HIMSS Word of the Day #305: AE (Adverse Event/Adverse Experience)
In drug safety, an adverse event (AE) is any untoward medical occurrence associated with the use of a drug or medical product, whether or not the product is thought to have caused it. This post explains the FDA definitions in 21 CFR 312.32, the 15-day and 7-day reporting rules, and how a text-mining study of 2.75 million Dutch health records and a Canadian NLP study found adverse drug events that spontaneous reporting misses.