an Observational Study to Determine the Factors Responsible for Underreporting of Adverse Drug Reactions Among the Resident Doctors of a Tertiary Care Center.

2016 
Spontaneous adverse drug reaction (ADR) reporting is the backbone of pharmacovigilance. However, underreporting is a huge problem due to lack of reporting practices amongst healthcare professionals. This cross-sectional, questionnaire based study was conducted to find out the factor responsible for under-reporting of adverse drug reaction reporting amongst resident doctors. Majority of the respondents felt that ADR reporting is necessary and is a professional obligation, but should be voluntary. Majority of the respondents suggested that lack of awareness was the major factor. Other factors responsible for underreporting of ADRs were lake of monitoring system in the Hospital, lack of time, concern that the reporter may be blamed, lackof confidence, laziness and fear of legal action. Unawareness for the pharmacovigilance needs attention on priority basis, not only for the success of the pharmacovigilance programme, but also better clinical management of the patients in general.
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