Drug supply and assurance: a cross-sectional study of drug shortage monitoring varieties in China

Abstract

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.

Keywords: China; Cross-sectional study; Drug shortages; Drug supply and assurance; Essential medicines; Monitored varieties.

Fig. 1

Timeline of landmark reform for the supply and assurance of drugs in shortage in China. (The publishing department is mainly the first responsible department: NDRC, National Development and Reform Commission; CFDA, China Food and Drug Administration (changed to the National Medical Products Administration in 2018); NHFPC, National Health and Family Planning Commission (changed to the National Health Commission in 2018); MIIT, Ministry of Industry and Information Technology; NHC, National Health Commission; NPC, National People’s Congress; GOSC, General Office of the State Council; NMPA, National Medical Products Administration)

Fig. 2

ATC classification of drugs in shortage that were included in monitoring (A): Alimentary tract and metabolism; (B): Blood and blood forming organs; (C): Cardiovascular system; (D): Dermatological; (G): Genito urinary system and sex hormones; (H): Systemic hormonal preparations, excluding sex hormones and insulins; (J): Antiinfective for systemic use; (L): Antineoplastic and immunomodulating agents; (M): Musculoskeletal system; (N): Nervous system; (R): Respiratory system; (S): Sensory organs; (V): Various