farmakovigilanssijärjestelmää

Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. It covers medicines and vaccines across their life cycle, from development and clinical trials to post-marketing surveillance. The goal is to improve patient safety by identifying risks early and ensuring that the benefits of medicines outweigh any harms. Internationally, the field is sometimes referred to as farmakovigilance in some languages.

Key activities include the collection and evaluation of adverse drug reaction reports, signal detection to identify potential safety concerns, and causality assessment to judge whether a reported event is likely related to a drug. Pharmacovigilance also involves risk assessment, safety communication, and the implementation of risk management strategies such as labeling changes, restricted use, or patient education.

Data sources encompass spontaneous reporting systems (for example the FDA Adverse Event Reporting System in the United States and EudraVigilance in the European Union), clinical trials, observational studies, scientific literature, and health records. Analyses may use quantitative methods to detect signals and qualitative reviews to assess plausibility and clinical relevance.

Regulatory frameworks set expectations for pharmaceutical companies and health authorities. International guidelines by the WHO and ICH, and national laws in many jurisdictions, define reporting timelines, safety duties of marketing authorization holders, and processes for risk communication and regulatory action.

Pharmacovigilance faces challenges such as underreporting, incomplete data, and confounding factors. Despite these, it plays a central role in post-approval safety monitoring, helping to identify rare or long-term adverse events and to protect public health through ongoing safety evaluation.