL) on ADR and pharmacovigilance. Group B was also given DL with an addition of a case narrative exercise and they were asked to fill an ADR form. Both groups were assessed based on an MCQ questionnaire for knowledge and skill. After 15 days of washout period, groups were crossed and reassessed. Feedback from students was taken on a 5 point Likert’s scale.

Results: The mean scores of batch A without case was 17.5±3 out of a total score of 25 marks, which showed improvement with case narrative and mean increased to 19.6± 2.4 (p 0.05). Similarly, Batch B showed improvement as well and the mean 17.7±3.1 score without case narrative increased to 19.2±2.7 (p <0.05). Student’s perception of the effectiveness of module-based teaching was positive.

Conclusions: Case narrative in addition to didactic lecture enhanced awareness and may strengthen ADR reporting culture among the medical students.


Adverse drug reaction, Pharmacovigilance, Teaching module

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