背景:药物短缺是一个严重威胁公众健康的世界性问题。中国发布了2022年最全面的药品短缺重点监测品种名单。分析清单内药品的属性和特点,为提高我国短缺药品的供应安全提供参考。
方法:我们使用公共数据来提取有关药物类型的信息,剂型,适应症,临床用途分类,它们是否被包括在国家基本药物等医疗目录中,以及药物和活性药物成分(API)制造商的数量。使用描述性统计分析。
结果:在列表中的980种药物中,99.59%是化学药品,92.65%是注射剂。血液和造血器官的药物,心血管系统,消化道和新陈代谢位居前三位。医学目录核查显示,90.41%的药品属于国家基本药物,95.10%是医疗药物,2.55%为批量采购药品,14.70%是罕见疾病,儿童占42.04%。在药品供应能力方面,21.33%的药品批件不到10个,甚至有26个药品为独家生产,近90%的制造商需要从外部购买API。在列表中包含的256个API中,152个原料药只有不到10个制造商,甚至全国只有一家企业生产了5种原料药。
结论:我国药品短缺形势严峻复杂,适应基本医疗保健需求的药品和临床必需的药品严重短缺,以及提高药品生产能力和原料药供应能力的需要。我们建议加强药品监测和储备,加快短缺药品审批,提高药品供应安全。
BACKGROUND: Drug shortage is a worldwide problem that seriously threatens public health. China released the most comprehensive list of key drug shortage monitoring varieties ever in 2022. We aim to analyze the attributes and characteristics of the medicines within the list to provide a reference for improving China\'s supply security of shortage drugs.
METHODS: We used public data to extract information on drug types, dosage forms, indications, classification of clinical uses, whether they were included in medical catalogs such as the National Essential Drugs, and the number of drug and active pharmaceutical ingredient (API) manufacturers. A descriptive statistical analysis was used.
RESULTS: Of the 980 drugs on the list, 99.59% were chemicals and 92.65% were injectables. Drugs for blood and hematopoietic organs, the cardiovascular system, and the digestive tract and metabolism ranked among the top three shortages. Verification of the medical catalogs showed that 90.41% of the drugs belonged to the national essential drugs, 95.10% were medicare drugs, 2.55% were volume-based procurement drugs, and 14.70% were for rare diseases, and 42.04% were for children. In terms of drug supply capacity, 21.33% of drug approvals are less than 10, and there were even 26 drugs for exclusive production, close to 90% of manufacturers need to purchase APIs from outside. Among the 256 APIs included in the list, 152 APIs had less than 10 manufacturers, and there were even 5 APIs produced by only one enterprise nationwide.
CONCLUSIONS: The situation of drug shortages in China was severe and complex, with serious shortages of medicines adapted to basic medical and healthcare needs and clinically necessary medicines, and a need to improve the production capacity of drugs and the ability to supply APIs. We recommend strengthening drug monitoring and stockpiling and accelerating the approval of shortage drugs to improve drug supply security.