Clinical and Practice Research Group, School of Pharmacy, Medical Biology Centre, Queen's University Belfast, 97 Lisburn Road, BT9 7BL Belfast, UK.
Eur J Clin Pharmacol. 2011 May;67(5):449-61. doi: 10.1007/s00228-010-0978-z. Epub 2011 Jan 18.
To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials.
A regional study in which a survey instrument with 39 items was issued to 500 randomly selected GPs, all community pharmacists (n = 512), 50 hospital consultants and 150 paediatric nurses in Northern Ireland.
Approximately half (46.5%) of the 1,212 healthcare professionals approached responded to the questionnaire. The majority of respondents indicated their familiarity with the term unlicensed (82.9%) or off-label (58.6%) prescribing with the most frequently quoted reason for such prescribing being younger age (33.6%). Apart from community pharmacists, most respondents reported having gained their knowledge through personal experience. Even though a large percentage of respondents expressed concerns about the safety (77.8%) or efficacy (87.9%) of unlicensed/off-label prescribing in children, only 30.7% reported informing parents/guardians of these concerns on the use of such medicines in children. In addition, only 56% of respondents believed that unlicensed/off-label medicines should undergo clinical trials in children. Overall, 28.4% of respondents (20.1% of GPs, 41.4% of community pharmacists, 27.7% of paediatric nurses and 94% of consultant paediatricians) indicated their willingness to be actively involved in, and recruit their patients for paediatric clinical research.
The use of unlicensed and off-label medicines remains a major issue in paediatric medicine. Until such times as more licensed medicines are available for children, clear guidance should be developed to allow consistency in practice across the spectrum of healthcare professionals who are involved with such medicines in their routine practice.
调查一系列医疗保健专业人员（儿科顾问医生、全科医生（GP）、社区药剂师和儿科护士）对儿童使用未注册/标签外用药以及儿童参与临床试验的知识和看法。
这是一项区域性研究，向 500 名随机选择的全科医生、所有社区药剂师（n=512）、50 名医院顾问和 150 名北爱尔兰儿科护士发放了一份包含 39 个项目的调查工具。
大约一半（46.5%）的 1212 名医疗保健专业人员对问卷做出了回应。大多数受访者表示熟悉未注册（82.9%）或标签外（58.6%）处方的术语，最常引用的处方原因是年龄较小（33.6%）。除了社区药剂师，大多数受访者表示他们是通过个人经验获得相关知识的。尽管很大比例的受访者对儿童未注册/标签外用药的安全性（77.8%）或疗效（87.9%）表示担忧，但只有 30.7%的人在儿童使用此类药物时向家长/监护人告知了这些担忧。此外，只有 56%的受访者认为未注册/标签外药物应在儿童中进行临床试验。总体而言，28.4%的受访者（20.1%的全科医生、41.4%的社区药剂师、27.7%的儿科护士和 94%的儿科顾问医生）表示愿意积极参与并招募他们的患者参与儿科临床研究。
在儿科医学中，使用未注册和标签外药物仍然是一个主要问题。在为儿童提供更多许可药物之前，应制定明确的指导方针，以便在涉及此类药物的医疗保健专业人员中保持实践的一致性。
