Utilization and Expenditures of Medications Withdrawn From Markets Due to Safety Concerns in China
Author(s)
Luyi Chen, Postgraduate1, shaoxi pan, Master1, Yuzhi Han, Postgraduate1, Hongyan Wu, PhD1, Beini Lyu, PhD2.
1School of Public Health, the Key Laboratory of Environmental Pollution Monitoring and Disease Control, Ministry of Education, Guizhou Medical University, Guiyang, China, 2Institute for Global Health and Development, Peking University, Beijing, China.
1School of Public Health, the Key Laboratory of Environmental Pollution Monitoring and Disease Control, Ministry of Education, Guizhou Medical University, Guiyang, China, 2Institute for Global Health and Development, Peking University, Beijing, China.
OBJECTIVES: Regulatory agencies may withdraw medications when potential risks outweigh clinical benefits. However, such decisions are not globally harmonized, and some withdrawn medications may remain available elsewhere, raising concerns about patient safety and inefficient use of healthcare resources. This study aimed to examine the utilization and expenditures of medications withdrawn due to safety concerns in China.
METHODS: We analyzed a 5% random sample of medication claims from 2019 to 2021 under the Urban Employee Basic Medical Insurance (UEBMI) program in one Chinese province. Medications with safety concerns were defined as those withdrawn in at least one country due to safety issues and not reintroduced for alternative indications or through revised production methods. We assessed their utilization, expenditures, and therapeutic categories. Logistic regression was used to identify patient and institutional factors associated with use.
RESULTS: Among 293,769 patients (mean age: 48.8 years; 50.5% male), 5.62% used at least one withdrawn medication (3.60% in outpatient and 8.65% in inpatient settings). Thirty-eight withdrawn medications were identified, with codeine, gangliosides, and benzbromarone being the most commonly used. On average, 4.93% of total medication expenditures were attributed to these medications, with gangliosides, rosiglitazone, and pioglitazone accounting for the highest costs. Neurologic drugs were the most frequently used therapeutic class. In multivariable analyses, age ≥65 years (OR: 1.41 [95% CI: 1.28-1.55]), male sex (1.11 [1.04-1.18]), retirement status (1.51 [1.38-1.65]), and supplemental reimbursement coverage (2.38 [2.17-2.61]) were significantly associated with higher likelihood of use. Race, occupation, and income were not significantly associated.
CONCLUSIONS: Despite safety concerns, withdrawn medications remain in use and contribute notably to medication spending in China. Older adults, males, and individuals with certain insurance benefits are more likely to use them. Strengthened regulatory oversight and enhanced pharmacoepidemiologic monitoring are essential to ensure medication safety and optimize healthcare resource use.
METHODS: We analyzed a 5% random sample of medication claims from 2019 to 2021 under the Urban Employee Basic Medical Insurance (UEBMI) program in one Chinese province. Medications with safety concerns were defined as those withdrawn in at least one country due to safety issues and not reintroduced for alternative indications or through revised production methods. We assessed their utilization, expenditures, and therapeutic categories. Logistic regression was used to identify patient and institutional factors associated with use.
RESULTS: Among 293,769 patients (mean age: 48.8 years; 50.5% male), 5.62% used at least one withdrawn medication (3.60% in outpatient and 8.65% in inpatient settings). Thirty-eight withdrawn medications were identified, with codeine, gangliosides, and benzbromarone being the most commonly used. On average, 4.93% of total medication expenditures were attributed to these medications, with gangliosides, rosiglitazone, and pioglitazone accounting for the highest costs. Neurologic drugs were the most frequently used therapeutic class. In multivariable analyses, age ≥65 years (OR: 1.41 [95% CI: 1.28-1.55]), male sex (1.11 [1.04-1.18]), retirement status (1.51 [1.38-1.65]), and supplemental reimbursement coverage (2.38 [2.17-2.61]) were significantly associated with higher likelihood of use. Race, occupation, and income were not significantly associated.
CONCLUSIONS: Despite safety concerns, withdrawn medications remain in use and contribute notably to medication spending in China. Older adults, males, and individuals with certain insurance benefits are more likely to use them. Strengthened regulatory oversight and enhanced pharmacoepidemiologic monitoring are essential to ensure medication safety and optimize healthcare resource use.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HSD121
Topic
Health Service Delivery & Process of Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas