儿科处方中超药品说明书用药的现状  

Current situation of off-label drug use in pediatric prescriptions

作　　者：葛盘春 GE Pan-chun(Department of Cardiology,Dagang Hospital of Tianjin Binhai New Area,Tianjin 300270,China)

机构地区：[1]天津市滨海新区大港医院心内科,天津300270

出　　处：《中国城乡企业卫生》2022年第10期15-17,共3页Chinese Journal of Urban and Rural Enterprise Hygiene

摘　　要：超药品说明书用药是指药品使用的适应证、剂量、疗程、途径或人群等超出药品监督管理部门批准的药品说明书记载范围的情况。由于儿童生长发育阶段的特殊性,所以在疾病治疗过程中,药品的用量和用法与成年人具有明显的差异。目前儿科处方中超药品说明书用药的情况相对普遍。随着临床医学的实践加深与快速发展,很多药品说明书信息落后于药物在临床实践中的使用,所以不可避免地会出现超药品说明书用药情况。但是对于医生来说,超药品说明书用药有较高的职业风险,因此应该尽快建立健全关于超药品说明书使用的相关法律,加强对此类情况进行管理。另外也要监督制药企业完善药品说明书的相关信息,从而为临床治疗提供及时、有益的依据。本文主要综述了儿科超药品说明书用药的现状与相关管理情况,希望能够为临床超药品说明书用药研究提供临床参考价值。Off-label drug use(OLDU)refers to the situation where the use of drugs whose indications,dosage,course of treatment,route or population exceed the scope of drug instructions approved by the drug regulatory department. Due to the particular stage of children when they grow and develop,there are obvious differences in the dosage and usage of drugs between children and adults in the process of disease treatment. At present,the off-label drug use in pediatric prescriptions is relatively common. With the deepening and rapid development of clinical medicine practice,many drug instruction information lag behind the use of drugs in clinical practice,so it is inevitable to appear off-label drug use. However,for doctors,there are high occupational risks in using drugs beyond the instructions. Therefore,relevant laws on the off-label drug use should be established and perfected as soon as possible to strengthen the management of such cases. In addition,it is also necessary to supervise pharmaceutical enterprises to improve the relevant information of the drug instructions,so as to provide timely and useful basis for clinical treatment. This article mainly reviews the current situation and relevant management of off-label drug use in pediatrics,hoping to provide clinical reference value for the clinical off-label drug research.

关 键 词：儿科 超药品说明书用药 现状 

分 类 号：R1[医药卫生—公共卫生与预防医学]