Global research publications on systemic use of off-label and unlicensed drugs: A bibliometric analysis (1990-2020).

IF 0.8 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE Pub Date : 2022-01-01 DOI:10.3233/JRS-210012

Waleed M Sweileh

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引用次数: 12

Abstract

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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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)。

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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来源期刊

INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

2.20

自引率

17.60%

发文量

102

期刊介绍： The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed. This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety.