Institute of Microbiology, Tartu University, Tartu, Estonia; Pharmacy Department, Tartu University Clinics, Tartu, Estonia.
Pharmacoepidemiol Drug Saf. 2011 May;20(5):474-81. doi: 10.1002/pds.2125.
We aimed to analyse the availability of paediatric information in Summaries of Product Characteristics (SPC) of ambulatory prescription medicines used in children and to compare the SPC information with other information sources.
In a cross-sectional drug utilisation study based on national prescription database, we analysed all dispensed prescriptions to subjects of <19 years in 2007. We reviewed SPCs of drugs for paediatric information and categorised them as being labelled, off-label and unlicensed.
Of 467,334 prescriptions dispensed to 151, 476 children, 69% were for labelled, 31% for off-label and 0.05% for unlicensed drugs. The proportion of prescriptions for drugs being off-label because of missing data was the highest in genitourinary group (97%) and dermatologicals (74%); off-label use because of contraindication in the musculoskeletal group (69%). The highest proportion of off-label drugs was among children aged less than 2 years and the lowest for 2-6-year-olds. Contraindicated medicines were most often prescribed to adolescents. Systemic drugs were more frequently prescribed according to the label than topical agents. SPCs were found often not to be comparable with the other information sources.
We show that one-third of Estonian children treated with prescription medicines are exposed to drugs not labelled for paediatric use. We believe that this is not only partly due to the limited number of paediatric trials but also due to lack of up-to-date information in the SPCs. We suggest that paediatric information should be regularly updated in SPCs to ensure that it is based on the best currently available evidence.
我们旨在分析儿童门诊处方用药品说明书（SPC）中儿科信息的可获得性，并比较 SPC 信息与其他信息来源。
在一项基于国家处方数据库的横断面药物利用研究中，我们分析了 2007 年所有 19 岁以下患者的处方。我们审查了儿科信息的药品 SPC，并将其归类为标签、标签外和无许可证。
在 467334 张分配给 151476 名儿童的处方中，69%为标签内用药，31%为标签外用药，0.05%为无许可证用药。由于数据缺失导致标签外用药的处方比例最高的是泌尿生殖系统组（97%）和皮肤科组（74%）；由于禁忌症导致标签外用药的是肌肉骨骼组（69%）。标签外用药比例最高的是 2 岁以下儿童，最低的是 2-6 岁儿童。禁忌药物最常开给青少年。与局部制剂相比，系统药物更常根据标签开处方。SPC 通常与其他信息来源不一致。
我们表明，三分之一接受处方药物治疗的爱沙尼亚儿童使用的药物未标签用于儿科用途。我们认为，这不仅部分是由于儿科试验数量有限，还由于 SPC 中缺乏最新信息。我们建议定期更新 SPC 中的儿科信息，以确保其基于当前最佳可用证据。
