Gijsen Ronald, Jochemsen Hadassa, van Dijk Liset, Caspers Peter
Department of Public Health Status and Forecasting, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
Pharmacoepidemiol Drug Saf. 2009 Jan;18(1):84-91. doi: 10.1002/pds.1689.
The aim of this study is to quantify the extent of ill-founded off-label drug prescriptions in Dutch general practice. The study is based upon information on both the prescription itself and the patient's medical history.
In total, 48 combinations of drugs and off-label indications were selected from a list of 477 known off-label combinations. These 48 combinations were considered as ill-founded since pharmacotherapeutic handbooks or clinical practice guidelines did not provide evidence for their efficacy and safety. They were considered to be relevant for investigation in general practice. We used a nationally representative information network of 85 general practices in the Netherlands. By using information on the patients' diagnoses and medication in the period before and after the prescription, we were able to exclude non-conclusively off-label prescriptions.
Twenty-one of the selected 48 off-label combinations did not occur in Dutch general practice. The drugs with the highest proportion of ill-founded off-label prescriptions were betahistine (26.7%), celecoxib (16.3%) and etoricoxib (12.5%). In total, 18.2% of the prescriptions, which were initially assessed as ill-founded off-label, were re-evaluated as on-label, after considering the patient's medical history.
Ill-founded off-label prescribing in Dutch general practice is limited for 48 relevant combinations of drugs and off-label indications. In order to overcome limitations in registration databases, it is useful to look at as much information as possible--for example, co-medication and co-morbidity--when determining off-label prescribing. Studying ill-founded off-label prescribing should be performed on a day-to-day basis, especially for recently introduced drugs.
本研究旨在量化荷兰全科医疗中无充分依据的药品标签外处方的程度。该研究基于处方本身及患者病史信息。
从477种已知的药品标签外组合列表中总共选取了48种药物与标签外适应症的组合。由于药物治疗手册或临床实践指南未提供这些组合有效性和安全性的证据，所以这48种组合被视为无充分依据。它们被认为与全科医疗中的调查相关。我们使用了荷兰85家全科诊所组成的具有全国代表性的信息网络。通过使用处方前后时期患者诊断和用药的信息，我们能够排除非结论性的标签外处方。
所选的48种标签外组合中有21种未在荷兰全科医疗中出现。无充分依据的标签外处方比例最高的药物是倍他司汀（26.7%）、塞来昔布（16.3%）和依托考昔（12.5%）。在考虑患者病史后，最初被评估为无充分依据的标签外处方中，总计18.2%被重新评估为符合标签规定。
对于48种相关的药物与标签外适应症组合，荷兰全科医疗中无充分依据的标签外处方情况有限。为克服注册数据库的局限性，在确定标签外处方时查看尽可能多的信息（例如，联合用药和合并症）是有用的。研究无充分依据的标签外处方应日常进行，尤其是对于新引入的药物。
