A STUDY ON THE KNOWLEDGE, ATTITUDE AND PRACTICE OF ADVERSE DRUG REACTION REPORTING AMONG INTERNS AND CLINICAL POST-GRADUATES IN A TERTIARY CARE TEACHING HOSPITAL
SAPNA PATIL *
Department of Pharmacology, USM-KLE IMP, Belagavi, India
P. A. PATIL
Department of Pharmacology, USM-KLE IMP, Belagavi, India
S. JAVALI
Department of Community Medicine, USM-KLE IMP, Belagavi, India
AMEETA PATIL
Bioclinica Safety and Regulatory Solutions, Mysore, India
HEETHAL JAIPRAKASH
Department of Pharmacology, MAHSA University, Kuala Lumpur, Malaysia
*Author to whom correspondence should be addressed.
Abstract
Background: Adverse Drug Reactions (ADRs) are an important cause of morbidity and mortality worldwide. Spontaneous reporting of ADRs has played a major role in the detection of suspected, serious, and unusual ADRs previously undetected during the clinical trial phases. Proper monitoring and reporting of ADRs for the prevention and the management of ADRs is need of the hour.
Aims: The objective of the study was to assess the knowledge, attitude and practice of ADR reporting among interns and clinical post-graduates in a tertiary care teaching hospital.
Methodology: One hundred and fifty two interns and clinical post-graduates were included in the study. Participation in the study was voluntary and without any obligation. The study was rolled out after receiving the approval from the Institutional Ethics Committee. The previously validated questionnaire consisting of a total of 24 items was distributed to the health care professionals. The data was analysed using Chi square test, one way ANOVA and Karl Pearson’s co-efficient of correlation tests with the help of SPPS software 20.0. Results: Out of 152 participants, 48(31.6%) were year 1, 44(28.95%) were year 2 clinical post-graduate students; as compared to 60(39.47%) interns. Thirty two (21.1%) participants out of which 20 interns, 7(14.6%) year 1 and 5(11.4%) year 2 clinical postgraduates, had knowledge of the local peripheral monitoring centre. The difference was found to be statistically significant (p<0.05). 88.2% of the total participants had never reported an ADR to the pharmacovigilance centre. There was no significant difference among the three groups of the participants, in terms of mean scores of knowledge, attitude and practice (p>0.05), but there was a significant (p<0.05) and positive co-relation between knowledge and practice (r=0.2110) and attitude and practice (r=0.2415).
Conclusion: The training of pharmacovigilance activities should start early in the professional training of doctors and needs to be reinforced during the postgraduate course. There is a great need to create awareness regarding Pharmacovigilance and to promote the reporting of ADR amongst health care professionals.
Keywords: Pharmacovigilance, health care professionals, questionnaire, under reporting