关于系统使用超说明书和未经许可的药物的全球研究出版物:文献计量分析(1990-2020年)。

Pub Date : 2022-01-01 DOI:10.3233/JRS-210012
Waleed M Sweileh
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引用次数: 12

摘要

背景:医疗保健提供者并不总是遵守政府对药品注册和许可的规定。目的:探讨超说明书和无证药品系统性使用的全球研究进展和模式,以了解该领域问题的严重性和主要研究主题。方法:在SciVerse Scopus检索1990年至2020年12月31日期间关于超说明书和未经许可的药物使用的论文,没有任何语言限制。采用文献计量学方法,给出了以下指标:被引频次最高的文献、最高产的国家、最活跃的期刊、国际研究合作、最常见的作者关键词和研究主题。结果:检索到论文1320篇,h指数为66,发表在721种不同的期刊上。医院药学杂志排名第一(n = 43, 3.3%)。总共有来自85个不同国家的5777位作者(中位数= 3)为检索到的论文做出了贡献。美国(n = 381, 28.9%)排名第一,德国和意大利紧随其后。活跃国家中国际作者的比例从中国的8.8%到荷兰的42.3%。在off-label旁边最常见的作者关键词是儿童/儿科。关键词unlicensed的出现频率低于off-label。检索到的论文的主要研究主题集中在住院儿童/儿科的超说明书用药、利妥昔单抗和rFVIIa等生物药物、精神疾病、法规以及社区药剂师和医生基于问卷的知识/态度研究。结论:在过去二十年中,超说明书用药的研究活动普遍增加。主要研究主题为住院儿童/儿科/新生儿超说明书用药。美国和某些欧洲国家对这一领域作出了重大贡献。
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Global research publications on systemic use of off-label and unlicensed drugs: A bibliometric analysis (1990-2020).

Background: Governmental regulations of drug registration and licensing are not always followed by healthcare providers.

Objective: To explore the global research growth and patterns on systemic use of off-label and unlicensed drugs to gain knowledge about the magnitude of the problem and the main research themes encountered in this field.

Methods: SciVerse Scopus was searched for papers on off-label and unlicensed drug use from 1990 until December 31, 2020, without any language limitations. A bibliometric methodology was adopted to present the following indicators: top-cited documents, the most productive countries, top active journals, international research collaboration, the most frequent author keywords, and research themes.

Results: The search query returned 1320 papers with an h-index of 66, published in 721 different journals. The Hospital Pharmacy journal ranked first (n = 43, 3.3%). In total, 5777 authors (median = 3) from 85 different countries contributed to the retrieved papers. The USA (n = 381, 28.9%) ranked first, followed distantly by Germany and Italy. The percentage of documents with international authors for active countries was from 8.8% for China to 42.3% for the Netherlands. The most frequent author keyword next to off-label was children/pediatrics. The keyword unlicensed was less frequently encountered than that for off-label. Major research themes in the retrieved papers focused on off-label drug use in hospitalized children/pediatrics, biological drugs such as rituximab and rFVIIa, psychiatric disorders, regulations, and questionnaire-based knowledge/attitude studies among community pharmacists and physicians.

Conclusions: Research activity on off-label drug use has witnessed a general increase in the past two decades. The major research theme was off-label drug use in hospitalized children/pediatrics/neonates. The USA and certain European countries made a major contribution to this field.

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