A cross-sectional study of adverse drug reactions reporting among doctors of a private medical college in Bihar, India

Buddhadev Panja, S Bhowmick, VR Chowrasia, Shipra Bhattacharya, RN Chatterjee, Arindam Sen, Manjula Sarkar, AK Ram, PK Mukherjee 
 Department of Pharmacology, MGM Medical College and LSK Hospital, Kishanganj, Bihar, India

Correspondence Address:
Dr. S Bhowmick
Department of Pharmacology, MGM Medical College and LSK Hospital, Kishanganj, Bihar
India

Full Text

Sir,

Few studies carried out in India on adverse drug reactions (ADR) reporting have shown poor knowledge, attitude, and deficient practices of reporting among the prescribers and healthcare professionals. This study aimed at evaluating the baseline awareness of the doctors at a private medical college in Bihar, where no published studies regarding ADR monitoring and pharmacovigilance (PV) have been reported till date.

A KAP questionnaire is containing 12 questions (knowledge: 8, attitude: 2, and practice: 2) was designed and prevalidated internally among 20 randomly selected postgraduate medical students by test-retest method. It was used to obtain information regarding the demographics of the respondents, knowledge about the ADR reporting system, attitude and practice of ADR reporting, and the factors that encouraged and discouraged reporting.

This was a cross-sectional, observational, questionnaire-based study performed in MGM Medical College and LSK hospital in Kishanganj, Bihar. The study was approved by the Institutional Ethics Committee. Statistical analysis was performed using SPSS software version 17.0 (SPSS Inc., Chicago, Illinois, USA) and  Microsoft Excel Office Worksheet 2007 (Microsoft Corporation, Redmond, Washington, USA).

A total of 66 postgraduate students working in different disciplines were included in the study for the duration of three months. About 81.8% of participants were male, and 18.2% were female. Mean age of the interviewees was 30.41 years (±4.81 years).

All the doctors were found to be aware of the terminology "ADR" although 27.3% were unaware of the term "PV."

A total of 59.1% respondents had received undergraduate (UG) teaching about ADR reporting, probably explaining their awareness about ADRs (P = 0.002). About 93.9% had encountered an ADR during their clinical practice, and 56.1% opined that the ADRs were predictable. However, only 22.7% were aware of PV Program of India (PVPI). About 42.4% respondents opted for "reporting form" as their preferred method of reporting. Regular training hours for PV in UG and postgraduate curriculum was recommended by majority of the respondents (31.8%) along with continuous medical education (33.3%) to increase awareness and practice of ADR monitoring and reporting [Table 1].{Table 1}

Though similar studies have been conducted across the country, no published study on a similar issue was found on extensive electronic literature database search from the state of Bihar, India. Majority of the respondents (90.9%) believed that dedicated teaching hours on ADRs during UG improved ADR reporting among the doctors. This finding is similar to one obtained by Upadhyaya et al. in Rajasthan where 86% of doctors reported that UG Curriculum Practical Training teaching would have improved the ADR reporting. [1]

The Indian Pharmacopoeia Commission on 11 th October 2013, created a toll-free number (1800 180 3024) facility under PVPI, for reporting of ADRs in order to ensure patient safety. [2] Hence, the authors strongly recommend the intimation of ADRs via online submission or calling up the dedicated 24 h helpline number to improve the reporting standards in the country.

The awareness about the ongoing PVPI was also found to be quite low among the respondents, which is an area of concern. Furthermore, the private hospitals must be included in the program in order to increase awareness and reporting of ADRs. These initiatives have to start at the earliest for a state like Bihar where a number of corporate hospitals and private medical colleges have been established in the past decade.

Although our study had limitations like small sample size and nonanonymous methodology of data capture, yet the results of this pilot study from Bihar showcases the immediate need to relook at the awareness and attitude toward the ongoing PVPI among the prescribers in the state of Bihar, India.

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