Objective: Pharmacovigilance education and reporting of adverse drug reactions (ADRs) are important competencies that healthcare sciences students should develop before completing their studies and entering clinical practice. Since students frequently lack adequate knowledge in this area and fail to recognize the importance of ADRs monitoring and reporting, the aim of this study was to develop and validate a unique and reliable instrument for assessing health sciences students' knowledge and attitudes toward pharmacovigilance and ADRs reporting.
Subjects and methods: A cross-sectional observational study was conducted from February to July 2021 to examine students' knowledge and attitudes toward pharmacovigilance activities. Students of medicine, dentistry, pharmacy, and nursing science of three faculties in the Autonomous Province of Vojvodina, Serbia were examined. A total of 211 of them completed the specially designed, three-section questionnaire (Demographic data section, Pharmacovigilance Knowledge test, PVKT, and Pharmacovigilance Attitude Questionnaire, PVAQ). The questionnaire was posted on the Google Forms platform, and the link was distributed to respondents via the official websites and social networks of all three faculties.
Results: Findings demonstrated good psychometric properties and reliability of the questionnaire. Six questions were removed from the PVKT after item analyses. After excluding these items, the calculated ordinal alpha of the final version of the PVKT, which included 14 items, was good (αord = 0.83), as were other statistical indicators. PVAQ reliability testing also revealed great performance of this questionnaire-calculated ordinal alpha for two PVAQ subscales was excellent (αord = 0.91, for both scales).
Conclusions: This questionnaire has favorable validity and reliability in assessing healthcare sciences students' knowledge and attitudes toward pharmacovigilance and ADRs reporting.