Research and practice on key drug safety monitoring under the normalization of centralized procurement: A case study of 13 selected drugs in a Province

The National Centralized Volume-Based Procurement policy for drugs has effectively reduced drug prices but has raised concerns regarding quality and safety. To address these issues, adverse drug reactions (ADR) are monitored through a national system. As the policy stabilizes, real-world data (RWD) may improve, making ongoing monitoring crucial for studies and assessments. This study monitored 13 drug types from batches 1 to 8 across 39 provincial hospitals, supplied by 12 marketing authorization holders. We compared tracking data with the "National Adverse Drug Reaction Monitoring System" to analyze reporting rates of ADR and identify risk signals for rational drug use in practice. The monitoring period was from May to December 2023, and routine data from 2019 to 2022 were analyzed using descriptive statistics and comparative methods. A safety evaluation of 13 drug types across 39 hospitals revealed ADR rates ranging from 0 to 4.58% and serious reactions ranging from 0 to 1.97%, with 4 identified risk signals. In comparison, routine monitoring indicated lower rates: 0 to 1.20% for ADR and 0 to 0.80% for serious reactions, with one risk signal. Despite these differences, the ADR risks associated with all drugs were manageable, with no unexpected events exceeding label listings. These findings suggest that the safety of domestic generic drugs is comparable to that of originator drugs, supporting the effectiveness of China's centralized procurement policy. This study aims to enhance coordination among the healthcare, insurance, and pharmaceutical sectors by improving the supervision of drug procurement and RWD research. It emphasizes the need for rigorous monitoring to address safety concerns.