Study of knowledge, attitude, and practices towards current updates of pharmacovigilance and adverse drug reaction reporting among doctors in a tertiary care teaching hospital of Western India

ABSTRACT

Background: In general, adverse drug reactions (ADRs) are global problems causing both morbidity and mortality. Spontaneous ADR reporting is important to monitor adverse effects of medicines but under reporting is still very prevalent so, there is a need of constant monitoring and rectification of system of Pharmacovigilance. The objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about Pharmacovigilance and to identify the reason for under reporting of ADRs.Methods: A cross-sectional study was carried out using a pretested questionnaire among doctors with minimum qualification MBBS or B.D.S. including faculties, senior and junior residents. Subsequently, analysis of association between education and experience was done by chi square test at P-value <0.05.Results: A pretested questionnaire was distributed among 403 doctors and 240 (59.16%) responded voluntarily. In general, 131 (54.58%) participants noted lack of time to report ADR while 90 (37.50%) participants noted no benefit of reporting already known ADR. On the other hand, total 104 (43.33%) participants were aware about need to report a serious adverse event during “Clinical Trial” within 24 hours to the Ethics Committee. Only 87 (36.25%) participants noted a need of reporting of already known ADR.Conclusions: Participants had good knowledge and attitude towards pharmacovigilance, but the actual practice of ADR reporting is still deficient among them that can be improved by sensitization training and involvement of grass root level health care workers.