Regulatory Focus™ > News Articles > 2019 > 9 > Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

Posted 04 September 2019 | By Zachary Brennan 

Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

Since 1969, health professionals and consumers have been able to voluntarily report pharmaceutical adverse events to FDA’s Adverse Event Reporting System (FAERS), and with a shift to plain language in the latest reporting form, a new study co-authored by FDA officials found that the quantity and quality of the adverse event reports has improved.

The shift in mid-2013 to this plain language reporting form, known as the consumer voluntary reporting (ConVR) form or Form FDA 3500B, from the general voluntary reporting (GVR) form, was designed to allow for “more accurate and analyzable consumer reports,” the research published Tuesday in the journal Pharmacotherapy finds.

An example of this shift to plain language can be seen in one item on the GVR form, which asks, “Event Abated After Use Stopped or Dose Reduced?” while the same information is captured in the ConVR form by asking, “Did the problem stop after the person reduced the dose or stopped taking or using the product?”

In a review of submitted forms before and after this switch, the FDA officials found, “Compared to direct consumer reports submitted on the GVR form, ConVR reports included more patient, product, and event data in the structured data fields” and the incorporation of the plain language form also lowered the amount of time necessary to fill the form out.

Prior to FDA’s implementation of the ConVR form, the researchers found that the monthly number of consumer reports received ranged from 521 (March 2013) to 906 (September 2011). But after the implementation, the number of consumer reports ranged from 726 (August 2013) to 1,349 (March 2015).

In addition to the increase in forms submitted, the researchers also said they observed “corresponding improvements in consumer report quality as measured by completeness and clinical documentation following the implementation of the ConVR form.” However, they also said that “improvement still exists with 35% of ConVR reports classified as poorly or moderately documented.”

The researchers further noted the importance of the study, which is the first of its kind, “to evaluate the impacts of initiatives targeting consumer reporting because several studies have demonstrated that consumer reports can contribute to signal detection by producing unique, early, and robust information about patient use of products.”

Study

 

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Tags: ConVR, FAERS, FDA, GVR

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