Abstract

Background: Adverse drug reactions (ADRs) are one of the leading causes of death and are responsible of 5–10% of the hospital costs. Every drug having more or less adverse effects which may leads to medical and economic burdens on patients. Some ADRs are severe enough to increase the risk of death. Pharmacovigilance aims to detect and monitor the ADR, to identify the risk factors responsible of it, and to disseminate the knowledge required for the improvement of prescription of drugs.

Aim and Objective: This study aims to assess the knowledge, attitude, and practice (KAP) of pharmacovigilance in MBBS interns of rural tertiary health center of Maharashtra.

Materials and Methods: This was a cross-sectional study to evaluate the KAP regarding pharmacovigilance among MBBS interns. KAP questionnaire contained 20 questions along with options and correct answer. For pre-test, 20 min were given to them for answering all questions then a seminar (an educational intervention) was taken on pharmacovigilance and its importance and last, post-test was conducted in 20 min.

Results: A total of 75 MBBS interns attended the CME on pharmacovigilance and filled the pre- and post-test questionnaire. Fifty-three (70.66%) participants were not known when the Pharmacovigilance Program of India (PvPI) started and 57 (76%) participants were unaware of regulatory body which is responsible for monitoring ADR in PvPI. Forty-seven (62.66%) participants had no clue that a serious adverse event should be reported within a stipulated time period to the regulatory body.

Conclusion: Interns are new budding health care workers and they do not have sufficient knowledge of pharmacovigilance. Inclusion of pharmacovigilance in undergraduate curriculum, conducting CME for doctors, nurses, and pharmacist and motivation of doctors for reporting ADRs are some measures which can improve the spontaneous reporting system, patient safety, and Indian pharmacovigilance program.

Key words: Adverse Drug Reaction; Pharmacovigilance; Medical Interns; Knowledge, Attitude, and Practice