Procena znanja i stavova o farmakovigilanci u populaciji studenata zdravstvenih nauka u Vojvodini
INTRODUCTION: Pharmacovigilance is defined by the World Health Organization as “a set of activities related to the collection, detection, assessment, understanding, and prevention of adverse drug reactions and other drug-related problems”, with protecting public health as its ultimate goal. By creating conditions for organized and systematic monitoring of potential adverse reactions, pharmacovigilance is an essential activity in the regulatory system of drugs that allows early detection of unexpected, delayed, and/or severe adverse reactions to all preparations and agents used in preventive and clinical medicine. In addition to more fully defining the safety profile of a drug, one of the main goals of post-marketing monitoring and reporting of adverse drug reactions (ADRs) is to more precisely define the benefits and potential risks of a drug in practice, which ultimately leads to the improvement of one of the important aspects of public health – patient safety in the medical treatment process. Pharmacovigilance and related activities education are important competencies that healthcare sciences students should adopt before completing their studies and engaging in clinical practice. Considering this, the aim of this study was to assess pharmacovigilance knowledge and attitudes in a population of health sciences students in AP Vojvodina, Serbia, using a newly developed and validated questionnaire. METHODS: From February to July 2021, an observational cross-sectional study was conducted among students of medicine, dentistry, pharmacy, and nursing science at three faculties that educate future health professionals in Vojvodina. The newly developed three-part Questionnaire for Assessing Knowledge and Attitudes About Pharmacovigilance for Students of Healthcare Sciences, PVKAQ (I Demographic data section, II Pharmacovigilance Knowledge test, PVKT, and III Pharmacovigilance Attitude Questionnaire, PVAQ), was voluntarily and anonymously completed by a total of 242 health sciences students via the Google Forms platform, with 211 meeting the inclusion criteria for the study. RESULTS: After an item analysis, six questions were excluded from the PVKT. The final version of PVKT with 14 items had a good ordinal alpha value (αord = 0.83), as were other statistical indicators of reliability. PVAQ reliability testing also showed excellent performance of this section of the questionnaire: αord = 0.91 for both USFV subscales. The achieved average PVKT score was M = 9.14 (SD = 2.65; Me = 10), in the range of 0-14. Results of statistical testing showed that all respondents knew significantly more than 50% of the correct answers in the test, and the highest average PVKT score was achieved among students of integrated studies of medicine (M = 9.96; SD = 1.81; Me = 10). In contexts of respondents’ attitudes toward pharmacovigilance, the average score on the PAPV subscale related to general attitude toward pharmacovigilance was M = 31.98 (SD = 3.68; Me = 33), in the range of 7–35. The average score on the PAADR subscale related to the willingness of the subjects to participate in pharmacovigilance activities was M = 43.12 (SD = 10.63; Me = 45), in the range of 13-65. The highest PAPV score was achieved by students of basic academic studies of nursing science (M = 32.84; SD = 2.59; Me = 34), while the highest PAADR score was registered among students of integrated studies of medicine (M = 46.69; SD = 8.03; Me = 47.5). CONCLUSIONS: The first universal, methodologically correct, precisely designed, and scientifically based questionnaire with two psychometric instruments was developed and thoroughly statistically validated, which can be used to assess knowledge and attitudes about pharmacovigilance among students from all healthcare sciences study programs without any additional adjustments. Respondents in the observed sample demonstrated a high level of pharmacovigilance knowledge, with an average score of 65.29% of the maximum possible. At the same time, the research found that very positive general attitudes towards pharmacovigilance prevailed in the examined population, but that respondents only slightly tended to have more positive attitudes toward reporting adverse drug reactions in future practice.
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