Drug-Related Deaths in China: An Analysis of a Spontaneous Reporting System

Background: Adverse drug reactions with an outcome of death represent the most serious consequences and are inherently important for pharmacovigilance. The nature and characteristics of drug-related deaths are to a large extent unknown in the Chinese population. This study aims to characterize drug-related deaths by analysis of individual case safety reports (ICSRs) with an outcome of death in China. Methods: The characteristics of death ICSRs were analyzed by descriptive statistics of a large multi-provincial pharmacovigilance database in China. Results: There were 1,731 ICSRs with an outcome of death, representing 0.95% of all serious cases and 0.05% of all reported ICSRs. Most death ICSRs (78.57%) were reported by medical institutions. Only 16.00% of death ICSRs were reported by manufacturers or distributors. The reporting rate of death ICSRs in the age group of 0-4 years was significantly higher than patients aged 5-64 years. Patients aged over 64 years had the highest reporting rate of death ICSRs. Male patients generally had a higher reporting rate of death ICSRs than female patients. However, the reporting rate of female patients exceeded that of male patients in the age group of 20-34 years. Among 3,861 drugs implicated, ceftriaxone sodium with 146 (3.78%) records of death ranked first. Dexamethasone with 131 (3.39%) records of death ranked second. Qingkailing, an injectable traditional Chinese medicine with 75 (1.94%) records of death, ranked the fifth most frequently implicated medicine. Conclusion: Young children and elderly patients have a higher risk of drug-related deaths than patients aged 5-64 years. Female patients generally have a lower risk of drug-related deaths than male patients. However, female patients of reproductive age (aged 20-34 years) have a higher risk of drug-related deaths than male patients, hinting that physiological changes and drug uses for child bearing, giving birth, or birth control may significantly increase the risk of death for female patients aged 20-34 years. This paper suggests more research on the safe use of drugs for young children, elderly patients, and female patients of reproductive ages. Pharmacovigilance databases can be valuable resources for comprehensive understanding of drug-related problems.