Advances in Pharmacoepidemiology and Drug Safety

Abstract

Under Reporting of ADRs by Medical Practitioners in India - Results of Pilot Study

Rakesh Kumar Rishi, Rakesh K. Patel, and Anil Bhandari

Spontaneous reporting of adverse drug reactions (ADRs) is an important method in pharmacovigilance, but under-reporting and poor qualities of reports are major limitations. The aim of this study was to investigate reasons for under-reporting of ADRs by the medical practitioners in India. The opinion of physicians on the under-reporting of ADRs was assessed by self administered, anonymous questionnaire. In this pilot study, a total of 100 doctors across the country responded to the questionnaire. A total of 81% of the respondents were males and the rest 19% were females with average age of 43.54 years. The surveyed physicians were from different backgrounds and they were having different medical qualifications. Vast majority of respondents (96%) stated that all drugs available in the market are not safe and 86% stated that they had experienced ADRs in patients. A total of 95% agreed that ADRs should be reported by the medical practitioners and 96% stated that ADR reporting and monitoring system would benefit the patient. The practitioners were allowed to select more than one reason for under reporting in the study questionnaire in this pilot study. All the practitioners cited one or the other reason for under-reporting. A total of 328 responses were obtained from 100 medical practitioners (average response 3.28 per medical practitioner). Our study suggests incorporating more training on pharmacovigilance to the willing physicians emphasizing more on the importance of training of reporting. It is also concluded that there is an urgent need to do more research to improve the understanding of the barriers to reporting ADRs and how they may be overcome.