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.

The most fundamental ideas in pharmacovigilance: harm (Adverse Drug Reactions), safety, and causation.

Understanding this terminology is crucial because it forms the standardized language used by healthcare professionals, regulators, and pharmaceutical companies worldwide to communicate about drug safety.

An Individual Case Safety Report (ICSR) is the fundamental building block of pharmacovigilance. It is a structured document that captures detailed information about a suspected adverse event (or any other drug-related problem) in a single patient that is potentially associated with a medicinal product. In simple terms, it is the official “incident report” for a possible side effect or safety concern...

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. In simpler terms, it is the ongoing process of: Monitoring the safety of medicines (and other health products) throughout their entire life cycle, from clinical trials to widespread public use. Identifying new or changing...