National ADR Monitoring Report Highlights Oncology Drugs and Elderly Patient Safety

The National Center for ADR Monitoring has published its “National Adverse Drug Reaction Monitoring Annual Report (2022)”, providing insights into the adverse drug reaction (ADR) landscape in China. The National Adverse Drug Reaction Monitoring Network received 2,023,000 ADR/Event Report Forms and 642,000 new and serious ADR/Event reports during the year. The report indicates no significant change in the reporting of ADRs in 2022 compared to the previous year.

Chemical Drugs and Oncology Drugs Dominate ADR Reports
Chemical drugs accounted for 82.3% of ADR/Event reports, with traditional Chinese medicines (TCM) at 12.8%, and biological products at 2.6%. Within the chemical drugs category, oncology drugs topped the list of ADR/Event reports. The top five categories with the highest number of cases were anti-infective drugs, tumor drugs, cardiovascular system drugs, analgesics, electrolyte/acid-base balance, and nutritional drugs. The proportion of reported anti-infective drugs continued to decline. Among serious reports involving chemicals, cancer drugs were the most commonly reported, accounting for 35.1%, followed by anti-infective drugs at 27.8%.

Trends in Pediatric and Elderly Patient ADRs
The proportion of children aged 14 and below involved in adverse reactions decreased. However, the proportion of elderly patients aged 65 and above maintained an upward trend, indicating a need for enhanced management of safe medication practices for elderly patients in clinical settings.

Biological Products and Injectables in Focus
Among biological products involved in ADR/Event reports, cytokines accounted for 74.2%, antitoxin and immune serum for 11.7%, blood products for 1.7%, and diagnostic biological products for 0.2%. Injectable and oral preparations accounted for 74.7% and 0.1% respectively, with other preparations making up 25.2%.

TCM Injectables Show Decrease in ADR Reports
Compared to 2021, the growth rate of ADR/Events in TCM in 2022 was 2.1%, with the proportion of serious reports being 5.8%, lower than the proportion of serious reports in the overall ADR/Event report. Drugs for promoting blood circulation and resolving stasis still topped the ranking, but their proportion slightly decreased. From the perspective of drug administration route, the proportion of TCM injectables decreased.-Fineline Info & Tech

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