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立陶宛公众中的药物警戒与药品不良反应报告:一项横断面研究

Pharmacovigilance and Adverse Drug Reaction Reporting among the General Public in Lithuania: A Cross-Sectional Study.

作者信息

Valinciute Agne, Gerbutaviciene Rima Jurate, Paukstaitiene Renata, Kubiliene Loreta

机构信息

Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu Ave. 13, LT-50166 Kaunas, Lithuania.

Department of Physics, Mathematics and Biophysics, Lithuanian University of Health Sciences, Eiveniu Str. 4, LT-50161 Kaunas, Lithuania.

出版信息

Healthcare (Basel). 2023 Apr 14;11(8):1133. doi: 10.3390/healthcare11081133.

DOI:10.3390/healthcare11081133
PMID:37107967
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10138446/
Abstract

: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. : A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of "poor", "moderate", and "good" knowledge, as well as "positive" and "negative" attitudes. : While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. : The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting.

摘要

尽管十多年来立陶宛消费者能够直接向主管当局报告药品不良反应(ADR),但报告率仍然很低。需要全面了解消费者对药品不良反应的认知和经历,以确定影响他们参与药品不良反应报告的其他因素。本研究旨在评估消费者对药品不良反应报告的知识、态度和实践。

2021年10月至2022年6月期间,对404名消费者进行了问卷调查指导的横断面调查。半结构化问卷包括开放式和封闭式问题,以探索社会人口学特征以及对药品不良反应和药物警戒的一般知识。其他问题项目评估了对药品不良反应报告的态度和药品不良反应报告实践。数据采用描述性统计进行汇总,而卡方检验用于评估显著性水平<0.05的分类变量。知识和态度领域的总体百分比得分分为“差”、“中等”和“良好”知识组,以及“积极”和“消极”态度组。

虽然总体理解较差,但本研究表明立陶宛消费者对药物警戒持积极态度,特别是在报告要求方面。数据还揭示了报告和不报告药品不良反应的理由。

本研究首次了解了消费者的认知和药品不良反应报告意图,这有助于开展针对药物警戒和药品不良反应报告的教育活动和干预措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/942e/10138446/a08718e813bf/healthcare-11-01133-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/942e/10138446/4e2e8e73d274/healthcare-11-01133-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/942e/10138446/a08718e813bf/healthcare-11-01133-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/942e/10138446/4e2e8e73d274/healthcare-11-01133-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/942e/10138446/a08718e813bf/healthcare-11-01133-g002.jpg

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