基于欧盟强化系统 10 年回顾的指导未来药物警戒的 STAR 指南针。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-07-10 DOI:10.1007/s40264-024-01451-3
Priya Bahri, Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber, Sabine M J M Straus
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引用次数: 0

摘要

本文对欧盟(EU)2010 年药物警戒立法进行了反思。该立法旨在通过赋予制药公司和监管机构新的责任来更好地保护患者和公众的健康,我们认为这一立法目标已经实现,并得到了良好药物警戒实践 "EU-GVP "的有力支持。对于未来的进展,我们提出了在医疗、技术和社会不断变革的世界中实现高质量药物警戒的愿景。为了实现这一愿景,我们提出了四项原则来指导欧盟药物警戒系统的进一步发展:与医疗保健系统的协同互动;监管决策的可信证据;适应性流程效率;以及为紧急情况做好准备("STAR 原则")。这些原则就像指南针一样,应指导能力、技术和方法建设行动;改进监管流程;扩大政策、框架和研究议程。为适应未来的发展,欧盟体系应在安全、有效和可信的用药方面取得进一步的成果,并在以患者为中心的医疗保健中取得积极的健康成果。
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The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.

This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices 'EU-GVP'. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes. To deliver this vision, four principles are proposed to guide actions for further progressing the EU pharmacovigilance system: synergistic interactions with healthcare systems; trustworthy evidence for regulatory decisions; adaptive process efficiency; and readiness for emergency situations (the 'STAR principles'). Like a compass, these principles should guide actions for building capacity, technology and methods; improving regulatory processes; and expanding policies, frameworks and research agendas. Fit for the future, the EU system should achieve further improved outputs in terms of safe, effective and trusted use of medicines and positive health outcomes within patient-centred healthcare.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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