Czarniak Petra, Bint Lewis, Favié Laurent, Parsons Richard, Hughes Jeff, Sunderland Bruce
Curtin University, Bentley, Western Australia, Australia.
Princess Margaret Hospital, Roberts Rd, Subiaco, Western Australia, Australia.
PLoS One. 2015 Mar 10;10(3):e0120630. doi: 10.1371/journal.pone.0120630. eCollection 2015.
To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia.
A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and prescribing data were collected. Drugs were classified as off-label or unlicensed based on Australian registration data. A hierarchical system of age, indication, route of administration and dosage was used. Drugs were classified according to the Anatomical Therapeutic Chemical Code.
A total of 1,037 paediatric patients were selected where 2,654 prescriptions for 330 different drugs were prescribed to 699 patients (67.4%). Most off-label drugs (n = 295; 43.3%) were from the nervous system; a majority of unlicensed drugs were systemic hormonal preparations excluding sex hormones (n = 22, 32.4%). Inpatients were prescribed more off-label drugs than outpatients or Emergency Department patients (p < 0.0001). Most off-label prescribing occurred in infants and children (31.7% and 35.9% respectively) and the highest percentage of unlicensed prescribing (7.2%) occurred in infants (p < 0.0001). There were 25.7% of off-label and 2.6% of unlicensed medications prescribed across all three settings. Common reasons for off-label prescribing were dosage (47.4%) and age (43.2%).
This study confirmed off-label and unlicensed use of drugs remains common. Further, that prevalence of both is influenced by the clinical setting, which has implications in regards to medication misadventure, and the need to have systems in place to minimise medication errors. Further, there remains a need for changes in the regulatory system in Australia to ensure that manufacturers incorporate, as it becomes available, evidence regarding efficacy and safety of their drugs in children in the official product information.
评估2008年西澳大利亚一家主要儿科教学医院中标签外用药和未获许可用药的发生率。
在玛格丽特公主医院开展了一项为期12个月的回顾性研究，使用从急诊科、住院病房和门诊诊所的145,550次患者诊疗记录中随机抽取的用药图表记录。收集患者和处方数据。根据澳大利亚注册数据将药物分类为标签外用药或未获许可用药。采用年龄、适应证、给药途径和剂量的分层系统。药物根据解剖治疗化学代码进行分类。
共选取了1037名儿科患者，其中699名患者（67.4%）开具了330种不同药物的2654张处方。大多数标签外用药（n = 295；43.3%）来自神经系统；大多数未获许可用药是不包括性激素的全身性激素制剂（n = 22，32.4%）。住院患者开具的标签外用药比门诊患者或急诊科患者多（p < 0.0001）。大多数标签外用药处方发生在婴儿和儿童中（分别为31.7%和35.9%），未获许可用药处方比例最高（7.2%）发生在婴儿中（p < 0.0001）。在所有三种诊疗环境中，标签外用药处方占25.7%，未获许可用药处方占2.6%。标签外用药处方的常见原因是剂量（47.4%）和年龄（43.2%）。
本研究证实标签外用药和未获许可用药的情况仍然很常见。此外，两者的发生率受临床诊疗环境的影响，这对用药差错有影响，并且需要建立相关系统以尽量减少用药错误。此外，澳大利亚的监管系统仍需变革，以确保制造商在官方产品信息中纳入其药物在儿童中的疗效和安全性证据（如有）。
