International Journal of Pharmacology and Clinical Sciences, 2013, 2, 3, 82-88.
Published: September 2013
Type: Research Article
Authors: Tanya Mary Thomas, Padmaja Udaykumar, and Scandashree K
Author(s) affiliations:
Tanya Mary Thomas1*, Padmaja Udaykumar2, Scandashree K1
1Post Graduate, Department of Pharmacology, 2Professor and Head, Department of Pharmacology, Father Muller Medical College, Mangalore, India.
Abstract
Background: A fundamental determinant to medical drug safety surveillance is voluntary adverse drug reaction [ADR] reporting; but there exists substantial under-reporting which is the main drawback of the system. The objective of the study was to evaluate the knowledge, attitude and practice of ADR reporting among doctors in a tertiary health care center. Materials and Methods: A cross-sectional questionnaire-based study was conducted on doctors in a tertiary health care center. Participants were selected randomly and those not willing to participate were excluded from the study. Collected data was assessed by frequency, percentage, mean and standard deviation. Statistical analysis was performed by using SPSS version 13.0. Results: 75% (45) of respondents were aware of the existence of ADR reporting system in India; on the contrary only (11.7%) of respondents were aware of regional center for ADR reporting. All respondents (100%) felt that seriousness of the ADR event, unusual reaction (95%), reaction to new drug (98.33%), and the certainty of ADR reaction (91.66%) would encourage them to report an ADR event. However, only 15 out of 60 respondents (25%) have reported ADRs. Conclusion: Though the level of knowledge about ADR reporting and the attitude towards ADR reporting were adequate, our study has shown that the actual practice of ADR reporting is unsatisfactory. This indicates that there is a need to create an awareness of the importance of ADR reporting through continuous medical education and training of ADR reporting among doctors.