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Tufts CSDD Raises Questions over Adverse Event Reporting in US

Posted 16 September 2015 | By Zachary Brennan 

Tufts CSDD Raises Questions over Adverse Event Reporting in US

Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday.


FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, medical devices and dietary supplements:

  • Form 3500, which healthcare providers can use on a voluntary basis
  • Form 3500A, which medical product manufacturers and some facilities are required to use when they are made aware of adverse events
  • Form 3500B, a voluntary, consumer reporting form

Launched by FDA in June 2013, 3500B is part of a push to increase patient involvement in the regulatory process. However, FDA only permits this form to be submitted by mail or fax.

New Report

While adverse drug event (ADE) reporting aims to ensure patient safety, this latest report from Tufts indicates that the US national system of reporting has issues with its accuracy, completeness and consistency.

The problems highlighted in the report are particularly important as FDA and other regulators worldwide begin collecting data and tracking side effects for recently approved biosimilars.

For the report, Tufts CSDD analyzed 10.2 million adverse event report records filed with FDA's MedWatch system between January 2005 and December 2010, using forms 3500 and 3500A.

Tufts also extracted all primary suspect reports received by the FDA Adverse Event Reporting System for human growth hormone (HGH) and human insulin between the fourth quarter of 2005 and the third quarter of 2013, which amounted to a total of 4,703 insulin and 6,478 HGH primary suspect adverse drug event reports.


As far as inaccuracy and incompleteness, the researchers found that more than two-thirds of all ADE reports did not include dosage level, and 90% lacked lot numbers. The absence of lot numbers makes it more difficult to identify and trace the source of ADEs.

"Inaccurate reporting, in particular, is problematic; 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," Tufts researchers wrote.

In addition, only one out of four nurses and physicians submitted adverse drug events to FDA’s MedWatch system, while 42% of physicians and 34% of nurses never reported an ADE.

“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. “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.”

Tufts CSDD Report Executive Summary

Press Release on Report

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