Department of Clinical Pharmacology, Puerta de Hierro-Majadahonda University Hospital, Majadahonda, Madrid, Spain.
J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):173-7. doi: 10.1097/MPG.0b013e3182566d92.
The clinical use of medicines outside the conditions authorized in their Summary of Product Characteristics (SPC) (off-label use) is a common practice in pediatrics. The aim of the present study was to describe and quantify the medicines received by children attended in the pediatric gastroenterology department, their off-label use, and compliance with accepted rules for said use.
A retrospective observational study was performed on all of the patients who had their first consultation in pediatric gastroenterology between January 1 and October 31, 2010. All of the clinical information and medicines prescribed were analyzed. Off-label use was defined as the use of medicines in indications not included in the officially approved SPC or in ages not included or recommended in the SPC as well as the use of doses, intervals, or administration routes different from those considered in the SPC.
A total of 695 patients (52.8% male) were included, 48.2% younger than 2 years. Two-hundred seven patients (29.8%) received 331 prescriptions. The most commonly used medicines were anti-H2 and proton pump inhibitors. Of all the prescriptions, 33.2% were considered off-label, and up to 47.3% of the prescribed patients had at least 1 medicine under off-label conditions. The medical records contained no documentation on information given to the parents regarding off-label use.
The study found a high percentage of off-label use of medicines in the Pediatric Gastroenterology outpatient setting, especially in children younger than 2 years. Several initiatives were derived from the present study and implemented in our hospital.
药品在其产品说明书（SPC）授权范围之外的临床应用（超说明书用药）在儿科领域较为常见。本研究旨在描述和量化在儿科胃肠病科就诊的儿童所使用的药物、其超说明书使用情况以及其是否符合公认的超说明书使用规则。
对 2010 年 1 月 1 日至 10 月 31 日期间首次在儿科胃肠病科就诊的所有患者进行了回顾性观察性研究。分析了所有的临床信息和开具的药物。超说明书用药被定义为使用药品的适应证未包含在官方批准的 SPC 中，或者年龄未包含或不推荐在 SPC 中，以及剂量、间隔或给药途径与 SPC 中考虑的不同。
共纳入 695 例患者（52.8%为男性），其中 48.2%小于 2 岁。207 例患者（29.8%）接受了 331 张处方。最常使用的药物是抗 H2 和质子泵抑制剂。所有处方中，33.2%被认为是超说明书用药，高达 47.3%的处方患者至少有一种药物处于超说明书条件下。病历中没有关于向家长提供超说明书用药信息的记录。
本研究发现儿科胃肠病科门诊中存在较高比例的药品超说明书使用，尤其是 2 岁以下儿童。本研究提出了一些措施，并在我院实施。
