Saullo Francesca, Saullo Ernesto, Caloiero Mimma, Menniti Michele, Carbone Claudia, Chimirri Serafina, Paletta Laura, Gallelli Luca
Centro Regionale di Informazione sul farmaco, AO Mater Domini, Catanzaro and Department of Health Science, School of Medicine, University of Catanzaro, Italy.
Unità Operativa di Pediatria, Presidio Ospedaliero "Giovanni Paolo II" Lamezia Terme, Azienda Sanitaria di Catanzaro, Italy.
J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S51-4. doi: 10.4103/0976-500X.120960.
Off-label use is very common among pediatricians, and the main cause is attributable to the lack of drugs specifically designed and marketed for children in different age groups. In this study, we evaluated, through a questionnaire, the knowledge of off-label drugs in pediatrics. Furthermore, we made a directory of 28 off-label drugs most commonly used by pediatricians in agreement with data obtained from Italian Agency for drugs (AIFA) referred to the law no. 648/1996; 180 pediatricians referred to the Italian Society of Pediatrics Calabrian section were asked to complete an online anonymous questionnaire. Eighty five (47.3%) of these completed the anonymous questionnaire, 40% revealed that they used off-label drugs "sometimes"; generally, drugs were used off-label for age and to treat respiratory diseases. For 75 pediatricians (88%) the information about the risk/benefit of off-label drugs is inadequate and 63 pediatricians (74%) did not have a good knowledge about this practice. In conclusion, the knowledge of off-label drugs is very low in pediatricians; more information about off-label drugs could be useful in order to improve the appropriateness of drugs' prescription and to reduce the development of side effects and improving drug safety.
超说明书用药在儿科医生中非常普遍,主要原因是缺乏专门为不同年龄组儿童设计和销售的药物。在本研究中,我们通过问卷调查评估了儿科超说明书用药的知识。此外,我们根据意大利药品管理局(AIFA)依据第648/1996号法律提供的数据,整理了儿科医生最常用的28种超说明书用药目录;邀请了180位隶属于意大利儿科学会卡拉布里亚分会的儿科医生填写一份在线匿名问卷。其中85位(47.3%)完成了匿名问卷,40%的人表示他们“有时”会使用超说明书用药;一般来说,超说明书用药是用于年龄相关情况以及治疗呼吸道疾病。对于75位儿科医生(88%)而言,关于超说明书用药风险/获益的信息不足,63位儿科医生(74%)对这种做法了解不多。总之,儿科医生对超说明书用药的了解非常有限;更多关于超说明书用药的信息可能有助于提高用药处方的合理性,减少副作用的发生并提高用药安全性。