US adverse drug event reporting beset by incompleteness and inaccuracy, says Tufts CSDD

Voluntary adverse drug event (ADE) reporting in the USA is incomplete, inaccurate and inefficient, which could deny or limit patient access to safe and effective treatments, according to recent studies completed by the Tufts Center for the Study of Drug Development.

"While ADE reporting aims to ensure and enhance patient safety, a high proportion-nearly 40%-of health care professionals have never reported an ADE," said Ken Getz, associate professor and director of sponsored research at Tufts CSDD, adding: "Aggravating the situation is the fact that 60% of health care professionals report it is often too difficult to determine if a drug-in-question caused an adverse event."

Adverse drug event reports are submitted to the Food and Drug Administration for injuries and harm resulting from the use of a drug, changes in dosage level, discontinuations of drug therapy and medication errors.