Identifying barriers to report adverse drug reactions using the Delphi method: Experience from an institute of national importance of India.

Abstract

Background: Spontaneous reporting of suspected adverse drug reaction (ADR) is an essential component of pharmacovigilance program, however, under reporting is a major drawback of it. Medical professionals cite many reasons for their inability to report suspected ADRs. Objective: This study aimed to seek consensus among resident doctors regarding barriers to report ADRs. Method: A two-round Delphi consensus study was conducted among resident doctors of a tertiary care institute of India. The participants used a five-point Likert scale to indicate each question of an initial questionnaire whether it should be considered a barrier for reporting ADR. The items for which ≥80% of all respondents agreed or strongly agreed were accepted as barrier for reporting ADR. Results: Forty-five participants completed the Delphi survey. Out of 25 questions participants unanimously selected 9 items such as unavailability of reporting form, complexity in filling reporting form and lack of motivation as barriers for reporting ADR. Conclusion: Using a Delphi method, this study identified a set of statements perceived as barriers by participants for reporting ADR