McIntyre J, Conroy S, Avery A, Corns H, Choonara I
Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK.
Arch Dis Child. 2000 Dec;83(6):498-501. doi: 10.1136/adc.83.6.498.
To determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice.
A retrospective analysis of all prescriptions for one year involving children (aged 12 years or under) from a single suburban general practice in the English Midlands. Prescribed drugs were categorised as licensed, unlicensed (without a product licence), or used in an off label way (outside the terms of their product licence).
During 1997 there were 3347 prescription items involving 1175 children and 160 different drugs. A total of 2828 (84. 5%) prescriptions were for licensed medicines used in a licensed way; 10 (0.3%) were for unlicensed medicines; and 351 (10.5%) were licensed medicines used in an off label way. For 158 (4.7%) the information was insufficient to determine licence status.
This is the first study to show that a significant number of drugs prescribed for children by general practitioners are off label and highlights the anomalies and inadequacies of drug information for prescribers.
确定全科医疗中儿童用药未获许可及超说明书用药的发生率和性质。
对来自英格兰中部一个郊区全科医疗所一年中所有涉及12岁及以下儿童的处方进行回顾性分析。所开药物分为已获许可、未获许可（无产品许可证）或超说明书使用（超出其产品许可证规定范围）。
1997年期间，有3347项处方涉及1175名儿童和160种不同药物。共有2828项（84.5%）处方为按许可使用的已获许可药物；10项（0.3%）为未获许可药物；351项（10.5%）为超说明书使用的已获许可药物。对于158项（4.7%），信息不足以确定许可状态。
这是第一项表明全科医生为儿童开具的大量药物为超说明书用药的研究，并突出了给处方者提供的药物信息存在的异常和不足。
