Pandolfini Chiara, Campi Rita, Clavenna Antonio, Cazzato Teresa, Bonati Maurizio
Laboratory for Mother and Child Health, Mario Negri Institute for Pharmacological Research, Milan, Italy.
Acta Paediatr. 2005 Jun;94(6):753-7. doi: 10.1111/j.1651-2227.2005.tb01976.x.
To evaluate the reason off-label use exists in paediatric general practice and to distinguish between non-compliance with respect to regulatory standards and non-compliance with respect to guidelines in order to determine what this difference means in terms of rational prescribing.
Information on patients visited by 35 general paediatricians in southern Italy was collected and their prescriptions analysed for off-label status. Off-label drug use in the Italian paediatric community setting was assessed. A sample indication, pharyngotonsillitis, was chosen and the related prescriptions analysed, distinguishing between non-compliance with regulatory standards (i.e. off-label use) and non-compliance with guidelines, in order to determine the appropriateness of prescribing.
Information was collected on 9917 patients (8476 prescriptions). In all, 17% of prescriptions were off label. When the 1675 pharyngotonsillitis prescriptions were analysed, 8% were off label and 63% were not in accordance with the guidelines. On the other hand, 55% of these prescriptions did not adhere to the guidelines, but were not off label either.
The results of this study were surprising because off-label drug use for pharyngotonsillitis, a common paediatric condition, was low, while non-adherence to guidelines was high. In cases such as this one, in which guidelines exist, physicians' prescribing habits were irrational because they did not follow the evidence. Physicians should keep up to date with new knowledge and should be provided with updated product information.
评估儿科全科医疗中存在药品未按说明书用药情况的原因，并区分不符合监管标准与不符合指南的情况，以确定这种差异在合理用药方面意味着什么。
收集意大利南部35名儿科全科医生诊治患者的信息，并分析他们的处方是否存在未按说明书用药的情况。评估意大利儿科社区环境中未按说明书用药的情况。选择咽扁桃体炎这一示例适应症并分析相关处方，区分不符合监管标准（即未按说明书用药）与不符合指南的情况，以确定处方的合理性。
收集了9917名患者（8476张处方）的信息。总体而言，17%的处方为未按说明书用药。分析1675张咽扁桃体炎处方时发现，8%为未按说明书用药，63%不符合指南。另一方面，这些处方中有55%未遵循指南，但也不属于未按说明书用药。
本研究结果令人惊讶，因为对于儿科常见病症咽扁桃体炎，未按说明书用药的情况较少，而不遵循指南的情况较多。在存在此类指南的情况下，医生的处方习惯不合理，因为他们没有遵循循证依据。医生应及时了解新知识，并应获得最新的产品信息。
