adverse drug reaction (ADR)

Abstract

ICH: (pre-approval clinical experience): “all noxious and unintended responses to a medicinal product related to any dose shoud be considered adverse drug reaction”; WHO/ICH (marketed medicinal product): “a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function”; CIOMS (council for international organisation of medical science) reports always refer to a suspect reaction (in contrast to event or experience), which implies that a physician or other professional health care worker has judged it a reasonable possibility that an observed clinical occurrence has been caused by a drug; some authorities (e.g. Japan) recommend to document a sufficient number of subjects to detect ADRs with an incidence of 0.1%; → see also adverse reaction, drug injury, expedited reporting, treatment emergent signs and symptoms, (un)listed adverse drug reaction, spontaneous adverse drug reaction report.