Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

target="_blank" rel="nofollow" href="#fb3_img_img_70f25250-4567-53ec-b306-dfc9813a51b8.jpg"/>“Reactions” are different from “events”. “Reactions” are reports of clinical occurrences that have been judged by a physician or healthcare worker as having a “reasonable possibility” that the report has been caused by a drug. “Events” have not had a causality evaluation made, and thus may or may not be related to or associated with the drug.

Images Causality is discussed. No particular method of assessing causality is recommended. The report recommends that manufacturers not separate out those spontaneous reports that they receive into those that seem to be drug-related and those not seemingly drug-related. The physician, by voluntarily making the report to the manufacturer, indicates that there is some level of causality possible in the report. This is a “suspected reaction”. This has become a fundamental concept in most spontaneous reporting systems around the world, wherein all spontaneous reports from physicians (now extended to all healthcare providers, and in most countries, such as the United States and Canada, to consumers) are to be considered possibly related to the drug; that is, they are “reactions”, not “events”.

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