School of Pharmacy and Biomedical Sciences, Curtin University, Perth, Western Australia, Australia.
Fiona Stanley Hospital South Metropolitan Health Service, Perth, Western Australia, Australia.
PLoS One. 2019 Jan 8;14(1):e0210237. doi: 10.1371/journal.pone.0210237. eCollection 2019.
To 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.
A 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.
There 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.
This 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.
评估西澳大利亚州一家主要儿科教学医院住院患者的标签外和无许可证处方的流行情况，并确定哪些药物通常标签外或无许可证处方，包括影响此类处方的因素。
2013 年 6 月进行了一项回顾性横断面研究。从 2013 年 2 月第二周的所有入院患者中随机选择了 190 份住院患者用药记录，收集了患者和处方数据。根据澳大利亚批准的注册产品信息（PI），将药物分为许可、标签外和无许可证。所有药物均按解剖治疗化学（ATC）代码分类。
共有 120 名男性和 70 名女性住院患者。平均年龄为 6.0 岁（±4.7）。该研究包括 1160 种适合分析的处方药物。每位患者开的药物数量从 1 种到 25 种不等，平均为 6.1（±4.3）。超过一半（54%）的药物是标签外使用。羟考酮、可乐定、帕瑞昔布和咪达唑仑总是标签外使用。最常见的标签外药物是昂丹司琼（18.5%）、芬太尼（12.9%）、羟考酮（8.8%）和扑热息痛（6.1%）。许多 ATC 分类包括高标签外比例，特别是泌尿生殖系统和性激素、呼吸系统药物、全身激素制剂以及消化道和代谢药物。
本研究强调，儿科药物的处方需要更好地得到现有和新证据的支持。应建立激励机制，鼓励在儿科人群中开展基于证据的研究。目前的标签外处方水平引起了儿童意外毒性和药物不良反应的问题，在某些情况下，儿童病情严重。
