Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines.

What is Known and Objectives: Potential inappropriate medications (PIMs) can increase the risk of medication-induced harm. However, there are no studies regarding PIMs in older and critically ill patients with cardiovascular diseases in China.Therefore, studies evaluating PIMs in these patients can help in the implementation of more effective interventions to reduce the risk of drug use. Our objective was to analyse the prevalence of PIMs in elderly patients admitted to the cardiac intensive care unit (CICU) comparing the 2019 Beers criteria (Beers criteria), Screening Tool of Older People's Potentially Inappropriate Prescriptions (STOPP) criteria version 2 (STOPP criteria) and criteria of potentially inappropriate medications for older adults in China (Chinese criteria); and analyse the factors influencing the PIMs. Methods: This cross-sectional and retrospective study was performed with elderly patients (≥65 years) admitted to the CICU of the Beijing Tongren Hospital in China from January 2019 to June 2020. The PIMs were identified based on the Chinese, STOPP and Beers criteria at admission and discharge. The three criteria were compared using the Kappa statistic. Multiple regression analysis was used to investigate the influencing factors associated with PIMs.Results and Discussion: A total of 369 patients who met the inclusion/exclusion criteria were included in this study. According to the three criteria used to evaluate the PIMs, the prevalence was 78.3% and 72.6% at admission and discharge, respectively.The prevalence rate of PIMs determined by the Chinese criteria was 62.1% at admission versus 56.6% at discharge (p = 0.134); the Beers criteria was 53.9% at admission versus 46.9% at discharge (p = 0.056); by the STOPP criteria was 20.6% at admission versus 13.8% at discharge (p = 0.015). Moreover, 28.9% (STOPP criteria), 56.8% (Beers criteria) and 73.4% (Chinese criteria) of patients taking PIMs on admission still had the same problem at discharge. The most common PIMs screened by the Beers, STOPP and Chinese criteria were diuretics, benzodiazepines and clopidogrel, respectively. Besides, the three criteria showed poor agreement. Finally, the stronger predictor of PIMs was the increased number of medications (p < 0.05).