An investigation of pharmacovigilance and reporting of adverse drug reactions in hospitals: a cross-sectional study in China

Abstract

Background

Pharmacovigilance is a science that plays a significant role in reducing ADRs and helps predict adverse reactions to drugs in community. To safely use drugs in treatment and prevention of disease, adverse drug reaction has been paid more attention.

Objectives

To evaluate the future needs of existing systems, the paper investigated the current state of pharmacovigilance and the reporting of ADR in Chinese hospitals.

Methods

This cross-sectional, questionnaire-based study involved 10,063 pharmacists, doctors, and nurses from primary, secondary, and tertiary hospitals in all 31 provinces of China. It was commissioned by the National Centre for ADR Monitoring of China and conducted in March 2020. Three areas were assessed: sociodemographic characteristics of participants, awareness of the pharmacovigilance system, and the current state of hospitals’ reporting of ADRs. Chi-square tests were used to calculate P values.

Results

Health care professionals had heard the term “pharmacovigilance” previously (89.40%) and knew the reporting object (68.47%), content (65.94%), and range (64.83%) of pharmacovigilance. Most hospitals dispatched responsible professionals (87.64%) and departments (86.25%) to monitor ADR reporting. A total of 58.66% of tertiary medical, 45.25% of secondary, and 38.90% of primary hospitals extracted ADRs from a hospital information system. Moreover, 53.09% of tertiary medical, 38.93% of secondary, and 23.89% of primary hospitals had established a prescription automatic screening system to warn about risks for ADRs. Health care professionals’ reports (99.92%) and patient feedback (77.99%) were included in most hospitals’ ADR reporting.

Conclusions

Chinese health care professionals generally have good awareness of pharmacovigilance, and pharmacovigilance is relatively more advanced in China compared to other developing countries.

Keywords:

• Pharmacovigilance system
• Adverse Drug Reactions (ADRs)
• China
• health care professionals
• knowledge
• hospital

Transparency

Declaration of funding

This study was funded by Clinical Toxicology Special Project of Chinese Society of Toxicology [CST2019CT501] and the National Natural Science Foundation of China [NSFC, 72074011].

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

Authors are grateful to all cooperating organizations and their staff whose hard work made this study possible, which are including Chinese Society of Toxicology, National Centre for ADR Monitoring, China Military Institute of Chinese Medicine, Beijing Tiantan Hospital, ADR Monitoring Centre of Jiangsu Province, Centre for ADR Monitoring Guangdong Province, and ADR Monitoring Centre of Shandong Province.

Data availability statement

The datasets generated and/or analysed during the current study are not publicly available.