Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data

doi:10.19803/j.1672-8629.20240376

Abstract

Abstract: Objective s To compare and analyze the active post-marketing safety surveillance practices based on real-world data (RWD) worldwide, in order to provide the reference for establishing an effective and feasible nationwide active surveillance system in China. Methods The literature on active surveillance systems around the world were searched and reviewed. The framework synthesis was used to determine the analytical framework, coding and mapping the information related to organizational structure, data characteristics, and operation mechanism. The similarities and differences of the active surveillance model were summarized. Results A total of 12 systems/organizations that conduct active surveillance based on RWD were included in this study, 9 of which are located in Europe and the United States, and in Asia. There are two Chinese systems, the China Hospital Pharmacovigilance System (CHPS) and the Adverse Drug Event Active Surveillance and Assessment System-Ⅱ (ADE-ASAS-Ⅱ). After integrating the information, the active monitoring model was summarized in six dimensions: (i) The organizational model was divided into three categories, including the government (with academia and pharmaceutical companies) led consortium, the direct government management, and the academic alliance consultation; (ii) The data integration and sharing model included the common data model, the common study protocol, and the centralized database; (iii) The data collection model could be divided into two forms: automatic collection from databases, and manual collection for target populations or specialized studies; (iv) The data management model included anonymizing, structuring and standardizing processes; (v) The data storage and transmission model can be categorized into the distributed data networks and the central database storage; (vi) Correspondingly, the data analysis model was divided into two categories: distributed computing and centralized analysis. Conclusion At present, the pattern of active surveillance for drug safety based on RWD are relatively mature in developed countries. While learning from those advanced experiences, we should also explore the active surveillance in line with the actual situation of China, to protect the medication safety of patients.

Key words: drug, post-marketing safety, active surveillance, pharmacovigilance, real-world data.

CLC Number:

R951
R994.1

SUN Yixin, NIE Xiaolu, WANG Xiaoling, GUO Peng. Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 892-899.

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