Pharmacovigilance (PV) for herbal medicines is a critical and complex field, often referred to as Phytovigilance. The core principle is the same as for conventional pharmaceuticals: to ensure the safety of patients by detecting, assessing, understanding, and preventing adverse effects. However, the practice of PV for herbal medicines presents unique and significant challenges.
Imagine a patient harmed by a medication error. The old approach asked, "Who is to blame?" The modern approach, fueled by pharmacovigilance, asks, "Why did our system allow this to happen?" This article explores the critical, data-driven partnership between pharmacovigilance and patient safety that is transforming healthcare from a culture of blame to...
Vaccinovigilance is a specialized branch of pharmacovigilance focused exclusively on vaccines. The term is widely used, particularly in French-speaking countries and in international health contexts, and it is entirely synonymous with Vaccine Pharmacovigilance.
Think of a new medicine as a new employee. For the first few years, you monitor them closely with frequent performance reviews. A PSUR/PBRER is like that comprehensive performance review for a medicine, looking at both its benefits (the good work it does) and its risks (its shortcomings or side effects) to decide if it...
The causality assessment of adverse events, to determine the relationship or connection between the drug and adverse events, is an essential and complex approach in pharmacovigilance. The recognition of a potential safety issue for a drug requires adverse drug reactions to be readily differentiated from adverse events.
The goal is not just to collect data on harms, but to actively use that data to minimize risks and promote the safe use of medicines. The process can be broken down into five key stages.
The data sources are presented in a sequence that mirrors the drug development process.
Advancing Medication Safety Through Knowledge and Vigilance
