Abstract
Purpose: Spontaneous reporting of adverse drug reactions (ADRs) is a significant activity to improve the safety of medicines and health care professionals are pivotal players. This study aims to assess the knowledge, attitude and practice of health professionals towards an adverse drug reaction reporting and factors associated with reporting. Methods: Institutional based cross sectional study complemented with qualitative study was conducted from May to November, 2012 in Amhara region. Using a two stage cluster sampling technique, 708 participants were selected for the study. A pretested self-administered questionnaire was used for data collection. An in-depth interview was used to collect qualitative data. Multivariate binary logistic regression was used for the analysis. Results: It was found that none of the respondents mentioned the national ADR reporting guideline as their source of information on ADR reporting. Based on the overall knowledge score, about two thirds 411 (65.8%) of the respondents had insufficient knowledge on the ADR reporting system. A very small proportion of respondents 101(16.2%) had ever reported ADR they encountered during their professional practice. Being participated in ADR related training [AOR: 1.82(1.10, 3.10) 95%CI], being introduced with ADR during college or university education and level of knowledge [AOR: 5.99(3.61, 9.94)95%CI] are found to be significantly associated with ADR reporting. Conclusion: The level of knowledge towards ADR reporting is low. ADR reporting practice is also low among health professionals. Hence, strategies need to be devised to create awareness among health professionals towards ADR reporting.
Highlights
The World Health Organization (WHO) initiated an international drug monitoring program in 1968 to coordinate activities worldwide [1]
As there is no study on level of knowledge and factors associated with reporting in Amhara region, this study aimed to assess the knowledge, attitude and practice of health professionals towards an adverse drug reaction reporting and factors associated with adverse drug reactions (ADRs) reporting
A systematic review on determinants of ADR reporting conducted in Spain confirmed that knowledge of health professionals appeared to be strongly related with reporting in a high proportion of studies [12]
Summary
The World Health Organization (WHO) initiated an international drug monitoring program in 1968 to coordinate activities worldwide [1]. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of ADR or any other medicine related problem to improve the safety of medicines. According to WHO definition, an ADR is any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy [2]. A number of studies conducted worldwide indicated spontaneous reporting of ADRs as a corner stone for successful pharmacovigilance and highlighted the significance of the contribution of health professionals in this regard. A study in Ethiopia highlighted that only few reports are sent to the national pharmacovigilance center [9]
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