关键词: 药物警戒, 药品安全, 风险治理, 实施路径

Abstract:

The proposed pharmacovigilance system is an innovation and supplement on the basis of adverse drug reaction (ADR) monitoring, marking the upgrade of national drug safety risk regulation in terms of concept, mechanism and method. This paper aims to analyze the practical opportunities and challenges faced in the practice of pharmacovigilance system through literature analysis and quantitative research method, and to explore the feasible path for the implementation of pharmacovigilance system in China. The development of pharmacovigilance actions has gained management and technical support based on the support of national policies, mature ADR reporting and monitoring mechanisms. However, it also faces challenges such as multiple data acquisition, implementation of vigilance responsibilities, and self-consistent regulatory logic. The proposal and implementation of pharmacovigilance system has practical significance for balancing the risk-benefit information of drugs in the whole life cycle and guaranteeing the safety of public drug use. It is suggested to consider the feasible path for the effective implementation of pharmacovigilance system from the following aspects: promoting the collaborative governance of multiple subjects, expanding the scope of pharmacovigilance information monitoring, continuously giving play to the professional role of medical institutions and pharmacists, clarifying the scientific logic of supervision, etc., so as to ensure the maximum safety of public drug use.

Key words:

pharmacovigilance, drug safety, risk management, implementation path