Abstract

Background: Adverse drug reactions (ADRs) are important causes of morbidity and mortality worldwide. Spontaneous reporting of ADRs is the cornerstone of pharmacovigilance (PV) and is important in maintaining patient safety.

Aims and Objective: The study was conducted to assess the knowledge, attitude, and practice (KAP) of PV among doctors of a medical college hospital.

Materials and Methods: It was a questionnaire-based cross-sectional study. A questionnaire containing 10 questions on knowledge, 11 questions on attitude, and 3 questions on practice of PV was utilized to assess the KAP among the doctors. The questionnaire was analyzed by using Microsoft excel spreadsheet and SPSS version 16 for statistical significance.

Results: A total of 120 doctors completed and returned the questionnaire. 98 (81.67%) doctors knew the specific aim of PV. A large number of doctors (88.33%) were aware that doctors including dentists, nurses, and pharmacists can report ADR in India. 66 (55%) doctors considered reporting of ADR as voluntary. A total of 52 (43.33%) doctors strongly agreed that ADR reporting was a professional obligation and 8 (6.66%) doctors strongly disagreed to this. The causes of underreporting were concern that reporting could cause legal challenge (38.33%), report might be wrong (50%), lack of time (53.33%), lack of confidence (33.33%), and absence of fee for reporting (16.67%). This study revealed that 66 (55%) doctors did not report any ADR.

Conclusion: The study suggests that there is a great need of educational intervention to improve awareness among health-care professionals regarding PV.

Key words: Adverse Drug Reactions; Pharmacovigilance; Knowledge; Attitude; Practice; Spontaneous Reporting