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Discuss the presentation of Adverse Events & Adverse Drug Reactions in the PI.
Member rating: No Rating | Words: | Submitted: Mon Jun 19 2006
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Activity One: Adverse Events & Adverse Drug Reactions Define "Adverse Event" & "Adverse Drug Reaction". Adverse Event An adverse drug event (AE) may be defined as "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". (WHO definition 1995). While an Adverse Drug Reaction (ADR) is an AE associated with drug treatment, the reverse is not necessarily true because the relationship between the events may not be causal. For example, a person who experiences a gastro-intestinal upset whilst on a particular medication has experienced an AE. However, the gastrointestinal upset may not necessarily be related to the drug treatment, therefore cannot be classifies as an ADR. Adverse Drug Reaction An adverse drug reaction (ADR) is a response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of...
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