Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials
Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials
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DOI：
10.1007/s00228-010-0978-z
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发表时间：
2011-05-01
影响因子：
2.9
通讯作者：
McElnay, James C.
中科院分区：
文献类型：
--
作者：
Mukattash, Tareq;Hawwa, Ahmed F.;McElnay, James C.
目的调查一系列医疗保健专业人员的知识和观点（儿科顾问医生、全科医生（GP）、社区药剂师和儿科护士）关于儿童使用无证/标签外药物和儿童参与临床试验的情况。方法一项区域性研究，向随机选择的500名全科医生发放了一份39项调查工具，所有社区药剂师（n = 512），50医院顾问和150儿科护士在北方爱尔兰。结果约一半（46.5%）的1,212名医疗保健专业人员接近回答问卷。大多数受访者表示他们熟悉无证（82.9%）或超说明书（58.6%）处方这一术语，最常引用的处方原因是年龄较小（33.6%）。除社区药剂师外，大多数答复者报告说，他们是通过个人经验获得这些知识的。尽管有很大比例的受访者对儿童无证/超说明书处方的安全性（77.8%）或疗效（87.9%）表示担忧，但只有30.7%的受访者报告称告知了父母/监护人对儿童使用此类药物的担忧。此外，只有56%的受访者认为未经许可/标签外的药物应进行儿童临床试验。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，并招募他们的病人进行儿科临床research.Conclusion使用未经许可和标签外的药物仍然是一个主要问题，在儿科医学。在有更多的许可药品可供儿童使用之前，应制定明确的指南，以确保在日常实践中涉及此类药物的医疗保健专业人员在实践中保持一致。
Objectives 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.Methods 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.Results 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.Conclusion 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.