Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature.
Yanping Li, Yuanlin Wu, Tingting Jiang, Haiyan Xing, Jing Xu, Chen Li, Rui Ni, Ni Zhang, Guiyuan Xiang, Li Li, Ziwei Li, Lanlan Gan, Yao Liu
Author Information
Yanping Li: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Yuanlin Wu: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Tingting Jiang: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Haiyan Xing: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Jing Xu: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Chen Li: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Rui Ni: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Ni Zhang: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Guiyuan Xiang: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Li Li: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Ziwei Li: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Lanlan Gan: Department of Pharmacy, Daping Hospital, Army Medical University, Chongqing, China.
Yao Liu: Department of Pharmacy, Daping Hospital, Army Medical University, No. 10 Changjiang Branch Road, Yuzhong District, Chongqing 400042, China. ORCID
The relatively new discipline of pharmacovigilance (PV) aims to monitor the safety of drugs throughout their evolution and is essential to discovering new drug risks. Due to their specific and complex physiology, children, pregnant women, and elderly adults are more prone to adverse drug reactions (ADRs). Additionally, the lack of clinical trial data exacerbates the challenges faced with pharmacotherapy in these populations. Elderly patients tend to have multiple comorbidities often requiring more extensive medication, which adds additional challenges for healthcare professionals (HCPs) in delivering safe and effective pharmacotherapy. Clinical trials often have inherent limitations, including insufficient sample size and limited duration of research; as some ADRs are attributed to long-term use of a drug, these may go undetected during the course of the trial. Therefore, the implementation of PV is key to insuring the safe and effective use of drugs in special populations. We conducted a thorough review of the scientific literature on PV systems across the European Union, the United States, and China. Our review focused on basic physiological characteristics, drug use, and PV for specific populations (children, pregnant women, and the elderly). This article aims to provide a reference for the development of follow-up policies and improvement of existing policies as well as provide insight into drug safety with respect to patients of special populations.
