scholarly journals Off-label drug use among hospitalized children: identifying extent and nature

2012 ◽  
Vol 59 (1) ◽  
pp. 48-54 ◽  
Author(s):  
J. Slažneva ◽  
L. Kovács ◽  
M. Kuželová
Keyword(s):  
Drug Use ◽  
Digestive System ◽  
Slovak Republic ◽  
Hospitalized Children ◽  
Medicinal Products ◽  
Older Children ◽  
Off Label ◽  
Paediatric Patients ◽  
Paediatric Indication ◽  
Period Data

Off-label drug use among hospitalized children: identifying extent and natureObjective of the study was to determine the extent and nature of medicinal products used off-label in hospitalized children and to highlight the therapeutic areas with the highest need. Over a 4 week period, data about prescribed drugs to patients under 18 years of age at two paediatric wards in Bratislava (Unit for Infants and Unit for Older Children) were recorded and the drug-licensing status according to valid Summary of Product Characteristics (SPC) was identified. In total, 206 medicinal products containing 70 different generic substances were given to 49 paediatric patients at the Unit for Infants. Of these, 22% were evaluated as off-label. The highest rates were established among the drugs used for diseases of respiratory system and diseases of digestive system. The 68 children had been given at the Unit for Older Children 267 medicinal products resulting in 97 generic substances. In 15.7% of cases medicines were used in off-label manner, mainly due to unapproved paediatric indication and age. This pilot study provided a preliminary survey on drugs administered off-label to paediatric patients in Slovak Republic.

scholarly journals Unlicensed and off label drug use for paediatric patients

BMJ ◽  
1998 ◽  
Vol 317 (7152) ◽  
pp. 204-204 ◽  
Author(s):  
R. M Martin ◽  
L. V Wilton ◽  
R. D Mann ◽  
P. Steventon ◽  
S. R Hilton ◽  
...  
Keyword(s):  
Drug Use ◽  
Off Label ◽  
Paediatric Patients

The Impact of Unlicensed and Off-Label Drug Use on Adverse Drug Reactions in Paediatric Patients

Drug Safety ◽  
2004 ◽  
Vol 27 (13) ◽  
pp. 1059-1067 ◽  
Author(s):  
Antje Neubert ◽  
Harald Dormann ◽  
Jutta Weiss ◽  
Tobias Egger ◽  
Manfred Criegee-Rieck ◽  
...  
Keyword(s):  
Drug Use ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Off Label ◽  
Paediatric Patients ◽  
The Impact

Relationship between adverse drug reactions and unlicensed/off-label drug use in hospitalized children (EREMI): A study protocol

Therapies ◽  
2021 ◽  
Author(s):  
Kim An Nguyen ◽  
Yanis Mimouni ◽  
Elham Jaberi ◽  
Nathalie Paret ◽  
Inesse Boussaha ◽  
...  
Keyword(s):  
Drug Use ◽  
Adverse Drug Reactions ◽  
Study Protocol ◽  
Hospitalized Children ◽  
Drug Reactions ◽  
Off Label

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

2021 ◽  
pp. 1-13
Author(s):  
Waleed M. Sweileh
Keyword(s):  
Drug Use ◽  
Research Collaboration ◽  
Hospitalized Children ◽  
Major Research ◽  
Research Activity ◽  
Field Methods ◽  
Off Label ◽  
Research Themes ◽  
The Usa ◽  
Global Research

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.

scholarly journals Drug utilization and off-label drug use among Spanish emergency room paediatric patients

2009 ◽  
Vol 66 (3) ◽  
pp. 315-320 ◽  
Author(s):  
Cristina Morales-Carpi ◽  
Luis Estañ ◽  
Elena Rubio ◽  
Empar Lurbe ◽  
Francisco J. Morales-Olivas
Keyword(s):  
Drug Use ◽  
Emergency Room ◽  
Drug Utilization ◽  
Off Label ◽  
Paediatric Patients
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