儿科疼痛管理中未获许可及超说明书范围使用镇痛药的情况。
Unlicensed and off label analgesic use in paediatric pain management.
作者信息
Conroy S, Peden V
机构信息
Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK.
出版信息
Paediatr Anaesth. 2001 Jul;11(4):431-6. doi: 10.1046/j.1460-9592.2001.00697.x.
BACKGROUND
The management of pain in children has advanced enormously in recent years. Pharmacological treatment of pain is complicated however, by the widespread use of unlicensed and off label medicines in the paediatric population, leading to everyday practical problems. This study aimed to document the incidence and nature of unlicensed and off label analgesic agents in children.
METHODS
Data regarding analgesic use were collected prospectively over a 4-week period from two wards. The data were analysed to determine whether the drug use was licensed, unlicensed or off label.
RESULTS
Seven hundred and fifteen prescription episodes were analysed. Some 480 of these (67%) were licensed; 235 were licensed medicines used in an off label manner (33%). No medicines were unlicensed. Paracetamol was the most common analgesic used.
CONCLUSION
Issues regarding the use of off label drugs in children at risk of pain are discussed. Suggestions are made regarding the way forward for the future.
背景
近年来，儿童疼痛管理取得了巨大进展。然而，由于未注册和超说明书用药在儿科人群中的广泛使用，疼痛的药物治疗变得复杂，导致了日常实际问题。本研究旨在记录儿童未注册和超说明书镇痛药物的发生率及性质。
方法
前瞻性地收集了两个病房四周内的镇痛用药数据。对数据进行分析，以确定药物使用是注册的、未注册的还是超说明书的。
结果
分析了715次处方事件。其中约480次（67%）是注册用药；235次是超说明书使用的注册药物（33%）。没有未注册药物。对乙酰氨基酚是最常用的镇痛药。
结论
讨论了有疼痛风险的儿童使用超说明书药物的相关问题。对未来的发展方向提出了建议。
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