TY - JOUR
AU - Sweileh, Waleed M.
AB - 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.
TI - Global research publications on systemic use of off-label and unlicensed drugs: A bibliometric analysis (1990–2020)
JF - International Journal of Risk & Safety in Medicine
DO - 10.3233/jrs-210012
DA - 2022-02-01
UR - https://www.deepdyve.com/lp/ios-press/global-research-publications-on-systemic-use-of-off-label-and-cTJOMIHsGV
SP - 77
EP - 89
VL - 33
IS - 1
DP - DeepDyve
ER -