A recent study shows that around 10% of serious and unexpected drug adverse reactions (SUSARs) miss the FDA’s mandatory 15-day reporting window. What seems even more alarming is that the proportion of late reports are even higher when the patient died!
The analysis, carried out by The University of Minnesota School of Public Health looked at 1.6 million reports to the FDA in the decade to 2014. The researchers examined how many days passed from the time companies were told of serious side effects until they reported the problems to the FDA.
About 91 percent of the non-fatal complications were reported within 15 days, compared with 88 percent of cases involving patient deaths.
SUSARs are subject to Expedited Reporting throughout the world. When drug manufacturers learn of serious complications linked to patient deaths, hospitalizations, disabilities, birth defects or previously unknown side effects, they should always tell the relevant authorities more quickly than for more minor problems.
We have prepared a useful guide to the key points of Expedited Reporting, taken from the first module of Whitehall Training’s 4-part Pharmacovigilance Course – Drug Safety & Reporting.
The key thing to remember is that we all live in the real world – reporting chains can take longer than anticipated and this must be allowed for when considering the 15-day deadline.
Labour-intensive tasks such as verifying the accuracy of adverse event reports must be done within the timeframe of false-negatives could end up causing unnecessary usage restrictions or even withdrawals.
Read the original article here (requires a subscription)...
..and the Reuters story here.
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