Trend analysis of adverse drug reactions to sedative-hypnotics among residents in Jiangsu Province of China, 2011-2019.

Abstract

BackgroundThe safety of sedative-hypnotic drugs represents an underrecognized and crucial public health concern, despite their widespread use.ObjectiveThe objective of this study was to investigate the characteristics and trends of adverse drug reactions (ADRs) to sedative-hypnotics in China.MethodData were extracted from the spontaneous reporting system (SRS) for ADR surveillance in Jiangsu Province. Sedative-hypnotic drugs for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We analysed the characteristics of ADR reports, including demographic and sedative-hypnotics information, ADR involvement of system organs and clinical manifestations, and cost of ADRs. Joinpoint regression was employed to estimate age-adjusted ADR rates stratified by sex from 2011 to 2019, and the percentage change annualized estimator was used to evaluate trends over time.ResultsA total of 899 reports of ADRs to sedative-hypnotics were found, with 440 (49.1%) males and 459 (50.9%) females. Regarding ADRs to sedative-hypnotics, neurological disorders (310 cases, 34.5%) were the most common. An estimated cost savings of RMB 6031.98-54,287.82 (USD 826.38-7437.43) could be realised if 10%-90% of the ADRs in this study were reduced. The age-adjusted ADRs reporting rates increased significantly from 0.06 to 0.18 per 100,000 population during 2011-2019, representing an annual increase of 14.5% (95% confidence interval 9.4-19.9%; p-value < 0.001). There was a gender difference, with an age-adjusted ADRs annual increase of 14.0% (95% confidence interval 6.6%-21.9%; p-value 0.002) for males and 14.8% (95% confidence interval 7.5%-22.6%; p-value 0.002) for females.ConclusionsReports of sedative-hypnotic ADRs were on the rise during the study period, and there was a gender difference. More rational policies and systems are needed to promote the safe use of sedative-hypnotic drugs.