USE OF MEDICATIONS WITHDRAWN FROM INTERNATIONAL MARKETS FOR SAFETY CONCERNS IN CHINA
Author(s)
luyi chen, Bachelor1, yuzhi han, Bachelor1, shaoxi pan, Master2, Hongyan Wu, PhD3, Beini Lyu, PhD4;
1Guizhou Medical University, School of Public Health, the key Laboratory of Environmental Pollution Monitoring and Disease Contro, Guiyang, China, 2Xinqiao Hospital, Army Medical University, Department of Health Economics and Medical Insurance,, Chongqing, China, 3Guizhou Medical University, School of Medicine and Health Management, Guiyang, China, 4Peking University, Institute for Global Health and Development, Beijing, China
1Guizhou Medical University, School of Public Health, the key Laboratory of Environmental Pollution Monitoring and Disease Contro, Guiyang, China, 2Xinqiao Hospital, Army Medical University, Department of Health Economics and Medical Insurance,, Chongqing, China, 3Guizhou Medical University, School of Medicine and Health Management, Guiyang, China, 4Peking University, Institute for Global Health and Development, Beijing, China
OBJECTIVES: Drugs approved for marketing may later be withdrawn in some countries due to emerging safety concerns. However, withdrawal decisions vary across jurisdictions, and medications withdrawn elsewhere may remain available in local market. Evidence on the extent of such use in China and the factors associated with continued prescribing is limited. This study examined the utilization of drugs withdrawn internationally for safety reasons within the Chinese healthcare system.
METHODS: We conducted a population-based study using a 5% random sample of the Urban Employee Basic Medical Insurance (UEBMI) database from a southwestern province of China (2019-2021). Withdrawn drugs were identified from two global datasets comprising 462 and 647 safety withdrawals, respectively. Prescription records were linked to demographic, occupational, and institutional characteristics. Generalized linear mixed models with hospital and city fixed effects were used to estimate factors associated with withdrawn drug use.
RESULTS: Among 293,859 insured individuals, 16,510 (5.62%) received at least one withdrawn drug for safety concerns between 2019 and 2021. We identified 38 withdrawn drugs prescribed during the study period, most of which had been removed in multiple countries. Overall use declined from 6.21% in 2019 to 5.46% in 2021, driven mainly by reductions in inpatient prescribing. Nervous system medications were the most frequently used and accounted for the largest share of expenditures. Codeine and ganglioside were the most commonly used drugs and with the highest expenditures. Greater use of withdrawn drug was observed among men, retirees, and civil servant-insured patients, and in tertiary, private, and general hospitals, whereas primary care facilities showed substantially lower use.
CONCLUSIONS: Many drugs withdrawn internationally for safety reasons continued to be prescribed in China, despite overall declines in use. Strengthening post-marketing surveillance, aligning domestic regulatory actions with global safety evidence, and enhancing prescribing oversight—particularly in higher-level hospitals—may help reduce avoidable patient exposure to unsafe medications.
METHODS: We conducted a population-based study using a 5% random sample of the Urban Employee Basic Medical Insurance (UEBMI) database from a southwestern province of China (2019-2021). Withdrawn drugs were identified from two global datasets comprising 462 and 647 safety withdrawals, respectively. Prescription records were linked to demographic, occupational, and institutional characteristics. Generalized linear mixed models with hospital and city fixed effects were used to estimate factors associated with withdrawn drug use.
RESULTS: Among 293,859 insured individuals, 16,510 (5.62%) received at least one withdrawn drug for safety concerns between 2019 and 2021. We identified 38 withdrawn drugs prescribed during the study period, most of which had been removed in multiple countries. Overall use declined from 6.21% in 2019 to 5.46% in 2021, driven mainly by reductions in inpatient prescribing. Nervous system medications were the most frequently used and accounted for the largest share of expenditures. Codeine and ganglioside were the most commonly used drugs and with the highest expenditures. Greater use of withdrawn drug was observed among men, retirees, and civil servant-insured patients, and in tertiary, private, and general hospitals, whereas primary care facilities showed substantially lower use.
CONCLUSIONS: Many drugs withdrawn internationally for safety reasons continued to be prescribed in China, despite overall declines in use. Strengthening post-marketing surveillance, aligning domestic regulatory actions with global safety evidence, and enhancing prescribing oversight—particularly in higher-level hospitals—may help reduce avoidable patient exposure to unsafe medications.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HSD71
Topic
Health Service Delivery & Process of Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas