Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature.

ABSTRACT

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.

Pharmacovigilance (PV) in special populations opportunities and challenges Why is it important to implement PV in special populations? Due to the particularity of physiological functions, the special population (children, pregnant women, and the elderly) are more susceptible to adverse drug reactions (ADRs) and have more drug safety problems. The implementation of PV is helpful for the detection of safety risks throughout the life cycle of drugs, so that healthcare professionals (HCPs) can take early measures to reduce the drug use risks of patients. What are the problems to implement PV for special populations? Many countries have implemented a PV system. However, PV policies and systems for the special population are not complete in various countries, or no independent PV system for the special population has been set up. What does this article add to our knowledge? This article discusses the PV systems of the European Union, the United States, and China with special focus on basic physiological characteristics, use of drugs, and the implementation of PV with respect to children, pregnant women, and the elderly. Focus on these problems are of great importance for formulating a more complete drug management scheme in the special population and can provide a reference for the development of follow-up policies and improvement of existing policies.