Impact of increased focus on pharmacovigilance on knowledge and attitude towards adverse drug reaction reporting among medical students in India

Abstract

BACKGROUND:

Recent years have seen a surge in pharmacovigilance (PV) related activities in India. In the present study the impact of these initiatives on medical students from across the country was evaluated to identify their effectiveness, lacunae and arrive at remedial measures.

METHODS:

A cross-sectional, questionnaire based study was conducted. The survey questionnaire consisted of 28 multiple response items. The areas covered included subject knowledge (theoretical and practical), attitude and awareness towards pharmacovigilance.

RESULTS:

The survey participants (n = 253) were from 71 medical colleges and 17 states across India. While 60% of the participants were familiar with the term ‘Pharmacovigilance’, many could not distinguish side effect and adverse drug reaction. The majority was unaware that ‘Periodic Safety Update Report’ (PSURs) is a mandatory pharmacovigilance activity by the industry. 91% felt reporting is a useful practice and causes for under-reporting are a lack of awareness followed by attitude, misconceptions about what to report, fear of litigation and interestingly the least important is lack of time. However, most were reluctant to have reporting as mandatory tool; they would rather use it voluntary.

CONCLUSION:

In spite of collaborative and synchronized efforts by various agencies there is a need to further improve the PV milieu in India by confidence building exercises, imparting training on PV programme, updating of the current knowledge on PV and also sustaining motivation.