Inaccurate and incomplete adverse event reports are submitted to the U.S. Food and Drug Administration at an alarmingly high rate, according to a study conducted 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 percent — of healthcare professionals have never reported an ADE," said Ken Getz, an associate professor and the director of sponsored research at Tufts CSDD.
Mr. Getz got his information from a Tufts survey of 123 health professionals, which also found that 60 percent of healthcare professionals report it is often too difficult to determine if a drug in question is the cause behind an adverse event.
Tufts CSDD also conducted a study analyzing more than 10 million adverse event report records filed with FDA's MedWatch system between January 2005 and December 2010.
The researchers examined primary suspect reports received by the FDA Adverse Event Reporting System for human growth hormone and human insulin between the fourth quarter of 2005 and the third quarter of 2013 as well, amounting to more than 4,700 insulin and 6,400 HGH primary suspect adverse drug event reports.
Ultimately, they found more than two-thirds of all the ADE reports submitted to the FDA did not include dosage level, and 90 percent were missing lot numbers which are normally meant to identify and trace the source of ADEs.
"Inaccurate reporting, in particular, is problematic," Mr. Getz said. "It may mislead drug safety professionals to draw incorrect conclusions, cause manufacturers to wrongly suspend and withdraw medical interventions, lead health professionals to mistakenly alter their clinical practices and deny or limit patient access to safe and effective treatments."
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