Pharmacovigilance in China: development and challenges

Abstract

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.

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

“…After the Proposed Regulation on Administrative Measures on Reporting and Monitoring of ADRs and the amendment of the Drug Administration Law of the People's Republic of China (PRC) in 2001, a national network for ADR monitoring developed rapidly. 3) Since 2003, a self-reporting internet-based monitoring system for spontaneous ADRs has operated. 4) This greatly facilitates the collection of ADR information, and the number of adverse drug reactions reported has increased year-on-year since its introduction.…”

“…3) Since 2003, a self-reporting internet-based monitoring system for spontaneous ADRs has operated. 4) This greatly facilitates the collection of ADR information, and the number of adverse drug reactions reported has increased year-on-year since its introduction. The national ADR monitoring network received 1.429 million ADR or event reports in 2017 (1086 per million population).…”

Exploration of Perception, Need and Barriers against Pharmacovigilance and Adverse Drug Reactions Reporting: Healthcare Professionals’ Insight

“…Overall, healthcare personals are thought to be responsible for ADRs documentation but patients could also be involved in adverse event reporting if motivated. The knowledge that patient can report ADRs is very least established healthcare units [15]. Various modes of ADRs reporting exists and utilized all over the world however; online systems are now launching to save the time and expenditure [16].…”

Liver function monitoring: a prospective nested case-control study of Salvia miltiorrhiza polyphenol injection

“…Alert thresholds for abnormal liver function. The HPS, which collects real-world clinical data, is an information system established to support sentinel surveillance, record and evaluate ADRs, conduct drug monitoring and re-evaluation, and obtain drug warning information [16][17][18] . The following ADR alert thresholds for abnormal liver function during S. miltiorrhiza polyphenol treatment or within 24 h of its withdrawal were used as settings in the HPS: glutamic-pyruvic transaminase or glutamic oxaloacetic transaminase values above 40 U/L or alkaline phosphatase values exceeding the normal range of 40-110 U/L; the total bilirubin exceeding the normal range of 1.71-17.1 μmol/L, the indirect bilirubin exceeding the normal range of 1.7-13.7 μmol/L, or the direct bilirubin exceeding the normal range of 1.71-7 μmol/L; the total serum protein, serum albumin, or serum globulin values exceeding the normal range of 60-80 g/L, 40-55 g/L, or 20-30 g/L, respectively; the prothrombin time, cholinesterase, and total serum bile acid values exceeding the normal range of 12-14 s, 130-310 U/L, and 10 μmol/L, respectively.…”