A survey of issues regarding ADR and ADR reporting amongst doctors in Delhi

Article type: Research Article

Authors: Bhatia, Ashima | Kapoor, Upender | Tayal, Girish

Affiliations: Department of Pharmacology, Maulana Azad Medical College, New Delhi, India

Note: [] Corresponding author. Upender Kapoor, C-493, Yojana Vihar, Delhi-110095, India. Tel.: 01122161675; E-mail: upenderkapoor@yahoo.com.

Abstract: The Drug Controller General of India (DCGI) and Indian Council of Medical Research (ICMR) have established ADR monitoring centres in many hospitals in the major cities of India. Despite these efforts and the presence of a large number of tertiary care facilities, pharmacovigilance is still in its infancy in India. Gross under reporting of ADR is a cause of concern, the reasons for which may be many. It is important to understand these reasons to improve the sad state of ADR reporting in India. The present study was carried out to study awareness about ADR and ADR reporting among private practitioners (PPs) and prescribers in government hospitals (PGHs) and to get some feedback and suggestions from them for improving the same. A total of 200 doctors of different clinical disciplines working in government setup (100) or private setup (100) in Delhi were included in the study. Each doctor was given a questionnaire to answer. The responses to the questionnaire were studied under three sections: (i) assessment of ADR and ADR reporting awareness, (ii) ADR feedback data, (iii) suggestions to improve ADR knowledge and its reporting. The responses of the two groups were analysed and compared with each other using the chi-square test. There was a lack of general awareness about adverse drug reactions and the factors that can lead to ADRs among the doctors in the present study. The overall knowledge of ADR reporting was also very poor in both the groups. Only 15 PPs and 3 PGHs knew where to report a suspected ADR and less than one third in both cases knew which ADR to report and the information to be included while reporting an ADR. Ignorance and lack of resources were voted the most important barriers in reporting ADRs in India while spontaneous reporting was ticked as the method of choice for ADR reporting by 66% PPs and 81% PGHs. There were only a few significant differences in awareness between the two groups. The present state of unawareness of ADRs and their reporting can be improved by incorporating the suggestions given by the doctors themselves in the present study, i.e. establishment of more ADR reporting and monitoring centres, more CMEs and workshops to create awareness, a multi-disciplinary team approach in reporting ADRs and legalized ADR monitoring of their products by the pharmaceutical companies.

Keywords: Adverse drug reactions, awareness, reporting, monitoring

Journal: International Journal of Risk and Safety in Medicine, vol. 17, no. 1-2, pp. 39-46, 2005