Pharmacovigilance

Pharmacovigilance is the science and activities used to detect, assess, understand, and prevent adverse effects and other medicine-related problems.

Adverse drug reaction: A harmful, unintended response to a medicine taken at normal doses. These suspected harms are the primary events pharmacovigilance seeks to identify and evaluate.
Causality assessment: The evaluation of whether an observed event was caused by a particular medicine. Safety reports describe suspicions; causality assessment weighs whether the medicine plausibly caused the event.
Postmarketing surveillance: Monitoring a medicine's safety after it has been authorized for use in the general population. Routine use exposes medicines to larger and more varied populations than preapproval trials.
World Health Organization Programme for International Drug Monitoring: A global program that coordinates national systems for monitoring and reporting suspected adverse drug reactions. It links national reporting efforts into international medicine-safety monitoring.
Clinical trial: A prospective study in which human participants receive one or more interventions under a defined protocol. Trials assess safety before and after authorization but often miss rare or delayed harms.
Spontaneous reporting: A system in which suspected medicine-related harms are reported without requiring participation in a formal study. Reports from patients and health professionals can reveal unexpected safety signals.
Benefit–risk assessment: A comparison of a medicine's expected benefits with its known and potential harms. Pharmacovigilance decisions depend on whether benefits continue to outweigh risks.
Pharmacoepidemiology: The study of medicine use and effects in large populations using epidemiological methods. It supplies population-level methods for investigating suspected harms and their frequency.
Uppsala Monitoring Centre: A WHO collaborating centre that manages the global database of suspected adverse reaction reports. Its database supports international signal detection from national submissions.
Toxicology: The study of harmful effects caused by chemical, biological, or physical agents. Toxicology characterizes hazards, while pharmacovigilance monitors harms associated with medicine use.

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