Department of Paediatrics, University Hospital Rijeka, Rijeka, Croatia.
Eur J Clin Pharmacol. 2012 Jul;68(7):1073-7. doi: 10.1007/s00228-012-1221-x. Epub 2012 Feb 4.
The aim of this study was to determine the prevalence and pattern of unlicensed and off-label drugs prescribed to hospitalized children at the Department of Paediatrics, University Hospital Rijeka, Croatia.
A prospective cross-sectional study was performed on 1 day each month during a 12 month period and included all hospitalized children and adolescents.
A total of 1,643 prescriptions for 198 different drugs were prescribed to 531 out of 691 (77%) hospitalized patients. Forty-six percent of the different drugs were prescribed in an unlicensed or off-label manner. Of all drug prescriptions, 25% were either unlicensed or off-label. Forty-eight percent of the patients received either an unlicensed or off-label drug. The most frequently prescribed off-label drugs were proton pump inhibitors.
Unlicensed and off-label drug use is common. It is not illegal and may be clinically appropriate but is associated with a number of clinical, safety, and ethical issues. Regulatory authorities should use existing clinical evidence on the use of off-label and unlicensed drugs in decision making. Marketing authorization holders and national regulatory authorities should monitor for any safety concerns associated with unlicensed and off-label drug use and take appropriate measures as well as identify research priorities and mandate clinical studies to resolve important questions.
本研究旨在确定克罗地亚里耶卡大学医院儿科住院儿童开具的未注册和标签外药物的流行率和模式。
在 12 个月的时间内，每月进行 1 天的前瞻性横断面研究，纳入所有住院的儿童和青少年。
总共为 691 名住院患者中的 531 名（77%）开具了 198 种不同药物的 1643 份处方。46%的不同药物以未注册或标签外的方式开具。所有药物处方中，25%为未注册或标签外处方。48%的患者使用了未注册或标签外药物。最常开的标签外药物是质子泵抑制剂。
未注册和标签外用药很常见。它不违法，可能在临床上是合适的，但与许多临床、安全和伦理问题有关。监管机构应在决策中使用关于标签外和未注册药物使用的现有临床证据。上市许可持有人和国家监管机构应监测与未注册和标签外药物使用相关的任何安全问题，并采取适当措施，以及确定研究重点，并授权进行临床研究以解决重要问题。
