儿科超说明书用药国内外相关政策分析

Analysis of related policies in China and abroad on pediatric off-label drug use

超说明书用药问题在儿童这一特殊群体中尤为突出，主要原因是儿童不作为药物临床试验的常规受试者，说明书中缺乏儿童用药信息。针对于此，多个国家制定了相关政策促进儿童药物临床研究，完善说明书中儿童用药信息，规范儿科超说明书用药。我国目前尚无儿科超说明书用药相关的法律法规，应借鉴他国经验，制定儿科用药的法律法规，实施儿科药品政策，促进药品儿科临床研究数据完善，使指导儿科用药的信息更加科学、充分。只有多部门共同协作，才能确实保障儿童安全、合理用药，促进儿童健康成长。

The problem of off-label drug use is particularly prominent among children. The main rea- son is that children are not routinely tested in drug clinical trials and lack of medication information in chil- dren＇s instructions. In view of this, a number of countries have formulated relevant policies to promote the clinical research of children＇s drugs, to improve the information of children＇s medication in the instructions, and to standardize the pediatric off-label uses. There are no current laws and regulations related on paediatric off-label drug uses in China, we should learn from the experience of other countries, make laws and regula- tions for pediatrics, implement pediatric drug policy, promote pediatric clinical research data to improve, to guide pediatric drug information more scientificly and sufficiently. Only mnlti-department cooperation can en- sure children＇s safety, rational drug use, and promote the healthy growth of children.