Glossary of terms used in Pharmacovigilance
Risk in a population of exposed persons; the probability of an event affecting members of a particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence) or at a given time (prevalence). Also see Attributable risk and Relative risk.
Adverse Event (AE):
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Also see Adverse reaction and Side Effect.
Synonym: Adverse experience
Adverse (Drug) Reaction (ADR):
A response which is noxious and unintended,and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. (WHO, 1972).
An adverse drug reaction, contrary to an adverse event, is characterized by the suspicion of a causal relationship between the drug and the occurrence, i.e. judged as being at least possibly related to treatment by the reporting or a reviewing health professional.
In the EU Directive 2010/84, which will become applicable in July 2012 an adverse reaction is defined as: A response to a medicinal product which is noxious and unintended.
Non-traditional, western scientific therapy, usually using synthesised ingredients, but may also contain a purified active ingredient extracted from a plant or other natural source; usually in opposition to the disease. Also see Homeopathy.
Events associated in time but not necessarily linked as cause and effect.
Difference between the risk in an exposed population (absolute risk) and the risk in an unexposed population (reference risk). Also referred to as Excess risk. Attributable risk is the result of an absolute comparison between outcome frequency measurements, such as incidence.
An estimated gain for an individual or a population. Also see Effectiveness/Risk.
Benefit – risk analysis:
Examination of the favourable (beneficial) and unfavourable results of undertaking a specific course of action. (While this phrase is still commonly used, the more logical pairings of benefit-harm and effectiveness-risk are slowly replacing it).
Medical products prepared from biological material of human, animal or microbiologic origin (such as blood products, vaccines, insulin).
A relationship between one phenomenon or event (A) and another (B) in which A precedes and causes B. In pharmacovigilance; a medicine causing an adverse reaction.