Ufer Mike, Kimland Elin, Bergman Ulf
Division of Clinical Pharmacology, Karolinska Institute, Huddinge University Hospital, Stockholm, Sweden.
Pharmacoepidemiol Drug Saf. 2004 Mar;13(3):147-52. doi: 10.1002/pds.858.
To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction.
A retrospective, cross-sectional, observational analysis of spontaneous adverse drug reaction (ADR) reports in Sweden in the year 2000. We included all reports concerning drugs prescribed for outpatients younger than 16 years. Each ADR was classified with respect to its causality, seriousness and type of reaction. Off-label prescribing was evaluated with respect to age, dose, indication, formulation and route and frequency of administration.
We identified 112 patient-linked reports corresponding to 158 ADRs of which 31% were serious. Antiasthmatic drugs were most frequently suspected as a cause of almost every third adverse reaction. The average proportion of off-label drug prescribing amounted to 42.4%. It was more frequently associated with serious than non-serious ADRs and mostly due to a non-approved age or dose. The most common clinical manifestations were psychiatric disorders and mucocutaneous inflammatory reactions.
Off-label prescribing for paediatric outpatients is common among drugs reported to have caused an ADR. It is suggested to further identify unlabelled drugs frequently contributing to, in particular serious ADRs in children for a proper benefit-risk assessment of off-label drug use.
调查在报告有不良反应的药物中，儿科门诊患者超说明书用药的程度和特点。
对2000年瑞典自发上报的药品不良反应（ADR）报告进行回顾性横断面观察分析。纳入所有涉及为16岁以下门诊患者开具药物的报告。每个ADR根据其因果关系、严重程度和反应类型进行分类。从年龄、剂量、适应症、剂型、给药途径和给药频率方面对超说明书用药进行评估。
我们确定了112份与患者相关的报告，对应158例ADR，其中31%为严重不良反应。抗哮喘药物最常被怀疑是几乎每三分之一不良反应的原因。超说明书用药的平均比例为42.4%。它与严重ADR的关联比非严重ADR更频繁，主要是由于未获批的年龄或剂量。最常见的临床表现是精神障碍和皮肤黏膜炎症反应。
在报告有ADR的药物中，儿科门诊患者超说明书用药很常见。建议进一步识别经常导致尤其是儿童严重ADR的未标注药物，以便对超说明书用药进行适当的获益风险评估。
