Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (3): 285-289.
DOI: 10.19803/j.1672-8629.20250768

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Construction of an Indicator System for Evaluating Safety of Pediatric Medication

LUO Qiang1, DENG Bin2, XIONG Huiyu2, WANG Chunting3, HUANG Yan2#, LIU Zuoren1,4,*   

  1. 1School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou Guangdong 510006, China;
    2Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510080, China;
    3Center for Drug Reevaluation, NMPA/NMPA Center for Innovation and Research in Regulatory Science, Beijing 100163, China;
    4NMPA Key Laboratory for Pharmacovigilance Technology Research and Evaluation, Guangzhou Guangdong 510006, China
  • Received:2025-10-31 Online:2026-03-15 Published:2026-03-17

Abstract: Objective To construct an indicator system for evaluating the safety of pediatric medication in order to contribute to children’s health. Methods A tentative framework was established via literature review and brainstorming. The Delphi method was used to analyze, screen, and refine the indicators. The Analytic Hierarchy Process (AHP) was applied to determine the weight of each indicator before the indicator system for evaluation of safety of pediatric medication was established. Results The final system comprised 3 first-level indicators, 10 second-level indicators, and 37 third-level indicators, with corresponding weights assigned to each indicator. Conclusion The significant weight of “inherent medication risks” underscores that the risk to pediatric medication lies in the drug itself. It is recommended that risks be managed throughout medication, pre-market research upgraded, and post-market surveillance enhanced. The constructed indicator system is well-grounded and can serve as a reference for evaluating the safety of pediatric medication.

Key words: Pediatric Medication, Indicator System, Safety Evaluation, Delphi Method, Analytic Hierarchy Process (AHP), Boundary Value Method

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