Aims: The present study aimed to assess the knowledge, attitude and practice of ADR reporting among interns and clinical post-graduates in a tertiary care teaching hospital.
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. ADRs are a threat to
the patient’s safety as well as the quality of life and they increase the
health care cost considerably. 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 management of ADRs is the need of the hour.
Methodology: This was an observational, questionnaire-based
study. A pre-validated questionnaire (from previous studies) containing both
open and close-ended items was used as the evaluation tool. 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
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 the 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 participants, in terms of mean scores of
knowledge, attitude and practice (p>0.05), but there was a significant
(p<0.05) and positive correlation between knowledge and practice (r=0.2110)
and attitude and practice (r=0.2415). Pharmacovigilance programmes have played a
major role in the detection of ADRs and the banning of several drugs from the
market. However, underreporting of ADRs is one of the major problems associated
with Pharmacovigilance programmes.
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 healthcare professionals. The health care professionals should realize
that ADR reporting is an integral part of their clinical activities and this is
very necessary for better patient care.
Author (s) Details
Sapna Patil
Department of Pharmacology, Sapthagiri Institute of Medical Sciences and
Research Centre, Bangalore, Karnataka, India.
P. A. Patil
Department of Pharmacology, Sapthagiri Institute of Medical Sciences and
Research Centre, Bangalore, Karnataka, 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.
Please see the book here:- https://doi.org/10.9734/bpi/prrat/v6/1920
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