Part One: An Introduction To This All Too Common Problem

The World Health Organization defines adverse drug reactions (ADRs), also known as adverse drug events (ADEs), in this manner:

A response to a drug that is noxious and unintended and occurs at doses normally used for man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function.

Essentially, therefore, the concept of adverse drug reactions includes all responses involving prescription drugs that cause a patient some harmful side effect, or puts them at risk of such harm.

In connection with its MedWatch reporting system, the FDA has more narrowly defined "serious adverse drug reaction" as a medical event caused by a prescription drug which resulted in a patient’s death, hospitalization, or disability, or has caused a congenital abnormality, a life-threatening event, or a required intervention to prevent permanent damage. 

Unfortunately, these serious adverse drug reactions are all too common in the U.S.  It has been estimated that over 770,000 Americans are hospitalized each year due to their adverse drug reactions.  In turn, the hospital expenses to treat those patients are estimated to be between $1.56 billion and $5.6 billion annually.

For many people the extent of serious adverse drug reactions (ADRs) in the U.S. was first brought to their attention in 1999, when the National Academy of Sciences’ Institute of Medicine issued a report entitled To Err Is Human: Building a Safer Health System.

In the next part of this ADRs in US series, we will consider how some of these serious adverse drug reactions might be prevented.

(Posted by: Tom Lamb)