Off-label and unlicensed drug use: Results from a pilot study in a paediatric intensive care unit

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• 作者：Isabel Garcí ; a-Ló ; pez^a ; ^{iglopez@salud.madrid.org} ; Javier Ezequiel Fuentes-Rí ; os^b ; Silvia Manrique-Rodrí ; guez^b ; Cecilia M. Ferná ; ndez-Llamazares^b
• 关键词：Paediatric intensive care units ; Drug utilization ; Drug approval ; Off-label use ; Unlabeled indication ; Off-label prescriptions ; Paediatrics
• 刊名：Anales de Pediatría (English Edition)
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：86
• 期：1
• 页码：28-36
• 全文大小：430 K
• 卷排序：86

文摘

To analyze the prevalence of use of off-label and unlicensed drugs in a paediatric intensive care unit of a University Hospital.MethodAn observational, descriptive, prospective six week pilot study in a paediatric intensive care unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the summary of product characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved.Results42 patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions were obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide.ConclusionPaediatric intensive care units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allowing us to document practice on paediatric drug utilization is required.