Chalumeau M, Tréluyer J M, Salanave B, Assathiany R, Chéron G, Crocheton N, Rougeron C, Mares M, Bréart G, Pons G
Pharmacologie Périnatale et Pédiatrique, Université René Descartes-Paris V, Hôpital Saint-Vincent de Paul, 82, avenue Denfert-Rochereau, 75674 Paris Cedex 14, France.
Arch Dis Child. 2000 Dec;83(6):502-5. doi: 10.1136/adc.83.6.502.
To determine the extent of off label and unlicensed drug use in French office based paediatric practice.
A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration.
A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions.
Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.
确定法国儿科门诊中无适应证用药和使用未获许可药物的情况。
对法国巴黎大区95名儿科门诊医生为15岁以下患者开具的所有书面处方进行为期一天的前瞻性调查。主要观察指标为：将每种药物的使用情况与其年龄、适应证、剂量和给药途径的产品许可进行比较。
共为989名患者开具了2522张处方；其中844张（33%）为无适应证用药（4%）或超适应证用药（29%）。共有550名（56%）儿科患者接受了一张或多张超适应证处方。
在儿科门诊中，超适应证处方（即超出产品特性摘要规定范围）很普遍，而在我们的研究中，使用未获许可药物的情况很少见。欧洲需要在许可程序方面制定新规定，以使儿童能够获得在其特定年龄组中经过充分评估的药物。
