Assessment of knowledge and reporting of adverse drug reaction in resident doctors in a teaching hospital in North India

Background: This study was done to assess the knowledge, attitude and practices of residents towards pharmacovigilance in a teaching hospital in North India.Methods: A cross-sectional study was conducted among residents of Chintpurni Medical College and Hospital, Pathankot (CMC&H). A questionnaire containing 17 questions was distributed to 80 residents of CMC&H, Pathankot. This study was conducted over a period of 3 months from July to September, 2017.Results: 64 out of the 80 residents (80%) responded to questionnaire. Among the respondents, 6% did not know the term adverse drug reaction (ADR) and almost 18% did not witness any ADR during clinical practice. Among those who witnessed ADRs nearly 25% could not ascertain the type of ADR. Those who ascertained ADRs claimed that upto 60% suspected ADRs required short hospitalisation. 6% residents did not consider ADRs avoidable and almost 25% residents did not consider ADRs predictable. 37% residents did not report the ADRs to anyone and nearly 43% did not know whom to report the ADRs. More than 18% claimed that they were not taught about PV in undergraduate curricular practical training teaching. Up to 31% residents claimed that nobody ever discussed with them about ADR reporting during internship.Conclusions: According to this study, residents lack adequate knowledge and practice of reporting ADRs. This study suggests a greater need to create awareness amongst them to promote reporting of ADRs. This study also suggests that incorporation of Pharmacovigilance in medical curriculum will strengthen pharmacovigilance activity.

Pattern of adverse drug reactions reported at a tertiary care teaching hospital in Punjab

Background: This study was undertaken to characterize the pattern of adverse drug reactions (ADRs) reported through spontaneous reporting system at ADR reporting unit in a tertiary care teaching hospital (Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar).Methods: A prospective, observational study was conducted over one year between 1st July, 2013 and 30th June, 2014. The ADRs reported were from patients attending outpatient department (OPD) and in-patient department (IPD) of this hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and ADR characteristics and outcome of the ADRs. Causality and severity assessment was done by WHO-UMC system and modified Hartwig and Siegel criteria.Results: A total of 202 ADRs which were reported over one year were evaluated. Overall ADRs were more common in females than in males (60.2% vs. 39.8%). Majority of the ADRs were reported from psychiatry department (50%). Most ADRs occurred due to antidepressant drugs (55.1%). Majority of the ADRs involved the central nervous system (25.24%). Upon causality and severity assessment, majority of the reports were rated as probable (57.42%) and mild (57.92%). None of the ADRs were severe or fatal.Conclusions: In conclusion, majority of the ADRs were reported by psychiatry department and occurred due to antidepressant drugs. Most of the ADRs were mild. This data reveals the need for regular spontaneous reporting by healthcare professionals of all specialties. This data also reveals the opportunities for interventions and policy initiatives to ensure safer use of drugs in future.