ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Constructing an Evaluation Framework for Primary Pharmacovigilance Systems in Developing Countries: A Case Study from China
Provisionally accepted
- Xi'an Jiaotong University, Xi'an, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Objective: This study aimed to develop an evaluation framework for primary pharmacovigilance systems based on the Chinese context, with potential applicability to regions with similar system maturity. The framework was informed by the WHO manual and tailored to national policies and resource constraints to support consistent pharmacovigilance practices in similar settings and enhance medication safety. Methods: This study employed semi-structured interviews, literature review, brainstorming, group discussions, and other common methods to establish a preliminary indicator system. The Delphi Method was employed to screen indicators at various levels based on inclusion principles. Subsequently, the Analytic Hierarchy Process (AHP) was applied to determine indicator weights. Results: The effective response rates for both rounds of questionnaires were 100%. Furthermore, the coefficients of reliability were 0.87 and 0.88 for each round, and the Kendall's W for the process and outcome indicators were 0.173 and 0.236. The significance tests for Kendall's W were both P < 0.001. The final evaluation indicator system consisted of 3 first-level indicators, 9 second-level indicators, and 35 third-level indicators. Conclusion: This study developed a practical and context-sensitive evaluation framework for primary pharmacovigilance systems in China. The framework offers a feasible assessment tool and may serve as a reference for regions with similar development stages or incomplete pharmacovigilance systems, providing guidance for system improvement and resource allocation.
Keywords: Pharmacovigilance system, Developing country, Evaluation indicator framework, Delphi method, analytic hierarchy process (AHP)
Received: 08 Jul 2025; Accepted: 03 Nov 2025.
Copyright: © 2025 Lei, Lin, Zhu, Liu, Liu, Yin and Feng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Bianling Feng, fengbianling@163.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.