全球儿童基本药物目录构建方法的比较研究

Comparative Study of Developing Methodologies of Essential Medicines Lists for Children Worldwide

目的循证评价全球儿童基本药物目录(Essential Medicine List for Children,EMLc)构建方法,为建立我国EMLc提供方法学参考。方法计算机检索Pro Quest、Science Direct、Springer Link、MEDLINE数据库、WHO官方网站和67个国家卫生部与药品监管部门网站,获取基本药物目录(Essential Medicine List,EML)遴选方法学文献,进行描述性分析。结果最终纳入文献14篇,包括EMLc遴选方法 6篇,成人EML遴选方法 8篇。WHO建立了独立的EMLc遴选机构,WHO与印度EMLc遴选工作均由儿科专家参与。目前全球尚无针对EMLc的遴选标准、流程,WHO、印度与南非的EMLc均参考WHO EML遴选标准和流程,尚未检索到印度与南非EMLc遴选流程相关文献。WHO、南非EMLc已有更新时间、周期和流程,其中WHO EMLc每2年定期更新,频率高,流程严谨,印度EMLc尚未更新。结论建议我国儿童基本药物遴选参考WHO儿童健康工作小组(Child HealtThWorking Group,CHWG)即WHO EMLc遴选机构的工作模式,建立中国EMLc遴选工作组,强调儿科专家与循证方法学专家的参与;建议参考WHO EML遴选标准,根据我国儿童疾病负担、药品可及性、医疗保险水平等国情,循证制定我国EMLc的遴选标准;与成人目录同步更新目录。

Objective To evaluate the developing methodologies of Essential Medicines Lists for Children （EMLcs） in global, in order to provide reference in developing EMLc of China. Methods We searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization （WHO） official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list （EML）. A descriptive analysis was conducted. Results A total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. Conclusion It is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.