Drug supply changes associated with a key policy on drug shortages in China: evidence from an interrupted time-series...

Drug shortages pose significant challenges to healthcare systems globally, including China. In October 2019, China's State Council launched a national strategy (D2019-47) to mitigate drug shortages. We aimed to characterize the supply status of medicines included in the National Drug Shortages List (NDSL), and assess changes associated with the local and national implementation periods of D2019-47.

We conducted a retrospective interrupted time-series study using monthly procurement and delivery data from 31 centralized drug procurement service centers in China from April 2019 to June 2022. Fifty-two eligible molecule-formulation drug markets were included. Four periods were defined: pre-pandemic, COVID-19 lockdown, local implementation of D2019-47 (intervention 1), and national implementation of D2019-47 (intervention 2). Level and slope changes represented the immediate outcome change and the difference between post- and pre-intervention monthly trends, respectively. Outcomes were overall delivery rate (national supply status), worst-three delivery rate (supply status in the three lowest-supplied provinces), shortage frequency (shortage occurrences), and shortage coverage (geographic spread). Subgroup analyses were performed for currently resolved, price-driven (insufficient supply incentives), and production-driven shortages (manufacturing issues).

The mean monthly overall delivery rate was 87.3% in period 1, decreased to 78.5% in period 2, and increased to 89.6% in period 4, with similar patterns in other outcomes. Intervention 1 was associated with a level increase in overall delivery rate (4.7%, 95% CI: 2.4-7.1) and a subsequent slope increase (1.2%, 95% CI: 0.7-1.8), while the other indicators showed no significant changes. After Intervention 2, changes in slopes were mainly observed, including a decrease in overall delivery rate (-0.2%, 95% CI: -0.4 to 0.0), an increase in overall shortage frequency (4.1, 95% CI: 1.7-6.5), and an increase in overall shortage coverage (0.1, 95% CI: 0.1 to 0.1), with these changes observed primarily in price-driven markets.

Overall delivery rates for NDSL medicines in China exceeded 75% from April 2019 to June 2022. Following intervention 1, the overall delivery rate improved, whereas most other aggregate shortage indicators showed no significant level or slope changes. Following intervention 2, additional improvement was limited, with adverse slope changes observed for several indicators. Regional disparities also persisted. These findings suggest that complementary strategies may be needed to sustain improvements and address persistent regional and market-specific supply vulnerabilities.