Department of Pharmacy, Children's Hospital of Fudan University , Shanghai , China.
Department of Pediatrics, Children's Hospital of Fudan University , Shanghai , China.
Front Pediatr. 2014 Mar 26;2:17. doi: 10.3389/fped.2014.00017. eCollection 2014.
Children are recognized as "therapeutic orphan" in many parts of the world, one expression of this is the lack of adequate pediatric labeling information. Some research studies have been done to investigate the pediatric labeling condition in the U.S. and other countries, but no national studies had been carried out in China. This survey was conducted aiming to inquire the current situation of pediatric labeling in China.
We investigated 6020 child-applied medicines from 15 representative Chinese hospitals, and analyzed the information according to the dosage forms, therapeutic category, and label information integrity.
Among all these medicines, only 238 (3.95%) are pediatric products, the rest are adult formulations with an extended use in children. The major pediatric formulations were injection (45.95%), tablet (23.69%), and capsule (4.93%), respectively. Alimentary tract/metabolism medicine (24.70%) and infections medicines (20.60%) had the most species. In prescription drugs, only 210 of 5187 (4%) medicines had adequate pediatric labeling information. The main cause of this deficiency was lack of evidence derived from pediatric clinical trials.
The dilemma of "therapeutic orphan" requires significant attention. Inadequate labeling information and lack of pediatric clinical trials were two prominent issues in China. It calls for more efforts from pharmaceutical industries, regulatory agencies, and legislature in China to collaborate and find solution to improve the situation.
在世界许多地方，儿童被视为“治疗孤儿”，这表现在缺乏足够的儿科标签信息。一些研究已经针对美国和其他国家的儿科标签状况进行了调查，但中国尚未进行过全国性研究。这项调查旨在了解中国儿科标签的现状。
我们调查了来自 15 家代表性中国医院的 6020 种儿童应用药物，并根据剂型、治疗类别和标签信息完整性对信息进行了分析。
在所有这些药物中，只有 238 种（3.95%）是儿科产品，其余的都是成人剂型，在儿童中延伸使用。主要儿科剂型为注射剂（45.95%）、片剂（23.69%）和胶囊剂（4.93%）。消化道/代谢药物（24.70%）和感染药物（20.60%）种类最多。在处方药中，只有 5187 种（4%）药物有足够的儿科标签信息。造成这种不足的主要原因是缺乏来自儿科临床试验的证据。
“治疗孤儿”的困境需要引起高度关注。标签信息不足和缺乏儿科临床试验是中国的两个突出问题。这需要中国的制药行业、监管机构和立法机构共同努力，寻找解决方案，以改善这种状况。
