Adverse Drug Events

The drug injury epidemic in America was brought to the public's attention in a 1999 Institute of Medicine (IOM) report entitled To Err is Human: Building a Safer Health System. This government-sponsored report estimated that medical errors account for 44,000 to 98,000 deaths per year. Moreover, the IOM report said medication mistakes made up the largest part of medical errors. The report suggested that over 770,000 people are injured or die each year from such adverse drug events (ADEs).

Adverse drug events can result in a number of different medical conditions or physical consequences, ranging from allergic reactions to death. One study estimated that 9.7% of ADEs caused permanent disability.

It is difficult to predict who will suffer an ADE, when, and from what medication. Research indicates that older age, severity of illness, intensity of treatment and use of multiple drugs at one time are among the relevant factors. It follows that the elderly have more ADEs than any other age group does because their exposure to a greater number of medications provides more opportunities for medication errors and drug-drug interactions.

An incident of this type could be a "serious reaction" for the purpose of reporting a suspected drug injury to the FDA MedWatch system.

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