Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia

Abstract

ObjectivesTo evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing.MethodsA retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.ResultsThere were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.ConclusionsThis study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.

Medicamentos não licenciados: uma discussão em pediatria

“…Os neonatos e as crianças possuem perfis farmacocinéticos e farmacodinâmicos distintos, implicando a necessidade de instituir o tratamento medicamentoso de forma personalizada (Shakeel et al, 2020;Tukayo et al, 2020;Landwehr et al, 2019;Aamir et al, 2018;Barker, 2018;Batchelor & Marriott, 2015).…”

“…A glicuronidação, uma reação de fase II, também varia com a idade e é reduzida em neonatos. Portanto, a variação no metabolismo dos fármacos dentro dos diferentes grupos de idade destaca a importância de pesquisas científicas nessa área para subsidiar a prescrição racional em pediatria (Landwehr et al, 2019).…”

“…O uso off label e a utilização de medicamentos não licenciados é frequente em pediatria e com riscos associados, uma vez que esses produtos não foram devidamente estudados, podem resultar maior frequência de eventos adversos na população (Aamir et al, 2018;García-López et al, 2016;Batchelor & Marriott, 2015). Research, Society and Development, v. 9, n. 10, e8919109262, 2020 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i10.9262 4 O Off label é caracterizado pelo uso de medicamentos para idades, doses, frequências e formas de administração discordantes das indicadas pela literatura (Tukayo et al, 2020;Dornelles et al, 2019;Landwehr et al, 2019;García-López et al, 2016).…”

“…Os medicamentos não licenciados são aqueles originados de modificações nos produtos licenciados. Também entram nessa categoria os medicamentos sem autorização no órgão regulador para a venda, bem como os importados, os contraindicados e os que não têm informação para uso em determinado grupo de pacientes (Tukayo et al, 2020;Kouti et al, 2019;Landwehr et al, 2019;Gonçalves & Heineck, 2016;Pereira et al, 2016;Blanco-Reina et al, 2016;Gonçalves et al, 2017).…”

Interventional effect of off-label use of alprostadil lipid microsphere injection in neurosurgical patients: a before-after study

“…At present, the phenomenon of unlicensed or off-label drug use is widespread in the worldwide [11][12][13][14]. Seven countries have laws related to off-label drug use: America, Germany, Italy, Netherland, New Zealand, India and Japan.…”