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Year : 2018  |  Volume : 17  |  Issue : 2  |  Page : 63-68

Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring among medical professionals attending Central Leprosy Institute

1 Department of Clinical Division, Central Leprosy Teaching and Research Institute, Chengalpattu, Tamil Nadu, India
2 Department of Information Technology, SRM University, Gangtok, Sikkim, India

Correspondence Address:
Dr. Pugazhenthan Thangaraju
Central Leprosy Teaching and Research Institute, Chengalpattu, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/MJ.MJ_20_18

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Background: The introduction of pharmacovigilance (PV) program helps in very early detection of adverse drug reactions (ADRs) and identification of risk factors and various measures to be taken once it happened. This study was aimed at investigating the knowledge and attitude of doctors in a research institute about ADR reporting and suggesting possible ways of improving ADR reporting. Materials and Methods: This study was a cross-sectional, questionnaire-based survey conducted at a tertiary care leprosy hospital which is a research institute. The respondents were doctors and students visiting this institute. The study instrument was a self-developed, prevalidated, semi-structured questionnaire of 25 questions. Results: A total of 55 questionnaires were considered for analysis, giving a response rate of 100%. In all, 87.93% of the respondents were aware about pharmacovigilance, 68.96% were aware of ADR reporting system in India, 91.37% opined that only serious ADR with any medicine should be reported, and 4.3% believed that ADR should be reported only for newly marketed agents. Although 88.79% of the respondents observed an ADR, only 31.03% reported it; 60% were aware about the complete step to be taken after ADR. The general attitude of the respondents about ADR reporting was as follows: ADR reporting should be mandatory (60.34%), voluntary (29.31%), and need base (10.34%) and the preferred mode to report should be phone (34.48%), dropbox (22.41%), E-mail (25.86%), and personal visit (8.6%). Nearly 77.58% of the respondents needed a complete feedback after the ADR reporting. Almost 51.72% of the respondents opted increasing awareness about PV through training/projects/continuing medical education, as the factor encouraging for ADR reporting, and 51.72% opted lack of knowledge about the process of reporting, as the factor discouraging ADR reporting. Conclusion: From the study, it was found that most of the doctors and students were unaware of the ADR reporting forms and their availability which should be sorted out in the institutional setting for better results.

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